“The draft guidance is a key step to enhance the recall process,” said Scott Gottlieb, Ph.D., commissioner of the FDA, when the guidance was released Jan. 18. “It gives industry clear direction on how to navigate and work with the FDA. to make sure that recalls are communicated promptly. Ultimately, it will better empower consumers by providing more timely and more accurate information on recalled products.”
The draft guidance may be found here.
The Office of the Inspector General of the Department of Health and Human Services in late December issued a review saying the FDA’s food recall process sometimes falls short of ensuring the safety of the nation’s food supply. The review covered 30 voluntary food recalls “judgmentally selected” from the 1,557 food recalls reported to the FDA between Oct. 1, 2012, and May 4, 2015.
The FDA’s draft guidance is called “Public Warning and Notification of Recalls Under 21 CFR, Part 7, Subpart C; Draft Guidance for Industry and FDA Staff” and was published in the Jan. 19 issue of the Federal Register, which may be found here. The guidance covers food and other FDA-regulated products, including drugs, medical devises and cosmetics.
The FDA’s draft guidance, when finalized, will establish official guidance for industry and the FDA staff regarding the use, content and circumstances for the issuing of public warnings and public notification of voluntary recalls under federal regulations.
“Specifically, the draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning and describes situations where the FDA may take action to issue its own public warning should a company's warning be deemed insufficient,” Gottlieb said. “The draft guidance also describes the FDA's policy for moving forward with posting recalls to FDA's Enforcement Report before a final health risk determination is made.”
The guidance gave examples of when recalls may present serious hazards to health and may warrant a public warning:
- Recalls of food products initiated by a company after receipt of consumer reports of illness or injury, including allergic reactions, for which there is an active outbreak associated with the product or its ingredients, or for which the FDA has substantiated reports of illness or injury;
- Recalls of food products that are intended for or more likely would be consumed by vulnerable populations. Examples of vulnerable human populations include infants, toddlers, the elderly, pregnant women and medically-compromised individuals, who may be more susceptible to foodborne hazards than healthy persons;
- Recalls of food products initiated because of manufacturing deviations where the consequences of the manufacturing deviations could have significant health impacts; e.g., under processed low-acid canned foods that could result in botulism if the product is consumed;
- Recalls of food products initiated because of microbiological pathogen findings (e.g., Listeria monocytogenes, Salmonella, etc.) in environmental testing where direct food manufacturing contact surfaces are found to be contaminated.
While timeframes will vary depending on the recall, a company generally should issue a public warning within 24 hours of the FDA notifying the company that it believes a public warning is appropriate.
The guidance also covered what should not be included in the company’s recall, including any promotion of the product being recalled.
“Phrases such as ‘an abundance of caution,’ that can be seen as trying to minimize the hazard, should not be used, for example, when illnesses or injury have resulted, or when there are positive results for pathogens associated with the finished product or ingredients,” the guidance said.
A 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 recalled product, according to the guidance.
The guidance also covered how to issues press releases.
“The distribution of the release should match the distribution of the product: If the product is available online or is distributed nationally, the public warning should also be available online and/or distributed nationwide,” the guidance said. “Similarly, if the product is only available in a regional market, and FDA and the firm are confident that no consumers from outside that region may have received it, the distribution of the public notification may be similarly targeted.
“If it is apparent that a significant percentage of consumers using the recalled product speak a language other than English, firms should consider having the public warning translated into that language and distributed via the appropriate distribution service.”
The FDA will accept public comments on the draft guidance until March 20. Electronic comments may be sent through the www.regulations.gov web site. Comments also may be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. All submissions received must include the Docket No. FDA – 2016-D-3548 for “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.”