August 28, 2015
A coalition of trade associations has written to the U.S. Food and Drug Administration commission formally requesting the creation of an office of dietary supplements. The move that highlights a growing consensus that greater enforcement of regulation is increasingly vital to the health of the industry and concrete restructuring inside the FDA is needed.
The letter, signed by the United Natural Product Alliance, the Council for Responsible Nutrition, the Consumer Healthcare Products Association and the Natural Products Association makes the much-talked-about request clear and formal. “We write to express collectively our interest in and support for the elevation of the Division of Dietary Supplement Programs (DDSP) to an “Office” status within the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN),” the letter reads. Moving from division to office status, allows regulators to take action without waiting for the Department of Justice to pursue the case.
While, if accomplished, the creation of such an office is more of an administrative than legislative move, the request is part of an increasingly open conversation calling for specific changes in enforcement that could include the creation of a premarket registration program. While not re-opening basic tenets of the Dietary Supplement Health and Education Act, pre-market registration marks a notable openness to new regulation among industry insiders.
Though premarket registration is a more complex matter, the letter to FDA Commissioner Stephen Ostroff proposes a change that could be accomplished fairly quickly. NPA CEO Daniel Fabricant, who led supplement enforcement at the agency through spring 2014, said the elevation of the division to “office” status will likely be simple and quick. “I don’t see it as a lot of change, “ Fabricant said. “It’s just formalizing the enforcement.” The request does require approaching Congress, but no formal vote or action is necessary. Such administrative changes are not uncommon and rarely refused. “Generally there’s not an objection from Congress. I don’t think there will be in this case.”
More emphasis, more enforcement
UNPA President Loren Israelsen said that while relatively simple, the creation of an office could have substantial effects. “Such a move would provide additional significance to dietary supplement issues and hopefully create a more robust environment for them within FDA,” Israelsen said.
Insiders have long talked about “bad players” making business difficult for responsible companies, and that sentiment is clear in the letter to Ostroff. The letter reads that “the industry is deeply concerned about entities—both individuals and companies—who engage in blatant criminal activity by manufacturing and marketing products that masquerade as ‘dietary supplements’ but contain anabolic steroids, active pharmaceutical ingredients (APIs), or analogues of APIs.”
Duffy McKay, CRN’s vice president for scientific and regulatory affairs, does not expect resistance and said trade groups have already been talking to FDA officials. The move could make enforcement more effective. “They can do some hiring and do some reshuffling of their resources,” McKay said, adding that the move has been in the works for some time and is not driven by the New York Attorney General’s February investigation into herbal supplement adulteration.
Natural Alternatives International CEO Mark LeDoux, however, did say the request should be considered as an example of an urgency felt within the industry. Ledoux said he was talking to Fabricant about the idea when the NPA CEO was still at the FDA but believes the NYAG investigation and eroding public trust have helped the trade groups come together on the issue. “We’re facing an existential crisis here,” LeDoux said. “Notwithstanding all the efforts at self-regulation, it’s clearly not working.”
LeDoux said the request and the creation of the office send a message that should resound outside the office. “The New York Times is going to be hard pressed to say this is an unregulated industry,” LeDoux explained.
The move may also reflect an increased level of cooperation among the trade groups. American Botanical Council founder Mark Blumenthal called it a “welcome” development. He also called it a vital need. “The FDA is unfortunately underfunded and is trying to regulate the fast-growing dietary supplement industry with limited financial and personnel resources,” Blumenthal said, calling out such catastrophic phenomenon as illegal pharmaceuticals in supplements and outright adulteration.
LeDoux said he is encouraged to see the groups working together. “I think it’s a sign of maturity and a recognition that this is serious,” Ledoux said. “I think when times get serious people start putting aside the parochial interests and getting things done.”
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