Recalls, FDA

The recall of a defective or possibly harmful product by the US Food & Drug Administration (the FDA).

These recalls are often highly publicized in newspapers and on radio and TV news broadcasts. Recent headlines in major newspapers such as “FDA Orders Peanut Butter Recall” and “FDA Orders 6,500 Cases of Red-Dyed Mints Recalled” are examples of a misunderstanding by the media regarding the FDA’s role in product recall. These headlines imply that the FDA can “order” a recall. The FDA has no authority under the Federal Food, Drug and Cosmetic Act to order a recall. The FDA does have the authority to ask a company to recall a particular product.

The FDA has jurisdiction over food, drugs, cosmetics, medical devices and other products and serves as a monitor over product recalls. In most cases recalls are done voluntarily by the manufacturer or the distributor of the product. In some cases, a company will discover that one of its products is defective and will recall it. In others cases, the FDA will notify a company that one of its products is defective and will suggest or request a recall. Usually, the company will comply; if it does not, the FDA can seek a court order authorizing the Federal Government to seize the product.

The FDA has guidelines for companies to follow in recalling defective products. These guidelines explain that the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify the FDA when recalls are started, to make progress reports to the FDA on recalls, and to undertake recalls when asked to do so by the FDA.

The guidelines specify for manufacturers and distributors to develop contingency plans for product recalls that can be put into effect when needed. The FDA’s role under these guidelines is to monitor company recalls and assess the adequacy of a firm’s action. After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.

The guidelines categorize all recalls into one of three classes according to the level of hazard involved.

Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. One example is a drug that is under- strength, but that is not used to treat life-threatening situations.

Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violates FDA regulations. An example might be bottles of aspirin that contains 90 tablets instead of the 100 stated on the label.

The FDA develops a strategy for each individual recall that sets forth how extensively it will check on a company’s performance in recalling the product in question. For a Class I recall, for example, the FDA would check to make sure that each defective product has been recalled or reconditioned. In contrast, for a Class III recall the FDA may decide that it only needs to spot check to make sure the product is off the market.

Even though the firm recalling the product may issue a press release, the FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard. For example, if a canned food product, purchased by a consumer at a retail store, is found by the FDA to contain botulinal toxin, an effort would be made to retrieve all the cans in circulation, including those in the hands of consumers. As part of this effort the FDA could issue a public warning via the news media to alert as many consumers as possible to the potential hazard.

The FDA issues general information about all new recalls it is monitoring through a weekly publication (FDA Enforcement Report) which is available for purchase from the Government Printing Office, Washington, DC 20402, Telephone 202-783-3238.

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