In November 2003, FDA issued a new Guidance on product recalls. It applies to recalls of all FDA-regulated products: food (including animal feed), infant formula, drugs, medical devices, biologics, and cosmetics. The Guidance essentially consists of a checklist of information the Agency wants industry to provide to FDA in the event of a recall. FDA will use the information to evaluate, classify, monitor, and audit the recall.

For example, according to the Guidance, companies should submit two complete sets of labeling for the product being recalled, the product’s expected shelf life (if perishable), and the type of packaging used. The recalling company also should explain “in detail” how the recalled product is defective, violative, or both. If, for instance, the recall is due to the presence of a foreign object, the company should describe the object’s size, composition, hardness, and sharpness. The Guidance recommends that a company provide information on how and when the problem occurred, and how and when it was discovered. It further asks that companies submit detailed information about product distribution, such as the number of direct accounts, what type of accounts they are (e.g., repackers, consumers), and geographic areas of distribution.

According to the Guidance, companies also should submit considerable detail regarding their recall strategy. For example, they should explain their method of notification (letter, phone, email, etc.), identify the parties to whom the notification will be directed, and discuss how they will monitor the effectiveness of the recall. Recalls of products that pose a “significant health hazard” should also be announced in a press release through the Associated Press “to assure the broadest coverage.” FDA will issue a press release itself if it believes such action is warranted (i.e., if the company fails to do so or its release is believed to be inadequate).

FDA regulations, 21 C.F.R. Part 7, contain general recommendations for recalls, but the Guidance provides more detailed suggestions. Also, the regulations apply only to voluntary recalls, but the Guidance applies to both voluntary and mandatory recalls.