FDA Issues Allergen Labeling Guidance

The U.S. Food and Drug Administration (FDA) has announced the
availability of industry guidance on food allergen labeling exemptions.
Titled “Food Allergen Labeling Exemption Petitions and Notifications,”
the guidance reportedly explains the agency’s “current thinking on the
preparation of regulatory submissions for obtaining exemptions for
ingredients from the labeling requirements for major food allergens
in the Federal Food, Drug, and Cosmetic Act (FD&C Act) through
submission of either a petition or a notification.”

The guidance aims to clarify the criteria for labeling exemption petitions
submitted under the Food Allergen Labeling and Consumer Protection
Act of 2004, which requires all food and beverage labeling to declare
the presence of major food allergens using their common names. Under
these rules, companies can obtain labeling exemptions by demonstrating
that an ingredient derived from a major allergen ‘‘does not cause an
allergic response” or “‘does not contain allergenic protein.” See Federal
Register, June 19, 2015.

Issue 569