FDA’s tepid response to intentional addition of allergens to foods fails consumers

FDA urged to prohibit food companies from intentionally adding an allergen, sesame, to evade cross-contamination rules

As a result, many manufacturers are labeling foods and cleaning up production practices to prevent foods from becoming contaminated with sesame through accidental cross-contact. But some manufacturers have responded to the new law by intentionally adding sesame to ingredients lists.

Re: Petition to FDA to notify manufacturers that they cannot mitigate allergen cross-contact risks by adding sesame and other major allergens to foods

The Center for Science in the Public Interest (CSPI) submits this petition under 21 U.S.C. § 350g, 5 U.S.C. § 553(e), 21 C.F.R. § 117.135, and 10 C.F.R. § 10.30 to equest that the Commissioner of Food and Drugs issue a notice to manufacturers and update its industry guidance to prevent manufacturers from intentionally adding sesame and other major allergens to products when they identify allergen cross-contact risks, a practice that violates food safety rules.

Comment to FDA re: draft guidance on allergen labeling

CSPI urges the agency to lay out a plan to proactively consider new allergens and develop controls for allergens prioritized under the proposed framework. We also urge FDA to develop an approach to prioritizing food intolerances not covered by the current guidance.

Letter to FDA re: Adverse event reporting

CSPI writes to draw FDA’s attention to our new publication in the journal Annals of Allergy, Asthma, & Immunology titled “Adverse Events and Labeling Issues Related to Suspected Sesame Allergy Reported in an Online Survey.” This study adds to the body of literature documenting under-reporting of adverse events related to foods to FDA. We request a meeting with the Center for Food Safety and Applied Nutrition (CFSAN) to discuss our findings and, more generally, our recommendations for an improved adverse event reporting system.

CSPI celebrates passage of the FASTER Act making sesame a major food allergen

The Center for Science in the Public Interest was the first organization to call for sesame to be labeled, petitioning the FDA in November 2014 to extend similar allergen disclosure requirements to sesame as were already provided for the “major” allergens.

Comment to FDA re: Voluntary disclosure as sesame as an allergen

More than six years have passed since CSPI and six allergy experts petitioned the FDA on November 18, 2014, for a rule to protect consumers from undeclared sesame in products. In November 2020, FDA solicited comments on a draft guidance providing voluntary recommendations to manufacturers regarding what the agency believes are best practices for sesame labeling. This comment explains why such a guidance falls well short in addressing serious risks to sesame-allergic consumers, and why agency should replace the proposed guidance immediately with a proposed rule requiring mandatory sesame labeling.

Sesame Allergy Labeling Quick Facts

FDA to seek information on sesame allergies

It’s hard to imagine picking up a packaged food that contains peanuts or shellfish and not seeing the familiar declaration on the label that identifies those allergens. Yet consumers who are allergic to sesame get no similar declaration.

Food industry split on disclosing sesame, an allergen

Fourteen of 22 major food manufacturing companies declare the presence of sesame and do not obscure it as an unspecified “spice” or “natural flavoring,” according to a new report by the nonprofit Center for Science in the Public Interest. But the remaining companies do not provide appropriate labeling, leaving consumers at risk for potentially life-threatening allergies.