June 17, 2005

FAC Meeting on Draft Report: Approaches to Thresholds
for Allergens and Gluten in Food

The FDA Food Advisory Committee (FAC) will consider a draft report entitled "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food" during a meeting set for July 13-14, 2005, in Greenbelt, MD. FDA notes that committee members are being asked to evaluate the draft report, which was prepared by an interdisciplinary group of scientists from FDA's Center for Food Safety and Applied Nutrition (CFSAN). This report was prepared to facilitate the further development of CFSAN's policy for food allergens, including the Center's implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

On July 13, the committee will discuss the draft report's approaches for food allergen thresholds. On July 14, the committee will discuss the draft report's approaches for gluten thresholds. On July 15, based on the charge and questions from FDA, the committee will determine whether the report is scientifically sound in its analyses and approaches and adequately considers available relevant data on allergens and gluten.

Individuals may register online or by calling the committee contact, Marcia Moore, at 301-436-2397; or by sending an email to . Individuals can also call the FDA Advisory Committee Information Line at 800-741-8138 (301-443-0572 in the Washington, DC area), code 3014510564. Those desiring to make formal oral presentations should notify the contact person before July 8, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Those who do not plan to attend the meeting may still submit written comments for the July meeting to dockets until July 8, 2005. The Federal Register Notice announcing the public meeting is available online.

In addition, FDA requests that members of the public submit comments and any relevant scientific data and information, particularly data and information that can fill the data gaps identified in the draft report, by August 16, 2005. The notice requesting comments and scientific information is available for online viewing.