FDA Warns 15 Companies to Stop Sale of Unapproved Diabetes Remedies By Tod Aronovitz | 07/29/13 | 0 Comment

Companies that market unapproved diabetes remedies and bogus dietary supplements are being ordered by the U.S. Food and Drug Administration to halt false advertising claims regarding unproven cures or disease prevention.

The agency recently issued warnings to 15 domestic and overseas companies whose illegal products were marketed—online and in retail stores—as remedies to alleviate, treat, cure or prevent diabetes and complications commonly associated with the disease.

The 11 letters, four cyberletters and one drug alert were issued to the companies listed below. The unproven product(s) being marketing by each company is also identified.

  • Amrutam Life Care Pvt. Ltd.: Diexi
  • Anastasia Marie Laboratories, Inc.: Anastasia Diapedic Foot & Leg Treatment
  • www.bestcheapmedsonline.com: Exermet GM, Galvus, Nuzide, Triexer and unapproved versions of Januvia
  • Enhance Nutraceutical: Diaberex
  • Glytain Internal Remedies, Inc.: Glytain
  • Health Care Products, Hi-Tech Pharmacal Co.: Zostrix Diabetic Foot Pain Relief Cream, Zostrix Diabetic Joint & Arthritis Pain Relief Cream, and Diabeti-Derm Antifungal Cream
  • Health King Enterprises & Balanceuticals Group, Inc.: Sugar Balancer
  • INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max: Insupro Forte
  • The Magni Group dba MagniLife: Diabetic Neuropathy Foot Cream, Diabetic Foot Cream, and Diabetic Hand & Body Cream
  • Naturecast Products: Eradicator
  • Nature’s Health Supply, Inc.: Diabetes Daily Care
  • Neuliven Health: Glucocil
  • Nutrient Synergy: Nepretin
  • Origin BioMed Inc.: Neuragen PN and Neuragen Cream
  • PharmaTerra, Inc.: ProBeta

The FDA is seeking to remove these illegal products from the market as they violate federal law. The agency is also advising consumers to not use these, or similar, products because they may contain harmful ingredients, may improperly be marketed as over-the-counter products when they should be prescription medicine, and may cause patients to delay proper medical treatment for their diabetes.

Specifically, these products are sold as dietary supplements, alternative medicines such as ayurvedics (medicine of the healing arts that originated in India), prescription drugs, and over-the-counter medicines, including homeopathic products. Some illegal claims include:

  • “Lowers your blood sugar naturally.”
  • “Lowers A1C levels significantly.”
  • “You’ll lower your chances of having eye disease, kidney disease, nerve damage and heart disease!”
  • “It can replace medicine in the treatment of diabetes.”
  • “For Relief of Diabetic Foot Pain.”

According to FDA Commissioner Margaret A. Hamburg, M.D. “Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments.”

“Consumers who buy violative products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management,” she said in a press statement.

A written response from these companies is required within 15 business days stating how the companies will fix their violations. Failure to comply may result in legal action such as product seizure, injunction, and/or criminal prosecution. To date, the FDA is not aware of any reports of injury or illness associated with the illegally sold products.

The FDA asks health care professionals and consumers to report any adverse reactions to FDA’s MedWatch program either by completing and submitting the report online at www.fda.gov/medwatch/report.htm or downloading and completing the form, then submitting it via fax at 1-800-FDA-0178. For more information, visit www.fda.gov.

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