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Aug 09

FDA Publishes Final Rule on Gluten-Free Labeling

On August 5, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, “Food Labeling; Gluten-Free Labeling of Foods,” that defines the term “gluten-free” and adopts requirements for its voluntary use in food labeling. The regulation will particularly help those with Celiac disease to maintain a gluten-free diet. Celiac disease is an autoimmune reaction that damages the small intestine whenever gluten, a natural protein in grains such as wheat, rye, and barley, is ingested. FDA has authority to issue the rule under Section 206 of the Food Allergen and Consumer Protection Act (FALCPA) of 2004. You can read the final rule here.

More specifically, under the final rule, only foods that comply with the FDA’s definition of “gluten-free” are allowed to include the term on the label. “Gluten-free” is defined under Section 101. 91 as any food that unavoidably contains less than 20 parts per million (ppm) gluten and is either inherently free of gluten or does not include an ingredient that is a gluten-containing grain; an ingredient derived from a gluten-containing grain that has not been processed to remove the gluten; or an ingredient derived from a gluten-containing grain that has been processed to remove gluten if it results in the food containing 20 or more ppm gluten.

A food that is labeled as “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” and does not meet this definition will be considered misbranded pursuant to the Food, Drug, and Cosmetic Act (FDCA). Additionally, a food whose labeling includes the term “wheat” in the ingredient list or in a separate “Contains wheat” statement– as required by Section 403(w)(4) of the FDCA–and is also labeled “gluten-free” will be considered to be misbranded unless its labeling also contains additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim.

The regulation applies to all foods regulated by the FDA, including dietary supplements. The actual use of the label “gluten-free” is voluntary, however, which means that manufacturers are not required to disclose if their food products are gluten-free. The regulation also does not replace other labeling requirements under the FDCA and FDA regulations, including those regarding allergens.

It is interesting to note that the final rule differs somewhat from the proposed rule on gluten-free labeling. In particular, the proposed rule would have required labelers of inherently gluten-free foods that voluntarily label their products as “gluten-free” to declare in labeling that all foods of that type are gluten-free. The final rule does not require this added distinction be made in product labeling.

In all, the final rule becomes effective on September 4, 2013. Food manufacturers will have one year after the date of publication—until August 5, 2014–to bring their labels into compliance with the rule’s requirements. More information about gluten-free labeling of foods is provided on the FDA’s website. If you have any questions about the final rule or compliance with any of these regulations, please contact us at: contact@giannamore-law.com.

FDA Attorney

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