The US Food and Drug Administration (FDA) announced updates to draft guidelines for food facilities’ adherence to current good manufacturing practices (CGMPs), adding a section on methods to prevent cross-contact with major food allergens and on accurate labeling of finished food products related to allergens.¹

Early in 2023, sesame was designated by the FDA as the 9th major food allergen on its list when the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was put into effect on January 1. The new addition led to mandatory disclosures of the presence of sesame in food labels, requiring food manufacturers to substantially reduce or prevent cross-contact with sesame.

FDA officials pointed out in their announcement that certain manufacturers may be intentionally incorporating sesame into products that did not contain it before, and they may label such items to indicate sesame’s presence, rather than implementing actions to prevent cross-contact. This may allow manufacturers to meet legal requirements of disclosing the existence of a major allergen.

Nonetheless, the officials noted that such actions limit choices for food product consumers with allergies to sesame, a consequence that the FDA does not agree with. The agency, consequently, urged the food industry to begin adoption of draft guidelines for minimizing or preventing allergen cross-contact and undisclosed allergens.

“The FDA is looking for opportunities that could help consumers who are allergic to sesame and other major food allergens find foods that are safe for them to consume,” FDA Commissioner Robert M. Califf, MD, said in a statement. “We encourage manufacturers to follow the guidelines in the draft guidance updates released today to prevent allergen cross-contact and ensure proper labeling.”

Among the chapters now added are Chapter 11 (the Food Allergen Program) and Chapter 16 (Acidified Foods), since the draft guidance—Hazard Analysis and Risk-Based Preventive Controls for Human Food—was issued by the FDA beginning in the year 2016.

Chapter 11 provides guidelines for a food allergen program designed to safeguard products from cross-contact and allow for the right labeling of food allergens, offering examples. Given that labeling errors are the main cause of allergen recalls by the agency, Chapter 11 includes guidance on monitoring and verifying proper declarations of allergens.

This chapter also includes situation examples where cross-contact, despite CGMPs and preventive measures, remains a concern. The chapter covers options in these cases, including the voluntary use of allergen advisory statements when deemed appropriate.

Chapter 16 elucidates how manufacturers of food can leverage the practices, procedures, and processes that are already in place to fulfill the acidified foods regulations and meet the stipulations outlined in the rule for preventive controls for human foods.

Though some responses among allergic individuals may be considered mild, others can be severe or even life-threatening. These reactions may end up requiring an auto-injection of epinephrine, another major topic in the allergy space currently.²

“We recognize there are challenges with ensuring products are free of allergens and we are engaging with stakeholders on this issue,” Califf explained in his statement. “The agency is interested in finding solutions, within our authorities, that meet the needs of consumers with food allergies. Updating this draft guidance with the new allergen chapter provides one tool to help manufacturers meet this goal.”

References

1. ^{FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens. September 26, 2023. Accessed September 26, 2023. https://www.fda.gov/news-events/press-announcements/fda-draft-guidance-could-result-safer-food-options-people-allergies-sesame-other-food-allergens.}
2. ^{Smith T. FDA Declines to Approve of Epinephrine Alternative to EpiPen, Requests Further Study. HCPLive. September 20, 2023. Date Accessed: September 26, 2023. https://www.hcplive.com/view/fda-declines-to-approve-of-epinephrine-alternative-to-epipen-requests-further-study.}