The FDA reinstates Comment Period to Define “Gluten Free” label

The FDA has declared the reopening of the comment period for its proposal of providing a consistent and enforceable definition for “gluten-free” labeling of foods. “A safety assessment of exposure to gluten for people with celiac disease,” will also be made available by the FDA. The agency welcomed any comments and suggestions on these additional data.

For a food maker or marketer requesting to claim that a product is gluten-free, the FDA has proposed a limit of 20ppm (parts per million) because the agency believes that any amount lower than 20ppm is hard to detect. Many countries including the European Union consider 20ppm as a threshold level.

Gluten is the protein component in barley, wheat, and rye that cannot be tolerated by individuals with celiac disease. In the US, approximately 1 in every 100 individuals has celiac disease. Celiac disease weakens the absorption of nutrients from food by damaging the small intestine.

Deputy Commissioner for foods, Michael Taylor, said: “Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance. We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
The FDA has welcomed suggestions and comments from the local governments, consumers, the state, and the food industry regarding the gluten-free labeling docket number FDA-2005-N-0404. Go to, select “Submit a comment” from the top task bar, enter the docket number in the keyword space, and press “Search.”

Leave a Reply