S. HRG. 108–997 REGULATION OF DIETARY SUPPLEMENTS HEARING BEFORE THE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION UNITED STATES SENATE ONE HUNDRED EIGHTH CONGRESS FIRST SESSION OCTOBER 28, 2003 Printed for the use of the Committee on Commerce, Science, and Transportation ( U.S. GOVERNMENT PUBLISHING OFFICE 20–196 PDF WASHINGTON : 2016 For sale by the Superintendent of Documents, U.S. Government Publishing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Nov 24 2008 11:04 May 24, 2016 Jkt 075679 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 S:\GPO\DOCS\20196.TXT JACKIE SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION ONE HUNDRED EIGHTH CONGRESS FIRST SESSION JOHN MCCAIN, Arizona, Chairman TED STEVENS, Alaska ERNEST F. HOLLINGS, South Carolina, CONRAD BURNS, Montana Ranking TRENT LOTT, Mississippi DANIEL K. INOUYE, Hawaii KAY BAILEY HUTCHISON, Texas JOHN D. ROCKEFELLER IV, West Virginia OLYMPIA J. SNOWE, Maine JOHN F. KERRY, Massachusetts SAM BROWNBACK, Kansas JOHN B. BREAUX, Louisiana GORDON SMITH, Oregon BYRON L. DORGAN, North Dakota PETER G. FITZGERALD, Illinois RON WYDEN, Oregon JOHN ENSIGN, Nevada BARBARA BOXER, California GEORGE ALLEN, Virginia BILL NELSON, Florida JOHN E. SUNUNU, New Hampshire MARIA CANTWELL, Washington FRANK R. LAUTENBERG, New Jersey JEANNE BUMPUS, Republican Staff Director and General Counsel ROBERT W. CHAMBERLIN, Republican Chief Counsel KEVIN D. KAYES, Democratic Staff Director and Chief Counsel GREGG ELIAS, Democratic General Counsel (II) VerDate Nov 24 2008 11:04 May 24, 2016 Jkt 075679 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 S:\GPO\DOCS\20196.TXT JACKIE C O N T E N T S Page Hearing held on October 28, 2003 .......................................................................... 1 Statement of Senator McCain ................................................................................. 1 Statement of Senator Smith ................................................................................... 35 WITNESSES Beales, Howard, Director, Bureau of Consumer Protection, Federal Trade Commission ........................................................................................................... 26 Prepared statement .......................................................................................... 28 Bell, Charles W.F., Programs Director, Consumers Union of U.S., Inc. ............. 55 Prepared statement .......................................................................................... 58 Letter dated February 10, 2000 from Karen Schlendorf ............................... 65 Davis, Greg, Student, University of San Diego School of Law ............................ 66 Durbin, Hon. Richard J., U.S. Senator from Illinois ............................................ 7 Grollman, Arthur P., M.D., Distinguished Professor, Pharmacological Sciences; Evelyn Glick Professor, Experimental Medicine, State University of New York at Stony Brook ............................................................................... 47 Prepared statement .......................................................................................... 49 Hatch, Hon. Orrin G., U.S. Senator from Utah .................................................... 2 Prepared statement .......................................................................................... 4 Madden, Terry, Chief Executive Officer, United States Anti-Doping Agency .... 37 Prepared statement .......................................................................................... 40 Seckman, David R., Executive Director/CEO, National Nutritional Foods As- sociation (NNFA) .................................................................................................. 41 Prepared statement .......................................................................................... 44 Taylor, John M., Associate Commissioner, Regulatory Affairs, Food and Drug Administration ..................................................................................................... 12 Prepared statement .......................................................................................... 14 APPENDIX Biden, Jr., Hon. Joseph R., U.S. Senator from Delaware, prepared statement . 77 Breaux, Hon. John B., U.S. Senator from Louisiana, prepared statement ......... 75 Lautenberg, Hon. Frank R., U.S. Senator from New Jersey, prepared state- ment ...................................................................................................................... 76 Letter dated November 25, 2003 to Hon. John McCain from David R. Seckman ................................................................................................................ 79 Sweeney, John E., U.S. Representative from New York, prepared statement ... 