VOL. 1, NO. 2/ MARCH 1967

CONSUMER RELATIONS An Interview with Maurine Neuberger

COLOR ADDITIVE CERTIFICATION Clinical Testin Synopsis of the New Drug Regulatioi

FAIR PACKAGING AND LABELING ACT Issues we face

r « ' ( j ~ 2 '-'

"We are carefully to preserve that life which the Author of nature has given us, for it was no idle gift."

Harvey W. Wiley From his commencement address "Life and the Coming Time" Hanover College, 1867

A point has been made that statistics are lack ing on deaths of children under five due to accidental ingestion of aspirin, aspirin-containing and other sali cylate products. There is evidence of 125 deaths in 1964; half of the Nation's poison control centers re ported more than 16,000 cases of accidental ingestion in 1965. Whatever the number, it is a frightening experience for each and every parent. Each case gives the attend ing physician anxious moments. Each statistic im poses an unnecessary burden on the Nation's over taxed health facilities. It is encouraging to note that a united effort to re duce the hazard is now being mounted by leaders of the drug industry in collaboration with distinguished pediatricians. The voluntary packaging and labeling actions agreed to last November (see page 4) are being implemented by drug makers whose representa tives have also had their first meeting with the pedia tricians on safety packaging. FDA is an interested observer of this effort which, it is hoped, will become a precedent for reduction or elimination of other health hazards through volun tary, united industry action in collaboration with medicine, and with the advice and consent of the Government.

FDA Papers / March 1967 / ; C t\ A Thile it is generally accepted that there is VV some minimum number of organisms comprising an infectious dose of Salmonella, this minimum is uncertain and not predictable. The general health of the individual, his resistance to the organism, the manner in which the product is used, and several other variables are involved. We are advised by our medical ex perts that viable Salmonella in a product to be in gested constitutes a potential hazard to health."

Kenneth R. Lennington, Salmonella Project Ingestion oi Officer, to the Drug and Allied Product Guild Workshop, New York, January 25, 1967. Consume] t CT A 7e speak of quality, quality products, and VV quality controls without, at times, ade quately understanding, appreciating, or denning the implication of the word 'quality.' ... I use the word in the sense of 'excellence.' The dictionary defines quality as 'character with re- sped to excellence or grade of excellence,' and quality control as meaning checking and direct ing the degree or grade of excellence of processes and products. It implies to the drug manufac turer that every drug bearing the name of the Clinica firm requires a detailed system of methods, facili ties, and controls covering manufacture, process ing, packing, storage, and distribution in an John W. Gardner is adequately housed and well-equipped plant. It Secretary, U.S. Department of the objective of such operations to produce drugs Health, Education, and Welfare that are safe, effective, and pharmaceutical^ ele James L. Goddard, M.D. Commissioner of Food and Drugs gant. In this sense the good manufacturing prac

Gifford 0. Hampshire / Editor tice regidations state the ground rules which must Sheldon Cohen Art Director be observed for attainment of such excellence.

K. Gardner Perine / Asst. Art Director F.arl I,. Ph.D., Meyers, Bureau of Medicine, to Joan M. Galloway / Managing Editor the Drug Manufaclurers-Repackers-Relabelers Frederick L. Townshend / Production Mgr. Workshop, Austin, Texas, February 22, 1967.

PHOTOGRAPHY: John Crane, 5, 13-20. 28, inside back cover; FDA, inside front cover,

30; George Tames, 9; Magnum, 11. c C TV /fuch of what is now regarded as quackery IVA. stems from a reluctance to discard pro were once but have cedures which accepted FDA PAPERS, the official magazine of the Food and

since been proven to be useless or even danger Drug Administration, is published monthly, except for combined July-August and December-January issues. ous; that is, what was medically and scientifically Subscriptions may be ordered from the Superintend accepted practices 100 or even 50 years ago may, ent of Documents, Government Printing Office, Wash a to a large extent, be regarded as quackery today. ington, D. C. 20402, at $5.50 year ($1.25 additional for foreign mailing). Conversely, some folklore of bygone times has Articles published in FDA PAPERS are In the public do later been found to have a scientific basis." main and text may be republished without permission. Use of funds for printing this publication approved by Harold F. O'Kcefe, Food and Drug Officer, Director of the Bureau of the Budget August 15, 1966. Medicine, to the First National Con

Bureau of gress on Chiropractic, January 13, 1967. Errata

Consent, the last para On page 23, Patient regulation would graph is in error. A proposed of written consent in remove the requirement It is not yet effect.ve. fSBEl Phase 3 investigations. PAPERS days to comment on Interested persons have 30 regulation be 1967 he proposal. Until the proposed VOL 1, NO. 2/ MARCH in the regula comes effective the policy stated continue in force. tion of August 30, 1966 will

Conference on Prevention of Accidental

alicylate Products by Children Report on conference 4 held November 21, 1966, summary of major recommendations, and list of participants.

L0iailOnS An Interview with Maurine Neuberger. The former Senator comments on 9 her new role as Consultant on Consumer Relations to Commissioner Goddard.

Fair Packaging and Labeling Act 12 The issues we face in carrying out the Truth-in-Packaging Law.

Color Additive Certification 17 eSlingsynopsis of the New Drug Regulations. This is an effort to clarify and explain the 21 law in simple, nonlegal language. The regulations govern the testing of new drugs in humans.

Field Reports 26

State Actions 30

Seizures and Prosecutions 31

Notices of Judgment 34

Section 705 [375] of the Food, Drug, and Cosmetic Act. Advisors to the Editor*

(a) The Secretary shall cause to be published from H. Nelson Fitton, Department of Agriculture; Wayne Phillips, Depart time to time reports summarizing all judgments, ment of Housing and Urban Development; Henry B. Montague, Post decrees, and court orders which have been rendered Office Department; James G. Morton, Department Commerce; Dr. charge of under this Act, including the nature of the and John L. Buckley, Department of the Interior; Dr. Sam Kaim, Veterans the disposition thereof. Administration; Dr. Peter V. Siegel, Federal Aviation Agency; Dr. Spofford English, The Secretary may also cause to be disseminated G. United States Atomic Energy Commission; Dr. (b) Carlson, Lewis, information regarding food, drugs, devices, or cos Harve J. National Science Foundation; Howard J. metics in situations involving, in the opinion of the National Academy of Sciences; J. Stewart Hunter, Public Health Secretary, imminent danger to health, or gross decep Service. tion of the consumer. Nothing in this section shall be "The Food and Drug Administration is solely responsible for the construed to prohibit the Secretary from collecting, contents of FDA PAPERS. The Advisors to the Editor are consul reporting, and illustrating the results of the investiga tants on matters relating to the functions of the Federal Depart tions of the Department. ments and Agencies listed.

FDA Papers / March 1967 I 3 Top industry leaders, distinguished physicians, and FDA officials gathered for a unique conference last November 21 in Washington. It was unique because: (l) they had specific problems to discuss and resolve, and (2) they were motivated by the suggestion of a congressional committee. The subject was: prevention of accidental ingestion

the background were several noted that "industry representa this conference," said Dr. Goddard, Inpoints considered by the Sub tives indicated a willingness ... to "and if the problem could not be committee on Public Health and abide by recommendations for fur solved on a voluntary basis that Welfare of the House Committee ther limiting the quantity of chil they would be willing then to en on Interstate and Foreign Com dren's aspirin in a retail container tertain legislation at a future date." merce during its autumn hearings if a new advisory panel . . . con Early in the meeting the group on the Child Safety Act of 1966: cluded that such a limitation reviewed the size of the individual each day U.S. industry manufac would reduce serious illness and children's aspirin tablet, which for death. . . ." tures 25 tons of aspirin; during many years has been generally 1965 over 16,000 children under 5 The House Committee's sugges standardized at 1% grains. Dr. tion led to the conference years of age accidentally ingested 1-day Edward Press offered a motion that aspirin and other salicylates; more sponsored by FDA and attended by the group agree to "stick with lhi- makers, than 10,000 cases involved fla drug physicians, public grain tablets for flavored children's vored "children's" aspirin; while health specialists, and FDA officials. aspirin." 125 deaths due to aspirin and Commissioner James L. God- Dr. Press's motion to limit the other salicylates were reported in dard, M.D., was host to the group size of flavored aspirin tablets to 1964, accurate records of deaths and Dr. Harry Shirkey from the the IVi -grain size was adopted. due to "children's" and "adult" Committee on Drugs of the Amer The group further adopted a reso aspirin are not available. ican Academy of Pediatrics, and lution that "we are opposed to The committee had considered Director of The Children's Hos prohibiting the manufacture of further limitation of the 50-tablet pital of Birmingham, served as flavored aspirin." bottle of children's aspirin. It was chairman. In opening the meeting Irving Sunshine, Ph.D., Cuya noted that this limitation followed Dr. Goddard stated that the first hoga County, Ohio Coroner's Of the recommendation of an FDA and major agenda item was how to fice, pointed out that vital statistics medical-industry advisory panel in accomplish the fact of limitation of records are inadequate— that they 1955. Another primary considera total grainage of aspirin in a retail do not usually show whether chil tion was safety packaging of chil package. "Congress suggested in a dren die from eating too many dren's aspirin. The committee very direct fashion that we hold children's aspirin or adult aspirin,

4 I March 1967 / FDA Papers of salicylate products ings due to aspirin, other salicy lates, and other substances; on incidence of accidental ingestion due to various salicylate products; by children and factors involved in poisoning, such as therapeutic overdosage, and it is important to recognize tional Office of Vital Statistics be storage, repeater problem. this. He said, "We are in igno formally requested to attempt to He pointed out that a surprising rance here and we should some deliberately gather additional fac proportion of children involved in where along the line try to get tual information ... on the cases accidental poisonings are repeaters some knowledge." Dr. Shirkey of salicylate deaths, particularly in —among reports of 700 children the added: "We have spoken glibly children under five where the pre percentage of repeaters ran as high about this . . . and we have ac sumption of accident is much as 28 percent. Also salicylate cepted data and used terminology higher . . . ." poisoning due to therapeutic over rather loosely." Henry L. Verhulst said that 341 dosage, through error on the part Dr. Maurice L. Tainter said, poison centers— a little more than of parents or medical personnel, "May I point out in the 125 deaths half of those in the Nation— re was noted to be significant. In sev (of children under 5 in 1964) there ported that 16,328 children in eral studies from the literature this are only 4 specifically stated to be gested aspirin during 1965. He averaged 39 percent, and in the from baby aspirin. There were, also said that data on fatalities 125 deaths in children under 5 however, 56 cases where the kind of showed a minimum dosage of 31 years occurring in 1964, according aspirin was not specified. And un grains taken by a 16-month-old to Dr. Tainter, there were 17 cases der the head of 'Other Salicylates' child. "That was the minimum," of therapeutic overdosage. there were 47 deaths . . . where he said, "most of them (fatalities) Dr. Tainter pointed out other there was no further indication of involved 50 or 60 grains." characteristics seen in childhood what the nature of it was or Dr. Tainter reviewed data from poisonings. In 2/3 of the cases in whether it was an aspirin or some the medical literature on mortality one study the tablets or bottles other salicylate. . . ." in preschool children from all were not in their usual place; 13 Dr. Press proposed that "the Na causes, home accidents, and poison percent of the children found as-

FDA Papers / March 1967 I 5 pirin on the ground; 25 percent treated early, developed moderate the absence of death as the end and 32 percent found the bottle intoxication when taking more point we ought to be striving for. on an open shelf. The figures than 45 (1% grain) tablets. Dr. ... I would suggest from these data varied in different studies. Dr. Done said, "We were surprised to at least, that the allowable number Tainter said that parental careless find no severe cases among the chil of children's aspirin (1^4 grain) ness certainly is involved in such dren who took children's aspirin per bottle be about 35 or 36. cases. ... all of our severe cases . . . took "Of these 500 cases, 13 percent In an attempt to determine the the adult (5 grain) variety instead. involved adults' and 87 percent minimum lethal dose, he cited lit The question of how many chil children's tablets .... I think these erature cases reporting age and dren's aspirin would seem ... to data indicate clearly as far as these dosage wherein 85-90 grains ap be safe in a single container de 500 cases go . . . that the adult as peared to be the minimum fatal pends upon the severity of poison pirin is certainly more dangerous dose. On the other hand, applying ing that one is willing to accept. I in individual cases and that what the figure of 140 grains as being personally am not willing to accept ever danger is entailed in the en- the toxic dose of aspirin for an adult—the comparable toxic dose for a 2-year-old of 12.4-kg. body Summary FDA weight would be 47 grains or 38 of Conference on Prevention Accidental Ingestion 1*4 -grain tablets. of Salicylate Products by Children Dr. Press of presented statistics on Arlington, Virginia accidental ingestion of from aspirin 21 November 1966 Poison Control Centers of down- Free, open, and vigorous, but cooperative discussion was entered state Illinois and Chicago for 1965. into by the practicing and teaching representatives of medicine, In downstate Illinois there were members from industry, and members of F.D.A. The discussion 3,653 cases of aspirin ingestion, of covered all salicylate-containing products packaged for retail sale which 2,967 were from children's to the public. aspirin, 408 from adult aspirin, and Only some points were determined after motion and voting 278 not specified as to children's or and are identified (V). Many points were gained by consensus. adult. In Chicago there were 1,590 It was understood from the representatives of industry that they cases of aspirin ingestion, of which could assure 100% cooperation by the packagers and dispensers 1,184 were specified as children's of aspirin-containing products for over-the-counter sales in im aspirin, 70 as adult aspirin, and plementing decisions made by this group. 336 unspecified. In 1,712 cases in The significant decisions were these: volving children's aspirin where in (V) (1) The smaller aspirin tablets, often referred to as "chil formation was available concerning dren's aspirin" tablets, shall continue as gr. M in size. amount taken, 970 took 25 tablets (V) (2) The group was opposed to prohibiting the flavoring of or more. Of 35 deaths due to "children's aspirin." aspirin over the last 5 years in (3) It was against flavoring 5 grain aspirin tablets Chicago, nine were ascribed to chil- ("adult aspirin tablets"). drens' aspirin and four of these (4) The maximum number of gr. IX tablets permitted were due to therapeutic overdosage. for a retail container would be 36. Dr. Alan K. Done presented a (5) Manufacturers would not ship out retail packages con of 500 of the most study recent taining a number more than 36 tablets after June 1, consecutive cases of aspirin inges 1967. Dr. Goddard assured all that the present bottle tion at the appearing University of size (to contain less tablets) would be permitted. Utah Teaching Hospital over a 2- (6) It was recognized that an ideal safety closure would be year period. The study included desirable for aspirin and all drugs if possible (O.T.C. only children under 5 years of age, and prescription). Previous and continuing efforts in and only children for which in producing safety closures were recognized. A committee formation was available as to was appointed to make a continuing study of improved whether they took children's or safety closures for "children's" and "adult" aspirin-con adult aspirin. He said that many taining tablets. Members: Dr. Edward Press, Chairman, of these children took up to 50 Dr. Jay M. Arena, A member from Glass Container In tablets (IV* grain) and had no dustry, A member from Sterling Drug, Inc., A member symptoms; however, all but one from Plough, Inc., A member from Bristol-Myers Co., A Guild, were treated within 4 hours. member from Drug and Allied Products A mem Another group of youngsters not

6 I March 1967 / FDA Papers ticement brought about by the those who took children's aspirin. of 1%-grain flavored children's as flavoring of children's aspirin He suggested that it might be ad pirin to 36 in retail packages. The would appear to be more than visable to warn parents of the dan group also agreed to make special over-weighed ... by the smaller gers of relatively small numbers of efforts to disseminate information dose in the pills ... I think I would adult aspirin. "It was quite appar so that small manufacturers or be forced to conclude . . . that it ent from these data the people manufacturers of the future would would be irrational to exclude whose children took 4 aspirin have no difficulty in discovering the adult aspirin and other salicylates weren't nearly as scared as those recommended limitations. Indus from any safety campaign that is whose children took 40 aspirin, ir try representatives agreed that 36- aimed at children's aspirin." respective of the children's variety tablet bottles could be on the Dr. Done said they were sur or the adult variety." market by June 1, 1967. In order prised to find that parents whose After Dr. Done's presentation to insure meeting this deadline, the children took adult aspirin tended and the ensuing discussion, the FDA agreed to permit use of the to come into the hospital later than group voted to limit the number same size bottle which previously held 50 tablets. It was also agreed that this would permit use of same- size labels to bear appropriate ber from Whitehall Laboratories. A strong feeling was warnings. in attention to the closure expressed favor of safety fea The participants then explored ture strip packaging. of problems associated with safety was reached all (7) Agreement for labeling aspirin

FDA Papers / March 1967 I 7 products. At the suggestion of Dr. In considering other safety meas police force. However, the group Edward Press, the recommendation ures to prevent injury or death, it did not act upon this suggestion. for safety packaging was extended was urged that medical directors Dr. Shirkey strongly suggested to include prescription drugs. How carefully review advertising. Dr. that this group, or a similarly con ever, it was pointed out by William Arena said, "I think that the in stituted one, be reconvened at a M. Bristol, III, that the packaging dustry certainly does know the later date to discuss the progress problems for OTC products are value of television for selling their and problems associated with as separate from those for prescription products and they can certainly use pirin-containing products. drugs. Dr. Press and Dr. Shirkey this media for selling safety for In concluding the meeting, Dr. agreed that this would necessarily their products. . . ." Industry's Goddard called the seminar "con entail a campaign to the retail efforts in education of the public structive" and said that the FDA druggist and the pharmaceutical through the Council on Family would maintain surveillance. He drug industry. Health were recognized. expressed optimism "that we will Near the conclusion of the meet make additional progress in the ing, Dr. Samuel C. Southard, past months and, hopefully, the years xV.ll major manufacturers at the chairman of the Committee on Ac ahead." In commenting on Dr. meeting agreed to a new warning cident Prevention, American Acad Southard's suggestion, he said, "I label soon to be on all aspirin bot emy of Pediatrics, called for a recognize the point that was tles: "Warning: Keep this and all self-regulatory mechanism within brought up. There is need for con medicines out of children's reach." the industry. This organization tinued surveillance because new The label also recommends in case would follow up recommendations ideas crop up from time to time, of accidental overdose a physician of the study group and in a sense and I, too, have the feeling that in should be contacted immediately. would be the manufacturers' own dustry should take the initiative."

