FDA seizes sexual enhancement products
April 10, 2008The U.S. Food and Drug Administration announced the seizure by U.S. marshals of more than 14,000 units of Shangai- and Naturale-brand diet supplements.
The FDA said the supplements -- including Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus and Lady Shangai -- were valued at more than $100,000. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction and impotency, as well as to provide sexual enhancement, causing them to be considered drugs under the Federal Food, Drug, and Cosmetic Act.
The seized products contained undeclared active ingredients that might result in serious side effects, the FDA said.
The products, which originated in China, are packaged and distributed by Shangai Distributors Inc. of Coamo, Puerto Rico. Although the products' labels state they are natural supplements, the products are considered drugs and their sale is illegal without FDA approval.
The FDA advised consumers who have used any of the products to discontinue use and consult their healthcare providers if they have experienced any adverse events believed related to the use of the products.
Consumers can also report adverse events to the FDA's MedWatch program at 800-332-1088.
Copyright 2008 by United Press International
Nov 20, 2009 |
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