As previously reported, FDA recently released a draft guidance regarding the agency’s approach to evaluating the public health risks of allergens other than the nine major food allergens. On the same day, the Center for Science in the Public Interest (CSPI) issued a statement regarding the guidance, arguing that FDA’s approach fails to provide consumers adequate protections.

Specifically, CSPI stated that, while the guidance provides a potentially useful framework, it does not indicate when the agency would act to take further action on an allergen if deemed to be a priority. Further, CSPI criticizes the agency for not proactively considering new allergens for prioritization and instead allowing “its allergen agenda be driven piecemeal by petitions from the public.”

CSPI highlights that it first petitioned FDA to require sesame to be labeled as a priority allergen in 2014 and that the agency did not respond until 2020, after Congress had mandated it.  CSPI encourages Congress to “direct FDA to create a more clear and efficient path towards adding new major allergens.”