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FDA Provides Guidance on Exempting Ingredients from Allergen Labeling

Jul 02, 2015

The Food and Drug Administration recently released a new guidance document for companies interested in filing petitions or notifications that would allow certain ingredients to be exempted from mandatory allergen labeling. The new “Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications” provides additional information about the data that FDA would require to make decisions on whether to exempt an ingredient from allergen labeling.

The Food Allergy Labeling and Consumer Protection Act (FALCPA) requires all ingredients derived from, and containing protein from, a major food allergen to have the plain English name of the allergen declared in the ingredient list or in a separate “contains” statement.

However, FALCPA also provided for two methods of exempting from labeling such ingredients that would not pose a risk to human health. Since FALCPA went into effect in 2006, only one notification and one petition have been submitted to FDA, which resulted in successful exemptions from labeling. These exempted ice-structuring protein derived from certain fish and also soy lecithin when used as a release agent applied to a food contact surface.

Members with questions may contact Michelle Matto, IDFA’s consultant on nutrition and labeling, at

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