A sexual enhancement supplements company has recalled two of its products following a public notification issued by the FDA. One of the supplements is meant for male use and the other for females. Not surprisingly, the products are reported to contain undeclared ingredients.
Evol Nutrition Associates has issued a recall of all lots of two dietary supplement products distributed by the company under the names Mojo Nights and Mojo Nights for Her, according to the Monterey County Health Department.
Testing by the U.S. Food and Drug Administration revealed the presence of undeclared tadalafil and sildenafil in Mojo Nights.
The company has also issued a recall Mojo Nights for Her as a precautionary measure.
Tadalafil and sildenafil are active ingredients of FDA-approved drugs for Erectile Dysfunction, making Mojo Nights an unapproved new drug. See original story
Indeed, there seems to be a growing trend of supplements being marketed as “natural” only to be found to contain chemical substances, some of which may be harmful. The FDA has appeared keen taking action, even taking manufacturers to court.
This is not the first sexual enhancement product to be found with undeclared substances. Not long ago a Utah man was indicted for selling “natural” erectile dysfunction supplements that were later found to contain Viagra-like ingredients imported from China. There is also the ongoing DMAA saga, if I may call it that. Several countries have banned this compound found in some energy supplements and “party” pills.
Here’s an excerpt of the FDA notification:
The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Mojo Nights,” a product for sexual enhancement sold on various websites and in some retail stores.
FDA laboratory analysis confirmed that “Mojo Nights” contains tadalafil, sildenafil, sulfoaildenafil, sulfosildenafil, and hydroxythiohomosildenafil. Tadalafil is the active ingredient in Cialis, and sildenafil is the active ingredient in Viagra. Cialis and Viagra are FDA approved prescription drugs for the treatment of Erectile Dysfunction (ED). Sulfoaildenafil, sulfosildenafil, and hydroxythiohomosildenafil are structurally similar to sildenafil, the active ingredient in Viagra.
These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
You can read the full notification at the FDA website. Presently, the FDA can only act on supplements after the fact as supplements are not regulated in the same way as drugs. Increased regulation is not something manufacturers want and may not be in the consumer’s best interests either.