The Food and Drug Administration has found hidden drug ingredients, potentially harmful to human health, in more than a dozen products shipped from abroad.
All 14 items in question have either been promoted for weight loss or sexual enhancement. The FDA said they were intercepted and identified during routine examinations of international mail shipments in recent months.
The FDA advised in several public notifications sent out Monday that consumers should not purchase the following products: Power Spring Oral Liquid, Weili (Yi Pao Dao Tian Liang), Ziyinzhuangyang, Zi Xiu Tang Beauty Face & Figure Capsule, the Golden Root, Super Bull 6000, Shangai Ultrax, Libigirl, Super Shangai, Ultimate Lean, Slim Fix X, Mang Luk Power Slim, Mang Luk Power Slim Detox and Maxx Easy.
A common problem among the listed products for sexual performance was that they failed to disclose the presence of sildenafil — the active ingredient used in the FDA-approved prescription drug under brand names Viagra and Revatio, treatments for erectile dysfunction. The ingredient may interact with nitrates usually found in drugs for people with diabetes, high blood pressure, high cholesterol or heart disease. Taken in combination, they could lower blood pressure to dangerous levels.
In one product, the Golden Root, the presence of sildenafil was confirmed by an FDA laboratory, yet it has a specific marking in Chinese saying that it’s suitable for people with heart disease, high blood pressure and even those who just consumed alcohol. Another, Super Bull 6000, claims to be a “herbal formula” for men, the FDA says.
Sibutramine, an oral anorexiant, and also another substance with similar molecular structure were found in some products promising to help people lose weight. Sibutramine was removed from the U.S. market in October 2010 out of concern that it could substantially increase blood pressure and thus present a high risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmia or stroke.
When FDA finds a mislabeled product, or one with unapproved ingredients, the agency holds it back and eventually destroys it.
A chemical called phenolphthalein — not approved by FDA — was found in a Chinese product called Zi Xiu Tang Beauty Face & Figure Capsule. The ingredient, the FDA says, is believed to pose risk for cancer.
Another undeclared component of the same weight-loss product is fluoxetine. Although an FDA-approved drug, fluoxetine is used as an antidepressant. Adverse effects of taking it include suicidal behaviors, and its interaction with some common medications like aspirin can cause gastrointestinal bleeding and even sudden death.
The FDA has found it challenging to monitor products that claim to prevent, treat, or cure health problems, but are not proven safe and effective for those uses. Even so, it has found that these products are often promoted for weight loss, sexual enhancement, bodybuilding and pain relief, said Lyndsay Meyer, a media aide for dietary supplements at FDA.
These fraudulent health products originate from all parts of the world, but many of them are shipped from China, said Meyer.
To protect future spot checks, the FDA would not reveal the products’ entry points, where they were shipped from, or their destinations.