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FDA Explains How to Exempt an Ingredient from Allergen Labeling

The Food and Drug Administration (FDA) has published a draft guidance document explaining what information it is looking for in petitions and notifications to exempt ingredients from allergen labeling.  Comments on the draft guidance are due September 5, 2014.

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA), which amended the Federal Food, Drug, and Cosmetic Act to require labeling of “major food allergens.”  FALCPA defines a “major food allergen” as:

(a) milk, egg, peanuts, tree nuts, wheat, soybeans, fish, and crustacean shellfish; and

(b) a food ingredient that contains protein derived from any of the 8 foods in (a), except for highly refined oils and ingredients derived from highly refined oils.

FALCPA also created two mechanisms for exempting ingredients from the allergen labeling requirement.  Any person may petition FDA to exempt a food ingredient from allergen labeling based on scientific evidence demonstrating that the ingredient does not cause an allergic response that poses a risk to human health.  In addition, any person may submit a notification to FDA based on either scientific evidence showing that the ingredient does not contain allergenic protein or a previous determination by FDA under Section 409 that the ingredient does not cause an allergic response that poses a risk to human health.  Inventories of petitions and notifications submitted to FDA, and the agency’s responses, can be found here and here.  Most have met with FDA rejection.

Perhaps because of that, FDA is now offering recommendations on how to prepare petitions and notifications to exempt ingredients from allergen labeling.  For purposes of the draft guidance document, an ingredient is any substance intentionally added to food that either:

  • Is derived from a major food allergen (e.g., through mechanical, chemical, biochemical, or bioengineering processes) and contains proteins or peptides; or
  • Is an organism, enzyme, or “other complex mixture” that is grown or prepared using a major food allergen.

A petition is appropriate where an ingredient derived from a major food allergen may contain allergenic proteins, or derivatives of allergenic proteins, such as peptide fragments, but the ingredient does not cause allergic reactions that pose a risk to human health in food allergic individuals.

A notification is appropriate where an ingredient may contain proteins or protein fragments derived from a major food allergen but the ingredient does not contain allergenic protein.  Presumably, if an ingredient contains no proteins whatsoever, it is excluded from the statutory definition of “major food allergen” and is automatically exempt from allergen labeling (without the need for either a petition or notification): “We are aware that a limited number of technologies (e.g., distillation) may be able to produce protein-free ingredients because of the nature of the process and fundamental biochemical properties of proteins, peptides, and amino acids.”

The draft guidance provides considerable detail regarding the information FDA expects in both petitions and notifications, including: a complete description of the ingredient, the manufacturing or preparation process, chemical and biological characterization of the ingredient (and particularly the proteins and peptides in the ingredient), the intended use of the ingredient in food, the analytical methods used to characterize the ingredient, and an environmental assessment or claim of categorical exclusion.

The draft guidance also provides recommendations for additional information to be included in petitions and notifications.  Petitions should include information on consumer exposure and either clinical testing (e.g., by oral food challenge, skin prick testing, or in vitro testing using serum from allergic individuals) or risk modeling to show that the ingredient does not cause an allergic reaction that poses a risk to human health.  Appendix 1 to the draft guidance explains FDA’s thinking on what constitutes an allergic reaction that poses a risk to human health.  In general, any objective reaction (e.g., vomiting, wheezing, hives) in a clinical trial should be considered indicative of a risk to human health.  Subjective symptoms (e.g., itching, mild nausea, GI discomfort) should not be considered indicative of risk to human health; however, subjective symptoms that are sufficiently serious to stop a dose escalation study or that are associated with objective reactions at higher doses may be considered allergic responses that pose a risk to human health.

For notifications that seek to show that an ingredient does not contain allergenic proteins, FDA recommends including a complete characterization of the proteins and peptides in the ingredient, as well as in vivo or in vitro clinical data demonstrating that the ingredient does not contain allergenic protein.

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