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FDA targets natural treatments for diabetes

Posted: July 24, 2013 |   Comments

( The Food and Drug Administration is cracking down on more than a dozen companies that market illegal treatments for diabetes, ranging from dietary supplements to prescription drugs sold online without a prescription.

The country's diabetes epidemic, which affects nearly 26 million Americans, has helped to make the U.S. market for prescription diabetes drugs the largest in the world, with sales of $22 billion last year. Sales have ballooned more than 60 percent in the last four years from $13.6 billion in 2008, according to health data firm, IMS Health. Regulators worry that consumers who buy unapproved natural products could put off getting costly allopathic medical care.

The FDA sent warning letters to 15 companies, both in the U.S. and abroad, ordering them to stop selling diabetes treatments which 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.

"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 whose claims to treat or prevent diabetes have not been approved by the FDA. 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 U.S. law, only FDA-approved medicines are permitted to make claims for treating or preventing disease.

The sudden attack on natural diabetic treatments is unwarranted as the FDA has not received any reports of injury or illness connected with the products, but claims to be taking action as a precautionary measure.

The FDA sent the warning letters to the companies last week, but posted them online Tuesday morning. The letters give each company 15 business days to reply and explain how they will come into compliance with U.S. law. FDA warning letters are not legally binding, but the agency can take companies to court if they are ignored.

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