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FDA seizes supplements over sibutramine tainting, disease claims

By Hank Schultz , 16-Feb-2013

FDA seized tainted dietary supplement products from a Florida company called Globe All Wellness, the agency said Friday.

Several of the products seized by US marshals contained the undeclared pharmaceutical ingredient sibutramine, the active ingredient in the obesity drug Meridia that was pulled from shelves in December, 2010 because of increased risk of heart attack and stroke.

The company markets products with claims that its products can lower blood pressure and reduce cholesterol, among others.  As these are conditions treated with drugs, these claims cause the products to be be considered unapproved new drugs under the law and subject to seizure, FDA said.

“Companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking.”

Warning letter, inspections

Weight management products tainted with sibutramine is not a new phenomenon.  While it is possible that a product marketer could be misled by a supplier or contract manufacturer over the inclusion of sibutramine, that’s not the case here.

Globe All Wellness received a warning letter on Feb 6, 2012 addressed to the company’s listed president, Eran Hamami.  In that warning letter, FDA stated that tests had confirmed that some of the company’s products contained sildenafil.  In addition, one of the company’s products called ViaXtreme tested positive for sildenafil, the active ingredient in erectile dysfunction drug Viagra.

The warning letter came after an FDA inspection of the company’s facilities that lasted from May 18 to July 6, 2011. Two follow up inspections, in October 2012 and February 2013, also found that the company was not complying with GMP regulations.

 “Two important protections for the public are that a firm may not sell new drugs unless they have been tested and approved by the FDA and a firm may not make false or unsubstantiated claims about drugs they sell,” said Melinda K. Plaisier, acting associate commissioner for regulatory affairs. “When a firm disregards these protections, it not only violates the law but also creates a risk for consumers.”

Global All Wellness had this to say about SlimXtreme, according to FDA: “SlimXtreme is a proprietary blend of herbs formulated to not only make you lose weight, but also to suppress your appetite. Prepared exclusively from all-natural herbs, SlimXtreme’s formula has been used for centuries effectively for the purpose of slimming and beauty.”

Class action lawsuit

Disregard for the law seems to be a pattern for Hamami and sometime business partner Alexander Treynker.  The two were named in a class action lawsuit over the sibutramine inclusion in their SlimXtreme weight loss product filed in July 2011 in the 17th Circuit Court in Broward County, FL.

“Treynker and Hamami intentionally spiked SlimXtreme with Sibutramine,” the complaint states. “To date, FDA has found illegal drugs present in at least five products developed and marketed by Treynker and Hamami as ‘natural’ ‘herbal’ supplements.”

According the lawsuit, Treynker and Hamami are associated with several business entities that share the same Hollywood, FL address.  The pair set up an “Amway-style pyramid scheme” to sell their products via unsalaried salespeople. The plaintiff in the case bought her diet pills at a health spa in Nevada and sought medical attention after she suffered “dizziness, anxiousness and severe pain in her groin area,” the lawsuit states.

The lawsuit is unresolved, according to one of the law firms listed on the original complaint.

2010 warning letter

On Oct. 5, 2010 Treynker, then listed as Executive Officer of Natural Wellness LLC, received an FDA warning letter citing three of that company’s products for having undeclared pharmaceutical ingredients.  Three of the products, all marketed in the sexual health category, contained phentolamine, a nonselective alpha-andrenergic agonist and the active ingredient in FDA approved drugs for the prevention or control of hypertensive episodes.  One of the three, called MasXtreme, also was found to contain sildenafil.

Efforts to reach Hamami for comment were unsuccessful.

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