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Focus on Regulation

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7. The agency is turning to public warnings to alert the public that a recalled product presents a serious health hazard, where other means of preventing use of a recalled product appear inadequate. Although the guidance provides manufacturers some flexibility in communicating product recalls to the public, FDA articulates stringent standards for public notice, particularly with respect to how promptly they must issue public warnings.

FDA believes that public warnings are appropriate for actual or potential Class I recalls and for some urgent Class II recalls that present a serious hazard to health. They are typically needed where the recalled product is widely distributed or it is hard to identify to whom the product has been distributed; they are less useful where the products have only been distributed to direct accounts, so that a prompt and initial oral communication may suffice to prevent use. The guidance covers recalls of most FDA-regulated products, including food, drugs, medical devices, cosmetics, biologics, and tobacco products, whether the recall is requested by FDA or voluntarily initiated by the manufacturer.

In the guidance, FDA emphasized that manufacturers should be prompt in issuing a public warning. The agency typically allows firms to first prepare and issue a public warning during the recall, although it may issue a warning on its own and without notifying the manufacturer where an immediate warning is required. Although FDA will provide the manufacturer a timeframe for issuing a public warning when it requests that a firm recall a product, the guidance states that firms should issue a public warning within 24 hours of the agency’s notification that a public warning is appropriate. Consequently, manufacturers seeking to comply with agency guidance will be on a tight timeline when they or FDA initiate a recall that warrants a public warning.

Manufacturers may also need more caution in drafting their public warnings. FDA made clear that the content of a public warning should be consistent with the urgency of a public recall. A public warning should carry a headline that includes the brand name of the recalled product, its product type, and the hazard prompting the recall. It should also contain information to help identify the recalled product, including images and relevant product codes; packaging information or brand names; the geographic areas and dates of distribution of the product; a thorough description of the product defect, health hazard involved and reason(s) for recall; the name and contact information for the recalling manufacturer; instructions to consumers or users; the number and nature of any illnesses, injuries, or complaints associated with the product; and, a description of common symptoms of any illness of concern. Public warnings should not contain language that detracts from the warning, including any promotion of the product being recalled or of any of the firm’s products, or phrases that minimize the hazard, such as the commonly-used phrase, “an abundance of caution.”

Finally, FDA appeared to allow firms more leeway in selecting which avenues to use for disseminating their public warnings. Under the guidance, public warnings can be issued through various channels, including press releases to the media, emails to a listserv or subscription service, or posting on FDA and company websites and social media. However, the agency stressed that public warnings will be deemed to be deficient if they are not distributed to the appropriate audiences. If a manufacturer issues a press release for a recall, it should use press release distribution services and other mechanisms to ensure that the information will be relayed to the public, for example, through the news media. FDA may also post a manufacturer’s public warning on FDA.gov/recalls if the agency believes the warning is factually correct and would be beneficial for consumers.

If you have questions about the draft guidance or are facing decisions regarding recalls, please contact Meredith Manning, Rob Church, Jim Johnson, Carlo Felizardo, or the Hogan Lovells attorneys with whom you regularly work.