United States: USFDA Draft Guidance For Strengthening Public Warning And Notification Of Product Recalls

The United States Food and Drug Administration (USFDA) on January 18, 2018, released a draft guidance "Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C" explaining new policy steps for strengthening public warning and notification of recalled products which eventually ensure that a better, and timely information reaches to consumers. Although we often hear the most about recalled food products, this guidance covers recalls of other FDA-regulated products including drugs, medical devices and cosmetics.

According to the US Federal Regulations, Recall means removal or correction of such marketed product, by the manufacturer-marketer, which the FDA considers to be in violation of the laws it administers and against which the Agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery55.

The draft guidance specifically outlines the circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such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.

This guidance applies to voluntary recalls of products subject to FDA's jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under part 21 Part 1240. The draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol and Tobacco Tax and Trade Bureau (TTB) in seeking and monitoring recalls of such beverages.

About Public warning:

According to the draft, 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 but are likely to be classified as, or have been classified as Class I recalls, unless specific circumstances indicate that the warning would not be beneficial to the public. According to this draft guidance, following 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), where an active outbreak is 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 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.
  • Recalls of animal food products which may be contaminated with low levels of drugs or unsafe food additives. Examples include pet jerky treats contaminated with antibiotics, and cat food products containing propylene glycol.
  • Recalls of medical devices which may malfunction and lead to incorrect dosingof drugs or blood volumes.
  • Recalls of sterile injectable drug products with particulate matter.
  • Recalls of drug products associated with reports of death or other serious adverse events.

The public warning should have the information of:

  • 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;
  • 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 (e.g., product testing, environmental sampling, etc.);
  • The name and contact information for the recalling firm;
  • Instructions to consumers or users;
  • The number and nature of any illnesses/injuries/complaints associated with the product; and
  • A description of common symptoms of any illness of concern. 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."

The draft also suggests that Public Warnings by the relevant firm and FDA should be distributed and displayed by various means, including issuing press releases to the media, sending emails to a listserv or subscription service, and posting on FDA and company websites or social media. All of these methods could be used to issue a public warning.

About Public Notification of Recalls

FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the "FDA Enforcement Report", whether they were requested by FDA or firm-initiated, and the specific action taken by the recalling firm. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled. Unlike with public warnings, the recalls listed in the FDA Enforcement Report are not limited to urgent situations that present serious hazards to health and are not necessarily used to alert the public about the risk or hazard of a product under recall56.

Conclusion:

The draft guidance is a key step to enhance the recall process. It gives the 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 timely and accurate information on recalled products. This draft guidance is just the first in a series of policy steps FDA has planned, as part of a broader action plan to further improve the oversight of food safety and implementation of the recall process.

Note: This draft guidance contains Nonbinding Recommendations Draft to industry ff regarding the use, content, and circumstances for issuance of public warnings and public notifications.

Footnotes

55. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=7.3

56. https://www.fda.gov/downloads/Safety/Recalls/IndustryGuidance/UCM592851.pdf

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