Consumer Beware: Illegally-Marketed Diabetes Treatments Flooding Marketplace
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Consumer Beware: Illegally-Marketed Diabetes Treatments Flooding Marketplace

Beware of these and similar red flags to avoid potential health complications

November 9, 2016

The number of people who suffer from diabetes is on the rise, and with them, the number of illegally-marketed products that claim to prevent, treat, and even cure the condition.

Consumers are urged not to use such products for several reasons, says the Food and Drug Administration (FDA). One is that these items may contain ingredients that are harmful to patients. Another is that they might be incorrectly marketed as over-the-counter products when, in reality, they should be advertised as prescription products. In the latter case, such products are even more dangerous if they cause patients to either delay or stop effective diabetes treatments. Diabetes patients are at higher risk for developing serious health complications if they do not manage the disease properly.

The Centers for Disease Control and Prevention states that more than 29 million U.S. patients have the disease, including approximately seven million who have not been diagnosed. And millions more are pre-diabetic, which means that their blood sugar levels are higher than normal. These people can lessen their risk of developing the disease by making healthy lifestyle changes, including exercise and diet modification.

"People with chronic or incurable diseases may feel desperate and become easy targets. Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than exposing patients to unproven and unreasonably risky products," said Jason Humbert, a commander with the U.S. Public Health Service, of the FDA's Office of Regulatory Affairs. "Failure to follow well-established treatment plans can lead to, among other things, amputations, kidney disease, blindness, and death."

The agency has sent warning letters to several companies marketing diabetes products in violation of federal law. These items were marketed in several ways: as dietary supplements; alternative medicines, like ayurvedics; prescription medications; over-the-counter drugs; and homeopathic items. Some companies also marketed the same unapproved items as treatments for other serious conditions, including cancer, sexually transmitted diseases, and macular degeneration.

Laboratory analysis conducted by the FDA has discovered that "all-natural" diabetes treatments contain undeclared active ingredients contained in approved prescription diabetes medications. These ingredients can cause serious harm to patients. If consumers and their healthcare professionals do not know about the actual active ingredients in their medications, the products can interact dangerously with other medications. One potential complication is that patients may eventually end up taking a larger combined dose of the products than they had meant to, which can result in a significant and dangerous drop in blood sugar levels, also known as hypoglycemia.

The FDA is also concerned about the illegal marketing of prescription medications by fraudulent online pharmacies. Signs of legitimate online pharmacies may include requiring a patient to have a valid prescription, providing a physical address located in the U.S. , being licensed by a state pharmacy board, and providing a state-licensed pharmacist to answer any questions.

Some fraudulent online pharmacies illegally market medications not approved in the U.S. or sell prescription drug products that are otherwise approved without meeting the necessary requirements for doing so. Though some such sites may offer prescription drugs that seem to be approved by the FDA, the agency cannot know for sure that the manufacture or handling of these products follows U.S. regulations or that they are safe and effective to be used as intended. There is also a risk that they may be counterfeit, contaminated, expired, or otherwise dangerous.

"Products that promise an easy fix might be alluring, but consumers are gambling with their health. In general, diabetes is a chronic disease, but it is manageable. And people can lower their risk for developing complications by following treatments prescribed by health care professionals, carefully monitoring blood sugar levels, and sticking to an appropriate diet and exercise program," Humbert said.

Watch out for the following and similar red flags printed on the packaging to make sure that your product is not a scam:

  • "Lowers your blood sugar naturally!"
  • "Inexpensive therapy to fight and eliminate type II diabetes!"
  • "Protects your eyes, kidneys, and blood vessels from damage!"
  • "Replaces your diabetes medicine!"
  • "Effective treatment to relieve all symptoms of diabetes!"
  • "Natural diabetes cure!"

Both healthcare professionals and consumers should report any negative reactions—often known as potential adverse reactions—to the FDA's MedWatch program by calling (800) 332-1088.