FDA has released a draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff” (1/17/2018). It essentially discloses FDA’s intent to accelerate the release of recall information to the public, to better safeguard consumers’ health and well-being. Recalls of many FDA-regulated products will be covered.
The draft guidance is, in part, a prompt follow-up to a 12/26/2017 Statement made by FDA Commissioner Scott Gottlieb, M.D., on efforts to support more efficient and effective food recalls (see prior blog). That Statement was prompted by an OIG Report, “The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply (Dec. 2017), which found that FDA did not have policies and procedures adequate to ensure that food facilities take prompt and effective action in initiating voluntary recalls. Commissioner Gottlieb’s Statement acknowledged that the OIG Report raised “significant concerns.”
FDA’s draft guidance addresses some of these concerns. In a blog posting that accompanied publication of the draft guidance, Douglas Stearn, J.D., Director, Office of Enforcement and Import Operations, FDA’s Office of Regulatory Affairs, noted:
The public’s primary source for recall information is FDA’s weekly, web-based Enforcement Report. Historically, only recalls that have already been classified into one of three categories based on the severity of the hazard have been listed in the report. ***
However, recall classifications can sometimes take weeks – or even months when FDA needs to conduct a complex evaluation. ***
FDA has decided that the public would benefit by having recall information about FDA- regulated products as soon as possible, even though further evaluation remains to be done. Moving forward, FDA will include “not-yet-classified” recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while classification work is still ongoing.
FDA’s regulations governing recalls are codified at 21 C.F.R. Part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The draft guidance provides advice on topics raised by these regulations:
- 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?
It also discusses public notification of recalls through the FDA Enforcement Report.
Additional updates of FDA’s food recall practices may be forthcoming. The draft guidance does not address all concerns raised in the OIG Report. Also, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee is holding a hearing today (1/19/2018) about the “Safety of the U.S. Food Supply: Continuing Concerns Over the Food and Drug Administration’s Food-Recall Process. Mr. Stearn and Ms. Gloria Jarmon, Deputy Inspector General of Audit Services, OIG, HHS are scheduled to testify.