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Feds Seize Unapproved Erectile Dysfunction Drugs

'Natural supplements' are illegal drugs and pose serious health risks

April 11, 2008

• Feds Seize Unapproved Erectile Dysfunction Drugs • FDA Warns Against Using 'Blue Steel' and 'Hero' Products • FDA Approves Daily Cialis Dosage • FDA Warns Consumers About Chinese 'Health' Supplements • Study Finds Viagra Increases Release of 'Love Hormone' • Erectile Dsyfunction Affects All Ages • What To Do about Erectile Dysfunction • Impotence Affects 18 Million American Men • "Smiling Bob" Not Smiling Anymore • Public Citizen Wants Stronger Blindness Warning on Erectile Drugs • Impotence Carries Increased Risk of Heart Problems • Viagra's Not For Playing Around • Actra-RX May Be Dangerous, FDA Warns ---

U.S. Marshals, acting at the request of the Food and Drug Administration, have seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai.

Although labeled as natural supplements, the seized products were all marketed to treat impotence, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.

The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for erectile dysfunction (ED), or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.

The seized 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, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.

In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural" or as not containing the active ingredients in approved, prescribed ED drugs.

Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients cannot be validated.

No action

Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products.

Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA's enforcement actions.

The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

FDA recommends that consumers talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

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