FDA Releases Gluten in Drug Products Draft Guidance

13/12/17

Event Title

08h00 - 16h30

Event Location

Print Bulletin PDF

On December 12, 2017, the U.S. Food and Drug Administration (FDA) published the Draft Guidance Gluten in Drug Products and Associated Labeling Recommendations. The scope of the guidance applies to drug products and products classified as both a drug and cosmetic for human oral use including, ingested drug products, drug products used on or near the lips, or drug products used inside the mouth. The draft guidance document does not apply to food, dietary supplements, or products classified as just a cosmetic.


In the draft guidance, the FDA recommends manufacturers use the following statement when truthful and substantiated:


“Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)”


Gluten statements should be visible at point of purchase, on the immediate container and carton labeling, and located outside the Drug Facts table. The gluten statement should not interfere with information required to be on drug labels and labeling. The draft guidance does not recommend the term “gluten free” as criteria has not yet been established for oral drug products and it is technologically infeasible to substantiate that a product is free from gluten.


Click to view the draft guidance:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588216.pdf


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