FDA Says Fraudulent “Dietary Supplements” Pose A Growing Health Threat

Federal regulators continue to warn consumers about tainted, dangerous products that are marketed as dietary supplements. These fraudulent products can cause serious injury or even death. According to the federal agency charged with protecting the public from dangerous drugs, medical devices and dietary supplements, nearly 300 fraudulent products have been identified so far, which probably represent the tip of an iceberg so large that no regulatory body can effectively deal with it.

Most of the tainted products identified so far have been promoted for weight loss, sexual enhancement, and bodybuilding, and contain “hidden or deceptively labeled ingredients” such as prescription drugs or unapproved and highly dangerous compounds such as synthetic steroids that do not qualify as “dietary supplements” under federal laws.

These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.” FDA has received numerous reports of harm associated with the use of these products, including stroke, liver injury, kidney failure, heart palpitations, and death.

Lawsuits have been brought by consumers who were seriously injured by some of the tainted products. One such case involves a young man who developed acute liver failure requiring a liver and kidney transplant after he ingested a so-called dietary supplement that was subsequently the subject of an FDA investigation and a recall. However, injured consumers face often face an uphill battle in obtaining compensation for their injuries because a large number of the tainted supplement products are marketed by fly-by-night Internet retailers who have no real assets and no insurance coverage.

Dietary supplements, in general, are not FDA-approved as is the case for prescription drugs and medical devices. Under the law (Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. Instead, it is the responsibility of supplement companies to make sure their products are safe and that any claims are true.

According to FDA officials, just because a consumer sees a supplement product on a store shelf does NOT mean it is safe or effective. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, “it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market” according to regulators.

“We need consumers to be aware of these dangerous products and to learn how to identify and avoid them,” says Levy. Consumers should look for potential warning signs of tainted products marketed as dietary supplements, such as:

  • products claiming to be alternatives to FDA-approved drugs or to have effects similar to prescription drugs
  • products claiming to be a legal alternative to anabolic steroids
  • products that are marketed primarily in a foreign language or those that are marketed through mass e-mails
  • sexual enhancement products promising rapid effects, such as working in minutes to hours, or long-lasting effects, such as working for 24 to 72 hours
  • product labels warning that you may test positive in performance enhancement drug tests

Generally, if you are using or considering using any product marketed as a dietary supplement, FDA suggests that you:

  • Check with your health care professional or a registered dietician about any nutrients you may need in addition to your regular diet
  • Ask your health care professional for help distinguishing between reliable and questionable information
  • Ask yourself if it sounds too good to be true
  • Be cautious if the claims for the product seem exaggerated or unrealistic.
  • Watch out for extreme claims—for example, “quick and effective,” “cure-all,” “can treat or cure diseases,” or “totally safe.”
  • Be skeptical about anecdotal information from personal “testimonials” about incredible benefits or results obtained from using a product.
  • See FDA’s website to help recognize fraudulent weight-loss products and claims.

If you suspect a dietary supplement sold online may be illegal, FDA urges you to report that information online. In addition, you or your health care professional can also report an illness or injury you believe to be related to the use of a dietary supplement by phone at 1-800-FDA-1088 or online.

Do I have a Dietary Supplement Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience litigating and resolving lawsuits and claims all over the United States involving injuries caused by exposure to a variety of dietary supplements. If you or someone close to you has suffered injuries that may be related to dietary supplements, we are here to help ensure that your rights are fully protected.

If you or someone close to you has been diagnosed with an illness linked to a dietary supplement, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.