USFDA Draft Guidance For Strengthening Public Warning And Notification Of Product Recalls

The United States Food and Drug Administration (USFDA) on January 18, 2018, released a draft guidance "Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C" explaining new policy steps for strengthening public warning and notification of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The draft guidance specifically outlines the circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such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 The draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol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...