WASHINGTON - The Food and Drug Administration is cracking down on more than a dozen firms that market illegal treatments for diabetes, ranging from bogus dietary supplements to prescription drugs sold online without a prescription.
All of the products aim to cash in on the country's diabetes epidemic, which affects nearly 26 million Americans. Regulators worry that consumers who buy such unapproved products could put off getting legitimate medical care, which could exacerbate heart disease, kidney failure and other deadly complications.
The FDA sent warning letters to 15 companies, both in the United States and abroad, ordering each to stop selling diabetes treatments that violate U.S. drug laws.
Three of the products targeted are marketed as natural supplements, but actually contain unlisted pharmaceutical ingredients. For example, Diexi, which is sold as a traditional Indian "herbal formula," actually contains metformin, the most common prescription drug used to treat diabetes. The product is sold by Amrutam Life Care, of Surat, India, the FDA said.
"Consumers should exercise caution before using products claiming to be herbal or all-natural alternatives to FDA-approved prescription drugs," the agency said in a statement Tuesday. "These products should be considered unsafe and should not be used."
Other products include genuine dietary supplements that make unproven claims to treat or prevent diabetes. For example, Diabetes Daily Care is a capsule-based supplement containing cinnamon extract and other herbs. Its manufacturer, California-based Nature's Health Supply Inc., claims it "safely and effectively improves sugar metabolism," the FDA said.
Under U.S. law, only FDA-approved medicines are permitted to make claims for treating or preventing disease.
Other companies targeted by the FDA run online pharmacies that sell prescription drugs for diabetes without a prescription. The FDA issued a warning letter to bestcheapmedsonline.com for marketing unapproved versions of diabetes drugs like Januvia, from Merck & Co. Inc.