Dietary supplement manufacturer USPLabs, LLC said on Tuesday that it will remove DMAA from the company’s best-selling dietary supplement products,OxyElite Pro and Jack3d. The company allegedly emailed marketers and said that, after a long battle with the FDA, it would remove 1,3-dimethlyamylamine (DMAA) from the supplements. DMAA is an organic compound that was initially used as a nasal decongestant and treatment for benign oral tumors. The compound also found its way into a number of dietary supplements, although it is usually marketed under a different name. According to researchers, DMAA dietary supplements may be responsible for at least five deaths.
The FDA published a news release challenging the marketing of DMAA products last year and sent warning letters to ten dietary supplement distributors and manufacturers – including USP Labs, LLC. “Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products,” the Director of the FDA Dietary Supplement Program said, “They haven’t done that and that makes the products adulterated.” The FDA mentioned that USP Labs, LLC and nine other dietary supplement companies failed to submit evidence that the DMAA products were safe.
After the FDA issued this warning, the nine other dietary supplement companies complied with FDA standards and eliminated DMAA from their products. Last week, the FDA issued an alert to warn consumers that fat-burning dietary supplements like OxyElite Pro and Jack3d were potentially dangerous and illegal – but a USP Labs statement disagreed. “USP Labs stands by the safety and legality of its products containing the dietary ingredient 1, 3-DMAA. We disagree with FDA’s position,” the statement said, “The company has nevertheless concluded for business reasons to phase out products containing 1, 3-DMAA.” The FDA reports that DMAA supplements are still available online, but consumers should still avoid using these products.