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Government Warns About Certain Dietary Supplements for Diabetes

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Government Warns About Certain Dietary Supplements for Diabetes

If you’ve ever heard miracle stories about dietary supplements that can help you with your diabetes, be careful. The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have sent warning letters to ten companies charged with illegally selling dietary supplements that claim to cure, treat, or prevent diabetes.

As the FDA has put it, “As the number of people diagnosed with diabetes continues to grow, illegally marketed products promising to prevent, treat, and even cure diabetes are flooding the marketplace.”

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In the United States, both drugs and dietary supplements are regulated by the FDA. But dietary supplements are usually regulated as food, not as drugs. This means they don’t need to meet the same safety and effectiveness standards that drugs do. To put it briefly, drugs are considered unsafe until proven safe and supplements are considered safe until proven unsafe.

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But even though supplements are regulated differently from medications, this doesn’t mean that the FDA doesn’t regulate food products and supplements at all. It depends on whether the seller makes health claims for its product. As the FDA explains, under the law “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.” For example, a company can’t (without overwhelming evidence) claim that its fruit juice cures cancer.

The ten companies that received FDA warning letters are 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; and Aceva, LLC. For each of these companies, the FDA listed objections to their public statements by citing specific claims made in company advertising. For example, in the case of Live Good, which markets a product called “Berry Gen Sugar Support,” the FDA quoted a claim that “Berry Gen Sugar Support is a treatment … that helps reduce blood sugar levels, control glucose, improve conditions for diabetic people, and protect the pancreas, as well as improve skin problems and joint pain.” Because of this claim, the FDA contended, “Berry Gen Sugar Support” is, according to the law, a “new drug,” adding that the supplement “is not generally recognized as safe and effective” and “new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.”

In the other warning letters, the FDA cited similar unsubstantiated claims of diabetes benefits. Aceva, LLC: “… a clinically‐effective formula containing powerful ingredients designed to improve insulin sensitivity and enhance blood glucose (sugar) control.” Phytag Labs: “lowers elevated blood sugar levels and blood pressure in Type 2 Diabetes across the day….” Pharmaganics, LLC: “Lower fasting blood sugars by 11%.” Holistic Healer & Wellness Center, Inc.: “Works great to lower high blood sugar….” And so on. The letters also warned: “Your product is intended for treatment of one or more diseases that, with certain exceptions not applicable here, are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes.”

The federal agencies explained that a couple of factors seem to be behind the appeal of the supplements. One is cost. According to Samuel Levine, Acting Director of the FTC’s Bureau of Consumer Protection, “… insulin prices are driving Americans to turn to questionable products rather than proven treatments.” Another is frustration. Jason Humbert, a captain with the U.S. Public Health Service who is with FDA’s Office of Regulatory Affairs, said, “People with chronic or incurable diseases may feel desperate and become easy targets. Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than exposing patients to unproven and unreasonably risky products. Failure to follow well-established treatment plans can lead to, among other things, amputations, kidney disease, blindness, and death.”

Want to learn more about diabetes and supplements? Read “Dietary Supplements: Hype or Helpful?”

Joseph Gustaitis

Joseph Gustaitis

Joseph Gustaitis on social media

A freelance writer and editor based in the Chicago area, Gustaitis has a degree in journalism from Columbia University. He has decades of experience writing about diabetes and related health conditions and interviewing healthcare experts.

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