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FDA Publishes Guidelines for Gluten Free Medication Labeling

Big news today! The Food and Drug Administration of the United States just published it’s draft guidance on Gluten in Drug Products and Associated Labeling Recommendations.

The FDA recommends that the words “Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)” be included when appropriate.

This labeling includes the following types of drugs:

  1. Orally ingested drugs that are absorbed in the intestine.
  2. Topically applied drugs that are placed near the mouth and may be ingested.
  3. Medications that are placed into the mouth.

This labeling does not apply to the following:

  1. Skin products not applied near the mouth.
  2. Costmetics.
  3. Supplements such as vitamins and minerals.

About John Libonati

John Libonati
Author Information: John Libonati, Philadelphia, PA Publisher, Glutenfreeworks.com & The Gluten Free Works Health Guide. Editor & Publisher, Recognizing Celiac Disease.
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