Today, the Food and Drug Administration warned 15 different companies that they were selling products that violate federal law: specifically, these companies are selling diabetes-related products that the FDA warns consumers should not be used because they are dangerous: among other things, some contain harmful ingredients; and others are being sold over-the-counter when they need to be pulled and provided only with a doctor’s prescription.
From the FDA today:
The U.S. Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. The letters were sent to foreign and domestic companies whose products were sold online and in retail stores.
The FDA is advising consumers not to use these or similar products because they may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter products when they should be marketed as prescription products. Using these products could cause consumers to delay seeking proper medical treatment for their diabetes. FDA-approved diabetes treatments, prescribed by a licensed health care professional and shown to be safe and effective, are readily available for people with diabetes. …
Many of the illegally sold products that are the subject to this action include claims such as “prevents and treats diabetes,” and “can replace medicine in the treatment of diabetes.” In addition, some of the products may cause harm because the products contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.
These illegally sold products include:
- Products sold as “natural” treatments for diabetes, but containing undeclared active pharmaceutical ingredients in unknown quantities that could cause harm or complicate medical conditions;
- Dietary supplements and ayurvedic products (medicine of the healing arts that originated in India) with claims to treat, cure, and/or prevent diabetes;
- Unapproved drugs sold over-the-counter, including some homeopathic products, intended to treat complications associated with diabetes, which include relieving symptoms caused by nerve damage in the arms and legs (also called peripheral neuropathy); and
- Prescription drugs for diabetes sold by online pharmacies without a prescription.
No Injuries Have Been Reported
The FDA has not received any reports from people that they have been hurt by these products; this warning is a preventative measure. Complaints apparently have been filed with the government and for anyone suffering from diabetes or who has a loved one dealing with this disease, it is important to be aware of the new FDA Warning about these diabetes-targeted products on the market.
The 15 companies targeted in the July 2013 Warning Letters are selling dietary supplements; alternative or homeopathic medicines including India ayurvedics; prescription medications; and over-the-counter drugs that are being marketed with phrases like:
“Lower 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.”
Beware These Diabetes Products and Know Your Rights
If you or a loved one has taken any of these diabetes-related products and have suffered harm as a result, then it is important to notify the FDA about your situation — and it’s also important to document what has happened (including saving the product container, the receipt from where you bought it, etc.). Claims may be made under appropriate products liability and negligence law against not only the makers of these products but also those companies who sell them to you (especially after this FDA Warning has been issued).
Be careful out there!
