Fake Indian Herbal Remedies for Diabetes-FDA taking legal actions:

July23,2013

Several Ayurvedic and Herbal medicines have been under secret investigation by the Federal officials during the last few months. Some fake drugs that claimed to cure flu during its out-break in the early spring this year were also taken off the shelves by the FDA (the Food and Drug Administration) since they were found to be fake and bogus.

Now the FDA is cracking down on more than a dozen companies 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 40 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 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.

FDA has cautioned consumers in the United States to avoid these products claiming to be herbal or all-natural alternatives to FDA-approved prescription drugs. In a statement issued today FDA stated that these products are 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, 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.

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 percent of online pharmacies actually comply with all U.S. pharmacy laws, according to a review by the National Association of Boards of Pharmacy.

Many diabetics require multiple drugs to control their blood sugar levels. Some of these herbal remedies have harmful elements that can worsen cardiac and renal problems.

The U.S. market for prescription diabetes drugs is 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.

The FDA sent the warning letters to the companies last week, but posted them online today morning. The letters gives 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.

(Courtesy AP)

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