Food and Drug Administration officials are cracking down on companies that sell illegal and fraudulent products that claim to treat, ease or even cure diabetes, which affects 1 in 9 Americans older than 20.
The agency posted warning letters on Tuesday that it sent to 15 firms in the U.S. and abroad that market unapproved supplements, creams and other so-called diabetes treatments. The firms, including online and retail stores, are peddling products that contain harmful ingredients or are otherwise unsafe, officials said. Others are selling diabetes medications without required prescriptions.
“These people are fraudsters who are scamming people and creating risks that people are going to get very sick,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
Targeted products include Zostrix Diabetic Foot Pain Relief Cream, DiabeRex, marketed as “the New Diabetes Miracle,” and Glytain, billed as “the all-natural way to support normal blood sugar levels".
The agency has received no reports of serious adverse events linked to the products and Sklamberg said officials have no way of knowing how many of the nearly 26 million Americans with diabetes may have used them.
The danger, however, is that people who don’t know better will take the products instead of seeking medical help for the potentially life-threatening condition, said Dr. Karen Mahoney, an FDA safety reviewer.
“All patients with diabetes need to be under the care of a licensed health care professional,” Mahoney told NBC News. “You need to go to a doctor. If they’re taking on one of these products, they should stop.”
Diabetes is a disease that causes blood sugar levels to rise higher than normal because the body does not produce sufficient amounts of insulin or to use its own insulin efficiently. Untreated, or treated improperly, it can lead to serious problems including heart disease, kidney failure, blindness and lower-extremity amputations.
Targeted firms and products include the following:
· Diexi by Amrutam Life Care Pvt. Ltd., Surat India.
· Anastasia Diapedic Foot & Leg Treatment by Anastasia Marie Laboratories Inc., Oklahoma City, Okla.
· Exermet GM, Galvus, Nuzide, Triexer and unapproved versions of Januvia, all from www.bestcheapmedsonline.com.
· Diaberex by Enhance Nutraceutical.
· Zostrix Diabetic Foot Pain Relief Cream, Zostrix Diabetic Joint & Arthritis Pain Relief Cream and Diabeti-Derm Antifungal Cream, all from Health Care Products, Hi-Tech Pharmacal Co., Amityville, N.Y.
· Sugar Balancer by Health King Enterprises & Balanceuticals Group Inc., Chicago.
· Insupro Forte by INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max, Selangor Darul Ehsan, Malaysia.
· Diabetic Neuropathy Foot Cream, Diabetic Foot Cream, and Diabetic Hand & Body Cream by The Magni Group, doing business as MagniLife, McKinney, Texas. A company spokeswoman, Lindsay Rohnke, said the firm was looking into potential marketing violations and would make "any necessary changes" to keep the foot cream available to the public.
· Eradicator by Naturecast Products, Coral Springs, Fla.
· Diabetes Daily Care by Nature’s Health Supply Inc., College Park, Md.
· Glucocil by Neuliven Health, San Diego,Calif.
· Neuragen PN and Neuragen Cream by Origin BioMed Inc., Halifax, Novia Scotia, Canada.
· Nepretin by Nutrient Synergy, Longmont, Colo.
· ProBeta by PharmaTerra Inc., Bellevue, Wash.
First published July 23 2013, 7:21 AM