FDA Posts “DRAFT” guidance on product recalls

January 17th the FDA, posted draft guidance for Recalls:  “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff.”

The draft covers all areas of the FDA. Here we’ll highlight some salient points  Food and Dietary Supplement, but by all means read the full posting to see examples for other FDA categories here.

For reference here’s the link to 21 CFR Part 7

FDA Commissioner Scott Gottlieb statement —

Today we published a draft guidance that better describes the FDA’s policy on public warning and notification of recalled products as part of our effort to ensure better, more timely information reaches consumers. Although we often hear the most about recalled food, this guidance also covers other FDA-regulated products including drugs, medical devices and cosmetics.

 

Specifically, the draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning,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’s full statement)

 

Under what circumstances should firms issue public warnings?

Public warnings are for urgent situations to alert the public that a product being recalled presents a serious hazard to health, and where other means for preventing the use of a recalled product appear inadequate  A public warning is also often needed when a recalled product has been widely distributed.

Examples of Food recalls

The following Food recalls present examples of serious hazards to health such that a public warning may be warranted:

  • Recalls of food products initiated by a firm 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 FDA has substantiated reports of illness or injury.
  • Recalls of food products that are intended for or would more likely 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 which 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.

Who prepares public warnings?

Since firms are “expected” to have a recall strategy 21§7.42(b), firms themselves may issue a recall, but the FDA continues to reserve the right to ensure a recall addresses, “among other things, whether a public warning is needed and how it will be issued.”  The FDA maintains the right to protect public safety as such “If a firm issues a public warning that is deficient in any respect the FDA may supplement or correct that warning with its own public warning.”

What should a public warning include?

The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health.  Public warning should be brief and concise and include:

  • Headline:
    • The headline of the public warning should include the brand name, type of product, and the hazard prompting the recall (e.g., “XYZ chocolate chip cookies recalled for potential Salmonella contamination.”).
  • Identity:
    • information to help identify the recalled product including images, codes (e.g., lot number, expiration date, serial number, unique device identification (UDI) number), packaging information or brand names;
  • Geography:
    • the geographic areas and dates of distribution of the product;
  • Defect/Hazard Description
    • a thorough description of the product defect, health hazard involved and reason(s) for recall (e.g., product testing, environmental sampling, etc.);
  • Name/Contact Information
    • the name and contact information for the recalling firm;
  • Consumer Instructions
    • instructions to consumers or users;
  • Defect details
    • the number and nature of any illnesses/injuries/complaints associated with the product; and
  • Illness description
    • a description of common symptoms of any illness of concern.

What NOT to include in  a public warning?

  • Nothing extra:
    • Nothing should detract from or defeat the purpose of the warning.
  • Nothing to diminish the hazard
    • Phrases such as “an abundance of caution,” that can be seen as trying to minimize the hazard, should not be used

How are Public Warnings Distributed and Displayed?

Firms and FDA can alert the public about a recall by various means, including (A) issuing press releases to the media, (B) sending emails to a listserv or subscription service, and (C) posting on FDA and company websites or social media. All of these methods could be used to issue a public warning.

Where are recalls reported?

FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report.

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