Miami, Orlando firms among 10 that got FDA Warning Letters about diabetes ‘treatments’
This week, the FDA and the FTC told 10 companies — across a geographic span from Miami to San Diego — to stop talking up their dietary supplements as treatments for diabetes.
The FDA says the companies are “illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA urges consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.”
Each company has 15 working days to stop the offending behavior. If the company wants to argue with the FDA that it’s not doing or saying anything wrong, the agency invites the company to make its case. Many times, it’s less time consuming and costly for the company to just change or remove the language.
For example, the letter to Live Good in the Miami suburb of Doral concerning its Berrygen Sugar Control points out that Live Good’s website says one scoop a day “Helps control diabetes” and “Helps regulate blood sugar and insulin levels.”
The FDA says that’s among the many claims on Live Good’s website, Instagram page and Amazon page showing Berrygen Sugar Control is intended for use as a drug. But Live Good hasn’t submitted testing data to show that Berrygen is a safe drug that actually does something of what it claims, so it hasn’t received FDA approval to be sold across state lines.
The companies that received letters and their products, in alphabetical order:
▪ Aceva, Peoria, Illinois, Sugar Balance.
▪ Ar-Rahmah Pharm, Laurel, Maryland, Diabetes Support.
▪ Holistic Healer & Wellness Center, Dearborn, Michigan, Diabalance Diabetes Supplement.
▪ Live Good, Doral, Florida, Berrygen Sugar Control.
▪ Lysulin, San Diego, 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.
▪ Metamune, Kent, Washington, DiabetesSupport.
▪ Nuturna International, Orlando, Diabetic Support Formula.
▪ Pharmaganics, Waconia, Minnesota, Diabetes Doctor Pre-Diabetes and Diabetes Doctor Blood Sugar 24 Hour.
▪ Phytage Labs, Bee Cave, Texas, Glucotype2.
▪ Radhanite/Curalife, Union City, New Jersey, CuraLin.
This story was originally published September 9, 2021 at 7:15 PM.
