Advocacy groups disappointed in FDA sesame allergen decision

Key takeaways:

• Adding sesame to products that do not have it to meet reporting regulations violates the spirit of the FASTER Act, groups said.
• The FDA said it is working with consumers and manufacturers to find solutions.

The Center for Science in the Public Interest and Food Allergy Research and Education both have expressed disappointment in the FDA’s decision to allow food manufacturers to intentionally add sesame to products to meet regulations.

Now that the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act is in effect, manufacturers must list sesame on the labels of any food they produce that include it as well as avoid cross-contamination with sesame during production.

However, the Center for Science in the Public Interest (CSPI) claims Chick-fil-A, Culver’s and Dave’s Killer Bread are now adding sesame to products that did not have it before to simplify labeling and avoid the expenses of cross-contamination efforts.

In January, the CSPI petitioned the FDA to prevent companies from engaging in these practices. Last week, the FDA rejected the petition, noting that adding sesame to products that did not have it before does not violate the FASTER Act.

But in its letter to CSPI, the FDA also acknowledged that “this practice could make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume, an outcome that FDA does not support.”

“That should be a clear message to industry to put an end to this lazy and cynical practice,” CSPI president Peter G. Lurie, MD, MPH, said in a statement.

“For people who are allergic to sesame, even trace amounts can trigger a threatening anaphylactic reaction,” Lurie continued. “It’s unthinkable that companies would add peanuts, say, to food products to evade cross-contamination rules, and it’s unacceptable with sesame.”

Food Allergy Research and Education (FARE), which supported the CSPI petition and noted that 1.6 million Americans have a sesame allergy, also disagreed with the FDA’s rejection.

“FARE is profoundly disappointed with FDA’s decision to deny CSPI’s request in its petition to FDA to prohibit intentional addition of food allergens, specifically sesame, to avoid thorough cleaning and food allergen controls,” Robert Earl, MPH, RDN, FAND, vice president of regulatory affairs at FARE, told Healio.

However, the FDA did tell CSPI that it would provide guidance for manufacturers clarifying that they cannot mitigate cross-contact risks by including sesame in the ingredients lists on their products when sesame is not actually intentionally included, although “may contain” advisories are still acceptable.

FARE reported that it was pleased that the FDA granted CSPI this clarification.

Also, FDA commissioner of food and drugs Robert M. Califf, MD, recognized that consumers with sesame allergy may struggle with these manufacturers’ practices despite the intentions of the FASTER Act.

“I don’t think anyone envisioned there being a decrease in the availability of products that are safe choices for sesame-allergic consumers,” Califf said in a statement.

Acknowledging the needs of consumers and manufacturers alike as well as the challenges in ensuring products are allergen free, Califf said the FDA is meeting with industry and consumer advocates to gain more information and gather their perspectives.

“The agency is interested in finding solutions, within our authorities, that meet the needs of consumers with food allergies, while also taking into account the practical limitations industry may be facing in implementing effective cross-contact controls and allergen labeling,” Califf said.

“Ultimately, we are looking for opportunities that could help consumers who are allergic to sesame find foods that are safe for them to consume,” Califf said.

References:

• An update on sesame allergen labeling on food packages. https://www.fda.gov/news-events/fda-voices/update-sesame-allergen-labeling-food-packages. Published July 27, 2023. Accessed July 31, 2023.
• FDA’s response to the CSPI allergen labeling citizen petition. https://www.cspinet.org/sites/default/files/2023-07/FDA-2023-P-0342%20-%20FDA%27s%20%20Response%20to%20the%20CSPI%20Allergen%20Labeling%20Citizen%20Petition%20-%207-26-23.pdf. Published July 26, 2023. Accessed July 31, 2023.
• Statement of Robert Earl, vice president, regulatory affairs, regarding FDA’s response to the CSPI petition on manufacturers adding sesame to products in response to FASTER Act. https://www.foodallergy.org/media-room/statement-robert-earl-vice-president-regulatory-affairs-fare-regarding-fdas-response. Published July 27, 2023. Accessed July 31, 2023.