The exponential growth in the use of dietary supplements has witnessed a twofold increase over the past ten years. Accordingly, their popularity has given rise to a $62-billion-a-year industry that shows no signs of slowing down. Of particular concern, however, is the rate in which illegally adulterated products are permitted access to the U.S. market. Such products contain undisclosed prescription ingredients while masquerading as dietary supplements. According to the U.S. Food and Drug Administration (FDA), Evol Nutrition Associates, Inc. is the most recent company to include prescription drugs in undisclosed doses of dietary supplements.
Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. Therefore, according to the DSHEA, a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement one’s diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
By no means are dietary supplements permitted to make claims that directly affect the structure or function of a subsequent body part. Only drugs, which have to go through an approval process in which they demonstrate efficacy, can make those claims.
However, an increasing number of dietary supplement manufacturers are knowingly and purposefully combining prescription approved drugs with dietary supplements and neglecting to disclose such actions. “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.” 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.
According to the U.S. Food and Drug Administration (FDA), Evol Nutrition Associates, Inc. is the most recent company to include prescription drugs in undisclosed doses of dietary supplements. In an FDA warning letter, regulatory officials acknowledged that the following Evol Nutrition products are unapproved new drugs under Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act:
- Sandman Party Powder Euphoric Drink Mix
- Sleep Walker Euphoria Awareness Enhancer
- Spark 4D Happy Caps
- Zan-X Extra Relaxation
- Red Dawn Liquid
- Mojo Nights
Furthermore, the letter addresses the critical issue of certain product claims that go beyond what’s permissible for dietary supplements. According to section 502 of the Act, dietary supplements can’t claim to directly affect the structure or function of a body part. The following Evol Nutrition products made impermissible claims:
- Zan-X Extra Relaxation
- Mojo Nights
According to the FDA warning letter, officials confirmed that “Mojo Nights contains undeclared tadalafil and sildenafil, the active pharmaceutical ingredients in Cialis and Viagra, respectively, both FDA-approved drugs used to treat erectile dysfunction (ED). According to section 201(ff)(3)(B) [21 U.S.C. § 321 (ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug.” Furthermore, the FDA also cited that “Mojo Nights also contained sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil, all of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogs of sildenafil or tadalafil, and none of which were declared on the product label.”
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 dietary supplements, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.