Jarrow Formulas, Inc. and James Gormley of Citizens for Health organized a tactical meeting during Expo East, with the hopes of encouraging industry members to take a stronger stand against the recently proposed guidance on new dietary ingredients (NDIs), and to consider formation of a new trade association. In attendance were some of the industry’s largest and most influential supplement makers, retailers, and raw materials suppliers, as well as interested observers such as the founder of the American Botanical Council.
The moderator and main speaker, Jarrow L. Rogovin, president and chairman of the board of Jarrow Formulas, Inc. (the meeting’s sponsor), and chairman of the board for Jarrow Industries, Inc., reiterated his chief concerns with the document (see last month’s Newslinks). He stated the guidance as it stands would “shut down the industry and tie us up with red tape.” Among his concerns are the need to prove the pre-1994 marketing and manufacturing of supplements; the short comment period; the contravening and rewriting of sections of DSHEA; the potentially inappropriate hiring of Daniel Fabricant, Ph.D., formerly vice president of scientific and regulatory affairs at the NPA and now FDA’s director of dietary supplement programs; FDA’s interpretation of all “new” formulations of “old
Jarrow L. Rogovin speaks during NDIs meeting.
Photos taken by Ara Soghomonian, courtesy of Jarrow Formulas, Inc.
” ingredients to be NDIs; the duplicative nature of the NDI submission process which would create 56,000+ submissions and only 10 people to review them; and more.
Attorneys Susan Brienza and Scott Polisky also spoke during the meeting. Brienza noted that Dr. Fabricant implied during an NPA teleseminar that FDA had little intention of changing the document for the Final Guidance, as she zeroed in on his statement, “If it is revised.” Polisky reminded all that earlier Freedom of Information requests to FDA yielded documents showing that supplements are safer than other FDA-regulated products and that FDA often disagreed with GAO recommendations for more regulation. Jarrow’s current 128-item FOIA on NDIs and future requests would be sure to uncover facts that once again refute FDA’s assumptions and interpretations, information that ultimately can only help stave off FDA's increasingly heavy hand.
Later that day, Marc Ullman told WholeFoods that historically, agencies like to use guidance documents as a way to regulate industries because they are generally not subject to legal challenge outside of the context of an enforcement action. “The real problem is that they have a chilling effect on industry,” he stated.
During the meeting, Rogovin made the case that industry needs to fight back, since the guidance sets a dangerous precedent. It must be withdrawn, he felt, and, “We can’t rely on Senator Hatch to pull a rabbit out of a hat on this one.”
The answer, suggested Rogovin, is to develop a strong industry trade association to represent supplement makers. The Dietary Supplements Manufacturers and Marketers Association (DSMMA), he feels, would take a proactive role in fending off threats to the industry (like the NDI guidance) by engaging consumers in public relations campaigns and filing Freedom of Information requests, where appropriate. Filing a lawsuit against FDA could even be in order. “If we don’t have consumers organized…we’re not going to come out of this,” he stated. “We need to get retailers organized to get consumers involved.”
Rogovin previously founded another successful association, the International Probiotics Association.
He feels even just five to 10 founding member companies of DSSMA could make a big difference. By developing the DSMMA, “we’ll all end up stronger,” he said. “If not now, then when?”
Published in WholeFoods Magazine, November 2011 (online 10/7/11)