FDA News

FDA proposes recommendations for labeling gluten in medications

Jocelyn Silvester, MD, PhD
Jocelyn Silvester

The FDA has issued a draft guidance with recommendations on the labeling of oral drug products regarding their gluten content.

The agency said it has developed these recommendations to reduce uncertainty about the presence of gluten in medications among health care providers and patients with celiac disease and other conditions that are treated with a gluten-free diet.

The agency noted that most oral medications contain “no or virtually no gluten,” but “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.”

This is an important issue for patients with celiac disease seeking information about the gluten content in their medications, according to Jocelyn Silvester, MD, PhD, director of research for the Celiac Disease Program at Boston Children’s Hospital.

“It’s often very difficult for patients to get information about their prescription medications because some manufacturers don’t feel comfortable telling them whether it has gluten in it or not, when in reality, as the FDA emphasizes in their statement, the actual amount of gluten a patient would be exposed to through medication is minimal relative to what is permissible in the gluten-free diet,” she told Healio Gastroenterology and Liver Disease.

In addition to providing reassurance to patients, the recommendations would also reduce uncertainty for manufacturers, Silvester added.

“I think it works both ways,” she said. “Giving wording to manufacturers so that they can feel comfortable saying their product is gluten-free is just as important as patients knowing what words to look for.”

Silvester also noted that, unlike with gluten-free foods, the issue of proper labeling for medications remains an issue because drugs are subject to different FDA standards.

“Patients know to look for the FDA’s gluten-free designation based on guidance for food, but because medications are a different type of matrix, and the dosing is a bit different, they don’t want to use those same standards and terminology for medications,” she explained.

Importantly, Silvester emphasized that the FDA’s recommendations would not apply to certain products.

“Vitamins are not drugs, so they wouldn’t be covered under this,” she said. “Probiotics are also generally considered dietary supplements and thus this guidance would not apply unless the probiotic is marketed as a drug with a specific health claim. Probiotics are sometimes grown on gluten-containing media, so they’re more likely to have gluten in their manufacture than Tylenol, Advil, cough syrup or other common medications.”

The FDA is currently accepting comments and suggestions on this draft guidance for the 60-day period following the document’s release on Dec. 12. – by Adam Leitenberger

References:

FDA. Medications and Gluten. Accessed Dec. 14, 2017. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/ucm410373.htm

FDA. Gluten in Drug Products and Associated Labeling Recommendations - Guidance for Industry. Accessed Dec. 14, 2017. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588216.pdf

Disclosures: Silvester reports no relevant financial disclosures.

Jocelyn Silvester, MD, PhD
Jocelyn Silvester

The FDA has issued a draft guidance with recommendations on the labeling of oral drug products regarding their gluten content.

The agency said it has developed these recommendations to reduce uncertainty about the presence of gluten in medications among health care providers and patients with celiac disease and other conditions that are treated with a gluten-free diet.

The agency noted that most oral medications contain “no or virtually no gluten,” but “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.”

This is an important issue for patients with celiac disease seeking information about the gluten content in their medications, according to Jocelyn Silvester, MD, PhD, director of research for the Celiac Disease Program at Boston Children’s Hospital.

“It’s often very difficult for patients to get information about their prescription medications because some manufacturers don’t feel comfortable telling them whether it has gluten in it or not, when in reality, as the FDA emphasizes in their statement, the actual amount of gluten a patient would be exposed to through medication is minimal relative to what is permissible in the gluten-free diet,” she told Healio Gastroenterology and Liver Disease.

In addition to providing reassurance to patients, the recommendations would also reduce uncertainty for manufacturers, Silvester added.

“I think it works both ways,” she said. “Giving wording to manufacturers so that they can feel comfortable saying their product is gluten-free is just as important as patients knowing what words to look for.”

Silvester also noted that, unlike with gluten-free foods, the issue of proper labeling for medications remains an issue because drugs are subject to different FDA standards.

“Patients know to look for the FDA’s gluten-free designation based on guidance for food, but because medications are a different type of matrix, and the dosing is a bit different, they don’t want to use those same standards and terminology for medications,” she explained.

Importantly, Silvester emphasized that the FDA’s recommendations would not apply to certain products.

“Vitamins are not drugs, so they wouldn’t be covered under this,” she said. “Probiotics are also generally considered dietary supplements and thus this guidance would not apply unless the probiotic is marketed as a drug with a specific health claim. Probiotics are sometimes grown on gluten-containing media, so they’re more likely to have gluten in their manufacture than Tylenol, Advil, cough syrup or other common medications.”

The FDA is currently accepting comments and suggestions on this draft guidance for the 60-day period following the document’s release on Dec. 12. – by Adam Leitenberger

References:

FDA. Medications and Gluten. Accessed Dec. 14, 2017. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/ucm410373.htm

FDA. Gluten in Drug Products and Associated Labeling Recommendations - Guidance for Industry. Accessed Dec. 14, 2017. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588216.pdf

Disclosures: Silvester reports no relevant financial disclosures.