In May, the FDA published draft guidance for industry on how the agency plans to implement the mandatory food recall authority granted it under the Food Safety Modernization Act (FSMA). Although FDA has exercised this mandatory recall power twice since FSMA was enacted in 2011, the draft guidance outlines specific steps the agency will take and how food producers, distributors, and other “registered facilities” are expected to respond.
Prior to FSMA, FDA had to rely on food companies to voluntarily recall their products when requested. If a company refused, FDA was required to take often time-consuming legal steps, including obtaining a court order to seize and remove unsafe products from commerce.
Section 206 of FSMA gives FDA the authority to order a recall directly when the agency determines that there is a reasonable probability that an article of food (other than infant formula, which is covered under a separate recall procedure) is adulterated or misbranded and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals (known as SAHCODHA).
This authority covers all articles of food that are manufactured, processed, packed, or held at any food facility that is required to register under section 415(a) of the FD&C Act. FSMA defines “articles of food” as those used for food or drink for humans or animals, chewing gum, and articles used as components of any such food. As such, “food” also includes dietary supplements such as vitamins, minerals, herbs or other botanicals, amino acids, and substances to supplement the diet by increasing total dietary intake. Dietary ingredients also include extracts, metabolites, constituents, or concentrates, the agency says.
A “responsible party” is the person who submits a food facility registration, and can be an individual, partnership, corporation, or association. The owner, operator, or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring that the recall is performed, the FDA says.
Two conditions must exist before FDA can exercise its mandatory recall authority. First, FDA has to determine that there is a “reasonable probability” that the product is adulterated (under Section 402 of the FD&C Act) or misbranded (under Section 403(w) of the FD&C Act). Second, the agency must determine that there is a “reasonable probability” that the use of or exposure to such food will cause SAHCODHA.
According to the seven-page document, once FDA has determined that these criteria have been met, the agency must give the responsible party an opportunity to voluntarily stop distribution and recall the article of food. Notification will be given in written form “using an expeditious method.” If the responsible party still refuses or does not voluntarily cease distribution and issue the recall within the timeframe and manner specified by FDA, the agency may order the responsible party to cease distributing the food, order it to notify others to also stop distributing it, and provide an opportunity for an informal hearing. Only after all these steps are completed may FDA formally order a recall, and this authority is reserved only for the FDA commissioner.
Adulteration and Misbranding
According to the guidance document, food is considered adulterated when it bears or contains “any poisonous or deleterious substance which 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.”
Adulteration for a dietary supplement occurs when an ingredient represents a “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling; 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 secretary [of Health and Human Services] to pose an imminent hazard to public health or safety.”