FDA Defines Gluten-Free For Food Labeling

WASHINGTONThe U.S. Food and Drug Administration (FDA) has defined the term "gluten-free" for labeling of food in a move the regulatory agency said would aid the three million Americans who are victims of celiac disease.

"Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life," said FDA Commissioner Margaret Hamburg, M.D.

Gluten-free claims must adhere to all aspects of FDA's definition, including the requirement that the food contains less than 20 parts per million of gluten. Foods containing the claims "no gluten", "free of gluten" and "without gluten" also must meet the gluten-free definition.

Food manufacturers will have one year to adhere to the FDA's labeling requirements, which were published today in the Federal Register.

The term gluten relates to proteins that occur naturally in barley, rye, wheat and cross-bred hybrids of these grains. Gluten-containing foods trigger production of antibodies that attack and damage the small intestine's lining in individuals who suffer from celiac disease, FDA explains. These individuals must adhere to a gluten-free diet in order to avoid health problems, according to the agency.

"To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer," Virginia Cox, Associate Commissioner of FDA's Office of External Affairs, wrote in a blog.

The rule was issued pursuant to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

FDA projects the new requirements will yield annual health benefits of roughly $110 million, compared to estimated annual costs (related to testing and relabeling) of $7 million.