FDA Update: Agency Seeks to Strengthen Public Warning and Notification of Recalls, Exercises FSMA Enforcement Discretion
Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things:
- Issued a Draft Guidance to strengthen public warning and notification of recalls of foods, drugs, medical devices, and cosmetics (Recall Draft Guidance); and
- Released a Guidance outlining key areas where the Agency intends to exercise enforcement discretion in four of the rules that implement aspects of the FDA Food Safety Modernization Act (FSMA) (FSMA Enforcement Discretion Guidance).
Recall Draft Guidance
On January 17, 2018, FDA issued a Draft Guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C,” the goal of which is to better describe FDA’s policy on public warning and notification of recalled products to ensure better, more timely information reaches consumers.
The Draft Guidance discusses:
- circumstances when a company should issue a public warning about a recall;
- the general timeline for companies to issue such a warning;
- what information should be included in a public warning; and
- situations where the Agency may take action to issue its own public warning should a company’s warning be deemed insufficient.
The Draft Guidance also outlines FDA’s policy for moving forward with posting recalls to the Agency’s Enforcement Report before a final health risk determination is made.
Although it is not addressed in the Draft Guidance, in his statement regarding the same, Commissioner Scott Gottlieb, M.D., announced that FDA is developing a new policy on what information the Agency will make available to help the public to identify a hazardous recalled food. Typically, recall information provided on FDA’s website will include descriptions, lot codes, and photographs to help consumers and others identify affected products. Often times, some geographic or retail-related information will be provided, as well. Per Gottlieb’s announcement, FDA is planning to make additional recall information available to the public, which could include specific stores that may have sold a potentially unsafe, recalled food.
FSMA Enforcement Discretion
On January 4, 2018, FDA released an immediately-in-effect Guidance in which the Agency indicated its intention not to enforce certain FSMA regulatory requirements as they currently apply to certain entities and/or activities.
The enforcement discretion pertains to specific provisions in:
- “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 C.F.R. Part 117);
- “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 C.F.R. Part 507);
- “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 C.F.R. Part 112); and
- “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 C.F.R. Part 1, Subpart L).
The provisions relate to:
- facilities that would be farms except for certain factors and activitie;
- written assurances provisions in all four of the rules noted above related to the control of identified hazards or microorganisms that are a potential risk to public health;
- the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food; and
- foreign supplier verification program (FSVP) requirements for importers of food contact substances.
As some will recall, FDA had previously extended the compliance dates for many of the provisions covered by the FSMA Enforcement Discretion Guidance. Per the Guidance, however, the Agency is now exercising enforcement discretion, which means that during the enforcement discretion period, FDA does not intend to enforce the provisions as they currently apply to the entities and activities described above. These enforcement discretion policies will be in place unless and until the Agency takes further action on each of these issues.
We will continue to monitor these and other FDA regulatory developments and provide further updates as more information becomes available. If you have any questions regarding an issue raised in this post, or would like to submit comments on the Recall Draft Guidance to the Agency (which are due by March 20, 2018), please contact the author or the attorney at the firm with whom you are regularly in contact.