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FDA Warns Consumers About Chinese 'Health' Supplements

'Natural' alternatives to Viagra may be dangerous

December 31, 2007

• 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 ---

The U.S. Food and Drug Administration is advising consumers not to buy or use Chinese health supplements imported from Puerto Rico.

The supplements, marketed under the names Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, are normally used to treat erectile dysfunction.

Although labeled as dietary supplements, the FDA says these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction.

The products, which contain the same active ingredient as Viagra, are thus illegal, the FDA said.

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.

Also, 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 can not be validated.

"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

"An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."

FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction.

Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

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 feel are related to the use of these products. The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.

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