September 9, 2021
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes. The products cited in these letters are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.
According to the Centers for Disease Control and Prevention, more than 34 million Americans have diabetes, which is the seventh leading cause of death in the United States. In just the last 20 years, the number of adults diagnosed with diabetes has more than doubled. Consumers who rely on unapproved products claiming to cure, treat, mitigate, or prevent diabetes instead of seeking safe and effective therapies could potentially suffer harm and may not receive appropriate treatment.
Warning letters were sent to the following companies:
- 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
- Aceva, LLC
Under the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today 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 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 correct violations promptly may result in legal action, including product seizure and/or injunction.
For more information, see the FDA press release.