Hidden Risks of Erectile Dysfunction 'Treatments' Sold Online
Levy says FDA has determined that many of these products or their active ingredients are imported into the United States from other countries.
"FDA is working closely with U.S. Customs and Border Protection to develop a more effective network to successfully screen and stop these shipments from entering U.S. commerce," says Huascar Batista, team leader of OOC's Import-Export Team.
"FDA uses all of its enforcement powers—including warning letters, seizures, injunctions, import alerts, and criminal prosecution—to protect consumers against these products," says Levy. Follow-up investigations continue to identify multiple problem products, resulting in additional import alerts, recalls, and seizure actions.
In 2008, U.S. Marshals, at FDA's request, seized products from two different firms that contained undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances.
In April 2008, they seized more than 14,000 dosages of products known as Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. The seized products, valued at more than $100,000, originated in China and were packaged and distributed by Shangai Distributors Inc. of Coamo, Puerto Rico.
In July 2008, the Marshals seized specific lots of illegal Xiadafil VIP tablets distributed by SEI Pharmaceuticals Inc. (SEI) of Miami, Fla. The total worth of the seized tablets neared $74,000.
In both cases, the firms prompted FDA enforcement by failing to act after being notified of the potential adverse health risks posed by the products.
FDA is also evaluating innovative ways to educate consumers about the risks of buying such sexual enhancement products and other drugs online.
Online Products to Avoid
Since 2004, FDA has identified several products sold online as so-called "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have contained potentially harmful, undeclared ingredients. Included among them are:
- Lycium Barbarum L.
- Adam Free
- Rhino V Max
- True Man
- Energy Max
- HS Joy of Love
- Blue Steel
- Super Shangai
- Strong Testis
- Shangai Ultra
- Shangai Ultra X
- Lady Shangai
- Shangai Regular, also marketed as Shangai Chaojimengnan
- Naturalë Super Plus
- Xiadafil VIP tablets (Lots 6K029 and 6K209-SEI only)
For more information about topics for your health, visit the FDA Consumer Information Center (www.fda.gov/consumer).
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