PARTICIPANTS

Harry Cameron Shirkey, M.D. Samuel C. Southard, M.D. Mr. Don Hamilton Director, The Children's Hospital of Past Chairman, Committee on Accident Rexall Products Birmingham Prevention University of Alabama Medical College American Academy of Pediatrics Mr. John L. Harvey Drug & Allied Products Guild Allan B. Coleman, M.D. Irving Sunshine, Ph.D. Mr. Fred B. Kienzle, President Chairman, Subcommittee on Accidental President, American Association of Poison Dr. K. R. Ravel Poisoning Control Centers American Academy of Pediatrics McKesson Laboratories Mr. Harry B. Solmson, Vice President Jay M. Arena, M.D Dr. Laurence Marks Mr. Charles Sullivan Director, Poison Control Center E. R. Squibb & Sons Plough, Inc. Duke University Hospital Dr. Robert S. Warner Dr. Tainter, Marjorie E. Conrad, M.D. Maurice L. Vice President Wyeth Laboratories Mr. James Luther American Academy of General Practice Wolcott, Dr. Audrey J. Jongbloed Dr. George L. Medical Director Consumer Products Division Alan Kimball Done, M.D. Sterling Drug, Inc. American Cyanamid Co. Associate Professor of Pediatrics Mr. L. F. Bonham, President Director, Poison Information and Therapy Mr. Richard Fisher Mr. Robert Becker Center Director of Public Affairs Norwich Pharmacal Co. University of Utah Medical Center Glass Container Manufacturers Institute

Mr. John Culligan, President William Kitto, M.D. Mr. Forest L. Neal Dr. John Shaul Associate Director The Garrett Corp. Mr. Marston Blunt Department of Drugs Whitehall Laboratories James L. Goddard, M.D. American Medical Association Commissioner of Food and Drugs Mr. William M. Bristol, III, Group Vice Edward Press, M.D. Basil G. Delta, M.D. Chairman, President Subcommittee on Safety Closures Mr. Gifford D. Hampshire Mr. J. Richard Edmondson, Assistant American Academy of Pediatrics Judith Ditsborough Illinois Secretary Department of Public Health Mr. Frederick J. Delmore Dr. Peter D. Orahovats, Vice President Mr. Donald Early Clarence E. Rozgay, M.D. Bristol-Myers Co. Food and Drug Administration Director, Poison Control Information Center Seattle Children's Orthopedic Hospital Mr. George W. Cain, Chairman and President Mr. Henry L Verhulst Medical Center Abbott Laboratories Public Health Service

8 I March 1967 / FDA Papers an interview with Maurine Neuberger

Senator Maurine B. Neuberger became Con The former Senator has published numerous articles Formersultant on Consumer Relations to the Commis in national magazines on consumer affairs and on na sioner of Food and Drugs on January 6, 1967. Mrs. tional health care and welfare. She is the author of Neuberger will advise the Commissioner on broad- the book, Smoke Screen: Tobacco and the Public Wel scale programs and policies in various areas of con fare, published in 1964. sumer needs. Mrs. Neuberger's first action as consultant was a in San Francisco with The widow of Senator Richard L. Neuberger, she program-planning session eight FDA consumer was elected in 1960 to fill out his unexpired term and specialists. She made her first in her new to serve a full 6-year term, which ended January 3, public appearance FDA role as the at the Annual Con 1967. keynote speaker vention of the Association of California Consumers in During her years in the Senate, Mrs. Neuberger took San Francisco on February 11. an active interest in the protection of the American consumer and in the activities of the Food and Drug Mrs. Neuberger, after serving 6 years in Wash Administration. Q. ington, how do you feel about being just a consumer Senator Neuberger served on the Senate's Special again? Committee on Aging, including its Subcommittees on Fraud and Health and Joint Subcommittee on Long- A. It has been a tremendously rewarding experience Term Care, and the Committee on Commerce. to have served in the U.S. Senate, and I must say it

FDA Papers / March 1967 / 9 was with some regret that I bade my colleagues goodby. Q. In that sense would you say that the consumer has However, I would like to emphasize that there is no an obligation to himself to be informed in order to be such thing as being "just a consumer." I always felt protected in the marketplace? that I was a consumer at the same time I was a Senator, am a now in new home in Massa and I consumer my A. The consumer does have that obligation but I chusetts. We must remember that the consumer is don't believe that he is always aware of it. He has to in our the fundamental agent expanding economy. be reminded of it continually. As you know, I've been of and services and the rate at The purchase goods associated with many issues in the area of health that which those purchases are made determines the kind really demanded of the consumer that he keep himself of economy we are going to have and the kind of informed, such as the relationship between cigarette standard of we are to have, so the living going ques smoking and lung cancer, the effects of fluorides in tion of being a consumer" is really not the "just proper preventing caries, and the place of supplements in diet. way of looking at it.

Senator, you have served on the Senate Subcom President in his state the Union Q. Q. Johnson of mittee on Frauds and Deceptions Affecting the Elderly. said, "The 88th and 89th enacted message Congresses What are your views on FDA relations with the aging? more social and economic legislation than any two Congresses in our history. But all of this legislation A. In the FDA you will find a number of responsibil will come to nothing unless it reaches the people." I ities which I think are directly related to the elderly. wonder how you react to that statement and what For example, I think the FDA program on insuring comments you might want to make. the quality and integrity of drugs in the marketplace is of prime interest to our elderly citizens. They now A. The President is quite right. As a participant in have vastly improved medical programs at their service those two Congresses, I still recall with a thrill the and are encouraged to use many of the newer thera work of our committees and the tremendous effort put peutic agents, as well as the old standbys. The second forth by the Administrative Branch. I must say that thing is a wholesome food supply. In addition, there the of this effective rests problem making legislation must be assurance that commodities are marketed, not solely with the Federal or State or local govern packaged, and labeled so that the buyer can determine ments. It does rest with all elements of our society what is the best value. Within a limited income there concerned with the health and well-being of all Ameri is a tremendous variety of food stuffs available. cans. I'm thinking, for example, of our physicians and Third, it is the FDA which protects the elderly from of our pharmacists, our dentists, our nurses, and other frauds and deceptions. For instance— FDA's campaign I'm of our in professional personnel. thinking great in combating device and nutritional quackery. Dr. dustries, such as foods, cosmetics and pharmaceuticals, Goddard has said that this campaign will be main those who other non-governmental groups work coop tained and strengthened. eratively with governmental agencies. These groups share the task of implementing the legislation passed Q. Mrs. Neuberger, during hearings by your Senate by the 88th and 89th Congresses. committee, representatives of the food, drug, and cos metic industries testified that there was a direct rela Q. How would you describe your job as Consultant tionship between the success of products in the on Consumer Relations? marketplace and the satisfaction of the consumer. Would you comment on this in light of the Fair Pack A. It was made clear in conversations between Dr. aging and Labeling Act? Coddard and me that I would not speak for the FDA. I would speak for the consumer to the FDA. The A. There is some merit to the argument that every establishment of this precedent is a very good one for time a consumer buys a product he is casting a vote for the Food and Drug Administration and I'm very that product. However, the Fair Packaging and proud to have the privilege of exploring this new kind Labeling legislation was enacted to make sure that the of activity. I will advise the Commissioner on matters consumer was able to cast an informed vote. of consumer needs as I see them; I'll bring them to his attention. They may or may not always be relevant Q. Mrs. Neuberger, your assignment to the FDA is to the kinds of responsibilities the FDA has to carry part-time, what other public activities will you carry out, but I see myself as the voice of the consumer at on? the highest administrative level of the FDA. It is with this understanding that I took the position and A. I am National Chairman of the Advisory Council it's with this understanding that I'm looking forward on the Status of Women and will continue to serve in to carrying it out. that capacity at the same time as I work for the FDA.

10 I March 1967 / FDA Papers This new FDA publication deals with the "generation gap" and the abuse of drugs by adolescents for runningawayness. Its " message: Escape through excessive use of drugs is a pathological response to social and economic pressures, physical, and emotional pains There are now legal controls over certain stimulants, sedatives, and hallucinogenic drugs, and there must be effective enforcement of the law. But there must also be education and psychological " understanding

Runningawayness, FDA Publication No. 38, will be published soon. Order from the Superintendent of Documents, U. S. Government Printing Office, Washington, D. C. 20402; price will be announced later. the issues we face in carrying out the fair packaging and labeling act

by William W. Goodrich

measures have promised so column headlines that help is com Here is a brief summary of what Fewmuch as the Fair Packaging and ing to the shopper; that she can is in this new law and how we are Labeling Act. It is popularly known say goodby to the "Jumbo-Pound" directed to proceed: as the Truth-in-Packaging Law. and the "Giant Quart"; that slack- First, there are mandatory pro The consuming public has high ex fill practices are soon to be elimi visions for agency regulations. pectations that, because of it, better nated; and that "cents-off" sales We are directed to require- That the label identify the product packaging and more informative soon will be stringently regulated. and give the name and address of Our goals are thus defined; and labeling will appear in the very its manufacturer, packer, or dis near future—about July 1, 1967. for those of us who must mold the tributor; The President, in signing this regulations to fulfill the promise of That the net quantity of contents law, bill, said that it would help the this new and satisfy the rea be separately and accurately placed sonable at a uniform location on the prin housewife save money; that it expectations of the pur cipal display panel; and would target labels that lie and chasing public, busy days lie just That any label which says anything confuse; ahead. packages that that it about servings, also says how much time for would restore truth in the market The talking generalities is in each serving. is over, and we must now begin place. The new law, he said, is to Since the existing law for food, to deal with the specifics of labeling tell the consumer exactly what is drugs, and cosmetics has long re and packaging reform. in the package, who made it, how quired the name of the product, While the bill was strongly sup much it contains, and how much it and the name and address of its ported in the Congress by consumer costs in comparison with competi manufacturer, packer, or distribu interests, and just as strongly tive packages. And, he said, it will op tor, we should focus our attention posed by the regulated industries, eliminate the need for a slide rule here on the quantity of contents it emerged from the House Com as a shopping aid, free the con provisions. These will require a mittee hearings with unanimous sumer from uncertainty in making basic overhaul of essentially all support, and it passed both Houses buying choices, and protect her existing labels. And while this is of the Congress with hardly a from being shortchanged by a taking place, we should give atten dissenting vote. slack-filled box. tion to all required label informa Thus, everyone apparently wants The January issue of Changing tion—whether called for by this new labeling and packaging changes as Times that new law or by existing law. magazine reports soon as possible. The quantity of contents state government measures are about We now face the test as to ment will have to have several new ready for announcement, with the whether the called for regulations features: result that package labels for foods, by the bill can be swiftly devised It must be a distinct part of the drugs, and cosmetics will soon be effect, and placed into or whether principal display panel; easier to read and will tell you protracted procedural delays will For many packages, it must contain more. "The Months Ahead" block early implementation. a dual statement of total ounces,

12 I March 1967 / FDA Papers *l ^ and pounds and ounces or quarts, pints, and ounces, identified as avoirdupois or fluid ounces, to gether with fractional ounces in common or decimal fractions; It must be conspicuous, easily legible, and in distinct contrast with other matter on the label; Its type size must bear a fixed rela tionship to the area of the principal display panel; The declaration must be in uniform type size for all packages of sub stantially the same size; and The declaration must be generally parallel to the base of the package as it is to be displayed. This is saying a lot. In a sen tence, it means that the quantity of contents statement must become an important design feature of the principal part of the label. We must decide where it shall appear— at the top left of the label, the top right, top center, im mediately above or below the most prominent feature of the label, or at some other uniform place. We must decide how large the print will have to be, and how the required conspicuousness, legibil ity, and contrast are to be achieved. And we must have uniformity in type size for all packages of essen tially the same size, even though they may have different sized labels. Foods, drugs, and cosmetics al ready bear net contents statements,

FDA Papers / March 1967 / 13 but now one must search several tor, or the serving information, deception or to facilitate value com label panels to find them. And required by the new law, or the parisons, regulations are to be pre even where voluntary improve ingredient information called for scribed- ments have been made to meet by existing law, also belong on the Establishing standards for "large," and "small," and "economy" sizes rising criticism, front panel place front of the package? If not, where of packages; ment, uniformity, and improved does it go, and what considerations Regulating, but not prohibiting, contrast will no doubt call for yet of prominence, conspicuousness, "cents-off" and other bargain pro another change. type size, and contrast will control? motions; Can, should, be and exemptions Requiring additional ingredient in of contents l\ s an example of what might be made for quantity formation on drugs and cosmetics, required, we may look to the label declarations for small packages? without divulging trade secrets; and ing requirements for hazardous When do we call for weight Preventing nonfunctional slack-fill. substances. Our regulations call declarations, as against a declara Of all this, perhaps the most for the signal word and the state tion by numerical count? When urgent are the controls over "cents- ment of principal hazard to be do we require avoirdupois ounces off" promotions and slack -filling. placed on the principal panel, dis and when fluid ounces? And perhaps the most controversial tinctly apart from other wording What additional supplemental will be ingredient labeling for or designs, and for prominence to statements as to quantity of con cosmetics. be achieved by placement within tents will be permitted elsewhere Only recently, representatives of the borders of a square or rectangle, on the label? As for example, that a large coffee distributor called on with or without a border line. We the product makes one pint, or a us to urge prompt action on "cents- require suitable contrasts of back three-layer cake? off" promotions. According to these ground, achieved by distinctive Are express prohibitions required representatives, their company had typography or color or both. We to eliminate the "giant quart"? stopped the practice at the time of specify the minimum point size for These are illustrative of our the recent Federal Trade Commis type, antl we require a reasonable problems in taking the first step in sion investigation, only to see an relationship with other label type the long journey to satisfy the immediate loss of business to com on the front panel. promise of the new law. petitors who did not stop. In short, These are some of the possibili But this is not all. they contended that this kind of ties for the net contents statements. We are authorized to make some competition was essential to sur What of other mandatory label exemptions from full compliance vival, so long as any important ing declarations required by the with the law to the extent that such competitors were allowed to use it. newly enacted law and by existing compliance is impracticable or un The Congress recognized, as did law? necessary, and to impose conditions we all, that most Americans are Does the name and address of the on such exemptions. bargain hunters. And the job set manufacturer, packer, or distribu Whenever necessary to prevent before us is to see that the promise

