By Elaine Watson Nutra Ingredients USA
All 10 recipients of FDA warning letters on DMAA have now written back, although only one - Nutrex Research - has so far revealed what it said (notably that the agency's interpretation of the law is “demonstrably wrong”).
An FDA spokesman told NutraIngredients-USA: “Each of the companies has responded to the warning letter it received and FDA is in the process of evaluating the responses.”
But he added: “Because the matter is still open, FDA cannot offer additional information at this time.”
G.N.C: You can still buy DMAA in our stores…
None of the firms targeted in the FDA crackdown has published it response, although Nutrex Research has made its letters to the FDA (accusing it of making "unfounded allegations") available upon request.
Along with most of the firms using the controversial stimulant, however, Nutrex has reformulated its products in response to “changing market perceptions”, although it reserves the right to use DMAA in future "if the uncertainty... over the status of this ingredient gets resolved”.
However, top selling pre-workout supplements Jack3d and OxyELITE Pro from USP Labs still contain DMAA (1,3-Dimethylamylamine), and are still available at G.N.C., which told us that “GNC consumers, both in our stores on online at G.N.C.com, have a selection of these products to choose from.”
Will the FDA seize 'adulterated' products?
Asked whether the FDA planned to seize such allegedly adulterated products - as it threatened to do in its warning letters - the FDA spokesman said:
“Retailers should take steps to ensure that the products they sell are legal. If a retailer is selling a product that doesn’t meet FDA’s requirements, FDA can take action at the retail level, such as seizing products.”
Nutrex: ‘Vigorously disagrees’ with FDA
Meanwhile, all eyes are now on USP Labs, and new research it says it has commissioned proving that DMAA is a natural constituent of geranium.
While the research has not been published yet (the only reference to it is in a memo published by consultancy Cantox last September), it has already been cited by Nutrex and others as proof that the DMAA in supplements is a synthetic copy of a constituent found naturally in geranium that has been safely consumed in the food supply for years.
In a letter to the FDA, Keller and Heckman attorney Frederick A. Stearns - representing Nutrex - wrote: “A close examination of the Ping, et al. study [a 1996 paper dismissed by one leading chemist as 'scientifically indefensible'] shows its original conclusions [that DMAA is a natural constituent of geranium] were correct.”
He then quotes from the Cantox memo, which claimed USP Labs had fresh data from ”two independent and highly respected analytical chemistry laboratories" that “corroborates the original data published by Ping et al, and further demonstrates the occurrence of DMAA in the geranium plant, Pelargonium graveolens, and its edible oil”.
However, Stearns told NutraIngredients-USA that he had not personally seen either the Ping paper or the new research.
He said: “I have not seen the Ping paper or the new studies cited by Cantox specifically, but I have been told that they are going through the peer review process.”
Cantox: We can’t say when new data will be published
Barry Lynch, the Cantox executive who wrote the memo, told us he could not say when the new research might be published: “This information is considered confidential.”
But he added: “Publication times can vary from weeks to months to over a year depending on the journal, nature of comments that are received on a given article, timeliness of response to comments etc.”
Nutrex - FDA stance on synthetic copies of botanical constituents has no legal basis
Assuming the new data does prove DMAA is in geranium, firms using nature identical synthetic copies of it in their supplements are not breaking the law, said Stearns.
“The [legal] definition of ‘dietary ingredient’ provides no basis for distinguishing between natural and nature-equivalent synthetic versions of the same substance.”
He added: “Nutrex’s position is that DMAA has been “present in the food supply” (geranium oil) “as an article used for food” (a component of geranium oil) “in a form in which the food” (geranium oil) “has not been chemically altered” (used in its oil form), and is thus exempt from the need for a new dietary ingredient notification.”
Safety: FDA has not kept up with scientific developments...
As for safety, said Stearns, “Nutrex respectfully believes that FDA’s knowledge base regarding the safety of DMAA has not kept pace with scientific developments. When used as directed, dietary supplements containing DMAA have a clear record of safety, considering the millions of doses that consumers have used over the years.
“In addition, the safety of DMAA has been the subject of considerable investigation, with at least seven recent articles either published or in-press in peer-reviewed scientific journals.”
Blumenthal: Hands up if you think DMAA is in geranium...
DMAA was a hot topic of conversation at a United Natural Products Alliance event in Utah this week, where American Botanical Council (ABC) boss Mark Blumenthal asked delegates to raise their hands if they thought DMAA was in the geranium plant. (No one did.)
He then paused for effect, before adding: "Well we've found it actually does come from two plants... in China.." (before showing his audience a slide with a picture of two large industrial manufacturing facilities).