FDA warns consumers against ED products sold by marketer who has been indicted

By Hank Schultz

- Last updated on GMT

FDA warns consumers against ED products sold by marketer who has been indicted
The Food and Drug Administration has issued a consumer warning over a line of male sexual enhancement products, citing a number of severe adverse health events suffered by consumers. The alleged marketer of the products has been arraigned on federal charges.

FDA issued the warning on Rhino male enhancement products​ yesterday. The warning said the agency had found more than 25 Rhino-branded products that contained one or more hidden drug ingredients.  The products, which are commonly sold in single serving packages, have names such as Platinum Rhino 25000, Krazzy Rhino 25000 and Gold Rhino 25000.

The products were sold on Amazon and eBay as well as at convenience stores and gas stations. FDA noted that they are also starting to show up in international mail shipments.

FDA had previously identified a number of hidden ingredients in Rhino products.  These include various knockoff versions of FDA approved drugs that treat erectile dysfunction, such as tadalafil and sildenafil.

Severe health implications

In the most recent warning, FDA noted that, “The FDA has received reports of people experiencing chest pain, severe headaches and prolonged erections after taking a Rhino product that led to surgical intervention and hospitalization due to extreme drops in blood pressure.”

“Over the past few years, the FDA has been combatting the retail sale of male enhancement drug products that are frequently misrepresented as dietary supplements and that contain hidden and potentially harmful active drug ingredients. Distributing unapproved drugs, disguised as supplements, places the US public health at risk,”​ said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

Alleged perpetrator indicted

The warning noted that a South Korean national named Nam Hyun Lee, who has been living in Fullerton, CA, has been indicted in the case. Lee is accused of producing not only Rhino-branded products, but others containing hidden drug ingredients under names such as Black Stallion and Black Mamba.

The indictment charges Lee with conspiracy, three counts of smuggling misbranded drugs into the United States, and eight counts of introducing misbranded drugs into interstate commerce. Lee’s products allegedly were sold in outlets in Southern California, and were shipped to distributors in Maryland and Texas.

The conspiracy count in the indictment carries a statutory maximum penalty of five years in federal prison. Each smuggling count could bring a sentence as high as 20 years. The charges alleging the introduction of misbranded drugs each carry a maximum sentence of three years.

 The indictment also seeks the forfeiture of a $1.2 million residence in Fullerton that prosecutors allege was purchased with proceeds from the illegal activity charged in the indictment.  

FDA noted that the issue of hidden drug ingredients in products masquerading as dietary supplements continues to be a problem.  The agency maintains a database​ of such products to help consumers avoid them.

“Hidden active drug ingredients continue to be identified in products that are misrepresented as dietary supplements and promoted for sexual enhancement, weight loss, bodybuilding and/or pain relief. Over the past decade, the FDA has posted on its website hundreds of public warnings and recall announcements related to these types of fraudulent products,” ​the warning stated.

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