FDA, FTC Send Warning Letters to 10 Companies over Diabetes Claims

Washington, D.C.—The FDA and FTC have posted warning letters to 10 companies for illegally selling dietary supplements claiming to cure, treat, mitigate, or prevent diabetes.

“More than 34 million Americans— just over 1 in 10 people— are living with diabetes. Dietary supplements that make fraudulent claims to treat diabetes are unapproved new drugs that could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments,” said Cara Welch, Ph.D., Acting Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, in a statement. “The FDA is committed to protecting U.S. consumers from products and companies that make unlawful claims to treat or prevent diabetes, and we’ll continue to hold companies accountable by alerting the public about products that place consumers at risk.”

The warning letters were issued to: Live Good Inc.; Pharmaganics LLC; Lysulin Inc.; Nuturna International LLC; Phytage Labs; Ar-Rahmah Pharm LLC; Metamune Inc.; Holistic Healer & Wellness Center Inc.; Radhanite LLC; and Aceva LLC.

FDA’s warning letters cited claims such as:

  • “[Product] helps improve insulin sensitivity and enhance blood sugar control.”
  • “For improved A1c levels and glycemic control.”
  • “The anti-diabetic properties of the ingredients contained in [product] work their best to support the fight against Type 2 diabetes and a number of other possible health ailments, before their onset.”
  • “[C]onquers insulin resistance and also shown to be useful in the treatment of certain classes of non-insulin-dependent diabetes”
  • “The combination and high level of these active ingredients have been shown to help maintain healthy A1c blood sugar levels in diabetics and prediabetics.”

FDA also cited social media statements, such as “If you need to decrease your body’s need for insulin, use [product]”; “help get your Diabetes under control”; and “clinically shown to help people with diabetes or pre-diabetes…works like a sponge to remove Glucose from your bloodstream.”

FDA further pointed to customer testimonials, such as reviews stating that a product had helped a user lower their HbA1c levels.

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FDA has requested responses from the companies within 15 working days, stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly correct violations may result in legal action, including product seizure.