14 I March 1967 / FDA Papers of reduced price is not an illusory All of this requires an oversight parisons. And the bill provided one; to see that, insofar as possible, of pricing practices, which is an that such standards should not pre any offer of "cents-off" is actually entirely new function for the FDA. clude the use of packages custom delivered to the consumer. Indeed, in our most extensive in arily used for related products The guidelines we have are spection authority— that over the of varying densities, except to the found in the House Committee re marketing of prescription drugs— extent that continued use was likely port. We are told that the regula we are not allowed access to "pric to deceive. tions may, for example, require a ing data." But we will have to These standardization provisions showing by the manufacturer that examine pricing practices to carry —even though largely voluntary the wholesale price has been re out the obligation to make "cents- under that bill— were the rallying duced enough to permit retailers off" offers real price reductions. points for industry opposition. And to pass the "cents-off" saving on to their elimination by the House the consumer. The regulations Committee in favor of completely may limit the duration and the CI on trolling slack-filled packages voluntary actions to eliminate con frequency of such promotions, and has, thus far, been a difficult opera fusing package sizes opened the they may fix the maximum per tion for FDA. Operating under a way to the final enactment of the centage of the annual output that law that declares misbranded any measure. may be marketed with "cents-off" package so made, formed, or filled The House bill, H.R. 15440, labeling. as to be misleading, FDA has been contained authority to prevent the notably unsuccessful in the courts. distribution of packages of sizes, About all our efforts have yielded shapes, or dimensions likely to de is a rule of decision to the effect ceive consumers. that a person using a package too This provision was not support big for its contents may justify this ed by administration proponents. apparent deception by proving that Nonetheless, the House Committee it is necessary to safeguard the retained a slightly modified slack- product and that no less deceptive, fill provision. The agencies were alternative method of packing is authorized to prevent nonfunc available. tional slack-filling of packages- S. 985, the Senate-passed bill, did defined as filling the packages to not contain authority to prohibit less than capacity for reasons other slack -filling. Instead, it provided than the necessities of protecting William W. Goodrich, Assistant General for standardization when the contents, or the Counsel, Food & Drug Division, U.S. De package requirements partment of Health, Education, & Welfare, proliferation of package sizes was of machine filling. So the agencies presented this paper on January 24, 1967 likely to impair the consumer's have authority to prevent such to the New York State Bar Association. ability to make price-per-unil com practices as the use of false bottoms

FDA Papers / March 1967 I H or unnecessarily bulky packaging adopted through the elaborate changes, the difficulties involved in material. public procedures for formal rule redesigning packages, and that the The House Committee report is making found in the Federal Food, new requirements will interfere wholly consistent with the judicial Drug, and Cosmetic Act. with established brand labeling. rule that the burden will be upon They begin with a notice of One need look no further than the user of a package that is too proposed rule-making. After com existing packages to see that there large for its contents to justify its ments are received, the rules are is no consensus about how or where use. adopted. Then objections by any to present the net contents declara Much has been said about the person who will be adversely af tion. And the same is true as to label declaration of ingredients for fected may stay the effectiveness most of the other issues that must cosmetics. The original Hart bill of the rules and precipitate a public be solved before this new law can contained provisions which would hearing on the objections. After have its intended effect. have required label declaration of the hearing, a decision is to be But the public is expecting sub composition for consumer commod made on the record, and it is sub stantial changes— for the better. It ities in general. As passed by the ject to judicial review in the United expects these changes to show up Senate, the bill called for regula States Courts of Appeals. about July 1, 1967. tions to require, consistent with We plan to announce very soon the requirements of the Federal JL hese hearing procedures and the initial draft of regulations deal Food, Drug, and Cosmetic Act, the opportunity for judicial review ing with the mandatory aspects of composition information other assure protection to the rights of the new law— net weight, name of than proprietary trade secrets. It manufacturers, packers, and dis commodity, name and address of was argued that this excluded the tributors of consumer commodities. the manufacturer, packer, or dis authority to require label declara But they also have an important tributor, and labeling as to servings. tion of cosmetic ingredients because bearing on how promptly the We hope to obtain a cross-section the Federal Food, Drug, and Cos public can expect to benefit from of views on which acceptable reg metic Act did not require it. But, improved labeling and packaging ulations can be promulgated and again, the House Committee made practices. Hearings and review on placed into effect by or shortly its intentions clear— that cosmetic the net weight regulations alone after July 1. ingredient information 'could and could cause protracted delays. There is much to be done, and should be required to assist the There will, no doubt, be very we must work together if the needs consumer in making value compari good arguments why the net weight of manufacturers and consumers sons. statement should not be at the top are to be reconciled within a rea But nothing in this entire law of the front panel, at the bottom, sonable time. can take effect until regulations are on the right, or on the left. Labelers We will have to have the full first promulgated. can undoubtedly show the costs cooperation of the affected indus And these regulations are to be involved in making labeling tries to meet this deadline.

16 I March 1967 / FDA Papers 1000 Kirux

color additive certification The Color Additive Amendments of 1960 provides that all color additives must be listed before they can be used in foods, drugs, or cosmetics. In order to be listed, proponents of the listing must produce convincing evidence that the color additive is safe for its intended use. Under the Act, the Commissioner is empowered to require batch certifi cation of color additives, or to exempt color additives from the certification requirement. FDA's color certification program is devoted primarily to the chemical examination of representative samples of each batch of color ad ditives subject to certification. At the time of listing, specifications are established for each color. If laboratory examination shows that the speci fications are met, a certificate is issued; if not, a certificate is denied. Research is conducted to develop methods where needed and to improve existing ones. Research is also conducted on many facets of color additive chemistry. For example, do reactions occur when a color additive is used in a food, drug, or cosmetic; and if reactions do occur, what products are formed? Approximately 1,700 samples representing 3.5 million pounds of color additives are examined each year by scientists in FDA's laboratories. . i I

4 A wide range of chemical and physical procedures are used in the certification program. They range from simple weighing, through complex chromatographic and X-ray techniques. Column chromatography (above) separates colors for identification and determination of the amount of each. Pure dye determination (left) is accomplished by titration using titanium trichloride, (lo.ver left) Separation of intermediates by column chromatography for analysis by ultraviolet spectrophotometer. Potentiometric titrimeter (upper left) is used to determine salt content of a batch of color. Samples are prepared (upper right) and diluted. Heavy metals, such as lead and arsenic, which may be present in batches of color are detected (left) by X-ray fluorescence. Colored disks, foreground, are subjected to X-rays. Instrument, back ground, counts metal atoms in parts per million. Lipstick colors (below) are identified on thin-layer chromato graphic plate under ultra violet light. Bottom line, drawn by lipstick, produces lines of colors in mixture. This sample shows mixture of five colors. Each can be identified and checked for certification. Clinical Testing Synopsis of the New Drug Regulations

1962 amendments to the Federal Food, Drug, The IND is usually required to include, among Theand Cosmetic Act strengthen the regulatory au other things, the following information: thority of the Government over clinical testing of new- a) Complete composition of the drug, its source, and information, drugs in order to minimize hazards inherent in new manufacturing adequate to show that drug development and to assure a responsible concern appropriate standards exist to insure safety. for the well-being of human subjects. Furthermore, b) Results of all preclinical investigations, including the new regulations establish a strong basis for pro animal studies. Initially, these should be directed to motion of improved methods and evaluation of stand ward defining its safety, rather than its efficacy. The ards in investigation of new drugs. data must demonstrate that there will not be unrea sonable hazard in initiating studies in human beings. This synopsis outlines the physician's responsibil Further animal studies may be conducted concurrently ities, under the Act, to the patients, to the pharma with clinical studies. The Bureau of Medicine will, on ceutical company, and to the Food and Drug request, comment on the adequacy of proposed animal Administration. studies. The FDA generally requires as a minimum that acute toxicity be determined in two species of animals, that results of administration of the drug for Definition of a New Drug two to four weeks be observed in at least two species, A new drug cannot be distributed interstate for use in and that the route of administration be that which man, without approval by the Food and Drug Ad will be used in the human trials. Additional animal ministration. An exemption is required to permit studies are frequently necessary. clinical investigation. c) A description of the investigations to be under Unless a drug is generally recognized by qualified ex taken. perts as being safe and effective for the use proposed, d) Information regarding training and experience of the it must be regarded as a "new drug." If there is uncer investigators. (See "Qualifications of Investigators" are tainty, the FDA will furnish its judgment on request. below.) Investigators responsible to the sponsor and are required to submit, to the sponsor (not the A drug may be "new" without necessarily being a FDA) , either Form FD 1572 for clinical pharmacology new substance. For example, if aspirin tablets were or Form FD 1573 for clinical trial. labeled or promoted as a seasickness remedy, they e) Copies of all informational material supplied to would be considered a "new drug." Even an accepted each investigator. (The type of information is listed remedy, used for years, if manufactured in a new form, in Form FD 1571.) such as a timed-release capsule, is considered to be a f) An agreement from the sponsor to notify the FDA new drug requiring evaluation by the FDA. Clinical and all investigators if any adverse effects arise during investigation may be required to show that the active either the animal or human tests. substance is released in a slow and sustained manner, g) Certification that "informed consent" will be ob and that the capsule is safe and effective as claimed. tained from the subjects or patients to whom the drug will be given. Agreement to submit First Steps in the Assessment of a New Drug: "IND" h) annual progress reports. Before a new drug may be tested on human beings, the "sponsor" (usually a pharmaceutical firm, some Physician-Sponsored IND times an investigator) must supply to the FDA the When an investigator wishes to act as sponsor for the information specified as a "Notice of Claimed Investi use of a drug solely as a research tool or for early gational Exemption for a New Drug" (Form FD clinical investigation of a drug of therapeutic or diag 1571), known as an "IND." Copies of these IND nostic potential (clinical pharmacology— phases 1 and forms are contained in the Investigational Drug Reg 2) a simpler abbreviated form of submission is ac ulations, which may be obtained on request. ceptable. An example would be the study of a drug

FDA Papers / March 1967 / 21 that no manufacturer is interested in sponsoring. An ministration, and safe dosage range. Such studies in outline of such a study should provide the following volve a comparatively small number of subjects and information: are ordinarily conducted under carefully controlled 1. The identity of the compound or compounds, to circumstances by persons with training in clinical gether with the facts that satisfy the investigator that pharmacology. The proposed clinical plan may allow the agent may be justifiably administered to man as considerable flexibility. intended. When phase 1 demonstrates satisfactory results, the 2. The purpose of the use and the general protocol. sponsor may proceed to phase 2: initial trials in the 3. Appropriate background information, including a treatment or prevention of the disease for which the brief statement of the investigator's scientific training drug is intended, in which the drug is administered to and experience and the nature of the facilities avail carefully supervised patients to determine safety and able to him. effectiveness. Additional pharmacologic studies, per formed concurrently in animals, may be necessary to indicate safety for the phase 2 extension of the in vestigation.

X he FDA is always willing to consider reasonable amendments to clinical plans and to discuss with sponsors the value of proposed studies. Of course, a plan of investigation may be revised during its course, but in each such instance the FDA must be notified. Finally, if the data obtained in phases 1 and 2 pro vide reasonable assurance of safety and effectiveness or suggest that the drug may have a potential value outweighing its hazards, proposals for phase 3, or ex tensive clinical trials, are in order. Phase 3 may, where practical, involve, in addition to work by experienced investigators, well-controlled studies by other groups including practicing physicians whose training and experience in drug evaluation has been less, and whose facilities may not be so elaborate. The studies should be carefully monitored, no matter how extensive. The regulations are designed to prevent exposure to risk of an unnecessarily large number of patients by re The physician sponsoring this form of IND deals quiring assurance of safety based on earlier studies. directly with the FDA and is responsible for com Once an IND has been submitted, the investigation pliance with the procedures set forth in this synopsis. may then proceed, unless the FDA presents an objec tion. If there appears to be an unwarranted hazard in Phases of Clinical Investigation the continuation of the ongoing clinical studies, the The first two phases are described as clinical pharma sponsor may be requested to modify or discontinue cology. clinical testing until further preclinical work has been In the first phase, the drug may be administered to done. An important function of FDA reviews is to in healthy volunteers, the object being tc determine form the sponsor regarding further investigation re toxicity, metabolism, absorption and elimination, quired before extending the clinical testing to another other pharmacological action, preferred route of ad phase.

22 I March 1967 / FDA Papers dangerous adverse effects are observed, so that the FDA and the other investigators can be notified, and the study stopped if the hazard warrants. The regulations regarding consent of human beings given investigational drugs must be observed.

Patient Consent The law requires that before using investigational drugs on human beings, the physician must "obtain the consent of such human beings or their representa tives except when it is not feasible or when in his Qualifications of Investigators professional judgment it is contrary to the best inter The sponsor of an investigational new drug (usually est of such human beings." This means that the con the manufacturer) will ask the clinical investigator to sent of persons (or the consent of their representa supply the following information on Form FD 1572 tives) to whom investigational drugs are administered (for the clinical pharmacologist engaged in phase 1 primarily for the accumulation of scientific knowledge or 2 trials) or Form FD 1573 (for the physician en must always be obtained; where patients are given a gaged in phase 3 clinical trials) : new drug for treatment, consent must also be obtained 1. A statement of his education, training and experi in all but exceptional cases. These exceptions are ence which qualify him. ("Curriculum Vitae.") defined in the law as situations "where it is not feasi 2. Information regarding the hospital or other medi ble to obtain the patient's consent or the consent of cal institution where the investigations will be con his representative or where as a matter of professional ducted, special equipment and other facilities. judgment exercised in the best interest of a particular The training and experience needed will vary, de patient under the investigator's care it would be con pending upon the kind of drug and the nature of the trary to the patient's welfare to obtain his consent." investigation. In phase 1, the investigator must be The consent for use of an investigational new able to evaluate human toxicology and pharmacology. drug in phase 1 and phase 2 must be in writing; in In phase 2, the clinicians should be familiar with the phase 3 it is the responsibility of the investigator, conditions to be treated, the drugs used in these con taking into consideration the physical and mental ditions and the methods of their evaluation. In phase state of the patient, to decide when it is necessary or 3. in addition to experienced clinical investigators, preferable to obtain consent in other than written physicians not regarded as specialists in any particular form. If written consent is not obtained, the investi field of medicine may serve as investigators. At this gator must obtain oral consent except as provided stage, a large number of patients may be treated by above, and record that fact in the medical record of different physicians so that a broad background of the person receiving the drug. experience may be secured. Causes for Termination of Investigation Obligations of Investigators The FDA may direct the sponsor to terminate an in The investigator must keep careful records of his study vestigation at any stage under stated conditions. These and retain them for at least two years after completion. include: The records must be made available promptly to the Evidence of significant hazard. drug sponsor and to the FDA when required. Progress Convincing evidence that the drug is ineffective. reports must be sent to the sponsor (in practice usually Submission of false data. the manufacturer) at intervals not exceeding one year. Omission of material information. Emergency reports must be sent to the sponsor when Unsatisfactory manufacturing practices.

FDA Papers / March 1967 / 2} Special Preclearance before Human Trials While the sponsor may ordinarily inaugurate a study as soon as the IND is submitted to the FDA, there are certain exceptions calling for preclearance. Before starting an investigation in any of the following cate gories, FDA approval is required. a) investigations of hallucinogenic drugs, such as LSD, b) investigations of drugs so toxic that their use may be justified only under special conditions, such as Failure to conduct the investigation in accordance DMSO, with the plan submitted by the sponsor and ap c) reinstitution of drug investigations which had been proved by the FDA. terminated by the Commissioner. Commercialization of the drug. The IND regula tions are not intended to a of marketing provide way Use of Drugs for Laboratory Procedures a drug for profit without an approved NDA. New drugs used only for studies in vitro or in labora Failure to submit progress reports at intervals not tory animals are exempted from the new-drug pro exceeding one year. visions of the Act provided they are labeled "Caution Failure to report serious or potentially serious ad —Contains a new drug for investigational use only in verse reactions. laboratory research animals, or for tests in vitro. Not Failure to meet requirements for patient consent. for use in humans." The Commissioner may notify the sponsor of any The exemption does not apply, however, for a new of the above conditions and invite immediate correc drug used in vitro when this use will influence the tion. A conference may be arranged. If the corrections diagnosis or treatment of disease in a human patient— are not effected immediately, the Commissioner may for example, discs to determine the sensitivity to anti require the sponsor to terminate the investigation and recall unused supplies of the drug. The drug in ques tion may not be reintroduced into clinical testing in man until additional data have been submitted to the FDA and the Commissioner has approved the proposed resumption of the study.

The Investigator and "Promotion" The regulations forbid manufacturers or any persons acting for or on their behalf to disseminate any promo tional material concerning a new drug prior to com pletion of the investigation. This is not intended to restrict the full exchange of scientific findings in sci entific or lay communications media; its sole intent is to restrict promotional claims by the sponsor until the safety and effectiveness of the investigational drug have been established. Violation of the regulations by an investigator may result in FDA action to deny him further supplies of the drug; the manufacturer may also jeopardize his right to sponsor the investigation.

