As reported by NutraIngredients-USA Friday, the FDA released a Consumer Update warning consumers stating: “… after reviewing the studies provided by USPLabs [manufacturer of Jack3d and OxyElite Pro, both of which contain DMAA], FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”
Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Program, told us: “We want to be clear about where we are: We don’t want people using DMAA.”
The process has worked
Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), told us: "The Dietary Supplement Health and Education Act (DSHEA) contemplated occasions where the regulatory status of a dietary ingredient could be in dispute, and as we have seen in the case of DMAA, this process has worked.
"The Agency has undertaken a careful review of the safety literature and has concluded there is inadequate evidence to support the dietary ingredient status of DMAA. As such we believe it is incumbent on industry to conform trade practices accordingly."
Commenting on the FDA stance, Dr Amy Eichner, special advisor on drugs and supplements for the US Anti-Doping Agency (USADA), told us: "We first addressed the fact that DMAA is a drug and not a dietary ingredient back in 2009, and we are pleased to see that the FDA has formed the same opinion.
“This issue highlights why it is so important for legislators to fix the loop holes in DSHEA, so that it can fulfill its original intent to give consumers the protection they need when choosing to take supplements."
‘No credible published scientific evidence to support the contention that DMAA is a naturally-occurring phytochemical’
Mark Blumenthal, founder & executive director of the American Botanical Council (ABC), an independent nonprofit research and education organization, told NutraIngredients-USA: “Based on the available information, ABC is gratified that the FDA has taken action on this issue.
“Based on the research conducted by ABC on DMAA to date, insofar as there does not seem to be any reasonably credible published scientific evidence to support the contention of some DMAA marketers that DMAA is a naturally-occurring phytochemical, and that from a regulatory perspective it is a New Dietary Ingredient, the submission of safety data for FDA review is required. So far as ABC is aware, such safety data has not submitted by marketers of DMAA.
“As many ABC members and readers of NutraIngredients-USA may recall, in the past year ABC has published two peer-reviewed articles on the DMAA issue. To help ensure accuracy, as is customary at ABC, both ABC articles were extensively peer reviewed by chemists and other experts knowledgeable with the literature on DMAA, including some of the authors of the university-based papers that were reviewed.
‘Concerns about the scientific validity of these marketer-funded papers’ conclusions’
Blumenthal continued: “The first of ABC's articles dealt with the two university-based articles that showed no presence of DMAA in properly-authenticated samples of geranium plants and geranium oil.
“The second ABC article reviewed the two analyses that were funded by a primary marketer of DMAA-containing products and were published in a so-called "pay-to-publish" journal — I.e., the authors had to pay ca $1800 per article to the journal as a condition of publication. The various experts consulted for this second ABC article raised numerous significant concerns about the scientific validity of these marketer-funded papers’ conclusions that there is DMAA in the geranium leaf and oil samples tested.
“Since ABC believes that DMAA is not a natural plant-derived compound, and since ABC is an organization that deals with beneficial plants, we do not intend to conduct a literature review and expert assessment of the safety of DMAA. We believe that the determination of the safety of DMAA is the responsibility of the marketer or the FDA.”
Michael McGuffin, president of the American Herbal Products Association (AHPA) added: “We all recall that FDA issued warning letters regarding DMAA last year, and this latest communication provides further information about FDA’s position regarding DMAA. If the ingredient is not lawful, the agency has full authority to remove it from the market.”
Cara Welch, senior vice president of scientific and regulatory affairs for the Natural Products Association (NPA) added that the FDA has made its case, but the "manufacturers looks ready to stand its ground, so let's wait and see what the next steps are".
Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), added: “As the primary agency charged with regulating dietary supplements, FDA is in the best position to evaluate the safety of the ingredient and determine whether it should be available to consumers," he said.
"[Following the announcement of FDA’s conclusions], CRN now calls on dietary supplement manufacturers to stop manufacturing these products and further advises consumers to stop using them.”
To read the full CRN statement, please click here.
Rock Center on NBC
Dietary supplement regulations and DMAA in particular were at the center of a report broadcast on NBC’s Rock Center Friday. Please click here to watch the report.
Picture credit: The U.S. Food and Drug Administration, Flickr