In regards to the growing concern of tainted dietary supplements, officials at the U.S. Food and Drug Administration (FDA) want to be clear in their intentions. Subsequently, they have announced that ridding the industry of products containing undisclosed active pharmaceutical ingredients (APIs) is a top priority warranting their full attention. According to the American Herbal Products Association (AHPA), an FDA warning letter, sent to a sexual enhancement supplements maker, should serve as a clear signal that the regulatory agency plans to continue with their enforcement efforts against illegal drugs that are masquerading as 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.
However, many companies are including undisclosed and often dangerous ingredients to boost their products performance. “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.” Complicating the already volatile situation, are reports received by the FDA that acknowledge 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 may occur, the FDA has announced that they intend to crack-down on the illegal adulteration of dietary supplements. Accordingly, the FDA recently sent a warning letter to Evol Nutrition Associates, expressing that they intend to continue their enforcement efforts against illegal drugs or drug alternatives masquerading as dietary supplements. The letter was in response to a 2011 inspection of Evol’s facility in Georgia that identified several products that were marketed as dietary supplements, but were in fact unapproved new drugs because of the inclusion of undisclosed ingredients.
Upon the inspection of Evo’s facility, regulators identified undisclosed amounts of tadalafil and sildenafil within capsules of Mojo Nights, a dietary supplement promoted to help erectile dysfunction. They also contained undeclared amounts of sulfosildenafil, sulfotadalafil and hydroxythiohomosildenafil. Unfortunately, these undisclosed ingredients are known to react to certain drugs, causing blood pressure to plummet to dangerously low levels.
In addition to the inclusion of undisclosed ingredients, several Evo products claimed to mimic the effects of recreational drugs. Sandman Party Powder Euphoric Drink Mix was one product in particular that was marketed as an alternative to other drugs. Products that claim to mimic the effects of recreational drugs are not intended to supplement the diet and, therefore, can not be lawfully marketed as dietary supplements.
The warning letter issued to Evo may serve as a subsequent warning to companies practicing similar illegal practices. It also helps to reassure consumers that the FDA intends to reduce the amount of tainted dietary supplements that make it to the market.
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