24 I March 1967 / FDA Papers biotics of bacteria in culture, or a stick or strip of paper incorporating a reagent to test for sugar in the urine. Apparent ineffectiveness of an antibiotic sensi tivity disc or a false negative test for glycosuria might well lead to an incorrect diagnosis and deprive the patient of appropriate treatment. Before such a preparation can be marketed there must be certification (in the case of antibiotics) or approval of a New Drug Application (in the case of other drugs) . For that reason, it is necessary to submit adequate proof of the effectiveness of these prepara tions before they can be marketed. approval is still withheld, the manufacturer is entitled to an administrative hearing, if he chooses to protest New Drug Application: "NDA" the judgment. Furthermore, a negative ruling follow After the human pharmacological and clinical studies ing a hearing may be appealed to the courts. previously described have been made, and the manu facturer is convinced that the new drug is safe and Antiobiotics and Insulin Preparations effective, he submits a New Drug Application New antibiotic drugs, and any new preparation of ("NDA") , on Form FD-356 with supporting data and insulin, are also subject to the usual IND procedures. proposed labeling to show that "it could fairly and When the sponsor of an antibiotic considers the IND responsibly be concluded by qualified experts that the investigations sufficient evidence of a safe, effective drug is safe and will have the effect it purports or is product, he submits an Application for Certification represented to have under conditions of use pre which is reviewed by the Bureau of Medicine. For a scribed, recommended or suggested in the proposed new insulin product, he submits an NDA. After the labeling." antibiotic or insulin is "approved," a sample of each If the investigational new drug studies were well batch must be submitted by the manufacturer for tests conducted, step by step, through each phase of in to assure the identity, strength, quality, and purity of vestigation, the FDA would have in its hands at the the product. end of phase 3 the complete information needed for an NDA which could be promptly approved. In prac Surveillance of New Drugs on the Market tice, however, this has frequently not been true. The responsibilities of the manufacturer do not end The FDA is required to act on the Application when a new drug has finally been approved for market within 180 days. FDA action takes one of the following ing. The manufacturer is required to send reports to forms: the FDA every three months during the first year, 1) If the NDA is "complete," it will be approved, and every six months for the second year, and annually may be marketed. thereafter. These periodic reports must include in 2) If the NDA is considered "incomplete" in certain formation concerning current clinical studies, the specified respects (such as inadequate clinical data to quantity of the drug distributed, and copies of mailing demonstrate safety or efficacy) , the manufacturer will pieces, labeling, and, if a prescription drug, adver be so informed. He may "complete" the application tising. Prompt reports (within fifteen days) are re by submitting the lacking data. quired of unexpected side effects, injury, toxicity or Should the manufacturer disagree with the conclu sensitivity reactions made known to the manufacturer. sions of the professional staff of the Bureau of Medi "Immediate" reports are required in case of drug mix- cine, he may request conferences for discussion of the ups, evidence of contamination, or failure of the drug data which has been regarded as deficient. In case to exert its expected pharmacologic effect.

FDA Papers / March 1967 I 25 t ' * T i y

ATLANTA DISTRICT The Sherwood Candy Co., At with excessive metal particles and an antibiotic with lanta, Ga., a partnership, and Albert J. Plunkett, part defects in the syringe. Zemmer Co., Oakmont, Pa., the ner and active manager, were each fined for holding manufacturer, destroyed approximately $9,000 worth food in a building accessible to rodents and insects, of ophthalmic ointment which it had recalled. G. C. nnd for the presence of rodent urine and cockroaches Hanford Manufacturing Co., Syracuse, N.Y.. destroved in food products. Inspections of the firm's operations 56,000 syringes of Super Mastol on December 8 be during the past have shown numerous insanitary con cause of defects in the syringe which allowed the ditions. During each inspection the conditions found medication to leak out. were reported to the management with suggestions for corrections. CHICAGO DISTRICT False and misleading claims by G.R.I. Pharmaceuticals, Inc., Chicago, 111., led to ATLANTA BDAC Sales of LSD accounted for the arrest large-scale seizures of a vitamin-mineral supplement of seven men in three different cases in Florida re and an analgesic. cently. The products, Over-Fifty Capsulets and R-T-C Ex-University of Florida students Robert Kenneth Tablets, were manufactured by firms outside of Illi Davis, Sergio Luis Abreu, Kerry Wolfe Mulford, and nois, but repacked and misbranded with accompanying Lawrence Yoeman were arrested on December 6 in literature by G.R.I., a mail-order distributor. Gainesville. The arrests followed investigation by a Seizure was made on December 29 of products and BDAC Agent in cooperation with the Florida Bureau literature valued at $382,900. of Narcotics. Over-Fifty Capsulets were labeled as "a vitamin- Following of LSD and DMT by a BDAC Agent buys mineral supplement to meet the needs of adults over and a marijuana purchase by a Florida Bureau of fifty and all members of their family who have a Narcotics Richard David Retblatt was arrested Agent, vitamin-mineral deficiency." R-T-C Tablets consisted on December 12 in Fort Lauderdale. of three different types of tablets, each with a different Edward (Fast Kddy) Kirschbaum and Michael analgesic-containing formulation for morning, after noon, Zukerman were arrested in Fort Lauderdale on De and bedtime use. Accompanying promotional cember 11 for selling LSD and marijuana. Arrests fol material falsely represented that the product would lowed delivery of 99 LSD cubes to a BDAC Agent. The provide 24-hour relief from the pain and discomfort of headaches, arthritis, case also involved delivery of LSD to a minor. neuralgia, lumbago, rheuma tism, etc., and would maintain tissue supplies of vita min C. BALTIMORE DISTRICT Goff P. Lilly, M.D., Charles ton, W. Va., was fined $1,000 and placed on probation CINCINNATI DISTRICT For shipping misbranded am for 1 year on December 1 for selling prescription drugs phetamine sulfate tablets in interstate commerce, a without a proper doc tor-patient relationship. Tennessee man was sentenced to a year in jail on Teething pe;irls filled with a fluid containing viable December 19. Floyd S. Foreman, trading as Darigon micro-organisms were seized in Grafton, W. Va., on De Corp., Knoxville, will serve the sentence concurrently cember 15. The vinyl rings shipped by Duo-Pac, Inc., with another 1-year sentence he received earlier for New York, N.Y.. were valued at $1,400. failing to register as a manufacturer of drugs. Ap parently all of his production went into illegal Since nomiuti itivc sweeteners had been substituted for channels. Detection of the plant cleared the way for nutritive sweeteners, FDA recently instituted seizure prosecution of a number of "bennie" peddlers. of orange and grape beverage concentrates. The con centrates, manufactured by DCA Food Industries, DALLAS DISTRICT The first sanitation workshop in Inc., Lllicott City, Md., and repackaged and shipped the Nation for food warehousemen was held in Dallas by Cumberland Packing Co., Brooklyn, N.Y., were on December 13. The District co-sponsored the work valued at $23,360. shop with the Texas Wholesale Grocers Association. Cooperating organizations were the Fish and Wildlife BUFFALO DISTRICT Goods voluntarily destroyed in Service, U. S. Department of Interior, and the Na the District during December included eye ointment tional Pest Control Association. The 98 food ware

26 I March 1967 / FUA Papers housemen attending learned about the following insulin. She plead guilty to the charges. FDA's of enforcement and topics: philosophy Two workshops were co-sponsored with Michigan birds, rodents, warehouse inspections; control of and State University: "The Salmonella Problem in Non- food warehouses; and control. insects in inventory Fat Dried Milk" on January 19, and "Salmonella in The District recently detained imports of coffee and Frozen Eggs and Egg Products" on February 14. cheese valued at $415,000. Coffee shipped from In cooperation with the Indiana Health Department, Angola and Guinea and valued at $75,000 was de the District conducted a workshop on "Salmonella in tained because of rodent excreta and insect contamina Non-Fat Dried Milk" on February 21. Another work tion. Colby cheese from New Zealand was detained shop, on "Good Manufacturing Practices for Drug because of adulteration with chlorinated pesticide Manufacturers," is planned at Purdue University on residues. April 20.

DALLAS BDAC For selling LSD, Donald Wayne Friz- KANSAS CITY DISTRICT More than 119,000 pounds zell, Dallas, Tex., was sentenced to a year in jail on of wheat containing a mercurial compound, shipped December 16. Frizzell was out on parole on a 2-year by Walsh Grain Co., Minneapolis, Minn., was seized sentence for unlawfully entering the United States at Wolcott fc Lincoln, Inc., Kansas City, Kans. Some without registering as a drug user. This conviction 130,000 pounds of similarly contaminated wheat, caused the revocation of his parole. He will be shipped by Frieling Grain Co., Gaylord, Kans., was required to serve the remaining 18 months of the old also seized at Wolcott 8c Lincoln. Both shipments, sentence after completing the new sentence. In addi valued at $6,156, were destroyed in Kansas City on tion, on December 14, he was indicted by a Federal December 13. grand jury on two counts of selling heroin. The District had 3,297 cases of canned broccoli seized on December 21 because the broccoli was misbranded. DENVER DISTRICTTo further Salmonella control ef The label showed whole broccoli heads, when the forts, the Utah Health Department will hold monthly product actually consisted of irregularly sliced and meetings in Salt Lake City for all Federal, State, and chopped pieces. The broccoli, shipped by Stokley-Van city health authorities. Participants will discuss cur Camp, Mount Vernon, Wash., was seized at Stokley- rent outbreaks of Salmonella infections and plan Van Camp, Kansas City, Kans.. and was valued at remedial measures to minimize further outbreaks. $7,250. The District also has started a program to supply the Utah Department of Agriculture with copies of the MINNEAPOLIS DISTRICT The entire State of Wis District's monthly work plans for Utah. State officials consin has now been assigned to the jurisdiction of review FDA's planned activities and coordinate certain the District. Previously part of Wisconsin was in the inspection efforts to give their inspectors an opportu Chicago District. The transfer will enable Wisconsin nity to train with FDA personnel. State officials to have a single channel of contact with one District office, and will equalize the workload At the invitation of the Utah Board of Education, between the two Districts. FDA co-sponsored a Midwinter Teachers Institute in Salt Lake City, January 28. Approximately 600 NEW ORLEANS DISTRICT Two shipments, worth teachers attended the statewide meeting on health $10,000, consisting of 1,600 cases of Portuguese canned education. tomato paste were detained. High mold content reflected use of unfit tomatoes. DETROIT DISTRICT An "Indian princess" spieler was given a suspended sentence on a charge of making Joint year-end inspections with the Mississippi State broad and unwarranted claims for three patent medi Board of Health and the Lincoln County Health cines. Chauncina White Horse, also known as Princess Department revealed Salmonella contamination of Yellow Rose, was sentenced at Fort Wayne, Ind., on non-fat dry milk in one plant. Over 300 50-pound December 22. The case developed from a doctor's bags, intended for use in ice cream, are being held for complaint that Mrs. White Horse was promoting an disposition at the direction of the Mississippi State herbal preparation for diabetes and one of his dia Health Department. The joint investigations are betic patients was taking the concoction instead of continuing.

FDA Papers / March 1967 / 27 NEW YORK DISTRICT In the Nations first jury trial PHILADELPHIA DISTRICT An excess of metal par dealing with the scope of the Government's right to tides in an eye ointment was revealed by District inspect drug shipment records, the Government won. analysis. Winthrop Labs., Meyerstown, Pa., was in spected in early December, as a follow-up to Buffalo Stanack Sales Co., Inc., Englewood, N. J., a whole District's analysis of a routine sample of eye ointment. sale drug firm, was convicted December 8, after it Inspectors found that the grid used by the firm to refused to allow FDA Inspectors to examine company measure particle sizes in ointments contained a 10-fold records on the receipt and distribution of prescription error. The result was that metal particles were drugs. Guilty verdicts were also returned against actually 10 times larger than those measured and Howard Ackerman, secretary-treasurer, and his broth recorded. The firm voluntarily recalled the batch er, a salesman for the firm. Stanley, from nationwide distribution. The Government charged that the defendants vio The pre-Christmas "Flammable Doll" incident started lated the 1962 Kefauver-Harris Drug Amendments. with a call from the New Jersey Department of One aim of the amendments was to halt the flow of Health. The District cooperated with State and local adulterated and misbranded drugs by inspecting rec officials taking action under their fire codes. The ords to find out the source and destination of District also tested the dolls and judged them flam shipments. mable under provisions of the Child Safety Act. The defendants had argued that the Government did not show proof of FDA violations, necessary before ST. LOUIS DISTRICT Due to misbranding, 18,700 FDA Inspectors could examine company records. The pounds of Premium Calf Milk Replacer, valued at Government successfully argued that many prescrip S2,116, were seized December 14. The labeling con tion drugs at the firm were misbranded because they tained false statements which represented that the did not contain full disclosure information, and had product was adequate and effective for prevention of incorrect addresses and misspelled generic names. bacterial enteritis in calves. Manufactured and shipped

Imported doll ignites in 20 seconds in FDA test. by Mutual Products Co., Minneapolis, Minn., the prod uct was seized at Triple "A" Feed Co., Springfield, Mo.

SEATTLE DISTRICT The District and State agencies have been active in curtailing use of contaminated lots of seed screening for cattle feed. District examina tion of lots of alfalfa seed disclosed residues of toxaphene and DDT. Allied Seed Co., Pendleton, Oreg., voluntarily destroyed 40,000 pounds of the seed, and Beal Seed Co., Ontario, Oreg., destroyed 15,000 pounds. The Washington State Department of Agriculture also reported that during November their activities resulted in embargo of 28,901 pounds of contaminated seed. To discuss problems of mutual concern, District laboratory and inspectional personnel and officials of the Washington State Department of Health and the SAN FRANCISCO DISTRICT Inspection of Hawaiian Seattle-King County Health Department met in mid- Fruit Packers, Ltd., Kapaa, Hawaii, revealed that December. The main topic was optimum use of facili pineapple products were being canned under insani ties to control food-borne illness. The three groups tary conditions. Heavy insect population was ob offered to share facilities and information. The District served throughout the establishment. Thereafter is taking advantage of an offer by Seattle-King County official samples were collected on the mainland from to train personnel in epidemiological investigations. shipments of canned pineapple tidbits, canned pine Due to excessive DDT residues, $55,328 worth of Colby apple chunks, and canned, sliced pineapple. Over cheese imported from New Zealand was detained. 1,200 cases, valued at $8,000, were seized.

