Florida Herbal Supplement Maker Gets FDA Warning Letter

A Florida herbal supplement maker received a U.S. Food and Drug Administration (FDA) warning letter for its ViaXtreme and SlimXtreme products.

Global All Wellness LLC touts the herbal products as providing solutions for weight loss and male sexual performance problems, said the Orlando Sentinel. The FDA says that SlimXtreme contains a controversial obesity drug banned in the United States over increased risks for heart attack and stroke. ViaXtreme contains the active ingredient of Viagra, wrote the Sentinel. Global All Wellness is located on Stirling Road in Hollywood.

The FDA’s warning letter says that both products contain the undeclared presence of these medications and that this constitutes a violation of the law, said the Sentinel. The firm was given 15 business days to comply with the FDA’s letter or face legal action.

Eran Hamami, president of Global All Wellness, said the problem has to do with bogus versions of the supplement and that the firm conducted its own laboratory tests of its supplements and found no evidence of the drugs, said the Sentinel. Hamami added that, regardless, the firm initiated voluntary recalls of SlimXtreme and ViaXtreme and was cooperating with the agency. “We do care about our customers,” said Hamami. “Herbal means herbal, and we take that very seriously,” he added, said the Sentinel.

The Global All Wellness web site advertises SlimXtreme as “a proprietary blend of all-natural ingredients designed to lose weight fast and strongly increase your energy” and that it “has been proven to be the most efficient and safe weight loss solution on the market,” wrote the Sentinel. Ingredients listed are bitter orange, konjac root, and lotus leaf. According to the FDA letter, lab tests detected sibutramine hydrochloride, the active ingredient in Meridia, the obesity drug withdrawn from the U.S. market in 2010, said the Sentinel.

“Sibutramine may pose serious health risks to consumers, including adverse health consequences such as heart attack, stroke, increased blood pressure, hallucinations, coma, and tachycardia for individuals with existing medical conditions,” the letter states.

Last year, we wrote that the FDA announced that it informed Global All Wellness that its SlimXtreme weight loss dietary supplement—sold by a seller not authorized by Global All Wellness to sell the product—contains an undeclared drug ingredient. FDA lab analyses of the supplement found that the product contained undeclared Sibutramine. Sibutramine was marketed as Meridia. The manufacturer stopped producing the drug based on clinical study data that found that those taking Sibutramine suffered an increased risk of cardiovascular events, including heart attack and stroke.

ViaXtreme’s web page claims it was “prepared exclusively from all-natural herbs and used for centuries to enhance sexual pleasure.” The ingredients listed are Asiatic dogwood, and horny goat weed, said the Sentinel. FDA tests found sildenafil, the active ingredient in Viagra, in lab tests of ViaXtreme.

FDA spokeswoman Pat El-Hinnawy told the Sentinel that medications in supplements is “not an uncommon problem”; that the FDA has issued many similar letters to other companies; and that the FDA was unaware of any illnesses related to Global All Wellness’s products, but if the company is noncompliant, the matter will be transferred to the Department of Justice for enforcement.

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