June 21, 2013
PITTSBURGThe U.S. Food and Drug Administration has gone to court in an attempt to seize dietary supplements that contain the controversial substance, dimethylamylamine or DMAA.
A civil complaint, filed in U.S. District Court, relates to products in a GNC Holdings warehouse in Leetsdale, PA, the Pittsburgh Post-Gazette reported. Earlier, FDA notified GNC that more than 15,000 cases of Jack3d and OxyElite Pro Super Thermogenic were considered adulterated, according to the article.
In April, the manufacturer of the dietary supplements, USPlabs, revealed plans to withdraw DMAA products from the market following regulatory concerns and reports linking the substance to deaths and other medical problems.
On Friday, Shelly Burgess, a spokeswoman for FDA, confirmed a complaint has been filed. She declined further comment.
In an emailed statement, GNC said USPlabs' products "represent a very small fraction of products at the Leetsdale facility."
"USPlabs has not indicated at this time whether it will contest this challenge against its products," the company said. "GNC will not distribute the detained products in the Leetsdale facility until the matter has been resolved by the FDA and USPlabs. GNC will continue to sell through its remaining inventory of the products in its stores."
USPlabs and GNC have asserted DMAA is safe. GNC noted FDA and the U.S. Department of Defense have been reviewing the safety and/or the legality of the substance for nearly two years.
"To date, despite requests by GNC for any studies or other information that would support any safety concerns, GNC has received nothing from these parties that calls into question assurances from the suppliers of the DMAA-containing products that GNC sells that the products are safe," the company said.
In April, FDA issued a public warning, calling DMAA a dangerous stimulant and advising consumers to avoid using any products containing the ingredient. The agency effectively said it rejected research supplied by USPlabs and would do everything it could to remove the ingredient from the dietary supplement market.
FDA has disclosed receiving 86 reports of illnesses and deaths associated with supplements containing DMAA.
"While the composition of the ingredient has always been in existence, FDA did not really get involved until the number of adverse event reports (AERs) became such that it felt it needed to take action," Justin Prochnow, a Colorado-based food and dietary supplement lawyer, told INSIDER in a recent story analyzing the DMAA controversy.
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