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PRODUCT RETRIEVAL PROCEDURES X-1 INDEX PAGE Overview 3 Analysis of FDA Recall Guidelines 4 A Product Retrieval Blueprint for Action 11 Food & Drug Regulations Title 21, Chapter 1 32 Subchapter A, Parts 7, 7.1 through 7.49 Method for Conducting Retrieval Effectiveness Checks 46 Published by Food and Drug Administration Example -- Corporate Retrieval Program 56 X-2 FOOD AND DRUG RECALL GUIDELINES OVERVIEW The regulations set forth in the Federal Register on June 16, 1978, established the following facts: 1. If an emergency of retrieval arises, it is the responsibility of a manufacturer or distributor to initiate voluntarily and carry out a retrieval of its product that is found to be in violation of the Food and Drug Act. 2. The retrieval must be initiated when the manufacturer discovers or is informed of the infraction. 3. The burden in carrying out a retrieval is totally that of a manufacturer or distributor. 4. Although a retrieval will be conducted by a manufacturer or distributor, it must be carried out to satisfaction of the FDA. To be able to conduct a product retrieval to the satisfaction of the FDA, the following preparation and conditions are essential: 1. An established contingency plan. 2. Assigned responsibility and authority to specific management personnel to carry out the contingency plan. 3. A thorough understanding of the regulation guidelines on retrieval. 4. Recognition of the urgency that FDA places on effectiveness, promptness and thoroughness. 5. Accurate documentation of ingredient and materials used. 6. Accurate documentation of distribution of products. 7. Accurate coding. The proof of effectiveness can only be learned through Trial Runs. X-3 ANALYSIS OF FDA RECALL GUIDELINES X-4 TABLE OF CONTENTS PAGE Legal Status 6 Recalls and Non-Recalls 6 Types of Recalls 7 Recall Conduct 8 FDA-Company Relations 9 X-5 RETRIEVALS AND RECALLS: FDA’s RECALL GUIDELINES FDA, on June 16, 1978, issued final regulations establishing recall guidelines, setting out current FDA policy on recalls, and the relationship between FDA and industry in conducting recalls. The final regulations, effective July 17, 1978, became 21 C.F.R. §7.3, 7.40-59. LEGAL STATUS The regulations are formally called “Guidelines” and, as to food products, are voluntary procedures recommended to industry. Their voluntary nature should not detract from recognizing the FDA power where industry cooperation is not given: FDA retains the court- enforced powers of seizure, injunction and criminal prosecution, and FDA claims that it can get a court to order a recall. While the basis for this claim is open to question, FDA’s unquestioned authority, as well as its control over publicity, as practical matter demand cooperation where FDA requests a recall. While FDA will not prosecute solely for failure to conduct a recall, such a failure may weigh heavily on the issue of company and individual good faith compliance with the law, and avoidance of product illegality, which are recognized criteria in prosecution decisions. RECALLS AND NON-RECALLS Recalls The guidelines recognize that not all removals of product from the distribution chain are “recalls.” Only where a product (1) has left the physical control of the vendor; (2) is in violation of the Act as adulterated or misbranded; and (3) would be subject to court action by FDA absent a recall, is a product removal a “recall.” Non-Recalls Any removal where the product in under the physical control of the manufacturer or distributor named on the label (and a public warehouse does not qualify for “physical control”) is a “stock recovery.” Any removal not involving a violation of the Act, or such a minor violation that FDA would not bring a court action if it knew of it, is a “market withdrawal.” Neither of these two removals needs to be reported to FDA and, if reported, neither will appear on FDA recall lists or enforcement reports. FDA encourages reporting “market withdrawals” wherever there is any doubt as to the issue of FDA’s enforcement policy absent a recall. X-6 Warning Manufacturers should be extremely careful in labeling their action -- for if it is labeled a “recall,” Attorney Eugene I. Lambert, of Covington & Burling, states “FDA or the manufacturer will have determined that there is sufficient evidence for FDA to demonstrate in court that a violation of the Act has taken place.” He further comments: “...if the manufacturer calls the action a ‘recall,’ it amounts to an admission that he has violated the Act with implications in product liability actions.” As a practical matter, manufacturers may be well advised to adopt a descriptive phrase not included in the FDA Guidelines for all internal corporate communications. For example, “product retrieval,” “product removal,” or a similar designation can be adopted for a firm for all internal use -- leaving the official determination of “recall,” “stock recovery,” or “market recovery” to