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FDA Recalls Mojo Nights for Undeclared Ingredients

FDA Recalls Mojo Nights for Undeclared Ingredients

September 21, 2012 — Evol Nutrition Associates, Inc. / Red Dawn, and the U.S. Food and Drug Administration (FDA) are announcing a voluntary recall of Mojo Nights and Mojo for Her because testing by the FDA revealed the presence of undeclared tadalafil (Cialis) and sildenafil (Viagra). The presence of these prescription drugs means that Mojo Nights cannot be sold as a dietary supplement. The FDA also found other ingredients in the product that are not allowed in dietary supplements.

These are the latest supplements to receive warning letters in the FDA’s ongoing efforts to regulate supplements that contain active pharmaceutical drugs that are not listed on the ingredient label.

In the warning letter, the FDA also cited illegal marketing of the products. Mojo Nights was advertised as a way to improve sexual performance and treat erectile dysfunction. According to the label, it could “Jump start your sex drive,” “Give you powrful (sic) erections,” “stop pre-mature ejaculations,” and “MojoNights increases the strength and power of your erection.”

These advertising claims clearly state that the product is intended to alter the human body, which is illegal marketing. Only drug products that are approved by the FDA may make marketing claims that they alter the human body.

According to the FDA,

“Its labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of this product. [The ingredients] contained in your “Mojo Nights,” may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the product’s label.”

The FDA was also concerned about potential health risks associated with Mojo Nights. Erectile dysfunction is a common problem in men with diabetes, heart disease, high blood pressure, and high cholesterol. These men might be attracted to a supplement advertising sexual enhancement. Unfortunately, many of these men take prescription medications containing nitrates, and Mojo Nights could potentially interact with a nitrate medication. Life-threatening side effects include dangerously low blood pressure.

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