7 Nov 2018
FDA Issues Mandatory Food Recall Guidance
The Food and Drug Administration issued on 5 November final guidance regarding mandatory food recalls. As FDA Commissioner Scott Gottlieb noted in a press release, his agency first gained authority under the 2011 Food Safety Modernization Act to mandate recalls when certain unsafe food products are identified and the manufacturer does not voluntarily remove the product from the market. Prior to the enactment of the FSMA, the FDA could generally only rely on manufacturers to voluntarily recall certain potentially harmful food products. While the FDA’s mandatory recall authority plays an important role in ensuring that potentially dangerous food products are removed from the marketplace, the agency remains committed to working with companies to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply.
The FDA has the authority to order a responsible party to recall an article of food where it determines that (i) there is a reasonable probability that such article is adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the FD&C Act, and (ii) the use of or exposure to such article will cause “serious adverse health consequences or death to humans or animals.” This circumstance is abbreviated in the guidance as SAHCODHA. There are many reasons a food may be considered “misbranded” or “adulterated,” including the following.
- if the food contains any poisonous or deleterious substance 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 have become contaminated with filth or rendered injurious to health
- if the food is a dietary supplement or contains a dietary ingredient that presents a significant risk of illness or injury under the conditions of use recommended 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 risk of illness or injury; or is a dietary supplement declared to pose an imminent hazard to public health or safety
- if a food 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
The FDA is committed to evaluating all applicable evidence in determining whether an article is adulterated or misbranded such that it will cause SAHCODHA. Examples of situations considered a SAHCODHA risk include Listeria monocytogenes or Salmonella spp. in ready-to-eat foods, certain undeclared allergens in food products, E. coli O157:H7 in leafy greens and botulinum toxin found in food products. Some past Class I food recalls representing these risks have included peanut butter, alfalfa sprouts and deli products found to be contaminated with Salmonella spp.; under-processed canned chili that contained Clostridium botulinum toxin; smoked salmon and pumpkin seeds found to be contaminated with Listeria monocytogenes; products containing undeclared allergens (e.g., milk, peanuts or eggs); baby food that posed a choking hazard; horse feed contaminated with elevated levels of monensin; pet foods contaminated with elevated levels of melamine and cyanuric acid or contaminated with Salmonella spp. or Listeria monocytogenes; and sheep feed containing elevated levels of copper.