Encouraging food manufacturers to keep options for allergic consumers on the shelf, the FDA released updated draft guidance for reducing risks of cross-contamination and inaccurate labeling of sesame and other food allergens.
The new document comes in response to the increasingly limited supply of sesame-free options, an unintended effect of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act — which declared sesame as the ninth major food allergen and aimed to make it easier for consumers to identify foods with or without the allergen.
But rather than taking measures to prevent cross-contamination risks, some manufacturers have taken the easy route to satisfy the law and opted to intentionally add sesame to products that previously did not contain sesame and label them as such.
“This keeps manufacturers in compliance with the law for disclosing the presence of a major food allergen. However, it also limits options for consumers who are allergic to sesame, a result the FDA does not support,” the agency wrote in a statement.
FASTER, which took effect on January 1 of this year, dictates that if an allergen is found in a food item, it must be clearly indicated on the item’s label. Food manufacturers also need to implement methods to either limit or prevent cross-contamination risks with the allergen in their facilities.
“We recognize there are challenges with ensuring products are free of allergens, and we are engaging with stakeholders on this issue,” said FDA Commissioner Robert Califf, MD, in a press release. “The agency is interested in finding solutions, within our authorities, that meet the needs of consumers with food allergies.”
Sesame is currently the ninth most prevalent food allergy in both adults and children throughout the U.S. Sesame is found in a wide array of food products, including baked goods, seasonings, oils, snacks, processed meat, and cereals, among many others. It can also be found in medications, cosmetics and fragrances, supplements, and even pet food.
The FDA’s updated recommendations add two new chapters to its guidance first issued in 2016, Hazard Analysis and Risk-Based Preventive Controls for Human Food.
Chapter 11 addresses the establishment and implementation of food allergen programs for food manufacturers, providing examples on how to limit and prevent potential cross-contamination. It is meant as a companion chapter to the FDA’s Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact. It also provides instruction on allergen monitoring and verification to ensure correct labelling practices, which the agency cites as its top source of food allergen recalls. The chapter also includes guidance for situations in which cross-contamination cannot be avoided.
Chapter 16, on acidified foods, addresses food manufacturers that specifically produce, process, or pack products with a pH of 4.6 or below, including some beans, processed sauces, cabbages, and cucumbers. The chapter provides examples of how existing practices to comply with acidified foods regulation can meet requirements under the preventive controls for human foods rule.