FDA Warns Evol Nutrition for Adulteration, Marketing Claims

ATLANTAA sexual health supplement from Evol Nutrition Associates Inc. contained undeclared drugs, and other products were marketed using illegal claims, according to a warning letter FDA sent the company's owner and CEO Jeremy E. Nickels.

FDA inspected the company's Kennesaw, GA, on July 13 to 29, 2011, where it collected product labels and samples. FDA also reviewed the firm's website, reddawnparty.com, and other Evol Nutrition Associates Inc. websites where its products are marketed, including reddawndrink.com and evolnutrition.com.

Spiked Supplements

According to the warning letter, the company's Mojo Nights contained undeclared tadalafil and sildenafil, the active pharmaceutical ingredients in Cialis and Viagra, respectively. FDA conducted lab tests and found  the product contained the pharmaceutical drugs used to treat erectile dysfunction (ED). Further, FDA found Mojo Nights also contained sulfosildenafil, sulfotadalafil and hydroxythiohomosildenafil. All of these phosphodiesterase type-5 (PDE-5) inhibitors are analogs of sildenafil or tadalafil, and none were declared on the product label.

FDA said other products, Sandman Party Powder Euphoric Drink Mix, Sleep Walker Euphoria Awareness Enhancer and Spark 4D Happy Caps, also cannot be dietary supplements because they contained 2-oxo-1-pyrrolidine acetamine (aka piracetam), which has been authorized as an investigational new drug (IND). IND ingredients are not dietary ingredients, and thus cannot be legally sold in dietary supplements.

Illegal Marketing Claims

Mojo Nights also had illegal marketing claims, including "Jump start your sex drive" and "stop pre-mature ejaculations." FDA said these statements make clear that Mojo Nights is intended to affect the structure or function of the body, making the product an unapproved new drug.

The product claims issues continued on the website reddawnparty.com and product labels that carryied disease prevention and treatment claims. For Instance, FDA said GHRelease and Zan-X Extra Relaxation were marketed as helping with insomnia, anxiety and depression.

Street Drug Alternatives

FDA also called attention to several of Evol Nutrition's products labeled as dietary supplements, but marketed as alternatives to illicit street drugs. For instance, the product Sandman Party Powder Euphoric Drink Mix was marketed as "designed to heighten euphoric pleasure ," and Red Dawn Liquid was said to give "Energy" and "Euphoria." Spark 4D Happy Caps had the marketing line, "Forget about the 'Red' pill or the 'Blue' pill. Take the Green pill and enjoy the 41th Dimension." FDA said products that claim to mimic the effects of recreational drugs are not dietary supplements.

Intake Issues

The way Spark 4-D Happy Caps are absorbed also takes the product out of the supplement category, according to the warning letter. FDA said its directions for use say, "[L]et dissolve in mouth for quicker absorption." However, dietary supplements are defined as products that are "intended for ingestion."  This product is intended to enter the body directly through the mucosal tissues, and therefore, FDA said it is not a dietary supplement.

INSIDER's Take

It's no secret FDA has increased its GMP (good manufacturing practice) GMP inspections, but this warning letter clearly shows FDA is still concerned with other issues.

As FDA Commissioner Margaret Hamburg noted in a December 2010 letter to industry, the agency is taking a closer look at supplements in the sexual health category.  Here, Evol Nutrition's sexual health product was subject to close scrutiny, and FDA found both adulteration and marketing claim issues.

Beyond that, FDA found other products contained illegal ingredients and carried illegal marketing claims, which is quite common of FDA recent warning letters.

However, here FDA also noted directions of use are also important, as it found Spark 4-D Happy Caps were described as entering the body through the mucosal tissues, making it not supplement.