On Friday, Sept. 23, in a meeting room above the show floor at Natural Products Expo East, Jarrow Rogovin, founder and president of supplement company Jarrow Formulas, announced his plan to arm the market against the potential threat posed by the FDA’s New Dietary Ingredient (NDI) guidance: to form a new supplement industry trade organization, the Dietary Supplements Manufacturers and Marketers Association (DSMMA).
The NDI guidance, released in early July, proposes tough new strictures on supplement products, potentially requiring ingredient notifications and toxicity tests for finished combination products, individual probiotic strains, synthetic botanicals, and grandfathered ingredients employing new extraction methods. In other words, more information than most companies currently have on hand, or could be reasonably expected to produce.
Current estimates have it that, were the guidance to go into effect, the supplements industry would have to supply at least 55,000 NDI notifications, all to be parsed out to a team of about 10 FDA employees.
Rogovin delivered a rhetoric-fueled call to arms to those in attendance, offering up quotations from Benjamin Franklin, Rabbi Hillel and Sun Tzu to inspire pathos. He called the guidance—which, it must be remembered, is still just guidance—a “Luddite, anti-technology, anti-freedom way to regulate us out of business.” He also inculcated the idea of Daniel Fabricant, PhD, the new head of FDA’s Division of Dietary Supplement Programs, as industry enemy number one.
Rogovin and his lawyers have laid the groundwork to file suit against the FDA. Rogovin recently sent a letter to FDA Commissioner Margaret Hamburg demanding that Fabricant resign, on the grounds that, as a former executive of the Natural Products Association (NPA), he has a conflict of interest in his new position. Jarrow Formulas also sent the FDA a 128-item Freedom of Information Act (FOIA) request that asks what implications the guidance would have on public health, the economy and the state of scientific research.
Rogovin proposed the creation of the DSMMA to keep the momentum going. He’s already hired a team of attorneys and law firm to set up a Delaware- or Washington DC-based non-profit. All that’s needed are members and money. Rogovin appealed to the audience for at least 10 companies to sign up, at $20,000 apiece.
Their first order of business? Oust Fabricant.
Though industry-to-government personnel shifts are commonplace, Rogovin posited that Fabricant’s hire was uniquely injudicious in that, as former head of government and scientific affairs at NPA, Fabricant was involved in a fiduciary, attorney/client relationship with the FDA and should not be able move from one job to the other.
Once Fabricant is removed, DSMMA’s next task—eliminating the guidance—would proceed smoothly, Rogovin asserted. “If Fabricant goes, NDIs go,” he said.
Building from the FOIA materials and regulatory precedent, DSMMA would then launch a lawsuit and a restraining order against the FDA to stall and then bury the guidance.
“We can’t wait for Senator Hatch to pull a rabbit out of a hat on this one,” Rogovin said. “We don’t have the time.”
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The question inevitably arises: Does the supplement industry need another trade organization?
Some might argue that the industry already has too many associations, and indeed, some have called for a unified federation of trade organizations.
But according to Rogovin’s rationale, efforts by existing associations, namely NPA and the Council for Responsible Nutrition (CRN), have been ill-conceived and too conservative. “Shame on the NPA and CRN,” he said. He took special offense against press releases from CRN and NPA around the time that the guidance was released that “applauded” FDA for finally issuing the document. DSMMA seems prepared to take the most hardnosed approach to this issue.
In all fairness, however, leaders of the four major industry associations—NPA, CRN, the American Herbal Products Association (AHPA) and the United Natural Products Alliance (UNPA)—have already outlined specific portions of the guidance document that need revision, and are currently working to submit those comments to FDA by Dec. 2. In August, the four organizations, along with the Consumer Healthcare Products Association, together submitted a request to have the comment deadline extended an extra 45 days. FDA gave them 60 extra days.
Jarrow Formulas, on the other hand, sent FDA a letter asking for an extra year. They also called for consumers to be involved, something the other organizations had not yet addressed.
Michael McGuffin, president of AHPA, sat next to Rogovin in the meeting, and though he pledged future support of and cooperation with DSMMA, he also sat confident with the idea that FDA would likely consider and implement the industry’s comments.
And while many in the room appeared to agree with Rogovin’s more salient points—that the guidance poses an economic threat and that the public should certainly be involved—few were ready to answer the $20,000 call.
The machinery is in place, however, and DSMMA does have legs. Rogovin may or may not prove the messianic figure that his discourse would imply, but he is a man with a plan.