The FDA issued warning letters to ten companies this week for illegally selling dietary supplements that claim to cure, treat, or prevent diabetes.
The following are the cited products, as well as the ten companies that promote them and got the warning letters:
- Berry Gen Sugar Control (Live Good Inc.)
- Diabetes Doctor Pre-Diabetes and Diabetes Doctor Blood Sugar 24 Hour (Pharmaganics LLC)
- Lysulin Weight Loss Shake, Lysulin Diabetes and Prediabetes Chewables, Lysulin Diabetes and Prediabetes Liquid, Lysulin Diabetes and Prediabetes Capsules, and Lysulin Diabetes and Prediabetes Powder (Lysulin, Inc.)
- Diabetic Support Formula (Nuturna International LLC)
- GLUCOTYPE2 (Phytag Labs)
- Diabetes Support (Ar-Rahman Pharm LLC)
- DiabetesSupport (Metamune Inc)
- Diabalance Diabetes Supplement (Holistic Healer & Wellness Center Inc.)
- CuraLin (Radhanite LLC, d/b/a CuraLife Ltd)
- Sugar Balance (Aceva LLC)
“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,” Cara Welch, PhD, acting director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, said 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,” she continued.
Unlike drugs approved by the agency, the FDA has not evaluated whether the unapproved products covered by the warning letters are effective for their intended use, what the appropriate dosage might be, how they might interact with FDA-approved drugs or other substances, or whether they have any dangerous side effects or other safety concerns.
The FDA urged responses from companies within 15 working days outlining how they intend to resolve these concerns or provide justification and supporting material for why they believe the products do not violate the law. Failure to immediately address infractions may result in legal action, including the seizure of products and/or an injunction.
If a consumer finds a product may have caused a side effect or illness, they should immediately discontinue use and inform their health care practitioner. Additionally, the FDA encourages health care practitioners and consumers to submit side-effect data to the agency via MedWatch or the Safety Reporting Portal for FDA-regulated goods.
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