In what appears to be the first large-scale action taken against an ingredient lacking a proper New Dietary Ingredient (NDI) notification, the U.S. Food and Drug Administration (FDA) announced Friday it has sent warning letters to 10 marketers and manufacturers of products featuring sports performance ingredient 1-3 dimethylamylamine HCI, otherwise known as DMAA.
“I think a lot of people have been operating under the assumption that the FDA wasn't going to do much about NDIs until it sifts through the 7,000 plus comments," said attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig.
"It's a warning message from FDA that, 'Hey, we're not freezing everything related to NDI notifications while we review these comments. It's still our position that if you have an NDI you need to file a notification,'" he said.
Proponents of DMAA assert that it is derived from geranium oil; others question that connection and believe it is a wholly synthetic ingredient. The ingredient, which functions as a stimulant, has been the subject of scrutiny for more than a year, following the deaths of two active duty soldiers who died of heart attacks and were found to have DMAA in their system. The military subsequently banned the sale of products with DMAA on military bases.
In the warning letters, FDA says that if companies have reason to conclude that DMAA qualifies as a dietary ingredient in the first place (still not a given), there should be a NDI notification vetting the ingredient’s safety.
“To the best of FDA's knowledge, there is no information demonstrating that dimethylamylamine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994,” the warning letters state, citing the grandfather date in DSHEA for determining whether an ingredient qualifies as an Old Dietary Ingredient. The warnings letters direct the companies to immediately halt distribution of the products.
“I knew this would happen and it’s nice to be vindicated for my positions on DMAA’s dubious history,” said James Neal-Kababick, director of Flora Research Laboratories, who has a long history of research into the area of DMAA as well as drug ingredients that are illegally and surreptitiously marketed as “dietary supplements.”
“All my research and review of 35 years of publications on geranium and my 20 years of personal experience analyzing geranium oil chemistry have shown no evidence of this compound’s existence as a naturally-occurring constituent of geranium oil,” he said.
What's the future of DMAA in sports nutrition?
Products containing DMAA have been big sellers in the sports nutrition category. USPLabs' 2011 total product sales topped $85 million with Jack3d as their bestseller, according to Nutrition Business Journal. But FDA's warning letters could cause quite a shake up in the category.
"A lot of companies have been looking for alternatives to DMAA and they probably have already been starting that process of reformulating products," Prochnow said. But FDA's warning letters are not law, he said, so "If you feel strongly about your position, maybe you feel that it's worth it to fight them. But sending out 10 warning letters means you better be prepared to fight because they believe you can't legally sell a product with that ingredient."
One company that received one of the warnings letters said it disagrees with FDA on the status of DMAA. iSatori, based in Golden, Colo., said it believes firmly that DMAA is a lawful and safe dietary ingredient in its PWR product and will respond to the warning letter with a detailed legal and scientific rationale.
However, the company said that it was already in the process of reformulating to remove DMAA for marketing and distribution reasons. iSatori said it plans to have the new product on the market by the end of June. In any case, the company said the sales of its PWR product accounted for only a tiny fraction of the total sports nutrition market.
Is this an isolated attack or the first salvo of a major campaign?
"It's always tough with warning letters. You never know if it's an isolated incident or if it's the first of many to follow. The NDI issue is such a big topic that FDA had to know that putting it in its warning letters was going to generate a lot of attention," Prochnow said.
With additonal reporting from Caren Baginski, Todd Runestad, Connor Link