Gluten in Foods, Drugs and FDA Surveillance

Near the end of 2017 FDA published test results from a gluten free food product surveillance project. By way of background, recall that in 2013 FDA published a final rule on gluten free labeling of foods, including dietary supplements. The rule, codified in 21 CFR 101.91, allows terms such as “gluten free”, “without gluten”, “no gluten”, etc. on products that contain less than 20 parts per million (ppm) of gluten.

In 2015 FDA issued a proposed rule on gluten free labeling of fermented or hydrolyzed foods that can be summed up in this quote:
“Because the current gluten tests do not adequately detect and quantify gluten in fermented and hydrolyzed foods or ingredients, FDA proposes that, in order to make a “gluten-free” claim, manufacturers of these foods would have to make and keep records to show all of the following:

  • The food meets the definition for “gluten-free” in 21 CFR 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis.
  • The manufacturer adequately evaluated the processing for any potential for gluten cross-contact.
  • Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.”

Most recently, in December 2017, FDA published a draft guidance on gluten in drug products. The guidance pertains to “human drug products that pass through the small intestine [including]

  • Orally ingested drug products.
  • Topical drug products applied to or near the lips (e.g., lip sunscreens)
  • Drug products applied inside the mouth (e.g., cold sore treatments, drugs delivered to or via the oral cavity).”

While noting that “wheat gluten itself is never or very rarely added as an inactive ingredient to oral drug products”, the guidance states that “any oral drug product that contains wheat gluten as an intentionally added ingredient should be labeled to indicate its presence.” The guidance recommends that drug manufacturers be aware of any wheat-derived ingredients used in their products and notes that the agency would be “likely to question [the use of wheat gluten] as an ingredient in an oral drug product for which few or no alternative treatments are available” and “in an oral drug product intended for long-term administration or intended to treat comorbidities of celiac disease.”

FDA expects that the amount of gluten in a dose of a drug product would be less than that found in a 30 gram cookie labeled as ‘gluten free’ but the guidance does not establish a ‘gluten free’ claim for drugs. The draft guidance instead allows for a statement similar to, “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” as long as such a statement can be substantiated.

More interesting than these rules and guidance is FDA’s November 2017 publication of the results of their surveillance of gluten-free foods. The agency tested 702 samples from cereals, grain bars and flours between July 2015 and August 2016. The agency found that all but 5 of those sampled products met the standards of less than 20 ppm of gluten.

I won’t dwell on the fact that FDA did not issue a press release on this finding of wide-spread compliance but I would like to point out the salient notion that FDA actually caries out product surveillance and sample testing. This made me wonder what other things FDA might be surveilling and testing. In addition to FDA’s robust testing of imported products for prohibited ingredients or to determine whether declared nutrient levels are accurate, I wonder whether the agency tests based on other label claim. Would they ever test for parabens in cosmetics labeled as “paraben free”? Will there perhaps be testing for amino acid ratios in the many new vegan food products whose labeling includes protein claims but whose manufacturers failed to undertake a close reading of 21 CFR 101.9(7) regarding protein declarations? I cannot predict what the agency will do but I’ll keep reading what FDA writes and let you know. In the meantime, my team and I are here to simplify your FDA compliance process and help you avoid running afoul of FDA regulations. Contact us with your questions.

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