FDA Warning Letters for Bodybuilding Products Containing Steroid-Like Substances

On June 20, 2017, the U.S. Food and Drug Administration (FDA) posted warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharm, and Hardcore Formulations for illegally marketing products labeled as containing steroid and steroid-like substances and promoted to increase muscle mass and strength.

The products are marketed as dietary supplements but the FDA considers these products unapproved drugs that have not been reviewed for safety and effectiveness.  

Dietary supplements do not require FDA approval before they reach the market, but the FDA can take enforcement action if a dietary supplement is found to be unsafe, adulterated or misbranded, or if the labeling is false or misleading. Dietary supplements cannot contain drug ingredients and they cannot claim to “diagnose, mitigate, treat, cure, or prevent a disease.”

Dietary supplements are widely used and because many of them contain herbs, minerals, or plant extracts, consumers believe the products are safe. But dietary supplements can interact with medications the supplement user is taking and can change the medicine’s potency. The person may end up with either too little or too much of the medication, the FDA warns.

The personal injury law firm Parker Waichman LLP notes that many supplement users have brought lawsuits over injuries allegedly caused by dietary supplement. The firm can advise individuals with concerns about the health risks of dietary supplements.

Bodybuilding Products May Contain Steroids

Cara Welch, Ph.D., a senior advisor in the FDA’s Office of Dietary Supplement Programs, explains that many of the body building products labeled as dietary supplements are, in fact, “unapproved new drugs.” The FDA has not reviewed these products for safety, effectiveness, or quality before the companies began selling them online and in stores.

The FDA’s Office of Regulatory Affairs says that potentially harmful, sometimes hidden ingredients in products promoted for bodybuilding continue to be a concern. According to Jason Humbert, a regulatory operations officer, “The companies making these products are breaking the law by exploiting an easily accessible marketplace to get these products to consumers.” Consumers are “put in harm’s way by taking dangerous ingredients from products promoted as having miraculous results or making empty promises, and who may not understand the risks.”

When a dietary supplement contains undeclared drug ingredient, the user is at risk for overdose if they are already taking that drug ingredient in prescription or over-the-counter form. Dietary supplements can interact with medications the supplement user is taking and can change the medicine’s potency. Users may also suffer allergic reactions or side effects to ingredients they have not been warned about. Dietary supplements with undeclared drug ingredients have been linked to serious health problems, including liver failure and kidney damage.

What Consumers Should Do

The FDA advises consumers who are taking bodybuilding products like those from Flex Fitness, Big Dan’s Fitness, AndroPharm, and Hardcore Formulations to discontinue taking them immediately because of the potentially serious health risks. The FDA recommends that supplement users talk to a health care professional about any body building products they have taken or are planning to take. Supplement users should seek medical attention immediately if they experience symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes), or brown or discolored urine.

Basis for the FDA Warning Letters

The FDA reviewed more than seven years of adverse event reports about these supplements and found 35 people who suffered liver injuries associated with this type of product. Many of them required hospitalization. A majority of the cases involved elevated liver enzymes (i.e., alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (AlkP)), which are indicators of liver injury. Mark S. Miller, Pharm. D., a regulatory review officer at the FDA said, “Some of the liver injuries were life-threatening,”

In some cases, consumers were taking more than one bodybuilding product, therefore the FDA was unable to conclude that specific products or ingredients might be responsible. The harmful effects may have been caused by an interaction between two or more products, the agency says.

These bodybuilding products are promoted as hormone products and/or as alternatives to anabolic steroids for increasing muscle mass and strength. Many of these products make claims about their ability to enhance or diminish androgen, estrogen, or progestin-like effects in the body, but actually contain anabolic steroids or steroid-like substances, synthetic hormones related to the male hormone testosterone.

In October 2013, there was a rash of cases of nonviral hepatitis in Hawaii linked to the supplement OxyELITE Pro. The Hawaii health department investigated more than 40 cases of acute liver inflammation in people who used various versions of OxyELITE Pro, according to the Associated Press (AP). Two people died of liver failure and two others suffered such severe liver damage that they needed liver transplants.

A 2015 study in the New England Journal of Medicine reveals that injuries caused by dietary supplements lead to more than 20,000 emergency room visits a year. Many of these visits involve young adults experiencing cardiovascular problems after taking supplements promoted for weight loss and energy enhancement. The researchers say about 10 percent of the cases—about 2,150 yearly—were serious enough to require hospitalization.

Legal Help for Those Harmed by Dietary Supplements

If you or someone you know has suffered liver or kidney damage or other adverse effects from dietary supplements containing steroid or steroid-like substances, contact the attorneys at Parker Waichman LLP today for a free, no-obligation evaluation of your legal rights. To reach the firm, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

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