We have long been reporting on the issue or erectile dysfunction supplements containing undeclared ingredient. Now, in a move made at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets from lots 6K029 and 6K209-SEI. The supplements were distributed by SEI Pharmaceuticals, Inc. (SEI) of Miami, Florida.
The product is marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement; however, the lots seized represent an illegally marketed drug containing an undeclared ingredient. The seizure followed an earlier formal FDA request to SEI on May 27, 2008, to recall the lots of Xiadafil VIP tablets which were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). Despite the formal request, SEI refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.
The FDA’s chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI revealed that the tablets contain hydroxyhomosildenafil, which is chemically similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use. Also, the safety and effectiveness of this product is unknown. Be aware that although offered for sale as dietary supplements, the seized products are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA. “Today’s seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers,” said Margaret O’K Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs. “FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by FDA
to do so,” she added.
On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. At that time, SEI was advised of the FDA’s findings; informed of the product’s potential adverse health risks; and warned of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. SEI committed to halting distribution and deactivated its Internet site; however, it refused to recall the product already in the market. On May 13, 2008, Florida state officials issued a “stop sale” action at SEI’s distribution facility to keep the illegal product out of the marketplace, which mandated that SEI hold, intact, violative Xiadafil VIP tablets found at the facility.
ED is a common problem in men with diabetes, high blood pressure, high cholesterol, or heart disease. These patients are often advised against taking ED drugs and may look for alternative products like Xiadafil VIP tablets because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs.