FDA issues guidance on food allergen labeling exemptions.

• Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), food producers have been required to identify the presence of major food allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) on food labels.  In certain cases, however, food manufacturers may modify ingredients derived from major allergens such that the final ingredients pose no risk of harm to allergic consumers.  Under FALCPA, manufacturers who wish to obtain an exemption from the labeling requirement for a specific ingredient must submit either:  (1) a petition providing scientific information establishing that the ingredient “does not cause an allergic response that poses a risk to human health” or (2) a notification providing scientific information establishing that the ingredient “does not contain allergenic protein” (or providing information that FDA previously has determined via premarket review that the ingredient does not cause an allergic response that poses a risk to human health).
• On June 18, 2015, FDA issued final guidance to assist manufacturers with the preparation of petitions and notifications to support exemptions from allergen labeling requirements.  The final guidance is not substantially different from the draft guidance on this topic that FDA issued in 2014.
• To date, there have been very few petitions and notifications submitted to FDA seeking exemptions from allergen labeling requirements, and even fewer have resulted in successful outcomes.  It remains to be seen whether the issuance of final Agency guidance on this topic will revitalize and improve the success rate of submissions in this area.