FDA DISTRICT OFFICES Kansas city 1009 Cherry Street FDA BUREAU OF DRUG ABUSE CONTROL Kansas City, Missouri 64106 FIELD OFFICES Atlanta 60 Eighth Street, N.E. Atlanta, Georgia 30309 Atlanta 1831 Peachtree Road, N.E. los anoeles 1521 W. Pico Boulevard Atlanta, Georgia 30309 Los Angeles, California 90015 Baltimore 900 Madison Avenue Baltimore 401 Water Street Baltimore, Maryland 21201 Minneapolis 240 Hennepin Avenue Baltimore, Maryland 21202 Minneapolis, Minnesota 55401 boston 585 Commercial Street boston J. F. Kennedy Federal Bldg. Boston, Massachusetts 02109 new Orleans U.S. Customhouse Bldg. Rm. E-311/Boston, Massachusetts 02110 Rm. 222/423 Canal Street buffalo 599 Delaware Avenue New Orleans, Louisiana 70130 Chicago 205 West Wacker Drive Buffalo, New York 14202 Engineering Building, Rm. 1700 york 850 new 3rd Avenue (at 30th Street) Chicago, Illinois 60606 chicaoo Main Post Office Bldg. Rm. 700/Brooklyn, New York 11232 Rm. 1222/433 W. Van Buren Street Dallas 1114 Commerce Street Chicago, Illinois 60607 Philadelphia U.S. Customhouse Rm. 723/Dallas, Texas 75202 Rm. 1204/2nd & Chestnut Streets Cincinnati 1141 Central Parkway Philadelphia, Pennsylvania 19106 Denver 1814 California Street Cincinnati, Ohio 45202 Denver, Colorado 80202 st. louis U.S. Courthouse & Customhouse Dallas 3032 Bryan Street Bldg., Rm. 1002/1114 Market Street Kansas city U.S. Courthouse Dallas, Texas 75204 St. Louis, Missouri 63101 Rm. 803/811 Grand Avenue san francisco Federal Office Bldg., Kansas City, Missouri 64106 oenver New Customhouse Bldg. Rm. 518/50 Fulton Street Rm. 5604/20th & California Streets angeles San Francisco, California 94102 los 714 West Olympic Blvd. Denver, Colorado 80202 Rm. 1010. Los Angeles, California 90015 Seattle Federal Office Bldg., Detroit 1560 E. Jefferson Avenue Rm. 501/909 First Avenue new YORK 346 Broadway, 12th Floor Detroit, Michigan 48207 Seattle, Washington 98104 New York, New York 10013

FDA Papers / March 1967 / 29 state actions Potato Products Destroyed A fire box" radionic machines, used to achieving better feed control will at Idaho Potato Growers, Idaho diagnose and treat diseases ranging be exchanged. Falls, caused smoke and water dam from cancer and heart trouble to Current presiding officers are Mr. age to more than 360,000 pounds of kidney infections and head colds. Van P. Entwistle, President, and prepared potato products. A city Treatments allegedly could be Mr. Bruce Poundstone, Executive health sanitarian directed the seg transmitted through the air merely Secretary. Mr. Entwistle is director regation of damaged products for by placing a sample of the patient's of feed control for the State of Cali diversion to livestock feed. blood in the machine. fornia. Mr. Poundstone is head of

Drown therapeutic device demonstrated by FDA employee

'Diagnosticians' Convicted Two In 1951 Dr. Drown was con Regulatory Services Division of the women have been convicted on victed, under the Food, Drug, and University of Kentucky. grand theft charges associated with Cosmetic Act, of misbranding the New State Appointments Among "radionic" treatments for serious device. This case involved a Chi the recent appointments to State diseases. cago woman who died of cancer food and drug posts are: Mr. Wal while taking the Drown treatment. Cynthia Chatheld, D.C., and Mrs. ter C. Leth, Director, State Depart Margaret Lunness, both of Los An ment of Agriculture, Oreg.; Mr. Annual Seminar The Association geles, Calif., were convicted in the James L. Casey, Commissioner, of American Feed Control Officials state action on November 29 in Los State Department of Consumer Pro will hold their Second Annual Angeles. Their attorney has moved tection, Conn.; Dr. Walter B. Quis- for a new trial. Seminar on Administration and enberry, Director of Health, Ha Management of Feed Laws, on waii; Mr. Earl Coke, Director, State Both women were associated with March 12-17, 1967. Department of Agriculture, Calif.; a laboratory founded Dr. Chat- by Mr. Richard Beard, Commissioner, field's mother, the late Ruth This to be held at the State Department of Agriculture Drown, D.C. Dr. Drown was origi meeting, of at and Industries, Ala.; Mr. nally indicted in 1963 with the University Kentucky Lexing James ton, Ballinger, President, State Board of other two women. She died in will be devoted to considera tions of in Agriculture, Okla.; and Mr. L. B. 1965 at age 74. uniformity legislation and enforcement policies. In addi Liddy, Secretary, State Department Involved in the case were "black tion, views and procedures for of Agriculture, Iowa.

30 I March 1967 / FDA Papers seizures and prose cull en JL V>

1AMe cnar8'n8 violation of the Federal Food, Drug, and Cosmetic Act and the Federal Hazardous SEIZURE ACTIONS Substances Act are published when they are reported by the FDA District Office.

A total of 76 seizure actions to remove adulterated, mis- because of contamination, and 11 because of economic branded, and unsafe products from the consumer market violations. Other seizures included 12 of human drugs, 2 of were reported in December. These included 54 seizures of veterinary drugs, 5 of medical devices, 2 of prophylactics, and foods; 3 because of poisonous and deleterious substances, 40 1 of a hazardous substance.

(P), PRODUCT, PLACE ft DATE SEIZED MANUFACTURER (M), PACKER CHARGES SHIPPER (S), DEALER (D)

FOOD / Poisonous and Deleterious Substances Horseradish, dehydr./Fort Polk, La. 12/8/66 Allen Foods, Inc./St. Louis, Mo. (S) Contains sharp particles of silica gel and insects. Lettuce, fresh/Forty Fort, Pa. 11/17/66 J. R. Norton Co./Phoenix, Ariz. (P,S) Contains toxaphene, a pesticide chemical not in con formity with regulations. Kearney, N.J. 11/15/66 Western Growers Distributing Co./Glendale, Contains toxaphene and parathion, exceeding estab Ariz. (P,S) lished tolerance for pesticide chemicals.

Contamination, Spoilage, Insanitary Handling Anchovies, can./Pittsburgh, Pa. 12/5/66 Don Juan Foods, Inc./Brooklyn, N.Y. (S) Partly decomposed. Butter/St. Paul, Minn. 11/10/66 Western Dairy Co./Clarkfield, Minn. (M,S) Prepared and packed under insanitary conditions-, in sect contaminated. Candy and Gum/Waco, Tex. 12/14/66 Harry Siegel Food Distr., Inc. -Waco, Tex. (D) Held under insanitary conditions. Corn Husks/Phoenix, Ariz. 11/25/66 California Corn Husk Co./Norwalk, Calif. (S) Insect-damaged and moldy corn husks. Cumin Seed, Garbanzos, Garlic/San Juan, Mendez & Co., Inc./San Juan, P.R. (D) Insect and rodent contaminated. P.R. 12/7/66 Eggs, frozen/Warminster, Pa. 12/2/66 Nulaid Foods/San Leandro, Calif. (S) Partly decomposed. Brooklyn, N.Y. 12/14/66 San Leandro, Calif. 12/20/66 Thomasville, Ga. 11/21/66 Pacific Growers/San Leandro, Calif. (S) Kansas City, Kans. 12/21/66 Flour/Mayaguez, P.R. 11/23/66 Arbona Hermanos/Mayaguez, P.R. (D) Held under insanitary conditions. Spruce Pine, N.C. 12/2/66 Spruce Pine Wholesale Co./Spruce Pine, N.C. (D) Harahan, La. 12/13/66 Food Suppliers, Inc./Harahan, La. (D) Columbia, S.C. 12/13/66 Rawl Dist. Co./Columbia, S.C. (D) Flour, Rice, etc/Lancaster, S.C. 10/25/66 Plyer Wholesale Co., Inc./Lancaster, S.C. (D) Macaroni, Rice, etc./ Lenoir, N.C. 12/2/66 City Flour & Feed Co., Inc/Lenoir, N.C. (D) Meat Casings/Detroit, Mich. 11/18/66 Butcher & Packer Supply Co./Detroit, Held under insanitary conditions; insect contaminated. Mich. (D) Peanuts, shelled/Olympia, Wash. 12/5/66 Matthews Candy Co./Olympia, Wash. (D) Held under insanitary conditions; rodent contaminated. Los Angeles, Calif. 12/1/66 Gust Picoulas & Co./Los Angeles, Calif. (D) Peas (Garbanzosl/Santurce, P.R. 12/1/66 Puerto Rico Warehouse Corp./Santurce, Insect contaminated. P.R. (D) Blackeye, can./St. Louis, Mo. 12/15/66 F. M. Weiling & Son Whse./Kansas City, Mo. Partly decomposed. (S) Pecans, shelled/New Orleans, La. 12/8/66 Williams Pecan Products Co./Gulfport, Miss. Prepared and packed under insanitary conditions. (P,S) " 12/13/66 Peppermint Candy/Mount Holly Springs, Earl's Candy Co./Macon, Ga. (M,S) Pa. 12/16/66 Rosenberg, Tex. 12/16/66 Perch/Gloucester, Mass. 12/9/66 Twin Light Fillet, Inc. Gloucester, Mass.(P.S) Contaminated by parasitic copepods. Pineapple, can./Orville, Calif. 11/18/66 Hawaiian Fruit Packers, Ltd./Kapaa, Hawaii Prepared and packed under insanitary conditions. (P,S) Alameda, Calif. 12/22/66 Prunes, froz./Chicago, III. 12/2/66 The Phillips Co./Chicago, III. (D) Moldy. Shrimp, froz./Washington, D.C. 11/30/66 Singleton Packing Corp./Tampa, Fla. (P,S) Prepared and packed under insanitary conditions; E. coli, staphylococci. Denver, Colo. 12/2/66 Booth Fisheries/Brownsville, Tex. (P,S) Des Moines, Iowa 11/14/66 Walterboro, S.C. 11/16/66 Singleton Packing Corp./Tampa, Fla. (P,S) Shrimp, froz., stuffed/N. Miami. Fla. Sea Pak Corp./St. Simons Island, Ga. (P.S) 11/14/66 breaded/Detroit, Mich. 11/30/66 Singleton Packing Corp./Tampa, Fla. (P,S)

FDA Papers / March 1967 I 31 seizure actions (M), PACKER (P), PRODUCT, PLACE & DATE SEIZED MANUFACTURER CHARGES SHIPPER (S), DEALER (D)

Contamination, Spoilage, Insanitary Handling (cont'd) Shrimp, breaded Sea Pak Corp./St. Simons Island, Ga. (P,S) Prepared and packed under insanitary conditions; Denver, Colo. 12/20/66 E. coli, staphylococci. Soup Mix/Miami, Fla. 8/25/66 Hi-Grade Food Co., Inc.. Miami. Fla. (0) Held under insanitary conditions; insect contaminated. Spinach, can. tola, Kans. 11/21/66 Model Wholesale Grocery Co./lola, Kans. (D) Decomposed. Strawberries and Blueberries/Chicago, II The Phillips Co./Chicago, III. (0) 12/2/66 Tomato Paste, can Roxbury, Mass. 12/5/66 Buy-Rite Co., Inc./Roxbury, Mass. (D)

Economic Violations Butter/Chicago, III. 12/21/66 A. Suchy Co./Chicago, III. (D) Contains less than 80 percent of burterfat. Candy Pecanettes/Fairless Hills, Pa. Hillside Enterprises, Inc./Cleveland, Ohio (S) Short weight. 12/2/66 Jellies, asst. Cleveland, Ohio 12/14/66 Utt Juice Co./Tustin, Calif. (S) Inaccurate quantity of content statement. Mango Juice, reconstit./Vernon, Calif. Dolphin Int. Trading Co./Houston, Tex. (S) False and misleading claims to calm the stomach, pro 8/24/66 mote health, and be of special dietary use. Oleomargarine/Vestal, N.Y. 11/28/66 Old Dutch Foods, Inc./Vestal, N.Y. (D) Fails to conform to margarine standards; below re quired butterfat content. Orange Juice Goldsboro, N.C. 11/25/66 Coble Dairy Products, Coop., Inc./Anderson, Other substances substituted in part for orange juice; S.C. (M,S) fails to conform to orange juice standards. Athens, Ga. 11/23/66 Shrimp, can./Phoenix, Ariz. 12/7/66 Safeway Stores, Inc./E. Stockton, Calif. (S) Misleading vignette depicting whole shrimp, broken pieces substituted. Shrimp, froz./Salt Lake City, Utah 12/22/66 Rose Frozen Shrimp/Los Angeles, Calif. (P,S) Fails to conform to standard and definition for shrimp. Tomatoes, can. tola. Kans. 11/21/66 Allen Canning Co. Siloam Springs, Ark. (S) Below quality standard for canned tomatoes. Martinsville, Va. 12/16/66 A. W. Sisk & Son/Cambridge, Md. (S)

DRUGS / Human Use Afrodex capsules/Houston, Tex. 11/16/66 Bentex Pharmaceuticals Co./Houston, Tex. Inadequate directions for use. (D) Alergimist "Solution A" and "Solution B" The Brunson Corp./ Miami. Fla. (M,S! New drug not approved for safety and effectiveness. Rosemead, Calif. 11/16/66 Van Nuys, Calif. 11/16/66 (2 actions) Gardena, Calif. 11/16 and 11/21/66 Los Angeles, Calif. 11/16/66 Vernon, Calif. 11/21/66 San Bernardino, Calif. 11/22/66 Baker's Hair Tonic/Oklahoma City. Okla. Hal Collins Co. Dallas, Tex. (M,S) Inconspicuous and insufficient mandatory labeling in 12/20/66 formation. Diazym caps, GH-4 Digestant caps., Multi- W. H. Crew Mfg. Co./Salt Lake City, Utah Contains poisonous Salmonella micro-organisms. Vit. No. 465 Los Angeles, Calif. 11/18/66 (M,S) Erosol (bath lotion) New York, N.Y. Erosol, Inc./New York, N.Y. (D) False and misleading claims to increase blood circula 11/23/66 tion, achieve complete satisfaction in marital rela tions, be ideal as a vaginal lubricant. Go-Pain Ointment/Dallas, Tex. 10/18/66 De Pree Co. Holland, Mich. (M,S) False and misleading claims to relieve muscular aches, sprains, neuralgia, lumbago, chest colds. Thyroid Powder/Auburn, Mass. 12/19/66 Elasto Chemical Corp./New York, N.Y. (M,S) Below U.S.P. quality standard.

Veterinary Electro Dex, Chloro-Histex, Chloro-Lac, Lyle A. Wittney & Co. Denver, Colo. (M.S) New drugs not approved for safety and effectiveness; Amino-Com 10/Billings, Mont. 7/8/66 below labeled quality; inadequate directions for use. Phenothiazine/Chicago, III. 12/266 William Cooper & Nephews, Inc./ Pittsburgh, False and misleading claims to remove ascarid worms Pa. (D) from hogs; inadequate directions for use.

MEDICAL DEVICES Catheterization Set/Evanston, III. 10/24/66 Pharmaseal Laboratories Irwindale, Calif. Below labeled quality, not "sterile." and/or Johnson City, Tenn. (M,S) Contour Control/Jackson, Miss. 12/15/66 Nemeth & Hammond Enterprises/Dallas, Tex. False and misleading claims for reducing. (M,S) Figure Control/Minneapolis, Minn. Consumer Electronics/Dallas, Tex. (M,S) and False and misleading claims for reducing, increasing 11/23/66 Hydro Massage, Inc./ Minneapolis, Minn. (D) flow of blood, getting rid of wrinkles; inadequate di rections for use. Hygienic Tooth Brush/St. Louis, Mo. Sterling Merchandise Co., Inc./New York, False and misleading claims of superior quality, bris 12/15/66 N.Y. (S) tles not securely fastened. Nord-Craft Finn-ette Sauna/Madison, Wis. Heritage Sauna Co./Minneapolis, Minn. (S) False and misleading claims to relax taut nerves, ease 12/22/66 tension, maintain excellent health.

12 I March 1967 / FDA Papers seizure actions MANUFACTURER (M), PACKER (P), PRODUCT, PLACE & DATE SEIZED CHARGES SHIPPER (S), DEALER (D) Prophylactics Rubber/Dallas, Tex. 10/19/66 Allied Latex Sales Co., Inc./Dothan, Ala. (S) Defective. Knoxville, Tenn. 12/8/66 National Hygienic Prod. Corp./Dothan, Ala. (S) •

HAZARDOUS SUBSTANCES Creme Hardener, Titan Catalyst "P'7 Sarfan Corp./San Francisco, Calif. (P,S) Lacks consumer protection information required by the, Seattle, Wash. 12/5/66 Fed'l. Hazardous Substances Act.

charging violation of the Federal Food, Drug, and Cosmetic Act are pub- TERMINATED CRIMINAL CASES lished when the court action has been reported by the FDA District office.