76 (III) VerDate Nov 24 2008 11:04 May 24, 2016 Jkt 075679 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 S:\GPO\DOCS\20196.TXT JACKIE VerDate Nov 24 2008 11:04 May 24, 2016 Jkt 075679 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 S:\GPO\DOCS\20196.TXT JACKIE REGULATION OF DIETARY SUPPLEMENTS TUESDAY, OCTOBER 28, 2003 U.S. SENATE, COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION, Washington, DC. The Committee met, pursuant to notice, at 9:30 a.m. in room SR– 253, Russell Senate Office Building, Hon. John McCain, Chairman of the Committee, presiding. OPENING STATEMENT OF HON. JOHN MCCAIN, U.S. SENATOR FROM ARIZONA The CHAIRMAN. Good morning. I want to thank the witnesses for appearing before the Committee today, especially those who made special arrangements to be here. The purpose of this hearing is to examine whether the current regulation of dietary supplements adequately informs and protects American consumers from the potential adverse health risks associ- ated with the use of certain supplements. Dietary supplements, as the witnesses can attest, are readily available, from the malls to the Internet, to consumers of all ages, and often are promoted with questionable marketing practices. I joined many of my colleagues, in 1994, in supporting the Die- tary Supplements Health and Education Act, DSHEA, or ‘‘the Act.’’ The intent of the Act was to alleviate certain unnecessary pre-mar- ket approval regulations on vitamins, minerals, and herbs which are considered safe supplements to the human diet. At that time, the objective was to strike a balance between providing consumers with better access to supplements that could be used to improve their health, on the one hand, and maintaining minimum health and safety protection for such consumers, on the other. While it is true that DSHEA succeeded in freeing many safe and useful supplements from unnecessary regulations, it is equally true that the Act appears to have provided a safe haven for substances that many experts believe pose potentially serious health risks. Of particular concern to many is the heavy use of supplements among teenagers. A 2001 national survey of 785 teens by Blue Cross/Blue Shield estimated that of the one million American children between 12 to 17 years of age, roughly 4 percent of that age group take at least one performance-enhancing sports supplement. Members of school sports teams appear particularly vulnerable to the lure of perform- ance-enhancing dietary supplements. For example, a 2001 study of 1,102 high school athletes in Westchester County, New York, found that 44 percent of the seniors, nearly all boys, had tried creatine. (1) VerDate Nov 24 2008 11:04 May 24, 2016 Jkt 075679 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\GPO\DOCS\20196.TXT JACKIE 2 This is not surprising, given that the supplement manufacturers appeared to target adolescent users through the use of enticing teen-friendly product names that incorporate terms like ‘‘extreme’’ and ‘‘Gen-X’’. While the long-term health consequences from the use of certain supplements are unknown, health experts warn that dietary sup- plements such as steroid precursors interfere with normal growth and bone development, cause hormonal imbalances, liver and kid- ney damage, and an increased risk of certain types of cancer. In fact, there is increasing concern in the medical community that to- day’s use of certain supplements could create a health crisis in the future. The Committee will hear testimony today about whether Amer- ican consumers are relying, to their detriment, on the notion that simply because supplements are so easily available and not illegal, they must be safe. I must tell my friends and colleagues that we obviously will, in some respect, refer to the recent reports in the media concerning allegations of a new type of steroid that has been uncovered recently. And I understand it’s the subject of an ongoing investigation. I’d like to thank my two colleagues from the Senate, who have been heavily involved in this issue for a long period of time, and I’d like to begin with the distinguished Chairman of the Judiciary Committee, Senator Hatch. Thank you, Senator Hatch, for being here, and thank you for the many years of work and effort you’ve put into this issue. Please proceed. STATEMENT OF HON. ORRIN G. HATCH, U.S. SENATOR FROM UTAH Senator HATCH. Well, thank you, Mr. Chairman. I appreciate you inviting us to this Committee, this important Committee, and I ap- preciate the opportunity to discuss a topic that’s very near and dear to my heart, and that is the regulation of dietary supple- ments. There is no question that tens of millions of Americans rely daily on safe dietary supplements to maintain