FDA Issues Draft Guidance on Gluten Labeling on Oral Drug Products
The Food and Drug Administration on Dec. 12 issued a draft guidance document on labeling of drugs that have gluten-containing ingredients or are gluten-free. Though FDA said it is not currently aware of any, FDA says any oral drug products that use wheat gluten, wheat flour or wheat starch as an intentionally added ingredient should be labeled to indicate its presence. Ingredients derived from wheat starch or fermented from wheat likely have very low levels of gluten, FDA said. Unintentional contamination of drugs by wheat-derived ingredients would likely result in very low amounts, but such drugs may nonetheless be subject to enforcement action due to violations of current good manufacturing practice (CGMP) requirements, FDA said. Comments on the draft are due Feb. 12.
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Wheat gluten and wheat flour must also be identified if they are present in orally administered biological products, FDA said. FDA’s regulations on licensed biologics require labeling of certain types of inactive ingredients that are “known sensitizing substances” and “inactive ingredients when a safety factor,” FDA said. Any labeling that identifies gluten-containing wheat products, whether for oral drug products or orally administered biologics, must use “the established name used in labeling for any wheat-derived ingredient that is the subject of a monograph in an official compendium [and it] must be the monograph title, where there is no official name designated pursuant to section 508. For example, wheat starch (not starch) is the established name by which wheat starch must be identified in drug labeling,” FDA said.
Drug manufacturers that want to label their products as gluten free should use the following statement on oral drug product labels or in required labeling: “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” Companies using that statement should have supporting documentation available, including information from ingredient suppliers about their processes and raw materials. “For firms wishing to use the recommended labeling statement, substantiation for such a statement should include a written commitment from ingredient suppliers that, for each ingredient potentially derived from wheat, barley, rye, or their crossbred hybrids or produced through fermentation, these grains are not used in the production of the ingredient,” FDA said.