The FDA has forced GNC Inc., a distributor of dietary supplements, to destroy two products that contained the stimulant dimethylamylamine (DMAA). The government obtained seizure orders for GNC facilities in three states before the company agreed to destroy the supplements.
The products are OxyElite Pro and Jack3D, distributed by USPlabs with an estimated retail value of more than $8.5 million. DMAA is an amphetamine derivative advertised for weight loss and muscle building, but the compound is implicated in narrowing of blood vessels and arteries, which can increase blood pressure and lead to heart attack, seizures, and death. There have been reports of more than 100 illnesses around the country associated with products containing DMAA. Six people have died.
USPlabs received a warning letter from the FDA in 2012 telling them that DMAA is illegal. The company challenged the legal theory that the FDA had power to stop them from selling the product. Since dietary supplements do not need to be approved by the FDA for safety and effectiveness before they are sold. For the FDA to ban a compound, the government must go through a series of scientific and legal steps. Enforcement action is the other way to remove products containing dangerous compounds. That action begins with a warning letter and can lead to seizures and injunctions.
USPlabs said it would continue to sell its remaining stock, so the state of Texas embargoed both products and the FDA invoked its administrative detention authority. This authority was granted by the Food Safety Modernization Act of 2011 (FSMA). The government can detain food “if an authorized agency representative has reason to believe that the product is adulterated or misbranded. If this standard is met, FDA can detain foods for up to 30 days, halting any shipments of suspect products while the agency considers other legal steps.” USPlabs finally agreed to destroy the remaining products.
Pubic health officials ask consumers to read dietary supplement labels and do not buy or consume a product if it contains DMAA. The FDA has a DMAA web page to help you decipher label terms. If you have suffered an illness or injury after taking a dietary supplement, you can report it at the FDA’s Dietary Supplements Adverse Event Reporting web site.
