U.S. FDA defines “gluten-free”

4.1.1For people with celiac disease, knowing whether a food contains gluten or not is vital.

Today the U.S. Food and Drug Administration (FDA) published new regulations that define gluten-free  in part as a food product that contains less than 20 parts per million of gluten. About 3 million Americans have celiac disease, a condition that leads to an immune reaction when the person consumes gluten, a protein in barley, wheat and rye. Consumption of gluten by someone with celiac disease can cause intestinal inflammation and damage, as well as a poor uptake of nutrients, according to the Mayo Clinic.

Celiac disease has no cure. The only way for people to manage the disease is adhering to a gluten-free diet.

“This is a tool that has been desperately needed,” said Andrea Levario, executive director of the American Celiac Disease Alliance, in a statement. “It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them.”

The new definition aims to standardize what gluten-free means across the food industry. Additionally, any product that uses labels of “no gluten,” “without gluten” and “free of gluten” must also meet the requirement.

Here’s what the FDA had to say about the new requirement in a question and answer document on the new definition:

“In general, foods may be labeled “gluten-free” if they meet the definition and otherwise comply with the final rule’s requirements. More specifically, the final rule defines “gluten-free” as meaning that the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.”

The rule will become effective 30 days after its publication in the Federal Register. However, producers will have a year following that date to bring products into compliance (many products currently labeled as gluten-free already meet the new requirements). After this period, any product labeled as gluten-free that doesn’t meet the requirements will be declared misbranded and could face repercussions.

The rule was issued under the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which governs food allergen labeling information.

For a question and answer on the rule, click here.

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