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College of Pharmacy

FDA issues consumer warning concerning illegally sold diabetes treatments

The U.S. Food and Drug Administration (FDA) issued a warning to consumers to beware of illegally sold diabetes products that claim to prevent, treat, and even cure the disease. According to the statement by FDA, these products are becoming more common in the marketplace, largely in part to the steady rise in the number of people diagnosed with diabetes. These products may contain harmful or unknown ingredients, or in some cases should only be available with a prescription and not over-the-counter (OTC). 


According to the Centers for Disease Control and Prevention (CDC), there are almost 19 million people in the U.S. who are diagnosed with diabetes, with an additional 7 million people who are yet to be diagnosed. This represents a large target market for the manufacturers and distributors of these illegal products. Due to the complexity of effectively treating diabetes, an easy fix approach may seem appealing to many consumers.


In July 2013, FDA took action to curb the availability of these illegal products by issuing warning letters to 15 companies that they identified as selling products in violation of federal law. Many of the products were marketed as dietary supplements or alternative medicines, including homeopathic products. Many even made unlawful claims such as:    

  • Lowers A1C levels significantly.
  • Lower your blood sugar naturally.
  • 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.


FDA notes that these products can be manufactured without the regulations and oversight that is present for prescription medications. This can lead to products that are counterfeit, contaminated, or expired.


Additionally, upon testing these products, FDA discovered ingredients also contained in prescription medications, posing a significant health risk to those already taking that medication. The potential for drug interactions and side effects can increase dramatically when the healthcare provider is unaware of the actual ingredient being consumed. For example, patients taking additional diabetic medication are at risk of their blood sugar levels dropping to an unsafe level, a condition known as hypoglycemia.


Managing diabetes appropriately can be complicated, and should be done under the care of a properly trained healthcare professional. Treatment involves a combination of diet, exercise, and prescription medications. Currently, there are no OTC treatments for this condition. It is important when selecting an OTC medication, for any condition, to check with the appropriate healthcare professional before consuming.


More information can be found under the consumer update section on the FDA website available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm361487.htm

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