the corporate lawyers and FDA. TYPES OF RECALLS Where a removal qualifies as a “recall,” it is either “Firm-initiated” or “FDA-requested.” An FDA requested recall exists only where a specific request is made by the Commissioner’s office in Washington (not by any field office) after FDA decides that there is a risk of illness, injury or gross deception, that action is needed to protect the public health, and the firm has not already initiated a recall. All other recalls, including those begun by a firm after being notified by FDA that a product is in violation of the Act, are “firm-initiated.” Recalls are also classified by the degree of hazard involved from the product, using the existing “I,” “II” and “III” designations. Class I recalls involve a “reasonable probability” of serious injury, illness or death. Class II recalls involve temporary or reversible adverse health effect, where the risk of serious effects is “remote.” Class III recalls are those where any adverse health effects are “not likely.” This classification is made by FDA and included in FDA reports of recalls. The hazard classification no longer automatically determines the depth of the recall; that is a separate issue often determined before any formal FDA type classification takes place. Based on recall classes, it is unlikely FDA would request what would be a Class III recall. X-7 RECALL CONDUCT FDA urges all firms to develop contingency plans for conducting a recall. In the absence of such plans, a recalling firm must develop a recall plan on a crash basis for a firm-initiated recall; where FDA requests a recall, it also provides instructions for the conduct of the recall. Recall planning must take into account (1) the depth of the recall; (2) recall publicity; (3) recall communications; and (4) effectiveness checks. Depth of Recall A recall plan may call for a warehouse, retail shelf or consumer return recall. The minimum recall level must take into account the amount of product distributed, its disposal at warehouse, retail and use levels, the nature and “obviousness” of the hazard involved and the difficulty of retrieval. While as a rule of thumb, recall Classes I, II and III generally correlate with consumer, retail and wholesale level recalls, the depth of the recall must be determined and justified in each case. Recall Publicity FDA media publicity concerning a specific recall (as opposed to routine listing of all recalls) is reserved for “urgent” cases where other means “for preventing use” appear inadequate; it will ordinarily be undertaken in consultation with the recalling form. As a practical matter, broad media publicity is more likely in an FDA-requested recall than in a firm-initiated recall. FDA also asks that it be given the opportunity to review any company press releases. Recall Communications In carrying out a recall, communicating with recipients of the product in a clear and direct fashion is of utmost importance. The recalling firm must: Identify specific product, down to lot or batch number; Describe the defect; Caution against further distribution or use, and; Instruct how to return the goods. An important element in these communications is prompt response from the recipient. The availability of a toll free number or the use of preaddressed, prepaid postcards can help both spur up and ensure prompt and full response from consignees about goods on hand and return preparations. X-8 Where a recall must operate through a number of levels of distribution, only one of which may be known to the manufacturer, it will be necessary to enlist and direct the assistance of subsequent distributors in spreading the recall message and retrieving the goods. Manufacturers must recognize that these services will not be provided gratuitously, and that the communications problems to be overcome will require extra effort. The alternative, however, to inadequate direct communications is media publicity, either by the recalling firm or FDA. Effectiveness Checks The guidelines place on the recalling firm the initial decision of the scope effectiveness checks, as well as the job of conducting those checks. A written guide on effectiveness checks is available from FDA. The vigor of the follow-up to see if direct accounts received and followed the recall message is essentially dictated by the same health considerations as the depth of recall: the greater the risk of serious adverse health consequences, the greater the need to check that the message was received and carried out. A significant risk of serious illness may require 100% follow-up; a labeling violation, 2% or none. FDA will state the level of effectiveness checks as an FDA- requested recall and will comment on the level proposed in a company-initiated action. FDA-COMPANY RELATIONS While FDA only “requests” that it be informed of recalls and stock recoveries, the Agency clearly anticipates compliance with this request.

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