Recent years have witnessed an influx of manufacturers incorporate active pharmaceutical ingredients into the development of dietary supplements. Accordingly, their actions suggest an attempt at increasing results without the hassles that accompany U.S. Food and Drug Administration (FDA) regulations. However, transgressions such as these are not only in violation of the Federal Food, Drug, and Cosmetic Act, but they serve as a significant danger to those who are exposed to the undisclosed drugs. Reports received by the FDA acknowledge that tainted products may be associated with an increased risk of stroke, liver injury, kidney failure, heart palpitations, and death.
Adding further complication to an already volatile situation, is a distinct neglect for consumer safety exhibited by the retailers of such products. Distributers have a clear responsibility to ensure that the products they are selling are indeed dietary supplements, and not approved pharmaceutical ingredients masquerading as such. Subsequently, the $8.1 million fine recently leveled against Bodybuilding.com should serve as a reminder for retailers that they have a responsibility to ensure that their products are safe and free of undisclosed ingredients.
According to the definition provided by congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements contain ingredients intended to supplement one’s diet. However, they are by no means permitted to make claims that directly affect the structure or function of a subsequent body part. “Dietary ingredients” contained within these products often include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
Unfortunately, however, recent years have witnessed an exponential increase in the amount of approved pharmaceutical ingredients being added to dietary supplements. “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.” The inclusion of undisclosed drugs may significantly increase the risk of adverse health effects. Reports received by the FDA acknowledge that these products may be associated with an increased risk of stroke, liver injury, kidney failure, heart palpitations, and death.
Due to the rate and severity in which these incidents have occurred, officials at the FDA have begun to crack-down on fraudulent practices within the dietary supplement industry. In doing so, a dietary supplement lawsuit was brought against Bodybuilding.com.
According to a plea agreement, Bodybuilding.com committed several violations of the Food, Drug and Cosmetic Act. According to representatives, “The FDA has concluded that a small handful of Bodybuilding.com’s products contained labeling that was not compliant with FDA laws.” Those products included I Force Methadrol, Nutra Costal D-Stianozol, I Force Dymethazine, Rage RV5, and Genetic Edge Technologies. The products contained synthetic anabolic steroids or synthetic chemical clones of anabolic steroids, therefore rendering them drugs.
Bodybuilding.com’s chief executive, Ryan DeLuca, has agreed to pay a fine of $600,000. Furthermore, the company has agreed to pay an additional $7 million for knowingly selling dietary supplements with undisclosed steroids.
According to a U.S. attorney, “ the $8.1 million fines imposed in this case send a clear message that retailers, as well as manufacturers, of products sold as dietary supplements have a clear responsibility under the law to ensure that they products they are selling are indeed dietary supplements, and not synthetic steroids or steroid clones masquerading as dietary supplements.”
Lisa Malinowski, Acting Special Agent in Charge, FDA-Office of Criminal Investigations said that the “sentencing should serve as a reminder and deterrent to those involved in the distribution of products promoted as dietary supplements that the FDA’s Office of Criminal Investigations will continue working with U.S. Attorneys’ Offices to protect consumers, vigorously pursuing and holding accountable those who sell unsafe and illegal products to the unsuspecting public.”
Do I Have a Dietary Supplement Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in dietary supplement lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been injured by a dietary supplement, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.