PRODUCT, PRINCIPAL VIOLATION PRODUCT, PRINCIPAL VIOLATION DEFENDANT CHARGED. SENTENCE & JURISDICTION DEFENDENT CHARGED, SENTENCE 8. JURISDICTION

UNFIT FOOD MISBRANDED FEED Sherwood Candy Co., and Peanuts and corn sirup held under insanitary Security Mills, Inc., and Shipping of adulterated and misbranded Albert J. Plunkett conditions. Company and individual each Charles P. Crawford medicated feed. Fined $2,000. (E. Dist. of Atlanta, Ga. fined $200. (N. Dist. of Ga.-Atlanta) Knoxville, Tenn. Tenn.-Knoxville) G. Santoro & Sons, Inc. Macaroni products prepared and packed un Joseph Signorelli der insanitary conditions. Corporation fined Brooklyn, N.Y. $8,000; individual placed on 18-month pro bation. (E. Dist. of N.Y.-Brooklyn)

ILLEGAL SALES OF PRESCRIPTION DRUGS Georgia-Mableton Drug Unauthorized refilling of amphetamine and Jimmy W. Mitchell Peddling amphetamine. Sentenced to 1 year Corp., t/a Liggett-Rexall tranquilizer prescriptions. Corporation fined Hamilton, Ohio in jail. (E. Dist. of Ky.-London) Drugs, and $200; Ballew and Daniel, each $100. (N. Oscar H. Locke, t/a Peddling amphetamine. Locke fined $500; Joe A. Ballew Dist. of Ga.-Atlanta) 60 Grand Truck Stop, and placed on 2-year probation; co-defendants Eddie Frank Daniel Donald Hughes not sentenced. (N. Dist. of Okla.-Tulsa) Mableton, Ga. Virgil L. Brown Albert H. Pollack Selling amphetamine and phenylbutazone Joe Curtis (pharmacist) without prescription. Fined $250 and $28 Junior Hoover Chicago, III. costs; placed on 3-year probation. (N. Dist. Wyandotte, Okla. of Ill.-Chicago) George Lee Peddling amphetamine. Sentenced to 2 David S. Macklin, mgr. Selling amphetamine and cortisone without Dallas, Tex. years in jail, suspended, and placed on 2- Eastgate Drugs, Inc. prescription. Fined $350, plus $15 costs. year probation. (N. Dist. of Tex.-Dallas) Lombard, III. (N. Dist. of Ill.-Chicago) Booker T. Metcalf Peddling amphetamine. Sentenced to 6 Harold S. Blume, t/a Selling antibiotic and tranquilizer without (employee Texas T.S.) months in jail, suspended, and placed on 2- Blume Pharmacy, and prescription. Blume fined $300, plus $41 Dallas, Tex. year probation. (N. Dist. of Tex.-Dallas) Wayne A. Andrews costs; Andrews, $100. (N. Dist. of Ind.- Frost Drug Co., and Unauthorized refilling of prescription drugs. South Bend, Ind. South Bend) Eldon L. Frost, pres. Company fined $800; Frost, $400, $200 sus Bahne K. Bahnson, D.O. Selling amphetamine outside doctor-patient Gerald K. Okabe, pharm. pended; Okabe, $1,200, suspended. (N. Dist. Burt, Iowa relationship. Fined $3,000, plus $76.88 Kaysville, Utah of Utah-Ogden) costs; placed on 4-year probation. (N. Dist. Dwight M. Hoke, M.D. Selling amphetamine and barbiturates out of Iowa-Fort Dodge) Beckley, W. Va. side doctor-patient relationship. Fined James Leo Lanham Peddling amphetamine. Sentenced to 4 $1,000; placed on 1-year probation. (S. Dist. Covington, Ky. months in jail. (E. Dist. of Ky.-London) of W. Va.-Charleston) Augustus D. Slone. M.D. Selling antibiotic, cortisone, and tranquili Goff P. Lilly, M.D. Selling amphetamine, penicillin, Enovid, and Paintsville, Ky. zers outside doctor-patient relationship. Charleston, W. Va. Norlestrin outside doctor-patient relation Fined $600, plus $35 costs. (E. Dist. of Ky.- ship. Fined $1,000; placed on 1-year proba Pikeville) tion. (S. Dist. of W. Va.-Charleston) Harry Zarafonetis Peddling amphetamine and barbiturates. Springhill, La. Sentenced to 2 years in jail, 1 additional MISBRANDED AND NEW DRUGS year, suspended, and placed on 3-year pro bation. (W. Dist. of Ark.-Eldorado) Chauncina White Horse, Misbranding ointments orally with false and John K. Newton Illegal sales of amphetamine. Fined $500; t/a Princess Yellow Rose misleading claims. Sentence suspended; no Minneapolis, Minn. placed on 3-year probation. (Dist. of Minn.- Shipshewana, Ind. probation imposed. (N. Dist of Ind.-Fort Minneapolis) Wayne) Jimmy Lee Buckner Peddling amphetamine. Sentenced to 1 Floyd S. Foreman, t/a Misbranding amphetamine, not manufac Weaverville, N.C. year in jail, suspended, placed on 3-year Darigon Corp. tured in a duly registered establishment, probation, and fined $500. (W. Dist. of N.C.- Knoxville, Tenn. and without adequate directions for use. Asheville) Sentenced to 1 year in jail. (E. Dist. of Joseph Ford Hodge Peddling amphetamine. Sentenced to 2 Tenn.-Knoxville) Wilkesboro, N.C. weeks in jail, placed on 5-year probation, and fined $500. (M. Dist. of N.C.-Wilkesboro) The Pharmadent Co., and Shipping of Prednisolone Desensitizing Solu Tom Allen Coalson Peddling amphetamine. Sentenced to 1 year Erwin J. Franke, Jr. tion, a new drug without an effective new- (t/a Coalson's Drive-in) in jail, and fined $1,000. (M. Dist. of N.C. Lake Jackson, Tex. drug application. Company fined $1,500; in Winston-Salem, N.C. Winston-Salem) dividual, $250. (S. Dist of Tex.-Houston)

FDA Papers / March 1967 / 3) ■*—► «r^ » ^l ..- A A_V * j*. %^J \^J aUV

NOTICESOF JUDGMENTon SeizureActions and moldy, decomposedchestnuts;402(a)(3).Default decree ordered FOOD; Poisonousand DeleteriousSubstances destruction.(21) Chestnuts,st Halethorpe,Dist. Md. Celery,fresh, Season'sDest,at Cleveland,N. Dist. Ohio. Charged1-10-66:when shippedby Squillante,New York, N. Y„ the Charged2-2-66:whensnippedby SeasonProduceCo., Inc.. Los Angeles, article containedinsect filth, and moldy,decomposed Calif., a quantityof pesticide nuts: 402(a)(3) the article contained the added chemical Defaultdecreeordereddestruction. (22) toxaphenein excess of the tolerance; 402(aX2)(B).Default decree ordereddestruction.(1) Chestnuts,at Philadelphia,E. Dist. Pa. Charged12-13-65:whenshippedby CuneoBros., Inc., NewYork, N. Y., WheatShorts,at WestPlains,W. Dist. Mo. the article decomposedchestnuts; Inc., contained 402(a)(3).Defaultdecree Charged 7-1-66: when shipped by Moore-LowryFlour Mills, ordereddestruction.(23) Coffeeville,Kans., the article containedthe food additive DDT, and it and its use and intendeduse failed to conformto regulationor Pecans,shelled,FiestaBrand,at Denver,Dist. Colo. exemption;402(a)(2)(C),409. Default decree ordered destruction.(2) Charged2-25-66:whenshippedby D. McCreat Son, Inc., Yancey,Tex., the article containedE. coll, and had beenpreparedand packedunder FOOD/ Contamination,Spoilage,InsanitaryHandling insanitary conditions; 402(aX3), 402(a)(4). Default decree ordered destruction.(24) Eggs,frozen,at Chicago,N. Dist. III. Charged12-16-65:whenshippedby SchneiderBros., Inc., Birmingham. Pecans,unshelled,at Nashville,M. Dist. Tenn. Ala., and J. K. Brokerage,Boaz,Ala., two lots of eggs containedde Charged12-7-65:whenshippedby GrizzardBros., ForestPark, Ga. trie composedeggs;402(a)(3).Consentdecreeauthorizedreleaseof the lot article containedinsect filth, and moldy,decomposed,and shriveled of eggsin labeledcans to SchneiderBros., Inc., for salvaging.Default nuts, and emptyshells; 402(a)(3).Defaultdecreeordereddestruction. decreeordereddestructionof the lot of eggs in unlabeledcans. (3) (25) Chickens,readyto cook,SunnyBoy, at Mankato,Dist. Minn. Pecans,shelled,at SiouxFalls, Dist. S. Dak. Charged6-24-65:when shippedby BramanPoultry, Inc., Cleveland, Charged3-10-66:when shippedby Texas Nut Co., Dallas. Tex., the Ohio, poultry, not ready to cook, containinghair, feathers,oil and article containedE. coli and other bacterial filth; 402(a)(3).Default sex glands, vents, lung, esophagus,and Intestinal tissue, and dirt decreeordereddestruction.(26) had been substitutedfor the article; and the article bore false and Peanuts,at Buffalo,W. Dist. N.Y. misleadingstatementsaboutits beingreadyto cook and its inspection Charged5-31-66:whenshippedby Co., by U. S. Dept.of Agriculture;402(b)(2), Consent authorized DixiePeanut Fitzgerald,Ga.,the 403(a). decree article containedinsectfilth, and had been preparedand packedunder releaseto shipperfor reprocessing,but shipperfailed to complyand Insanitaryconditions;402(a)(3), the articlewas ordereddestroyed. 402(a)(4).Consent decree authorized (4) releaseto the shipperfor salvaging.(27) product,frozen,"Tater-Buds," Milton, Potato at Mass. Flourandmixednuts,at Xenia,S. Dist. Ohio. Charged7-19-65:when shippedby Vahlsing,Inc., Easton,Maine, the Charged3-24-66:whileheldby SuperValuStores,Inc., Xenla,Ohio, the article containedE. coli, and other bacterialfilth, and had been pre filth, pared packed articles containedrodent and were held under insanitarycon and underinsanitaryconditions;402(a)(3),402(a)(4).Default ditions; 402(a)(3), Default decree authorizeddonationto public/charitableInstitutionfor use as 402(a)(4). decree ordered destruction.(28) animalfeed. (S) Flour,at Jackson,E. Dist. Ky. Charged2-7-66and amended5-9-66:while by Potatostarch,at Houston,S. Dist.Tex. held JacksonWholesale Co., Jackson, Ky., the article containedrodent filth, and was held Charged6-8-66:while held by HoustonCity DockWarehouse,Houston, under insanitary conditions; 402(a)(3), Tex., the filth and nondescriptdirt, was 402(a)(4). Consent decree article containedinsect and authorizeddestruction.(29) held under Insanitaryconditions;402(a)(3),402(a)(4).Default decree ordereddestruction.(6) Flour,at Canton,N. Dist. Ga. Charged9-19-66:while held by Co., •tans, red, Azuki,at Los Angeles,S. Dist. Calif. CantonWholesale Canton,Ga., the Charged MaruyaCo., Calif., article containedrodentand insectfilth, and was held underInsanitary 1-14-66:while held by Los Angeles, the conditions;402(a)(3), Default article containedrodentfilth, and was held underinsanitaryconditions; 402(a)(4). decreeordereddestruction.(30) 402(a)(3),402(a)(4).Defaultdecreeordereddestruction.(7) Flour,at Springfield,Dist. Mass. Charged4-15-66: by Magazlner's Beans,pinto, dried, peas, split, green, Stockton,N. while held BakeryCo., Inc., Springfield and at Dist. Calif. Mass.,the article containedrodentfilth, and was held underinsanitary Charged3-1-66:while held by Port StocktonFood Distributors,Inc., conditions;402(a)(3), Stockton,Calif., the articles containedrodent filth, and were held 402(a)(4).Defaultdecree ordereddestruction,or donationto public/charitableinstitutionfor use as animal feed. under insanitaryconditions;402(a)(3),402(a)(4).Defaultdecreeordered (31) destruction,(t) Candy,rice, andflour, at SouthHill, E. Dist.Va. Charged by Oleomargarine,at Hendersonvllle,W. 11-9-65:while held SouthHill GroceryCo., Inc., SouthHill, Dist. N.C. Va., the articles containedinsectfilth, and were held under insanitary Charged6-13-66:whenshippedby Shedd-BartushFoods,Inc., Greenville, conditions;402(a)(3), S.C., the article had been prepared,packedand held under insanitary 402(a)(4).Default decree authorizeddonationto public/charitableinstitutionfor use as animalfeed. conditions,402(a)(4).Default decree ordereddestruction.(9) (32) Cocoa,at Chicago,N. Dist. III. Charged8-4-65:while held for sale by BakersSpecialtyCo., Chicago. FOOD / EconomicViolations III., the article containedrodentfilth, and was held under Insanitary conditions;402(a)(3),402(a)(4). Consentdecreeauthorizedreleaseto Pickles,at NewYork, S. Dist. N. Y. BakersSpecialtyCo., for salvaging.(10) Charged1-4-66:when shippedby WholesaleSociety of GermanCon sumersCooperativeSocieties, Tomatojuice, canned,Hunt's,at Rossford,N. Dist.Ohio. Hamburg,West Germany,the article was short weight(approx.8.7 percent);402(e)(2).Consentdecreeauthorized Charged3-2-66:whensnippedby Hunt Foods& Industries,Inc., Ross- release to Co., ford, Ohio,the decomposed material; Haram-Christensen& Inc., New York, N. Y., for re article contained tomato 402(a)(3). labeling. (33) Defaultdecreeordereddestruction.(11) Nuts,mixed,salted,Big Valu,at Fargo, Tomatojuice, canned,Del MonteBrand, Frankfort,S. Dist. N. Dak. at Dist. Ind. Charged11-5-65:when shippedby Super Valu Stores, Inc.. Hopkins, Charged3-21-66:whenreturnedto the shipper,CaliforniaPackingCorp., * * * Frankfort, Minn.,the article labeled"Big ValuSaltedMixedNuts Distributed Ind., the article labeled"Del Monte Brand OualityTomato by Select * * *" Juice " • " Distributedby PackingCorporation* • • Products bore a false and misleadinglabel vignette, California San since the vignettedepictedmostly nuts other than peanutsand the Francisco,California"containeddecomposedtomatomaterial;402(a)(3). article was mostlypeanuts,(approx. percent); Defaultdecreeordered 88 and the label failed destruction.(12) to state that the article containedchemical preservatives;402(a), Tomatopuree,canned,GatewayBrand,at St. Paul, Dist.Minn. 403(k). Default decree authorized donation to public/charitable Charged1-27-66:when shippedby Perry CanningCo., Perry, Utah, the institution. (34) article containeddecomposed material; tomato 402(a)(3).Defaultdecree Mackerel,canned,Tip-ApaBrand,at and Camuy,Dist. ordereddestruction.(13) Falardo P. R. Charged6-26-64:when shippedby Van CampSea FoodCo. (a division Tomatopaste,canned,at Toledo,N. Dist.Ohio. of Ralston Purina Corp.), TerminalIsland, Calif., Jack mackerelhad Charged11-16-65:whenreturnedto the originalshipper,HirzelCanning beensubstitutedfor the article,andthe label was false and misleading, Co., Toledo, Ohio, the article containeda decomposedsubstance; since Jack mackerelis not mackerel(or Californiamackerel)and does 402(a)(3).Defaultdecreeordereddestruction.(14) not belongto the true mackerelfamily Scombridae;402(b)(2),402(a). Consentdecreeauthorized shipper Tomatoesand tomatoJuice, canned,Bitty Brand,at Richmond,E. Dist. Ky. releaseto for relabeling. (38) Charged1-27-66:whenshippedby KennethN. RiderCo., Inc., Trafalgar, Lemonjuice,reconstituted,Twoliuys,2 seizureactionsat Garfield,Dist. N. J. Ind., the articles containeddecomposedtomato material; 402(a)(3). Charged9-28-65and on or about 10-21-65:when shippedby Arthur Defaultdecreeordereddestruction.(15) Mitchell FoodProducts,Inc., Brooklyn,N. Y., the article labeled"Two Guys ReconstitutedLemonJuice * * * Distributedby Two Guys, Inc. Nuts,mixed,Martin'sFinest,at Bedford,N. Dist. Ohio. Garfield, Charged1-17-66whenshippedby B Co., Detroit,Mich., N.J." had had a valuableconstituentomitted,a substance & S Produce other than reconstitutedlemon juice had been substitutedfor the the article contained[insectI filth, and moldy,rancid,decomposedand article, shrivelednuts; and the label was false and misleading,since the article was 402(a)(3).Defaultdecreeordereddestruction.(16) a mixture of reconstitutedlemon juice and a different substance; Filbertsand trull nuts, shelled,at Norfolk,E. Dist. Va. 402(b)(1),402(b)(2),403(a). Default decree authorizeddonation to Chargedon or about12-7-65:whenshippedby PeanutProductsCo., Des public/charitableinstitution. (36) Moines,Iowa, the articlescontainedinsectfilth and moldy,rancid,and puree, decomposednuts; Tomato canned,CandidBrand,at Hamilton,S. Dist. Ohio. 402(a)(3).Default decree ordereddestruction.(17) Charged11-18-65:whenshippedby EatonFoods,Inc., Eaton, Ind., the Nuts,mixed,unshelled,at Atlanta,N Dist. 6a. article was short weight (approx. 2.74 percent); 403(e)(2).Default Charged11-26-65:while held for sale, the article containedrancid, decreeauthorizeddonationto public/charitableInstitution. (37) decomposed,shriveledand gummynuts, and empty shells; 402(a)(3). CranberryJuice cocktail, Defaultdecree destruction. CloverFarmBrand,at Nashua,Dist. N. H. ordered (18) Charged12-22-64:when shippedby New EnglandApple ProductsCo., Nuts,mixed,unshelled,at Landover,Dist. Md. Inc., Littleton, Mass., the article was madeto appearbetter and of Charged12-14-65:while held tor sale, the article containedInsect greater value than It was; and its label lacked the name of each filth, and rancid,moldy,gummy,and shrivelednuts, and emptyshells; ingredient,and failed to declareartificial coloring, since the article 402(a)(3).Consentdecreeauthorizedreleaseto GrahamCo., Inc., New containedan unstatedartificial red coloring;402(b)(4),403(0(2).403(k). York, N. V., for salvaging.(19) Consentdecreeauthorizeddonationto public/charitableinstitution. (38) Pecans,shelled,FiestaBrand,at Jackson,E. Dist. Mich. Shrimp,breaded,fantall.frozen,Albuquerque,Dist. N. Mex. Charged2-25-66:whenshippedby D. McCreat Son, Inc., Yancey,Tex., Charged4-1-66:whenshippedby RoseFrozenShrimp,Inc., Los Angeles, the article containedE. coll, ana had been preparedand packedunder Calif., the articletestedless than50 percentshrimpmaterial;403(g)(1). insanitary conditions; 402(a)(3),402(a)(4).Default decree ordered Consentdecreeordereddestruction.(39) destruction.(20) Sausageseasoning,Keepsweet,at KansasCity W. Dist. Mo. Chestnuts,at Norfolk,E Dist.Va. Charged3-23-66:when shippedby Kadlson Labs., Chicago,III., the Charged12-3-65.while held for sale, the article containedInsectfilth, label did not declarethe Ingredientascorbicadd, and failed to state

