Officials Seize Unapproved Drugs Labeled “Natural Supplements”

In a press release on April 9th, the FDA announced that U.S. Marshals seized more than $100,000 of product labeled as “natural supplements” but which contain undeclared active ingredients found in prescription erectile dysfunction (ED) drugs. The products originated in China and are packaged and distributed by Shangai Distributors Inc. of Coamo, Puerto Rico. Consumers who use these products could experience serious side effects, as well as interactions with medications they are already taking.

The seizure includes more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus, and Lady Shangai marketed to treat (ED), impotency, and/or to provide sexual enhancement, in effect causing them to be classified as drugs and rendering their sale illegal without FDA approval.

Margaret O’K. Glavin, associate commissioner for regulatory affairs said, “The FDA will not tolerate companies marketing unapproved drugs —products that have not proven to be safe or effective—as dietary supplements. The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products."

In November 2007, in response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc. Their investigation and subsequent testing revealed that the seized products contained sildenafil, the active ingredient in Viagra, or a compound with a chemical structure that mimics sildenafil. These chemicals could interact with nitrates found in prescription drugs that are often taken by people with diabetes, high blood pressure, high cholesterol, or heart disease. The result could lower blood pressure to dangerous levels.

Erectile dysfunction is a common problem in men with the above medical conditions. Because they have been advised against taking ED drugs, they may seek out products like these that are marketed as “all natural” or as not containing the active ingredients in prescribed, FDA approved ED drugs. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these Chinese made so-called supplements.

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

The company was advised of the FDA findings and the potential health risks posed by the seized products, as well as the possibility of regulatory action, but failed to correct the violations. On December 28th the FDA issued a press release advising consumers not to buy or use the products. And prior to the seizure, in an attempt to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions, the Puerto Rico Department of Health embargoed the seized products.

The FDA continues to advise consumers to discontinue use of these products and to report any adverse events to their health care provider as well as to FDA’s MedWatch Program at 800-FDA-1088 or online here.