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FDA says that most drugs are gluten-free???


Pat B

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Pat B Newbie

I was very surprised to read the following in the link below:

Medications and Gluten | FDA

What types of ingredients that may contain gluten are in oral drug products?

The majority of oral drug products either contain no gluten or virtually no gluten.

Based on information available to the Agency, we are aware of no oral drug products currently marketed in the United States that contain wheat gluten or wheat flour intentionally added as an inactive ingredient. We would expect any such product, if it existed, to include wheat gluten or wheat flour in the list of ingredients in its labeling.

FDA has identified very few oral drugs that contain wheat starch as an ingredient. Starch can also be used as a starting material for manufacturing various ingredients found in oral drugs. Starch used for this purpose is often corn starch or potato starch, not wheat starch. Even if wheat starch were used, either as an ingredient or as a starting material, there would be very little gluten, if any, expected to be present in the ingredient or the drug product. Very few, if any, oral drug products contain ingredients derived from barley or rye.

Typically, how much gluten is in a drug product?

The vast majority of oral drug products either contain no gluten or virtually no gluten. In the very rare cases where gluten may be present, we estimate based on drug formulation information that wheat starch and other ingredients derived from wheat would contribute no more than 0.5 mg gluten to a unit dose of an oral drug product. This amount is less than may be found in a single 30-gram serving of food labeled gluten-free according to FDA’s regulations.   

Does this mean we no longer have to be so particular in what manufacturers we use?  I'd be interested in everyone's thoughts.

Thanks!


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