WASHINGTON — The Food and Drug Administration on Feb. 7 published a final guidance to industry and staff on the issuance of public warnings and notifications in connection with recalls of F.D.A.-regulated products, including human and animal food products. The release of the guidance is the latest in a series of F.D.A. actions aimed at modernizing and strengthening the agency’s recall procedures.
The guidance, “Public Warning and Notification of Recalls under 21 C.F.R. Part 7, Subpart C,” is the finalized version of the draft guidance on the same subject and with the same title that was issued in January 2018.
Scott Gottlieb, Ph.D., F.D.A. commissioner, in announcing the final guidance, acknowledged that most companies collaborate with the F.D.A. to rapidly initiate voluntary recalls and work with their supply chain partners to remove the recalled product from shelves to prevent further distribution.
“However, there are situations where the F.D.A. may need to provide safety advice to the marketplace to protect consumers,” Dr. Gottlieb said.
“The final guidance we’re issuing today outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the F.D.A. may take action to issue its own public warning should a company’s warning be deemed insufficient, ” Dr. Gottlieb explained.
The F.D.A. already has begun implementing the recommendations outlined in the final guidance.
“In accordance with the draft version of this guidance, we have issued alerts or consumer warnings related to many products like Kellogg’s Honey Smacks, recalled vegetables, romaine lettuce, angiotensin II receptor blocker drugs like valsartan, losartan and irbesartan, and King Bio homeopathic products,” Dr. Gottlieb said.
The final guidance explained, “Public warnings are for urgent situations and are issued to alert the public that a product being recalled presents a serious hazard to health, and where other means for preventing the use of the recalled product appear inadequate.”
The recalling company has the primary responsibility for issuing any necessary public warning. The F.D.A. noted the recalling company is expected to develop its own recall strategy, which should address, among other things, whether a public warning is needed and how it will be issued. In most cases, the F.D.A. will review and comment on the recall strategies, including any public warnings developed by companies. Developing a public warning should not delay the recall, though.
In some situations, companies may choose to issue public warnings without the F.D.A.’s review. In such cases, the F.D.A. may supplement that warning with its own public statement. When the F.D.A. believes that a public warning should be issued and the recalling company does not include one in its initial recall strategy, the F.D.A. will request the firm develop one.
The F.D.A. noted it may issue its own warning or supplement a company’s public warning in the following situations: a company refuses to issue its own public warning when one is recommended or requested by the F.D.A., an ongoing recall or public warning is not prompt or effective, or the F.D.A. learns of a completed recall where new adverse events associated with the product are reported after completion of the recall.
The F.D.A. indicated it generally will provide a timeframe for when the company should issue a public warning based on the circumstances of the individual recall. While timeframes will vary depending on the recall and product, the F.D.A. said a company generally should issue a public warning within 24 hours of the F.D.A. notifying the company that it believes a public warming is appropriate.
A public warning should include information to help identify the recalled product, including images, numerical product information (lot number, expiration date, etc.), packaging information or brand names; geographic areas and dates of distribution of the product; a thorough description of the product defect, the health hazard involved and the reasons for the recall; name and contact information for the recalling firm; instructions to consumers; number and nature of any illnesses/complaints related to product, and a description of common symptoms of any illnesses of concern.
“The headline of the public warning should include the brand name, type of product, and the hazard prompting the recall,” the guidance said, giving as an example: “XYZ chocolate chip cookies recalled for potential Salmonella contamination.”
A company’s public warning may be considered deficient if, among other things, it does not adequately identify the recalled product, describe the health hazard involved, or identify relevant information about the product’s distribution. It also may be deemed deficient if the warning does not sufficiently reach the target audience.
“It is critical that public warnings are distributed in such a way that ensure the information conveyed in the warning actually reaches the public,” the guidance said.
The F.D.A. said it was open to different vehicles to accomplish this. The distribution of any press release containing a warning should match the distribution of the recalled product. Also, the company should translate the warning into another language or languages if it is apparent that a significant percentage of consumers using the recalled product speak a language other than English.