On June 20, 2017, the U.S. Food and Drug Administration (FDA) posted warning letters to FlexFitness/Big Dan’s Fitness, AndroPharm, and Hardcore Formulations for illegally marketed products with labels alleging they contain steroid and steroid-like substances and claim to increase strength and muscle mass.
These products are marketed as dietary supplements, but they are not. Rather, they are unapproved drugs that the FDA has not reviewed for safety and efficacy. The FDA advises consumers immediately stop using over-the-counter (OTC) bodybuilding products labeled or marketed to contain steroid and steroid-like substances because of the risk of severe liver damage and other adverse health consequences that include kidney injury, increased risk of heart attack and stroke, shrinkage of the testes, and male infertility.
The FDA examined more than seven years of adverse event reports from those who suffered liver damage, many requiring hospitalization, that were linked with these kinds of body-building products.
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Symptoms of Adverse Side Effects
If consumers are experiencing symptoms that have been connected to these products, especially nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the whites of the eyes or of the skin) or brown or discolored urine, they should consult their health care professional immediately.
Health care providers should be watchful for patients with the warning signs linked to the use of steroids or steroid-like substances including liver damage, kidney injury, stroke, and hormone-associated adverse effects that may include pulmonary embolism (a blockage in one of the pulmonary arteries in the lungs) and deep vein thrombosis (DVT). This occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs. Deep vein thrombosis may cause leg pain or swelling, but may occur without any symptoms, according to the Mayo Clinic.
FDA Promotes Awareness of Potential Steroid Dangers
A regulatory review officer at the FDA, Mark S. Miller says that bodybuilding products that contain steroids or steroid-like substances are associated with potentially serious health risks, such as liver injury. “Some of the liver injuries were life-threatening,” Miller says. Miller was the lead reviewer evaluating hundreds of adverse event reports made to the FDA from July 2009 through December 2016. Thirty-five reports showed evidence of serious liver damage.
Along with liver damage, anabolic steroids have been associated with serious reactions such as severe acne, hair loss, irritability, altered mood, increased aggression, and depression. Many of these bodybuilding products make claims about the ability of the active ingredients to enhance or diminish androgen, estrogen, or progestin-like effects in the body, but actually they contain anabolic steroids or steroid-like substances, synthetic hormones related to the male hormone testosterone, according to the FDA.
Fraudulent Bodybuilding Marketing
Cara Welch, Ph.D., a senior advisor in FDA’s Office of Dietary Supplement Programs, explains that many of these bodybuilding products sold online as well as in retail stores, are labeled as “dietary supplements.” “In fact,” she says, “many of these products are not dietary supplements at all, and are illegally marketed, unapproved new drugs.”
Jason Humbert, a regulatory operations officer in the FDA’s Office of Regulatory Affairs, says that potentially harmful, sometimes hidden ingredients in products promoted for bodybuilding continue to be a concern. “The companies making these products are breaking the law by exploiting an easily accessible marketplace to get these products to consumers,” Humbert says. “In the end, it’s consumers who 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.”
Some people who use bodybuilding products engage in “stacking” using multiple products (that may include stimulants or products providing false assurances of liver protection) to enhance results or “gains.” These combinations may put consumers at greater risk for serious and life-threatening episodes.
FDA Takes Regulatory Action
In addition to issuing warning letters, Humbert says, the agency can pursue other regulatory or enforcement actions against sellers of these illegal products. However, this can be challenging, especially when so many sellers operate exclusively online. “Firm names or websites frequently are easily changed, or products can be relabeled in an attempt to evade authorities and scam consumers,” Humbert says.
Legal Information Involving Steroids and Dietary Supplements
If you or someone you know has been negatively affected by steroids or dietary supplements, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).