On November 6, the US Food and Drug Administration (FDA) announced that its final guidance on Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff (Mandatory Recall Guidance) is now available. The Mandatory Recall Guidance provides information on the implementation of the mandatory food recall provisions of the Food Safety Modernization Act (FSMA). The Mandatory Recall Guidance comes in the form of a Q&A on common topics about the FSMA’s mandatory recall provision.
In the wake of a number of large-scale food contamination outbreaks and recalls, Congress enacted FSMA on January 4, 2011. Section 206 of FSMA (Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 423) significantly expanded FDA's enforcement powers over potentially dangerous foods. Under Section 423(a) of the FD&C Act, FDA has the authority to order the mandatory recall of foods for which there is a "reasonable probability" that the articles are "adulterated . . . or misbranded . . . and the use of or exposure to such article[s] will cause serious adverse health consequences or death to humans or animals." Prior to the enactment of the FSMA, FDA generally had to rely upon manufacturers' voluntary recall efforts or obtain a court order to remove contaminated or misbranded foods, other than infant formula, from the food supply.
Foods Subject to FDA’s Mandatory Recall Authority
Generally, all articles of food (other than infant formula) that are manufactured, processed, packed, or held at a food facility that is required to register under Section 415(a) of the FD&C Act. Infant formula is not covered under Section 423 because it has its own recall requirements under Section 412 of the FD&C Act. Further, the Mandatory Recall Guidance specifically notes that “food” includes dietary supplements, which are deemed to be foods under Section 201(ff) of the FD&C Act.
Who Is Subject to FDA’s Mandatory Recall Authority?
As mentioned above, the FSMA’s mandatory recall authority allows FDA to mandate a recall when a “responsible party” chooses not to conduct a voluntary recall when the criteria under Section 423 of the FD&C Act are met (discussed below). Section 417(a)(1) of the FD&C Act defines the term “responsible party” as a person who submits the required registration under Section 415(a) of the FD&C Act for a food facility where such article of food is manufactured, processed, packed, or held.
Criteria and Process for a Mandatory Recall
To mandate a recall, FDA must undergo a two-step process.
- FDA must first make the determination that there is a reasonable probability that the article of food (other than infant formula) is adulterated under Section 402 of the FD&C Act or misbranded under Section 403(w) of the FD&C Act. FDA must also make a determination that there is a reasonable probability that the use of or exposure to such food will cause “serious adverse health consequences or death to humans or animals” (SAHCODHA). In making this determination, FDA may consider any of the following:
- Significant food safety observations made during establishment inspections
- Results from sample analyses, which may include those for raw materials or finished food products, and certain sample swabs from the food facility manufacturing environment
- Epidemiological data on foodborne outbreak data directly related to the food product
- Vulnerability of the population that normally consumes or is exposed to the food product
- Nature of the food product (e.g., ready-to-eat, raw, or cooked food)
- Reportable Food Registry data
- Consumer and trade complaints
- Whether the responsible party has failed to initiate a voluntary recall
- After making the determination above, FDA must then provide the responsible party with the opportunity to initiate a voluntary recall. Under Section 423(b)(1) of the FD&C Act, if the party does not discontinue distribution and initiate the recall, the secretary of the US Department of Health and Human Services is empowered to order that distribution stop and require a recall. Should the secretary order a recall, the responsible party has the opportunity to request a hearing within two days to contest the order and convince FDA that the product should not be recalled.
The issuance of the Mandatory Recall Guidance provides another example of FDA attempting to improve its recall processes since the enactment of the FSMA. Other recent examples of this effort include the following:
- September 2018: FDA issued new draft guidance that describes situations when disclosing retail information for recalled products.
- January 2018: FDA issued new draft guidance on public warnings for consumers that outlined situations where FDA and companies would publicize public warnings to help carry out a recall.
To date, FDA has only had to issue one mandatory recall order of a food. In April 2018, it issued a mandatory recall order for all food products containing powdered kratom after several products were found to contain salmonella.
Responsible parties are encouraged to review, and update as necessary, their recall procedures to ensure proper alignment with FDA’s current thinking of its mandatory recall authority.