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As the number of people diagnosed with diabetes continues to grow, an increasing number of products marketed under the guise of “dietary supplements” or “over-the-counter drugs” promising to prevent, treat, and even cure diabetes are being sold illegally.

The U.S. Food and Drug Administration advises consumers not to use such products - for many reasons. For example, they may contain harmful ingredients or no active ingredients at all. They may also be improperly marketed as nonprescription (over-the-counter) drugs or dietary supplements when they have hidden prescription drugs in the product. 

These products carry an additional risk if they cause people to delay or discontinue effective treatments for diabetes. 

More than 38 million people in the U.S. have diabetes, and almost 1-in-4 adults don't know they have it, according to the Centers for Disease Control and Prevention. Additionally, approximately 96 million adults have pre-diabetes, meaning they have higher than normal blood sugar levels and can reduce their risks of developing diabetes through lifestyle changes, including diet and exercise.

People with diabetes are at a greater risk for developing serious Health complications, including:

• Death
• Heart disease
• Chronic kidney disease, 
• Nerve damage, 
• Foot health, 
• Oral health, 
• Hearing loss, 
• Vision loss, 
• Mental health

A Far-Reaching Problem

Products that promise an easy fix might be tempting, but you are gambling with your health if you choose an unapproved, unregulated, or fraudulent product. 

Diabetes is a chronic disease but is generally manageable. You can lower your 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.

Unfortunately, “snake-oil peddlers” still prey on people with chronic or incurable diseases, such as diabetes. 

Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than risk exposing patients to unapproved or dangerous products.

One way to tell if a diabetes product is unsafe or ineffective is if it is marketed as a nonprescription product or dietary supplement. 

FDA-approved diabetes drugs are only available by prescription. Additionally, there are no dietary supplements that treat or cure diabetes. In fact, the FDA requires dietary supplement products to be labeled with a disclaimer saying the product is not intended to "diagnose, treat, cure or prevent any disease." You can read more about how to identify fraudulent products at 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams.

To protect the public health, the FDA investigates consumer complaints and monitors the marketplace for fraudulent products, including those promising to treat diabetes and its complications.

Unapproved Diabetes Drugs

The FDA issues warning letters to various companies marketing products for diabetes in violation of federal law. These products are often marketed as:

• Dietary supplements
• Alternative medicines 
• Over-the-counter or nonprescription drugs
• Homeopathic products

In September 2021, the FDA and the Federal Trade Commission issued warning letters to 10 companies for illegally selling dietary supplements claiming to cure, treat, mitigate, or prevent diabetes.

FDA laboratories find some “all-natural” diabetes products contain hidden active ingredients found in approved prescription drugs used to treat diabetes. You may ask, what the harm is if the products contain these undeclared active ingredients? Don’t be fooled, these are illegal products and can be dangerous. 

If consumers, and their Health care professionals, are unaware of the actual active ingredients in the products they are taking, these products may interact in dangerous ways with other medications. One possible complication: patients may end up taking a larger combined dose of the diabetic drugs than they intended. This may cause a significant and unsafe drop in blood sugar levels, a condition known as hypoglycemia.

Fraudulent Pharmacies

The FDA also monitors the internet for illegal marketing of prescription drugs or potentially unsafe products by fraudulent online pharmacies. 

Buying medicines from unsafe online pharmacies may put consumers at risk. These websites often sell unapproved, counterfeit, or otherwise unsafe medicines outside of safeguards followed by licensed pharmacies. The products sold, while being passed off as authentic or effective, may contain the wrong ingredients, contain too little, too much, or no active ingredient at all, or contain other harmful ingredients.

Additionally, consumers cannot be certain the manufacturing or handling of these drugs follows U.S. laws or meets other necessary safeguards, such as storing the medicine at the right temperature, which is extremely important for diabetes medicine, such as insulin, to ensure it doesn’t lose or have decreased effectiveness.  

Visit BeSafeRx for more information about the potential dangers of buying drugs from unsafe websites, tips for purchasing medicines online safely and how to report unlawful sales. 

The FDA maintains a list of Internet Pharmacy Warning Letters issued to companies for:

• Selling illegally marketed products
• Selling counterfeit drugs
• Offering prescription drugs without a prescription
• Offering prescription drugs without adequate directions for safe use
• Offering prescription drugs without FDA-required consumer warnings about the serious health risks associated with the prescription drug

Identifying Legitimate Online Pharmacies

To help ensure you select a safe, licensed online pharmacy, look for one that requires you to have a valid prescription to purchase prescription drugs, provides a physical business address in the U.S., is licensed by a state pharmacy board, and provides a state-licensed pharmacist to answer your questions. You can find your state’s pharmacy board using the FDA’s Locate a State-Licensed Online Pharmacy webpage.

Talk to your Health care professional if you have any questions about your diabetes treatment or if a specific online pharmacy is safe to use. 

How to Report

If you believe you have found a website that may be illegally selling human drugs, dietary supplements, or other medical products, we encourage you to submit the information through the Reporting Unlawful Sales of Medical Products on the Internet available on the FDA website.

Health care professionals and consumers should report any problems or reactions—often referred to as potential adverse reactions—to FDA’s MedWatch program at www.fda.gov/Medwatch/report.htm. Or, you can call 800-FDA-1088 (800-332-1088), send a fax to 800-FDA-0178, or mail FDA form 3500 (available on the MedWatch “Download Forms” page) to the address on the pre-addressed form.

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