FDA Issues Draft Guidance on Mandatory Food Recalls
22 May 2015
The Food and Drug Administration has issued a guidance document on the implementation of the mandatory food recall provisions of section 423 of the Federal Food, Drug, and Cosmetic Act, which was added by section 206 of the FDA Food Safety Modernization Act of 2011. While the guidance document does not establish any legally enforceable responsibilities, it provides answers to common questions that might arise about the mandatory recall provisions and lays out the FDA's current thinking regarding their implementation.
Section 206 of FSMA gives the FDA the authority to order a responsible party to recall an article of food where the agency determines that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals. While the FDA continues to rely on responsible parties to voluntarily recall violative food products, the mandatory recall authority allows the agency to order a recall in instances where a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met.
The mandatory recall authority covers articles of food (other than infant formula) manufactured, processed, packed or held at a food facility that is required to register under section 415(a) of the FD&C Act. The term "food" refers to (i) articles used for food or drink for man or other animals, (ii) chewing gum, and (iii) articles used for components of any such article. Products labelled as a dietary supplement intended to supplement the diet and containing at least one dietary ingredient fall within the scope of the term "food." Dietary ingredient(s) in these products include vitamins, minerals, herbs or other botanicals, amino acids and substances for use by man to supplement the diet by increasing total dietary intake. Dietary ingredients can also be extracts, metabolites, constituents, concentrates, or a combination of any of the above-mentioned dietary ingredients.
Once the FDA has determined that the criteria for a mandatory recall have been met, it must first provide the responsible party (as defined in section 417(a)(1) of the FD&C Act) with an opportunity to voluntarily cease distribution and recall the article of food. The agency will provide this opportunity in written form using an expeditious method. If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, if so prescribed, the agency may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity for an informal hearing. After these steps are completed, the FDA may order a recall under section 423(d) of the FD&C Act if it is determined that the removal of the article from commerce is necessary.
Section 402 of the FD&C Act includes many reasons a food may be adulterated, including:
- if the food bears or contains any poisonous or deleterious substance that may render it injurious to health; consists in whole or in part of any filthy, putrid or decomposed substance or is otherwise unfit for food; or has been prepared, packed or held under insanitary conditions whereby it may be rendered injurious to health; or
- if the food is a dietary supplement or contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labelling; is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; or is a dietary supplement declared by the FDA to pose an imminent hazard to public health or safety.
Under section 403(w), a food, other than a raw agricultural commodity, is considered to be misbranded if it bears or contains a major food allergen and the label for the food does not identify the name of the food source from which the major food allergen is derived, either through a "contains" statement or in the ingredient list, as specified under section 403(w). Major food allergens are defined at section 201(qq) of the FD&C Act as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and any food ingredients that contain a protein derived from these foods (with limited exceptions noted under section 201(qq)(2)).
The FDA will evaluate all applicable evidence when determining whether there is a reasonable probability the article of food (other than infant formula) is adulterated or misbranded and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals. Evidence may include observations made during inspections of the responsible party or other parties, results from sample analyses, epidemiological data, Reportable Food Registry data, and consumer and trade complaints.
- Food & Beverages
- North America