Two separate companies have recalled nine different dietary supplement products that were deemed unsafe by the U.S. Food and Drug Administration (FDA) after analysis found the companies were using ingredients approved for drugs and not dietary supplements in their products. No consumer illnesses or injuries have arisen as a result of the adulterated products, according to separate FDA press releases, but the companies have issued voluntary recalls due to safety concerns raised by the FDA.
Opteron 1 Inc., which also operates as Nature & Health Co.,announced on July 15 that it is conducting a voluntary nationwide recall of its five supplement products sold under the following names: Y-4ever, Libimax X Liquid, Powermania Liquidand Capsule, Herbal Disiac and LibieXtreme. The products were primarily being marketed as sexual enhancers and contained tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), its analog aminotadalafil, or the analog of sidenafil, an active ingredient in another FDA-approved ED drug. The six products were distributed in retail locations across California, Georgia, Illinois, Texas and Ohio.
Young You Corp. also issued a voluntary nationwide recall of its products containing Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The products being recalled were primarily marketed as weight-loss supplements and sold under the following names: Slimbionic, One Weight Loss Pill 30 Capsules, SlimDemand Capsules and Botanical Weight Loss. The company sold and distributed its products nationwide via the Internet and at the company’s headquarters in Tarzana, California.
The voluntary recalls from both companies come on the heels of Iovate Health Sciences’ recall of its widely-used weight-loss supplement brand Hydroxycut, which was pulled off of shelves in May over concerns of health risks including damage to the liver. The primary difference between the Hydroxycut recall and the recalls announced last week is that the FDA issued a warning regarding the safety of the Hydroxycut products based on concerns that arose out of 23 specific adverse event reports from consumers. The most recent recalls, however, were brought about due to lab tests that revealed ingredients not approved for use in dietary supplements. The adulterated products could aggravate existing medical conditions and produce negative side effects if mixed with other drugs. This is why they were recalled, but no adverse events have yet been reported, according to the FDA.
U.S. consumers spent approximately $3.8 billion on weight-loss supplements in 2008, while the sexual health dietary supplement market grew 8% to $476 million in 2007, according to Nutrition Business Journal estimates. NBJ’s September issue will focus on the U.S. sports nutrition and weight-loss markets, and will include an in-depth look at the Hydroxycut recall and the implications it has on the weight-loss supplement market. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue, go to www.nutritionbusinessjournal.com.
Related NBJ links:
How Worrisome is the Hydroxycut Recall for the Dietary Supplement Industry?
McLemore: ‘There Is No Question That a New and Improved FDA is Emerging’
Mineral Premix Problem Triggers Voluntary Recall of Nutro Cat Food