Posted July 27, 2012

Prescription and Street Drug Alternatives Found in Male Enhancement, Mood, and Sleep Supplements

On July 10, 2012, the FDA issued a warning letter to Evol Nutrition Associates, Inc. subsequent to a 2011 inspection which found a number of the company’s products contained prescription and investigational drugs and were misbranded. As a result, the FDA has designated the following products as unapproved new drugs: Mojo Nights, Sandman Party Powder Euphoric Drink Mix, Sleep Walker Euphoria Awareness Enhancer, Spark 4D Happy Caps, GHRelease, Zan-X Extra Relaxation and Red Dawn Liquid. GHRelease, Zan-X Extra Relaxation and Mojo Nights were also cited for misbranding since they lacked adequate directions for use.

Evol’s Mojo Nights was promoted as treating low sex drive, pre-mature ejaculation and erectile dysfunction. The supplement was found to contain tadalafil and sildenafil, prescription erectile dysfunction drugs, and their analogues sulfosildenafil, sulfotadalafil and hydroxythiohomosildenafil. These drugs can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure.

(See ConsumerLab.com’s Review of Sexual Enhancement Supplements for tests of related products.)

Sandman Party Powder Euphoric Drink Mix, Sleep Walker Euphoria Awareness Enhancer, Red Dawn Liquid and Spark 4D Happy Caps were promoted as alternatives to street drugs, which is not allowed by FDA regulations. Sandman Party Powder Euphoric Drink Mix, Sleep Walker Euphoria Awareness Enhancer and Spark 4D Happy Caps contain piracetam, which has been designated an an investigational new drug.

In addition to piracetam, these supplements contained a variety of herbs. Sandman Party Powder Euphoric Drink Mix was promoted as producing a feeling euphoria, and contains gamma-Aminobutyric acid (GABA), thiamin, riboflavin and vitamin B6. Spark 4D Happy Caps was promoted for energy and mood enhancement, and contains caffeine, GABA and a blend of B vitamins.

GHRelease was misbranded and declared an unapproved new drug because it was promoted to treat insomnia. It contains a blend of L-theanine, valeric acid, glutamine, arginine, GABA and 5-hydroxytryptophan (5-HTP). Zan-X Extra Relaxation was misbranded and declared an unapproved new drug because its name closely resembles the prescription drug Xanax, and was promoted for the treatment of anxiety and panic disorder. This product contains thiamin, riboflavin, vitamin B6, chamomile, L-theanine, melatonin and valerian extract.

For tests of dietary supplements used for sleep, see ConsumerLab.com’s Reviews of Melatonin Supplements and Valerian Supplements as well as a review article about L-Tryptophan and 5-HTP.

For more details regarding the FDA’s warning letter, use the link below.