What makes the case even more shocking is that the FDA had warned manufacturer NovaCare two years before the man bought Stiff Nights that the supplement, which was marketed as a 100 percent natural, scientific and medically safe way to enhance sexual performance and treat erectile dysfunction, was not allowed to be sold on the U.S. market without FDA approval. In fact, the FDA banned the use of and sales of sulfoaildenafil and sildenafil citrate in over the counter products like Stiff Nights. Yet, even though Stiff Nights never received FDA approval it had not been recalled or removed from store shelves.
The lawsuit alleged that the product is a drug under the Food, Drug, and Cosmetic Act because statements included on the label, like Male Sexual Stimulant, are intended to affect a body function or structure. The FDA must approve all drugs before they can be sold on the market.
Yet these same types of products remain on store shelves everywhere, just waiting for an unsuspecting consumer to buy them. When Lamar Odom took herbal Viagra tablets in 2015 and ended up fighting for his life after suffering heart failure, he probably never thought that the supplement could cause stroke, liver injury, kidney failure and death. But regulators have been worried about these types of products for years.
In fact, the FDA reported that more than 300 herbal male sexual enhancement products tested contained ingredients that were not listed on the label – including sildenafil and tadalafil, the active ingredients in Viagra and Cialis. Alarmingly, one of the products analyzed by the government agency had an amount of tadalafil that was 31-times higher than the prescription dose!
The FDA has issued Public Notifications concerning tainted sexual enhancement products that have hidden ingredients that are potentially harmful and the list is unfortunately quite long. To make matters worse, the agency warns that only a small fraction of tainted or adulterated over-the-counter supplements have been tested.
Consumers should never take sexual enhancement products like Stiff Nights as they are very dangerous and often adulterated with unknown ingredients. Once an herbal supplement maker, distributor, or retailer is warned about a product, they have a duty to remove it from the market and store shelves. Some of these products contain prescription medicine and selling a prescription medicine without a license is a very serious offense.