In May, the FDA published draft guidance for industry on how the agency plans to implement the mandatory food recall authority granted it under the Food Safety Modernization Act (FSMA). Although FDA has exercised this mandatory recall power twice since FSMA was enacted in 2011, the draft guidance outlines specific steps the agency will take and how food producers, distributors, and other “registered facilities” are expected to respond.
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Explore this issueJune/July 2015
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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.
About Ted Agres
Ted Agres is an award-winning writer who covers food safety regulatory and legislative issues from the nation’s capital in the Washington Report column. He has 40 years of experience in reporting on issues such as health policy, medical technology, and pharmaceutical development. He holds an MBA from Johns Hopkins University and a bachelor’s degree from the University of Chicago. He enjoys playing the piano, amateur radio, and paintball. He lives in Laurel, MD. Reach him at firstname.lastname@example.org.