FDA Issues Draft Guidance Regarding Food Allergen Labeling Exemption Petitions and Notifications

May 12, 2014

By Ricardo Carvajal

FDA issued a draft guidance for industry that sets out the agency’s expectations for the content of petitions and notifications for exemption from food allergen labeling requirements.  To date, such petitions and notifications have met with very limited success – a situation that guidance might help ameliorate.

As explained in the guidance, the FDCA (as amended by the Food Allergen Labeling and Consumer Protection Act) provides petition and notification mechanisms through which an ingredient derived from a major food allergen can be exempt from the labeling requirements of section 403(w)(1).  A petition must demonstrate that the ingredient does not cause an allergic response that poses a risk to human health, whereas a notification must demonstrate that the ingredient does not contain allergenic protein or that the ingredient was previously determined not to cause an allergic response to human health pursuant to review under section 409. 

The guidance provides recommendations for preparing both types of submissions, including information on the identity and manufacture of the ingredient, characterization of its protein content, and methods of analysis.  The guidance also provides recommendations specific to petitions, including the need for information on consumer exposure and either clinical testing or risk modeling.  The guidance also provides recommendations specific to notifications, which can rest heavily on protein characterization.  An appendix to the guidance explains the agency’s thinking with respect to evaluation of subjective symptoms of allergic reaction, and makes clear that the agency views animal testing data to be of limited utility.  Comments on the draft guidance are due September 5.