FDA stiffs $100,000 worth of 'natural' erectile drugs
the FDA for making inappropriate pharmaceutical claims and
containing unauthorized ingredients.
Food and Drug Administration inspectors seized more than 14,000 doses of five products labeled as 'natural supplements' but offering drug-like treatments for erectile dysfunction, impotency, and/or to provide sexual enhancement according to the Federal Food, Drug, and Cosmetic Act. Analysis of the products revealed they contained active ingredients approved for use in prescription drugs used to treat erectile dysfunction but not in dietary supplements. The active ingredients were also not listed on the products' labels. The FDA said use of such drugs could result in serious side effects especially if used in conjunction with other medications or supplements. The products - Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai - are manufactured by an unnamed party in China and distributed by a Puerto Rican company called Shangai Distributors. Drug bust The FDA warned the company of the potential health risks its products posed back in December 2007. When the company failed to act, the FDA moved in and seized the contraband after the Puerto Rican Department of Health embargoed the products upon FDA request. "The FDA will not tolerate companies marketing unapproved drugs - products that have not proven to be safe or effective - as dietary supplements," said the FDA associate commissioner for regulatory affairs, Margaret O'K. Glavin. "The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products." The FDA said potentially dangerous interactions with other drugs included nitroglycerin which is found in drugs commonly consumed by diabetes sufferers, those with high blood pressure, high cholesterol or heart disease. It warned consumers to cease using the products and consult their doctors if they experienced any adverse events believed to be associated with use of the products. "Erectile Dysfunction is a common problem in men with these medical conditions," the FDA stated. "Because they may have been advised against taking erectile dysfunction 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 erectile dysfunction 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 can not be validated." Andrew C. von Eschenbach, MD, the FDA Commissioner of Food and Drugs, said recently, in the wake of another seizure of products containing dangerous levels of selenium, the FDA was stepping up its enforcement activities. In 15 years, the FDA's criminal investigations have resulted in more than 4,500 arrests, more than 3,500 convictions, and about $5.7 billion in fines and restitution of illegal profits.