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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 US and abroad, ordering them to stop selling diabetes treatments which violate US 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.
"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
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, Nature's Health Supply Inc., claims it "safely and effectively improves sugar metabolism".
Under US 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 www.bestcheapmedsonline.com for marketing unapproved versions of diabetes drugs like Januvia, from Merck & Co. Inc.
The FDA warns patients against buying prescription medications on the Internet. Only 3% of online pharmacies actually comply with all US pharmacy laws, according to a review by the National Association of Boards of Pharmacy.
The US market for prescription diabetes drugs is the largest in the world, with sales of $22 billion last year. Sales have ballooned more than 60% in the last four years from $13.6 billion in 2008, according to health data firm, IMS Health.
The FDA said it has not received any reports of injury or illness connected with the products, but is taking action as a precautionary measure.