H I March 1967 / FDA Papers that a chemicalpreservativehad been added;403(0(2),403(k).Default Amphetaminedrugs,various,at Sprlngdale,W. Dlst. Ark. decreeauthorizeddonationto public/charitableInstitution. (40) Charged6-8-65:while held by Carrol C. Worthy, D.V.M., Sprlngdale, Ark., the labelinglackedadequatedirectionsfor use and the ortfcles FOODADDITIVES were not exemptas prescriptiondrugs, since they were not for use or dispensingIn professionalpractice;502(f)(1).Defaultdecreeordered Etheiyquinpremli. at Charlotte.W. Oltt. N.C. the ortfclesheld,pendingfinal orderof destruction.(55) Charged12-9-65:when shipped by Peter Hand Foundation,Chicago, ethoxyquln, Amphetaminetablets,at KansasCity, Dist. Kans. III., the article containedthe food additive and It and Charged by Shelton, driver, labeling its use and intendeduse failed to conformto regulations,since the 6-7-65:while held David truck the use; of Die articles lacked adequatedirections for use and were not article failed to bear adequatedirectionsfor 402(a)(2)(C).409. possessor to shipperfor relabeling. exemptas prescriptiondrugs, since the was not a regular Consentdecreeauthorizedrelease (41) and lawful dealer In such drugs, and the articles were not to be lawfullydispensed;502(f)(1)-Defaultdecree ordereddestruction.(56) VITAMINS/ DIETARYFOOD Pontrate-3tablets,at Oswego,Dlst. Kans. Dlttary FeedSupplementtabletsand powders,at Old Saybrook,Dist. Conn. Charged3-24-65:when shippedby Bush Laboratories,St. Louis, Mo., Charged2-24-65:while held for sale, valuableconstituentshad been the strengthof the article was deficientand the label false and mis omittedor abstractedfrom the articles,and the label statementswere leading,since the article wos deficient in pentaerythritoltetranltrate false and misleadingsince the tablets were deficient In vitaminA (approx.39 percent);501(c), Defaultdecreeordereddestruction. powders In vitamins C 502(a). (approx.50 percent)and the were deficient (57) and A (approx.90 percent and 60 percent, respectively);402(b)(1), Defaultdecreeordereddestruction. (42) Rauwolflaserpentinatablets,N.F., at Washington,Dlst. Columbia. 403(a). Charged sale, quality Dietary Pownal, 3-26-66:while held for the of the article was supplementaltablets,at Dist.Vt. deficientas to tablet disintegrationfor coatedtablets;501(b).Default ChargedU-9-M while held for sale, a valuableconstituenthad been decreeordereddestruction.(56) omittedor abstractedfrom the article, and the label was false and misleadingsince the article was deficient in vitaminA (approx.40 MedicalFluid 360,at Mesquite,N. Dlst.Tex. percent);402(b)(1),403(a).Defaultdecreeordereddestruction.(43) Charged3-23-65:whenshippedby DowCorningCorp., Hemlock,Mich., the article wos a new drug withoutan effectiveNew DrugApplication Feed SupplementCapsules,Naellfe.at Oakland,N. Dist. Calif. and was not exempt,since it did not complywith regulationswith Charged4-6-64:when returnedto its original shipper,Neo-LlfeCo. of respectto new drugs for investigationaluse; and the labelingof the America,Oakland.Calif., the article containedthe food additivefolic article failed to bear adequatedirectionsfor use end it was not acid,and It and Its use and intendeduse failedto conformto regulation exemptas a bulk drug for manufacture,since compliancewith the or exemption;402(a)(2)(C).409. Defaultdecreeordereddestuction.(44) exemptingregulationswas lacking; 505(a), 502(f)(1).Default decree authorizedreleaseto FDA. (59) ANIMALFEEDS Fetaltissue,sheep,Lvocell,at Phoenix,Dlst.Ariz. Poultrypremlx,special,at Lexington,E. Dist. Ky. Charged9-27-65:when shippedby Plnco, Inc., LagunaBeach, Calif., Charged2-11-66: when shipped by Philips Roxane Dlv., Thompson- the article was a new drug withoutan effectiveNew DrugApplication, HaywardChemicalCo.. subsidiaryof Philips Electronics,KansasCity, and no notice of claimed Investigationalexemptionhad been filed; Mo., a valuableconstituenthad beenomitted,and the label was false the labeling containedfalse and misleadingrepresentationsthat the and misleadingsince the article was deficient in vitaminD (approx. article was a drug for investigationaluse; and the labeling lacked 90 percent);402(b)(1),403(a).Default decree ordereddestructionor adeqautedirections for use, since It was a new drug lacking an releaseto public/charitableInstitutionfor use as animalfeed. (45) effective New Drug Applicationand the article did not complywith Poultryfeed, medicated, Starter, City,W. Mo. the exemptingregulationsfor Investigationaldrugs; 505(a), 502(a), QB Plus at Kansas Dist. Defaultdecreeordereddestruction. Charged4-13-65:while held by QulsenberryMills, Inc., KansasCity, 502(f)(1). (60) Mo., the article had beenpreparedfrom the food additivenihydrazone, Olmethylpolyslloxanefluid, at BeverlyHills, S. 01st.Calif. whichhad beenshippedin interstatecommerce,and it and its use and Charged4-19-65:while held by HarveyD. Kagan M.D., BeverlyHills, Intendeduse failed to conformto regulationor exemption;the strength Calif., the labelingof the article, which the holderhad repackedInto of the article was deficient;and the label false and misleadingsince unlabeledbottles for use by Injection into humans,lacked adequate the article was deficient In nihydrazone(approx.50 percent)(see directions for use and was not exempted,since it lacked required D.D.N.J. No. S605); 402(a)(2)(C),409, 501(c), 502(a). Default decree informationfor use by licensedpractitioners;502iful). Defaultdecree authorizeddonationto public/charitableinstitutionfor use as animal ordereddestruction.(II) feed. (46) Nepcozymetablets,at Wyandotte,E. Dlst. Mich. Poultryfood, medicated,ArizonaStar, at Phoenix,Dist. Ariz. Charged11-13-64:while held by NewEnglandPharmacalCo., Wyandotte, Charged1-21-65:while held by ArizonaMilling Co., Phoenix,Ariz., the Mich., the labelingof the article, whichhad beenmanufacturedlocally articles had been preparedfrom the food additivenihydrazone,which for the dealerfrom arglnaseshippedin interstatecommerce,contained had been shippedIn Interstatecommerce,and It arid its use and false and misleadingtherapeuticclaims; and the articles labeling intendeduse failed to conformto regulationor exemption,since Its lackedadequatedirectionsfor use, since the article was a new drug labeling failed to declare nihydrazoneand it lacked other required andits labelingwasnot authorizedby an effectiveNewDrugApplication; statements;and the label was false and misleadingin claimingthe 502(a),502(f)(1),505. After New EnglandPharmacalCo. claimedthe article containednitrofurazoneand furazolidone(see D.D.N.J. No. 6620); article, and filed an answer, the court granted the Government's 402(aM2KC),409, 502(a).Defaultdecreeordereddestruction.(47) motion for judgmenton the pleadings,found the article mlsbranded under502(f)(1),and orderedthe article destroyed. StockFoodTonic,U. I., at Atlanta,S. Dist. Ind. (62) Charged2-23-65:whenshippedby the UnitedStatesFoodCo., Pleasant Bandage,adhesive,absorbent,sulfathiozolepads, U.S.P. Blue Cross, at City, Ohio,the article containedthe food additiveAmericanWormseed. Athol,Dlst. Mass. and It and its intendeduse foiled to conform to regulationor Charged5-5-65: when shipped by HamptonManufacturingCo., New exemption,since the article was Intendedfor continuousfree-choice Rochelle,N. Y., the article's quality and purity were deficient, and feeding to cattle, sheep, and young pigs; 402(a)(2)(C).409. Default the labelingfalse and misleadingas to sterility, since the article was decreeordereddestruction.(48) contaminatedwith living micro-organisms;and the article lacked the prescriptionlegend; 501(b),502(a),503(b)(4).Default decree ordered Food,medicated,Pre-Wean-R-Jets,at RedwoodFalls, Dlst. Minn. destruction, Charged 3-2-66: when shipped by DoughboyIndustries, Inc., New (63) Richmond,Wis., the article was deficient and its labelingwas false Bandages,nonadhesivogauze,U.S.P.. at Los Angeles,S. Dlst. Calif. and misleading,since the article was deficient in sulfamethazine Charged9-2-65: while held for sale, the quality and purity of the (approx.25 percent)and lackedexemptionfrom antibioticcertification; article were deficient and the label false and misleadingas to 501(c),502(a),502(1).Defaultdecreeordereddestruction.(49) sterility, since the article containedmold; 501(a)(1),501(b),502(a). Medicatedfood,at Louisville,w, Dlst. Ky. Defaultdecreeordereddestruction.(64) Charged3-30-65,amendedon or about 7-27-65:while held by Henry FruechtenichtCo., Inc., Louisville, Ky., the strength of the article, DRUGS/ Veterinary which had been manufacturedlocally by the dealerfrom on orsanilic acid premlx shipped In interstatecommerce,was deficient and its Iodine Tincture,Strong,Non-Official,veterinary,at Phoenix,Dlst. Ariz. Charged 12-28-65:when shipped by Albion VeterinarySupply, the labelingwas false and misleadingas to amountand efficacy,since the • * • article in diethylstilbestrol;501(c), article labeled"Strong Iodine Tincture(Non-Offici?l) Distributed was deficient 502(a). Consent by DairySupply * * *" manufactured,processed, decreeordereddestruction.(50) Beck's Co. had been packed,and held under conditionslackingcurrentgood manufacturing Medicatedfood, DakotaMaid,at GrandForks,Dlst. N. Dak. practice;and the strengthof the article was deficientand the label Charged3-23-66-while held by North DakotaMill & ElevatorCo., was false and misleadingas to amount,since the article was deficient Grand Forks, N. Dak., the strengthof the article, which had been in Iodineandpotassiumiodide(approx.28 percentiodineandapprox.22 manufacturedlocally by the dealer from diethylstilbestrolshipped In percent potassiumiodide); 501(a)(2)(B),501(c),502(a).Default decree interstatecommerce,was deficient and its labeling was false and ordereddestruction.(63) misleadingas to amountand efficacy,since the article was deficient In diethylstilbestrol;501(c), Procainepenicillin,veterinary,U.S.P.,at KansasCity, W. Dist. Mo. 502(a).Defaultdecreeauthorizeddonation Supply to public''charitableInstitutionfor use as animalfeed. (51) Charged5-14-65:while held by EdwardsVeterinary Co., Kansas City, Mo., the strengthof one lot of the article was deficientand the labelingfalse and misleadingas to strength,since the article was DRUGS/ HumanUse deficientin penicillin(approx.16 percent),and no antibioticcertificate Lounges,Blo-Loi,at WestHazelton,M. Dist. Pa. or releasewas In effect for both lots, since the expirationdate for Charged1-27-66:when shippedby SchlicksupDrug Co., Inc., Peoria, the drug had passed;501(b),502(a),502(1X2)-Defaultdecreeordered III., the strengthof the article was deficientand the labelingfalse destruction. (66) and misleading,since the article was deficient in tyrothrlcin and benzocalneand the article lackedan antibioticcertificateor release; MEDICALDEVICES 501(c),502(a), 502(1).Defaultdecreeordereddestruction. (52) Electro-therapydevice,Rose, at Atlanta,N. Dist. Ga. Pituitarytablets,at Pasadena,S. Oist.Calif. Charged12-14-65:when shippedby Rose Electro-TherapyManufacturing Charged6-11-65:while held for sale, the labelingof the article labeled Co., Los Angeles,Calif., the accompanyinglabeling containedfalsa "Tabletspituitary• • * Nelson-BoyerCompany• • * Glendale,Calif. and misleadingtherapeuticclaims; and the article was dangerousto • * * Oral don * * *," which had been manufacturedlocally from health when used as directedby its labeling;502(a),502(j). Default pituitary shipped in Interstatecommerce,lacked adequatedirections decreeauthorizedreleaseto FDA. (67) for use and was not exemptfrom such requirement;502(fXl). Default rtlng chairs, pads, units, Niagara, Denver, decreeordereddestruction. and heating and ether at (53) Dlst. Colo. Amphetaminedrugs,various,ot Lewlsvllle,S. Dlst. Ind. Charged4-15-65:while held by Niagaraof Colorado,Denver,Colo., Chargedon or about9-8-64:while heldby MarlonR. Scheetz,M.O., the the accompanyinglabeling containedfalse and misleadingtherapeutic labelinglackedadequatedirectionsfor use and the articles were not claims;and the labelingof the articles lackedadequatedirectionsfor exemptas prescriptiondrugs,sincetheywerenot for use or dispensing the therapeuticuses for which the articles were offeredby Mel Hopf, in professionalpractice;502(f)(1).Defaultdecreeordereddestruction. salesmanfor Niagara of Colorado;502(a), 502(f)(1).Default decree («) authorizeddonation of 3 chairs, after all electrical units were

FDA Papers / March 1967 / 35 removed,to public'charitableinstitution,and releaseof the remainder ChemicalCorp., Chicago,III., the article was an extremelyflammable

of the articlesto FDA. (66) substance,and its containerslacked a numberof the requiredcon 8>

spicuous statements;2(p)(l)(E,F I). Vibratingand heatingchairs,and etherunits, Niagara,at Denver,Dist. Colo. label Default decree ordered Charged3-10-65:whenshippedby NiagaraTherapyManufacturingCorp., destruction.(64) Los Angeles. Calif., and Brocton, NY., the accompanyinglabeling NOTICESOF JUDGMENTon CriminalCases containedfalse and misleadingtherapeuticclaims; and while held by Niagara of Colorado Denver, Colo., the articles' labeling lacked UNFITFOOO adequatedirectionsfor the therapeuticuses for which the articles GeorgeH. Leach,t/a PlalnviewCanningCo., Plainview,N. Dist. Tex. were offered by Mel Hopf, salesmanfor Niagaraof Colorado;502(a), Charged8-3-66:when shipped,cannedtomatoescontaineddecomposed 502(f)(1).Default decree authorizeddonationof 4 chairs to public/ tomato material and contained excessive tomato peel; 402(a)(3), charitableinstitution,and releaseof remainingdevicesto FDA. (69) 403(h)(1).Guiltyplea;fine. (65)

Vibratingand heatingchairs, pads, and ether units, Niagara,at Denver, Brinkley t Co., Inc., andHenryW. Brinkley,president,Petersburg, E. Dist.Va.

