Recently there has been much talk about dietary supplements. We have reported how the industry is furious about the new guidelines and regulations that the FDA is imposing, as well as how 2 soldiers died last year after taking energy supplements on military bases. Now, we have another story on supplements. This time about the recall that was recently made involving a number of dietary supplements.
According to Reuters, Healthy People Co is recalling 15 lots of seven different dietary supplements because they contain appetite suppressants or a drug for male erectile dysfunction, the Long Beach, California, company said.
The seven brands of supplements were sold at the company’s store at 13105 Ramona Boulevard, Irwindale, California, Healthy People said in a Friday statement carried on the Food and Drug Administration’s website.
FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in these products, which makes them unapproved new drugs.
Sibutramine is an FDA-approved appetite suppressant drug that treats obesity. Because of this, the following dietary supplements are considered unapproved drugs: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate.
Sibutramine, a Schedule IV controlled substance, should be taken only under the direct supervision of a qualified health care professional. Sibutramine, which has been withdrawn from the U.S. marketplace, is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The active drug ingredient is not listed on the label for these recalled products.
Tadalafil is a FDA approved for the treatment of male Erectile Dysfunction (ED), which makes Perfect Men Dietary Supplement and Herbal Drink Acai-Man Mangosteen Dietary Supplement unapproved drugs. The FDA advises that these products post a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The recall involves the following items:
30 Capsule Dietary Supplements
Mince Belle: Lots HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021; UPC7503013203305.
Perfect Men: Lot HPCPM/002; UPC7503013203190.
Everlax: Lots HPCEX/074, HPCEX/076, HPCEX/072; UPC 7503013203046.
Ever Slim: Lots HPCES-079, HPCES-070, HPCES-071; UPC 7503013203053.
16.6 Fluid Ounce Dietary Supplement
Herbal Drink Acai-Man Mangosteen: Lot HPJAC/004; UPC7503013203015.
17.6 Fluid Ounce Dietary Supplement
Ever Slim Shake Mix Strawberry: Lot HPESSF/168; UPC7503013203084.
Ever Slim Shake Mix Chocolate: Lot HPESSC/061; UPC7503013203077.
The statement did not say if any deaths or injuries had resulted from their use.
Healthy People Co. advises any customers in possession of these recalled products to return any unused product for a full refund to the company directly.