Speaking with NutraIngredients-USA recently, Rogovin expressed his determination to create the Dietary Supplements Manufacturers and Marketers Association (DSMMA), citing the threat posed by the FDA’s New Dietary Ingredient (NDI) draft guidance, and his perceived failings of the existing ‘big 5’ trade associations.
At last week’s Natural Products Expo East, Rogovin appealed for an initial 10 companies to sign up to his fledgling association at $20,000 apiece, according to a report from the Nutrition Business Journal.
FOIA and 1 year extensions
Rogovin and his California-based Jarrow Formulas have taken an offensive stance on the NDI issue, having submitted a 128-item Freedom of Information Request to the US FDA with questions it deems ‘vital’ to any comments it seeks to file in response to the NDI draft guidance.
The company also requested to extend the comment period from 90 days to one year.
FDA recently granted a 60-day extension to the comment period for the NDI draft guidance last week. The announcement pushes the comment due date to December 2, 2011.
“The last thing we need”
Responses have been quick from representatives from some of the 'big 5' trade associations: The Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), the United Natural Products Alliance (UNPA), the American Herbal Products Association (AHPA), and the Consumer Healthcare Products Association (CHPA).
Speaking to NutraIngredients-USA, Steve Mister, president and CEO of CRN, said that the “last thing the industry needs is another trade association”.
“The existing associations are vigorously and aggressively defending the interests of the industry, especially on the NDI draft guidance,” said Mister.
He noted that the main cause for the proposed DSMMA seems to be the NDI draft guidance. “We at CRN have a comprehensive strategy for this and we are addressing this on a lot of fronts. We’ve reached out to members of Congress, the mainstream media, and we’re educating the industry,” he said.
“We are being methodical and respectful of FDA. We vigorously and aggressively disagree with FDA on issues where we think they got it wrong [in the draft guidance], and we are comfortable in the position we are in.”
“The five trade associations are working together to aggressively defend the dietary supplement industry,” added Harry Rice, PhD, director of regulatory & scientific affairs for UNPA.
“Regardless of who is leading the charge, the formation of another trade association with no interest in a constructive solution would be a disservice to the industry.”
CRN’s Mister acknowledged that the industry is unlikely to get everything it will ask for in the comments to the NDI draft guidance. “We will have an impact on the final guidance,” added Mister. “This fight isn’t over.”
"I understand the concern, but..."
John Gay, executive director and CEO from NPA, told NutraIngredients-USA that he found it “hard to believe that anyone thinks this industry would be well served with one more association.
“I have been in Washington for over 25 years, and I can tell you that it can be downright dangerous for an industry to have conflicting messages going to policymakers,” he said.
“On the NDI draft guidance, NPA and the other associations are working closely together with a comprehensive strategy to address this serious challenge to the industry. Our goals are to put forth the most forceful, unified comments we can for the industry and, at the same time, put ourselves and our Congressional allies in the best possible position for further action – perhaps in Congress, perhaps in the courts – if FDA does not agree with our comments.
“To the extent that a new association runs counter to those goals, then it is not productive,” added Gay.
“I do understand the concern in the industry and their desire to do something. But this is a different situation from, say, the McCain bill, which required a splashy campaign with an all-out call for the grassroots to charge Capitol Hill. In this case, such a “charge” could even be counterproductive. This regulatory/guidance process is frustrating, but we believe we have the best game plan to address it.
“For now, the best thing for the industry to do is focus on preparing thoughtful, united comments to the FDA. We don’t need another association that could divide us and weaken our stance with FDA and Congress,” added the NPA CEO.