USPlabs has agreed to stop manufacturing dietary supplements containing DMAA

USPLabs Jack3d and Oxy Elite Pro

USPlabs has agreed to stop manufacturing dietary supplements containing DMAA

DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient found illegally in some dietary supplements and often touted as a “natural” stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. 

Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. In 2012, FDA issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance. Most companies warned are no longer distributing products with DMAA. While FDA is working to get these products off the market, consumers should not buy or use any dietary supplement product containing DMAA.

On July 2, 2013, as a result of follow-up legal action by FDA, the dietary supplement firm USPlabs voluntarily destroyed its DMAA-containing products located at its facility in Dallas, Texas. The products - USPlab's OxyElite Pro and Jack3d - are estimated to have been worth more than $8 million at the retail level. USPlabs has agreed to stop manufacturing dietary supplements containing DMAA.

USPlabs agreed to destroy the products after FDA administratively detained them under the Federal Food, Drug and Cosmetic Act, recently amended by the Food Safety Modernization Act (FSMA). Under its administrative detention authority, FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure. Under FDA regulations, detained articles can be voluntarily destroyed by their owner.

FDA continues to advise consumers not to buy or use dietary supplement products that contain DMAA due to the health risks they present.

Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner. Consumers can also report such incidents directly to FDA, see Dietary Supplements - Adverse Event Reporting. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label.

article source: FDA