Tuesday 20 February 2018

Gluten Free Rule Issued by FDA Allows Trace Amounts of Gluten

The US FDA issued a new rule today defining “gluten free” for voluntary food (and dietary supplements) labeling. The new definition standardizes the meaning of “gluten-free” claims across the food industry. Once finalized a food using the term “gluten-free” on its label must meet all of the requirements of the definition, including containing less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The new rule will be important for Americans affected by celiac disease. Celiac disease is a chronic  inflammatory disorder of the small intestine in genetically susceptible individuals triggered by ingesting gluten. The rule estimates between 0.4-1% of Americans experience symptoms of celiac disease in some form. “Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

The FDA recognized in issuing the rule that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. The Agency is providing one year after the rule is published to bring labels into compliance with the new requirements.

It may be surprising to find gluten in a gluten product, even if the rule only allows trace amounts. The FDA explains in the rule it determined the 20ppm threshold on the basis of a “safe” level or “tolerable daily intake” (TDI) of a substance as calculated using the NOAELs and the Lowest Observed Adverse Effect. In other words, the best available science suggests this level is both safe and is not likely to trigger the symptoms associated with celiac disease.

Here is the full definition of “gluten-free”

The final rule defines and sets conditions on the use of the term “gluten-free” in foods, including:

  • Foods that inherently do not contain gluten (e.g., raw carrots or grapefruit juice) may use the “gluten-free” claim. 
  • Foods with any whole, gluten-containing grains (e.g., spelt wheat) as ingredients may not use the claim; 
  • Foods with ingredients that are gluten-containing grains that are refined but still contain gluten (e.g., wheat flour) may not use the claim; 
  • Foods with ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten may use the claim, so long as the food contains less than 20 ppm gluten/has less than 20 mg gluten per kg (e.g. wheat starch); and
  • Foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten containing grains.

In addition, the final rule provides that:

  • A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed to be misbranded. 
  • A food whose labeling includes the term “wheat” in the ingredient list or in a separate “Contains wheat” statement as required by FALCPA and also bears the claim “glutenfree” will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim.

Facilities should begin to review their labels for compliance.

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