March 20, 2025 – In a recent joint action, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to 10 companies accused of illegally marketing dietary supplements with unproven claims to treat, cure, mitigate, or prevent diabetes. The agencies cited violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), warning that these products pose potential risks to consumers and have not been evaluated for safety or effectiveness.

This enforcement action, announced in an official press release by the FDA, highlights the ongoing concern over unapproved supplements that make fraudulent health claims, particularly those targeting chronic conditions like diabetes, which affects more than 34 million Americans — approximately 1 in 10 people, according to the Centers for Disease Control and Prevention (CDC).

Companies Named in the Warning Letters

The 10 companies receiving the FDA and FTC warning letters include:

• 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

The FDA is urging consumers to avoid using products from these or similar companies for diabetes management, as they have not been evaluated by the FDA and may be harmful. These products are considered unapproved new drugs under federal law because they are marketed with disease-related claims, despite being labeled as dietary supplements.

“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. “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.”

Legal Implications Under the FD&C Act

Under the FD&C Act, any product that claims to diagnose, cure, treat, mitigate, or prevent a disease is classified as a drug, regardless of its labeling as a supplement. Such products must undergo FDA evaluation for efficacy, dosage, interactions, and potential side effects before being legally marketed.

Unlike FDA-approved drugs, none of the products cited in the warning letters have been evaluated for these factors. The FDA advises consumers to be wary of supplements with “too good to be true” claims and urges consultation with a health care provider—such as a physician, pharmacist, or naturopathic doctor—before using any dietary supplement or medication.

For more on how the FDA evaluates and regulates supplements, visit the agency’s Dietary Supplements Overview.

Reporting Adverse Effects

Consumers who suspect a reaction or illness linked to a supplement are advised to immediately discontinue use and seek medical attention. Additionally, the FDA encourages both consumers and health care providers to report adverse events through either MedWatch or the Safety Reporting Portal. These platforms help regulators track safety concerns and take action where necessary.

Enforcement and Next Steps

The FDA has requested formal responses from each of the 10 companies within 15 working days, detailing how they will address the cited violations or provide evidence supporting their products’ legality. Failure to adequately respond or correct violations may result in legal action, including product seizures or injunctions.

To view specific enforcement actions, you can review the FDA’s Warning Letters database here.

The FTC is also actively involved in enforcing regulations against deceptive marketing, particularly within the supplement industry. For more information on FTC’s role and recent actions, visit the FTC’s Health Products Business Guidance.

Implications for Vendors Serving Naturopathic Practices

For companies marketing to naturopathic doctors and integrative health professionals, this enforcement action is a critical reminder to ensure all product claims comply with federal law. Claims around disease prevention or treatment must be carefully evaluated and substantiated, or they risk triggering regulatory scrutiny.

Moreover, health professionals should remain vigilant when recommending or retailing supplements, ensuring that product claims align with current regulations and do not mislead patients about their efficacy, especially when addressing serious conditions such as diabetes.

As the FDA and FTC continue to crack down on unapproved products, vendors and health care providers alike must remain informed and proactive to maintain compliance and protect patient safety.

For guidance on proper supplement marketing practices, the Council for Responsible Nutrition and the American Herbal Products Association offer resources tailored to the natural products industry.

Conclusion

This latest action by the FDA and FTC underscores their commitment to protecting consumers from misleading and potentially dangerous products, particularly in the rapidly growing dietary supplement market. While nutritional support plays an important role in holistic health, unsubstantiated disease claims undermine public trust and can jeopardize patient outcomes.

By staying informed and adhering to regulatory best practices, both vendors and practitioners can continue to support safe, effective, and legal options for their patients and clients.

For the full FDA press release and detailed information about the warning letters, visit the FDA Newsroom.