WASHINGTON — Both Congress and federal regulators have accelerated efforts to defend populations whose sensitivity to major food allergens puts them at risk for illness or even death. In Congress, legislation requiring sesame be added to the existing list of eight major allergens subject to labeling requirements advanced with the Senate’s unanimous passage of the Food Allergy, Safety, Treatment, Education (FASTER) Act on March 3.
At the same time, the Food and Drug Administration in recent statements and through warning letters affirmed its commitment to ensuring food manufacturers comply with existing regulations pertaining to labeling allergens when they are present in foods. The FDA also warned food companies to ensure their manufacturing practices effectively prevent allergen contamination of foods that are supposed to be free from the major allergens.
On the legislative front, with the FASTER Act’s passage in the Senate, attention shifted to the House of Representatives, where the bill was introduced on Feb. 22.
Both the Senate and House passed the FASTER Act in 2020, but the 116th Congress was adjourned before the House could consider the Senate’s revised version of the bill. This left the bill to be reintroduced in each chamber when the 117th Congress convened. Final passage was not in question.
In addition to declaring sesame the ninth food allergen for which the Food and Drug Administration requires plain-language labeling, the FASTER Act would establish a process and framework for determining what additional allergens should be covered by the Federal Food, Drug, and Cosmetic Act.
Susan T. Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, in a recent statement, acknowledged the agency was aware of other allergens beyond the eight now subject to labeling requirements — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans — that may be subject to future actions, including sesame.
“Our goals are to provide consumers with the information they need to make informed decisions, to enforce regulations that require the industry to properly label food allergens, and to significantly minimize or prevent the presence of undeclared major food allergens in food,” Dr. Mayne asserted.
With regard to sesame, Dr. Mayne pointed to the FDA’s draft guidance for industry issued in November 2020 that encouraged manufacturers to voluntarily declare sesame in the ingredient list when it is used as a flavoring or spice, or when the common or usual name, such as tahini, does not specify sesame.
“This draft guidance is an initial first step while we explore other potential actions to protect consumers who may have allergies to sesame or other food allergens beyond the major eight,” Dr. Mayne explained.
“Approximately one-third of foods reported to the FDA through the Reportable Food Registry as serious health risks involve undeclared food allergens,” Ms. Mayne said. “Since March 2020, the FDA has sent warning letters to eight registered food facilities that have manufactured and distributed foods with undeclared food allergens that resulted in Class I recalls. Those registered food facilities are required by statute to implement food safety preventive controls that significantly minimize or prevent the hazard of undeclared major food allergens before the food is distributed.”
Dr. Mayne also noted the FDA in December 2020 sent a warning letter to Whole Foods Market for a series of major food allergen food recalls.
“This warning letter is the first time the FDA has warned a retailer for engaging in a pattern of misbranding food that they labeled,” Dr. Mayne said. “The food industry must and can do better to prevent exposing consumers to incorrectly labeled packaged food, which can cause serious and life-threatening harm.”
Anna El-Zein and John Johnson III of the law firm Shook, Hardy & Bacon LLP observed, “Recent actions by the US Food and Drug Administration suggest that in 2021 the agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare the presence of major food allergens.”
“In a series of high-profile warning letters and press releases, FDA confirmed that it is moving beyond expecting non-compliant food to be recalled and is concentrating on how companies are preventing the issue,” Ms. El-Zein and Mr. Johnson said. “Manufacturers and private labelers need to audit their practices and expect an FDA inspection, especially if they have had an allergen-related recall.”
David Acheson, MD, founder of the Acheson Group (TAG), said of the FASTER Act, “As major legislation in and of itself, the pending act is also indicative of the increased food regulation and enforcement that TAG sees as becoming a hallmark of 2021. As we gradually come out the pandemic — with more people vaccinated and vaccines hopefully providing control of the variants as well — the food regulatory agencies will be back on the trail.”