Dist. Colo. Charged7-18-66:flour was held in a building accessibleto rodents Charged7-16-65:while held by Niagaraof Colorado,Denver,Colo., and contaminatedwith rodent filth; 402(a)(3),402(a)(4).Guilty pleas; the labeling lacked adequatedirectionsfor the therapeuticuses for fines. (86) which the articles were offered by Cyril Ruder and Melvin Hopf, LedermanBros.Bakery,Inc., and Beryl Lederman,president,Worcester,Dist. salesmenfor Niagaraof Colorado;502(f)(1).Defaultdecreeauthorized releaseto FDA. (70) Mass. Charged1-19-66:flour was held in a buildingaccessibleto insectsand Exerciserdevice,electronic,Figurecare,at St. Paul, Dist. Minn. contaminatedwith insect filth; 402(a)(3),402(a)(4).Guilty pleas; fines. Charged12-10-65:while held by Figurecare,St. Paul, Minn.,the labeling (87) lacked adequatedirectionsfor the therapeuticuses for which the article was offeredby Mrs. Irene Rice, a sales representativeof the PRESCRIPTIONDRUGS J. dealer; 502(f)(1).Default decreeauthorizedrelease to FDA. (71) Andrew Persichand Anthony01 Donato,Peoria, S. Dist. III. lack aid device,MarkFore,at Portland,Dist. Maine. Charged 9-23-64: conspiracy to dispense amphetamine-containing Charged3-14-66:when shippedby Market Forge Co., Everett,Mass., tablets without a prescription;and amphetaminesulfate tablets and the labeling containedfalse and misleading therapeutic desoxyephedrinehydrochloridetablets were dispensed without a statementsand prescription;18 U.S.C.371, Guilty plea by Persich;fine and claims;502(a).Defaultdecreeordereddestruction.(72) 503(b)(1). probation.Guiltyplea by Di Donato;fine, plus costs. (88) Slant boards,Dr. Jensen's,at Phoenix,Dist. Ariz.

Johnston, Pharmacy,Detroit, E. Chargedon or about5-13-66:whenshippedby BernardJensenProducts, WilliamE. t/a Willis Dist. Mich. Solana Beach, Calif., the accompanyinglabeling Charged5-11-65 by grand jury: penicillin tablets and Enovidtablets containedfalse and weredispensedwithoutprescription; Guiltyplea; imprisonment misleadingtherapeuticclaims;502(a).Defaultdecreeordereddestruction. 503(b)(1). (73) under21 U.S.C.4208(b). (89)

Bath-pumpdevice,AquassageWhirlpool,at Joplln, W. Dist. Mo. DwlghtM. Hoke,M.D., Beckley, S. Dist., W. Va. Charged9-30-65:when shippedby DakonCorp., New HydePark, N.Y., Charged 3-7-66: meprobamatetablets were dispensedwithout pre the accompanyinglabelingcontainedfalse and misleadingtherapeutic scription;503(b)(1).Guiltyplea;probation. (90) claims; 502(a).Defaultdecreeordereddestructionof the accompanying Paul Cole, t/a Paul Cole Drug Co., and Thomas F. Evans, pharmacist, labeling and authorizeddonationof the devices to public'charitable LaGrange,N. Dist. Ga. institution. (74) Charged5-4-66:Librium capsulesand Equaniltablets were dispensed Vacuumcleaner,Filter Queen,at Fresno,S. Dist. Calif. as unauthorizedrefills; 503(b)(1).Nolo contenderepleas; fines. (91) Charged 5-3-65:while held for sale, the labelingof the article lacked Arthur C. Bryant, truck stop owner, and James E. Walker, truck stop adequatedirectionsfor the therapeuticuses for which the article manager,RichmondHill, S. Dist. Ga. was offeredby E. Ludvickson,representativefor ReglnaFresnoAgency, Charged11-1-65:secobarbitalsodium capsules, pentobarbitalsodium Fresno, Calif.; 502(f)(1).Default decree authorizedrelease to FDA. capsules, penicillin tablets, and dextroamphetaminesulfate tablets (75) were dispensedwithoutprescription;503(b)(1).Guilty plea by Bryant; PROPHYLACTICS fine and probation.Nolo contendereplea by Walker; fine and pro bation. (92) Prophylactics,rubber,at Chicago,N. Dist. III. Charged Joe Simmons,t/a Joe SimmonsCafe 8. Truck Stop, and OonnieSimmons, 7-5-66,amended8-2-66:when shippedfrom London,England. stop New York, N. Y., Northfleld,Ohio,Chicago.III., or Newark,N. J., the truck employee,Robertsdale,W. Dist.Ala. quality article, Charged5-3-66:dextroamphetaminesulfatetabletsand desoxyephedrine of the whichhad beenrepackedlocallyfrom commingled hydrochloride lots, was deficient and the labelingfalse and misleading,since the tablets were dispensedwithout prescription;503(b)(1). article containedholes fapprox.2.3 percent);501(c), Guiltyplea by DonnieSimmons;probation.Guiltyplea by Joe Simmons; 502(a).Default imprisonmentandprobation. decreeordereddestruction.(76) (93) F. S. Prophylactics,rubber,at Fort Worth,N. Dist.Tex. Leland Andersonand Wayne Anderson,partners in a drug store, Charged shippedby Carlisle, S. Dist. Ind. 3-30-66:when Barnett's,Inc., the quality of the Charged article was deficient and the labelingfalse and misleading, it 7-15-66:Librium capsulesand Diuril tablets were dispensed since without prescription; Nolo contenderepleas; fines. containedholes (approx.0.7 percent);501(c),502(a).Default decree 503(b)(1). (94) ordereddestruction.(77) Armon Boswell Neel, St., t/a Neel's Pharmacy,and Clinton C. O'Brien, pharmacist,Griffin.N. Dist. Ga. Prophylactics,rubber,RoyalKnight,at Columbia.Dist.S.C. Charged shippedby Co., Inc., Charged5-4-65:Biphetamine12V4capsuleswere dispensedas unauthor 4-18-66:when Allied Latex Sales the pleas; probations. quality of the article was deficient and the labelingfalse and mis ized refills: 503(b)(1)-Nolo contendere fines and (95)

leading,since It containedholes (approx.0.9 percent);501(c),502(a). Harris MedicalCenterPharmacy,Inc., Edward J. Berlnsteln,presidentand

Defaultdecreeordereddestruction.(76) treasurer,and Ugo Giannasi,William J. Cizek,and EugeneA. Pederzoll, Jr., pharmacists,Springfield.Dist. Mass. HAZARDOUSSUBSTANCES Charged3-25-65:Premarintabletswere dispensedwithoutprescription, Spansulecapsules dispensed Ceramicglazeremover,Gold-Off,at Stewartsvllle,Dist. N.J. and Dexedrine and Miltown tablets were Charged shipped Inc., Mo., as unauthorizedrefills: 503(b)(1).Guilty plea by corporation;fine. 3-22-65:when by Etchall, Columbia, the pleas individuals;fines, article was an eye irritant and corrosive substance containing Guilty by suspendedsentences,andprobations.(96)

ammoniumbifluorlde(approx.21 percent),and its containerslackeda ThomasH. Goldberg,t/a ThomasH. Goldberg'sChemistShop,and Walter E. number of the required conspicuous label statements; 2(p)(l) Colvin,pharmacist,Providence.Dist. R.I. (B,C,E,F,G& J). Defaultdecreeordereddestruction.(78) Charged3-10-66:Butisol Sodiumtablets and DexedrineSulfatetablets Penetrantoil, Loose'nIt, at GasCity, N. Dist. Ind. were dispensedas unauthorizedrefills; 503(b)(1).Guilty pleas; fines. Charged7-19-65:when shipped by Spee-DeeChemicalProductsCo., (97)

Davison,Mich., the article was a toxic substancepresentinga special FreemanDrug Co., a partnership,Joseph C. Freeman,partner,and Robert hazardbecauseof its petroleumdistillate content,and its containers M. Lee,pharmacist,LaGrange,N. Dist. Ga.

lackeda numberof the requiredconspicuouslabel statements;2(p)(l) Charged5-4-66:Enovidtablets were dispensedwithout a prescription, (BE & F), 3(b). Defaultdecreeordereddestruction.(60) and Equaniltablets and Biphetamine20 capsuleswere dispensedas Repellent,x.33, actions, Somervllle, Brookllne, unauthorizedrefills; 503(b)(1).Nolo contenderepleas; partnershipand Water 7 seizure at Sudbury, Lee,fined; Freeman, and Sharon,Dist. Mass., Vestsburg,W. Dist. Mich., and Waterboro, fine andprobation. (99) Dist. Maine. Georgla-MabletonDrug Corp., t/a Llggett-RexallDrugs, Joe A. Ballew, Chargedbetween5-14-64and 2-15-65:when shipped by Wilmington pharmacist-manager,and Eddie Frank Daniel, pharmacist,Mableton,N. ChemicalCorp., Chicago,III., the article was an extremelyflammable Dist. Ga. substance,and its containerslacked e numberof the requiredcon Charged5-11-66:Miltown tablets and DexedrineSulfate tablets were spicuous statements; label 2(p)(l)(E,F& I). Default decree ordered dispensedas unauthorizedrefills; 5031(b)(1).Nolo contenderepleas; destruction.(61) fines. (99) 7 S. seizureactions,at Columbusand Owensvllle, Dist. Ind., Wenatchee, HerbertOelschlegel,t/a Thrifty Drug#1, at CorpusChrlstl, S. Dist. Tex.

E. Dist. Wash.,Rice Lake,W. Dist. Wis., Monroe,Dist. Maine,Bloomer, Charged11-22-65as violationof probation:quinidlnesulfate tablets, W. Dist.Wis., andKamrar,N. Dist. Iowa. quininesulfatetablets,thyroidtablets,progesteronetablets,endothyrin

Chargedbetween3-22-65and 5-27-65:when shippedby Wilmington tablets,and Benzestroltablets were dispensedwithout a prescription; ChemicalCorp., Chicago,III., the article was an extremelyflammable 503(b)(1).The court found probation had been violated, revoked

substance,and some of its containers lacked 6 of the required probation,and imposedimprisonment.(100)

conspicuouslabel statements;and other containerslacked 3 of the I), required conspicuouslabel statements;2(p)(l)(B.C,E,F.G & 2(p)(l) Notices of Judgment are given pursuant to section 705 of the S (E.F I). Defaultdecreeordereddestruction.(82) Federal Food, Drug, and Cosmetic Act and section 13 of the Federal actions, Alnsworth,Valentine,Mullen, Elba, Loup Hazardous Substances Labeling Act. Notices of Judgment report 12 seizure at Farnam. involving City, Sargent,Ord, Scotia,TableRock,Eddyvilleand Kimball,Dist. Nebr. cases seizure proceedings, criminal proceeding, and in Charged12-3-65:when shippedby WilmingtonChemicalCo., Chicago, junction proceedings. Seizure proceedings are civil actions taken III., the article was an extremelyflammablesubstance,and its con against goods alleged to be in violation, and criminal and injunc tion proceedings are against firms or individuals charged to be tainers lacked a numberof the requiredconspicuouslabel statements; responsible for violations. The cases generally involve foods, drugs, & 2(p)(l)(E,F I). Defaultdecreeordereddestruction. (83) devices, cometics, or hazardous substances which were alleged to

20 seizureactions,at Rolla, E. Dist. Mo.. Wellesley.Dist. Mass.,Aliquippa, be adulterated or misbranded or otherwise violative of the law when W. Dist. Pa., Gallatin,W. Dist. Mo., Benton. E. Dist. Ark., Suver,Dist. introduced into and while in interstate commerce, or while held for Oreg., Greensburg, S. Dist. Ind., Omak, E. Dist. Wash., Milo, Dist. sale after shipment in interstate commerce. Maine, Ellsworthand Richmond.W. Dist. Wis., Aberdeen,Dist. S. Dak.. Published by direction of the Secretary of Health, Education, and Lewlstown,Dist. Mont.,Connell. E. Dist. Wash.,Jeffersonville, S Dist. Welfare. Ohio, La., Eva, Ala., Lake Providenceand Vidaha.W. Dist. N. Dist. GODDARD, Pittsfleld, Dist. Maine,and Alamo.Dist. N. Dak. JAMES L. Commissioner of Food and Drugs.

Charged between4-1-64 and 4-22-65: when shipped by Wilmington WASHINGTON, D. C, March 1, 1967. / 36 I March 1967 FDA Papers THEY WEAR THEIR LABELS WITH I Diane Place/ Detroit 2 Leona All- man/Dallas 3 Josephene Simpson/ DISTINCTION Consumer Specialists in New Orleans 4 Carolyn Miller/ Cin FDA's 18 Districts are distinguished for cinnati 5 Lois Meyer/ Buffalo 6 Elaine McNally/Los Angeles 7 Helen their professional training and for lead Keaveny/ Denver 8 Marguerite Rob ership in behalf of the American con inson/Chicago 9 Julia Hewgley/ Baltimore 10 Yolan Harsanyi/ Boston sumer. They provide a two-way channel II Una Wood/San Francisco 12 of communication . . . explaining the Lorena Meyers/Kansas City 13 life-protection mission of FDA to pro Blanche Erkel/ Minneapolis 14 Joan Bergy/Seattle 15 Mary Gill/ New York fessional and consumer groups and re 16 Wilhelmina Lombardi,'Atlanta 17 porting consumer needs and attitudes Jeanne Devers/ Philadelphia 18 Lor- etta Louis back to FDA. Johnson/St. United States PUSIAtet WIU rtca t-mir government printing office U. S. GOVERNMENT PRINTING OFFICE DIVISION OF PUBLIC DOCUMENTS WASHINGTON, D. C. 20402

OFFICIAL BUSINESS

Announcements

THE FOOD AND DRUG LAW INSTITUTE, FDA INDUSTRY WORKSHOPS During March and April, FDA Districts and BDAC INC., will hold a Second Annual One- Field Offices will conduct a series of workshops and regional conferences on specific Day Seminar on "Legal Guidelines for compliance problems of major health significance. These problems deal with Self Regulation in Advertising, Labeling drugs (good manufacturing practices (GMP) and drug abuse control) and foods and Promotion of Drugs" at the School (microbiological contamination, chemical residues, and sanitation) . Anyone de of Law, Northwestern University. Chicago. siring further information should contact the nearest District or BDAC Field Office. III., April 14.

SCHEDULE OF FDA WORKSHOPS AND CONFERENCES / MARCH & APRIL 1967 The meeting ". . . will afford members of the legal, medical, advertising and FDA District or promotional staffs of pharmaceutical BDAC Field Office Date Location Subject Area manufacturing concerns and their adver tising agencies, an opportunity to bring Atlanta March Atlanta, Ga. Drugs—GMP up-to-date their own information in this March 15 Atlanta, Ga. Sanitation in Food important area. It will provide, too, a Wareb'*- !ng special opportunity for Midwestern staff Boston March 28 Boston, Mass. Drugs—UMP who were unable, because of time and March 30 Hartford, Conn. Drugs—GMP distance involved, to attend the earlier President, Eastern program,"' said FDLI Buffalo March 7 Albany, N.Y. Drugs—GMP Franklin M. Depew. March 9 Syracuse, N.Y. Drugs—GMP March 14 Pittsburgh, Pa. Drugs— G7P The panel pf experts will include Dr. March 16 Buffalo, N.Y. Drugs—GMP R. S. McCleery''and H. W. Chadduck, Division of Medical Advertising, FDA; Kansas City March 14 Manhattan, Kans. Medicated Feeds Mr. J. K. Kirk, Associate Commissioner March 29 Ames, Iowa Salmonella in Dried for Compliance and J. Hauser of that Milk FDA office. March 31 Lincoln, Nebr. Salmonella in Dried Milk Representing industry is David Sutton, New Orleans March 9 Mobile, Ala. Pecan Shellers V. P. Marketing, Arnar Stone Labs., and President of the Midwest Pharmaceutical St. Louis March 2 Little Rock, Ark. Sanitation in Food Advertising Club; Warren Whyte, At Warehousing torney, Abbott Labs.; Arthur Wright, Attorney, Baxter Labs. Seattle March Northwest Canned & Frozen Foods with North S. H. Willig, FDLI, will be the princi west Canners & Freezers pal lecturer. Mr. Willig is Professor of March 20-21 Corvallis, Oreg. Drugs—GMP and Drug Law at Temple University. "Pro Drug Abuse Control fessor Willig enjoys the respect of industry heads anl government officials Baltimore April Richmond, Va. Canned Foods for his objective and reasonable approach to effectuate compliance with the Act Detroit April 11 Michigan Drugs—GMP and its auxiliary regulations, and is (Jointly with April 17 Columbus, Ohio Drugs—GMP called upon frequently for assignments and consultations," said Mr. Depew. Cincinnati District)

Pre-registration prior to April 1 if (Jointly with April 20 Lafayette, Ind. Drugs—GMP recommended. The $25 registration fee Cincinnati includes luncheon. Write: Franklin M. District) Depew, President, Food and Drug Law Institute, Inc., 205 East 42nd Street, New Philadelphia April 5 Philadelphia, Pa. Drugs— GMP York, N. V. 10017. April 6 Philadelphia, Pa. Drugs— GMP