By Dave Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) on Feb. 8 announced the availability of a final guidance for industry and FDA staff regarding the use, content and circumstances for issuance of public warnings and public notification of recalls.
FDA’s intent in issuing the guidance, entitled “Public Warning and Notification of Recalls under 21 CFR Part 7, Subpart C,” is to increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled.
Among other things, the final guidance provides recommendations on the following topics:
- Under what circumstances should firms issue public warnings?
- Who prepares public warnings?
- What information should be contained in a public warning?
- How are public warnings distributed and displayed?
The guidance states that FDA’s policy is to evaluate the particular circumstances of each individual recall in determining whether a public warning is needed. The guidance also states that 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 a recalled product appear inadequate. In general, FDA recommends public warnings for recalls that 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.
The guidance also discusses public notification of recalls through the FDA Enforcement Report. This report provides a public listing of products in the marketplace that are being recalled. However, 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 recall.