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FDA Requests Comments on Food Allergen Thresholds

Today, FDA published a notice in the Federal Register informing the public that it is requesting comments and information on conducting a risk assessment to establish regulatory thresholds for major food allergens.  77 Fed. Reg. 74485 (Dec. 14, 2012).   Comments must be submitted by February 12, 2013.

The Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”) defined the term “major food allergen” and required foods to declare the presence of major food allergens (i.e., milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) on the product label.  21 U.S.C. § 343(w).  Failure to do so misbrands the food under section 403 of the Federal Food, Drug, and Cosmetic Act.

A food is exempt from the major food allergen labeling requirement if: (1) FDA grants a petition for an exemption that provides scientific evidence that the ingredient “does not cause an allergic response that poses a risk to human health”; or (2) a notification is submitted that either contains scientific evidence showing that an ingredient “does not contain allergenic protein” or shows that a previous premarket approval process resulted in a determination that the ingredient “does not cause an allergic response that poses a risk to human health.”  Id. at § 403(w)(6)(C), (7)(A).

FDA will be carrying out a quantitative risk assessment for establishing the regulatory thresholds for major food allergens.  According to FDA, establishing regulatory thresholds serves two purposes.  First, it would help the agency “determine whether, or what types of, enforcement action is appropriate when specific problems are identified and also help [it] establish a clear standard for evaluating claims in FALCPA petitions that an ingredient ‘does not cause an allergic response that poses a risk to human health’ or ‘does not contain allergenic protein.’”  77 Fed. Reg. at 74485-774486.  Second, it helps industry create standards for evaluating the efficacy of allergen preventative controls and perform allergen hazard analyses.  Id. at 74486.

In order to help it design and carry out its quantitative risk assessment, FDA invites comments on the following:

  1. How should we define “an allergic response that poses a risk to human health?”
  2. Which major food allergens are of greatest public health concern and what is the size of the at-risk population?
  3. How should clinical dose distribution data be used when establishing regulatory thresholds for the major food allergens?
  4. What approaches exist for using biological markers or other factors related to the severity of allergic responses in a threshold risk assessment?
  5. What data and information exist on dietary exposure patterns for individuals on allergen avoidance diets?
  6. What data or other information exist on current levels of exposure associated with the consumption of undeclared major food allergens in packaged foods?
  7. What other information or data should we consider in establishing regulatory thresholds for major food allergens?


It is unknown how long it will take FDA to develop the regulatory thresholds after it receives comments.

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