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New FDA Guidance on “Gluten Free” Claims

Following up on last year’s “gluten-free” labeling rule, the FDA has now published guidance to help industry interpret and apply the rule.  All food products claiming to be “gluten-free” must comply with the rule by August 5, 2014.  At its essence, according to the FDA, “gluten-free” means that the food does not contain an ingredient made from a gluten-containing grain unless that grain has been processed to remove the gluten and the remaining gluten in he ingredient does not exceed 20 parts per million.  Food containing unavoidable amounts of gluten, such as from cross-contact, must still be below the 20 ppm threshold to use the “gluten-free” claim.  The rule does not require testing of gluten levels, but a company using the claim is responsible for ensuring that its product meets the established threshold to avoid product being adulterated and/or misbranded.

Interestingly, FDA has specifically stated that the “gluten-free” claim can

FDA Issues Guidance on “Gluten Free” Labeling

FDA issued a final rule today on the voluntary use of “gluten-free” on food labels, as directed by the Food Allergen Labeling and Consumer Protection Act.  In summary, FDA set a threshold for gluten of less than 20 parts per million in foods that are labeled “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.”  Food manufacturers will have one year to bring their labeling into compliance with the new regulation.  After that one year implementation period, any food labeling “gluten-free” or a similar claim with gluten more than 20 parts per million will be considered misbranded.  A threshold of 20 parts per million was selected because that is the lowest level of gluten that can currently be detected with validated methodology, and, as stated by FDA, “some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of

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