In joint action, the FDA also warns the companies they may be violating the law
The Federal Trade Commission sent cease-and-desist letters to 10 companies suspected of advertising unproven treatments or cures for diabetes, ordering the companies to stop making unsubstantiated claims within 15 days or face potential legal action by the FTC.
“Out-of-control insulin prices are driving Americans to turn to questionable products rather than proven treatments,” said Samuel Levine, Acting Director of the FTC’s Bureau of Consumer Protection. “The FTC and FDA are joining forces to call out 10 companies for selling supposed diabetes treatments that don’t appear to be supported by sound science.”
The FTC demands were issued jointly with U.S. Food and Drug Administration (FDA) warning letters, in which the FDA warned the companies that their diabetes products are both unapproved and misbranded, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FTC’s cease and desist demands were issued to the following companies: 1) Ar-Rahmah Pharm, LLC; 2) Aceva, LLC; 3) Live Good Inc.; 4) Holistic Healer & Wellness Center, Inc.; 5) Lysulin, Inc.; 6) Metamune Inc.; 7) Nuturna International LLC; 8) Pharmaganics LLC; 9) Phytag Labs; and 10) Radhanite, LLC d/b/a Curalife Ltd.
The FTC Act
The letters state that the Commission is concerned that one or more of the efficacy claims in the companies’ advertisements may not be substantiated by competent and reliable scientific evidence, as required by the FTC Act. Further, the agency demands the companies stop making any claim that a product can prevent, treat, or cure diabetes without the required scientific evidence, or potentially face legal action by the Commission. The letters also note that marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a disease may be subject to a civil penalty of up to $43,792 per violation. They also may be required to pay refunds to consumers who purchased the deceptively marketed products under section 19(b) of the FTC Act. The letters order the companies to notify the FTC by email within 15 working days of receipt of what specific actions they have taken to address the FTC’s concerns.
The FD&C Act
Under the FD&C Act, products intended to 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 Federal Trade Commission works to promote competition, stop deceptive and unfair business practices and scams, and educate consumers. Report fraud, scams, or bad business practices at ReportFraud.ftc.gov. Get consumer advice at consumer.ftc.gov. Also, follow the FTC on social media, subscribe to press releases, and read the FTC’s blogs.