A Food and Drug Administration (FDA) warning letter sent to a sexual enhancement supplements maker should serve as a “clear signal that FDA continues its enforcement efforts against illegal drugs or drug alternatives masquerading as dietary supplements” says the American Herbal Products Association(AHPA).
In a note to members following the publication of an FDA warning letter sent to Evol Nutrition Associates, the AHPA said it was also the first letter it had seen for some time reminding a firm that it is illegal to market dietary supplements as alternatives to recreational drugs.
Undeclared pharmaceutical ingredients
In the letter , the FDA says that during a 2011 inspection of Evol's facility in Georgia, it identified several products that were marketed as dietary supplements but were in fact unapproved new drugs.
For example, its Mojo Nights supplements contained undeclared tadalafil and sildenafil, the active ingredients in erectile dysfunction drugs Cialis and Viagra, claimed the FDA.
They also contained undeclared sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil, which are phosphodiesterase type-5 (PDE-5) inhibitors and analogs of sildenafil or tadalafil.
These could interact with nitrates found in some prescription drugs and “may lower blood pressure to dangerous levels”, argued the agency.
Products that claim to mimic the effects of recreational drugs cannot be marketed as dietary supplements
Separately, several of Evol’s products including Sandman Party Powder Euphoric Drink Mix were marketed as alternatives to recreational drugs, it added.
“Products that claim to mimic the effects of recreational drugs are not intended to supplement the diet and… cannot lawfully be marketed as dietary supplements.”
Finally, even if these products did not make such claims, they would still be illegal because they contain piracetam, which has been authorized as an investigational new drug and therefore cannot be a lawful dietary supplement, noted the agency.
Evol Nutrition Associates did not respond to calls or emails from NutraIngredients-USA.