U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
May 3, 2001

Dear Colleague Letter on Allergen Guides

Dear Colleague, FDA Foods Community:

A Federal Register Notice announcing the availability of the FDA's Compliance Policy Guide (CPG) on Allergens, entitled "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens," published in the Federal Register on May 3, 2001.

A CPG provides guidance to the Agency's compliance staff, field investigators, and the regulated industry on Agency policy and actions that the Agency may or may not take under the Federal Food, Drug, and Cosmetic Act (the Act) and regulations based on the Act. A CPG represents the Agency's current thinking on a specific regulatory issue.

The FDA's policy with respect to allergens is that products that contain an allergenic ingredient by design must comply with section 403(i)(2) of the Act, which requires each ingredient in a food to be declared. Processing aids that contain allergenic ingredients must also be declared in accordance with 21 CFR 101.4(a)(1). Production practices that lead to unintentional addition of allergens to food may be considered insanitary conditions that may render the food injurious to health and cause the food product to be adulterated under section 402(a)(4) of the Act.

The only exemption to labeling requirements is found in section 403(i)(2) of the Act and provides that spices, flavors, and certain colors used in food may be declared collectively without naming each. In some instances, these ingredients contain sub-components that are allergens. Therefore, FDA strongly encourages the declaration of any allergenic ingredient contained in a spice, flavor, or color. The Agency is considering whether to require, by regulation, declaration of an allergenic ingredient in a spice flavor, or color, 403(i) notwithstanding. FDA will hold a public meeting on August 13, 2001 in Washington, DC to discuss the labeling of food allergens.

FDA is making this CPG effective immediately. It will help FDA identify problems that can result in serious allergic reactions in sensitive individuals. Although the CPG is being implemented immediately, FDA is requesting comments on it and comments may be submitted at anytime. FDA will review all comments received, revise the CPG in response to the comments, as appropriate, and publish a notice of availability of the revised CPG, if it is revised.

The FY 2001 CFSAN Program Priorities identified the publication of a CPG and the issuance of a field inspection guide as key goals to combat undeclared allergens. The CPG reiterates the information provided in a 1996 "Notice to Manufacturers" issued by the FDA to increase allergen awareness. The CPG also addresses issues identified in the recent FDA/Minnesota & Wisconsin Partnership study on food allergens. The CPG focuses on the most common allergens that cause 90% of allergic reactions: milk, eggs, fish, crustacea, tree nuts, wheat, peanuts, and soybeans. The Allergen Inspection Guide, titled "Guide to Inspection of Firms Products Food Products Susceptible to Contamination with Allergenic Ingredients," was issued to the FDA field offices on April 9, 2001 and provides field investigators and inspectors with specific guidance on inspectional methods, procedures and policy relating to allergenic ingredients. FDA will be training field investigators on how to use the guide to conduct on-site inspections.

The Allergen CPG is available on the Internet at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm. Copies of the Allergen CPG can also be obtained by faxing requests to (301) 827-0482. The Allergen Inspection Guide is available on the Internet at http://www.cfsan.fda.gov/~dms/wh-alrgy.html. You may also obtain a copy of the Allergen Inspection Guide by faxing a request to (301) 443-6919.

  Sincerely yours,

Joseph A. Levitt
Center for Food Safety and Applied Nutrition

Food Allergens
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