FDA Finalizes 'Gluten-Free' Food Labeling Requirements
The Food and Drug Administration is adopting a voluntary definition for “gluten-free” foods, in a final rule set for publication Aug. 5. Under the new requirements, food may be marked “gluten-free” if it inherently contains no gluten, or if it has been refined to remove gluten. Any food that claims "gluten-free," “no gluten,” “free of gluten”, or “without gluten” but doesn’t meet FDA’s new gluten-free requirements will be considered by the agency to be misbranded, FDA said. The final rule is effective Sept. 4.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
FDA originally proposed requirements for "gluten-free" labeling in January 2007 (see 07020625). It reopened the comment period on its proposal in 2011 (see 11080231). More information on FDA gluten-free requirements, including a Q&A on this final rule, is (here).
Foods w/ No Gluten, Refined Foods Under 20 ppm May Use Claim
Under FDA’s final rule, the following foods can use the “gluten-free” claim:
- Foods that inherently do not contain gluten, like raw carrots or grapefruit juice
- Foods with ingredients that are gluten-containing grains that have been refined to remove the gluten, as long as the food contains less than 20 ppm gluten or has less than 20 mg of gluten per kg.
The following foods may not use the “gluten-free” claim:
- Foods with any whole gluten-containing grains, like spelt wheat, as ingredients
- Foods with gluten-containing grains that have been refined but still contain gluten
- Foods that contain 20 ppm or more gluten because of cross-contact with gluten containing grains
Non-compliant Food Deemed Misbranded
Foods that claim to be “gluten-free,” but don’t meet the new FDA requirements, will be deemed by the agency to be misbranded. FDA will also consider foods misbranded in the following cases:
- The food bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and doesn’t meet FDA “gluten-free” requirements
- The food’s labeling includes the term “wheat in its ingredient list or in a separate “contains wheat” statement and also bears the claim “gluten-free”, unless its labeling has additional language clarifying that the wheat has been processed to meet FDA “gluten-free” requirements.
Enforcement Discretion for Some Current “Gluten-Free” Beers
FDA said it will “in limited circumstances” exercise enforcement discretion for some beers that currently make a “gluten-free” claim. FDA may look the other way if a beer:
- Made from a non-gluten-containing grain
- Made from a gluten-containing grain, where the beer has been processed to remove gluten below a 20 ppm threshold
FDA said it plans to issue a proposed rule to address its compliance approach for fermented or hydrolyzed products.