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FDA Warns Manufacturer of Sports Supplement ‘Craze’

The FDA has sent an official warning letter to Craze about concerns that have been raised about its safety for more than a year.
The letter questions whether compounds listed on the label as coming from dendrobium orchids are really found in the plant. It says that the proprietary blend of ingredients listed on the label as “Dendrobex” makes the product contaminated under federal law since the FDA is unaware of any evidence that the ingredient has been present in the food supply and the company never submitted paperwork to have it allowed as a new dietary ingredient.
The FDA notes that Craze contained a meth-like compound and the agency is not aware of this compound being found in the food supply and without paperwork declaring it a new dietary ingredient, products containing it would be considered contaminated.
In the letter, the FDA warned that continued sales of products containing “Dendrobex” could result in the seizure of products and injunctions against the maker and its distributors.
Craze had been named 2012 New Supplement of the Year by
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Andrew Finkelstein

Mr. Finkelstein is the Managing Partner of Finkelstein & Partners, LLP. He has become a noted consumer activist through his representation of injured individuals against corporate wrongdoers and irresponsible parties. An accomplished litigator, Mr. Finkelstein has represented Plaintiffs in wrongful death and catastrophic personal injury cases. He has successfully handled dozens of multi-million dollar cases.