The cited products, and the 10 companies that market these products and received the warning letters, are as follows:
- 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 FDA, the agency has not evaluated whether the unapproved products subject to the warning letters are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA requested responses from the companies within 15 working days stating how they will address these issues or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
If a consumer thinks that a product might have caused a reaction or an illness, they should stop using the product right away and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.