In a public portion of the recent NBJ Summit, which yearly features a number of closed-door, off the record meetings that influence what stances the attendees are willing to adhere to in public, the notion that some sort of pre-market notification process for dietary supplement was given a public airing. Several attendees told NutraIngredients-USA this was the first time the idea was discussed publicly and they were surprised by how positively it was greeted.
Many industry stakeholders who were at the meeting said they shared that generally positive view, and several said the idea has been kicking around in those back rooms for a while, slowly gaining a momentum that was accelerated somewhat by the negative publicity that surrounded the New York Attorney General affair.
“It did make its way into the discussion of the general assembly. The reality was that there was a generally favorable viewpoint from that room about discussing premarket notification,” said Scott Steinford, executive director of both the CoQ10 Association and the Natural Algae Astaxanthin Association.
“Pre-market notification seems reasonable for all the obvious reasons including traceability and transparency,” Steinford told NutraIngredients-USA.
Pre-market notification could be expected to include some combination of giving the Food and Drug Administration a list of the name and address of the manufacturer, the name of the new product and its ingredients, facsimiles of the labels and so forth. Much of this information is already supplied to or gathered by authorities. Facilities are already mandated to be registered under the Food Safety Modernization Act and the National Institutes of Health has been amassing a database of thousands of dietary supplement labels. But some healthcare professionals who deal with adverse events arising from the use of dietary supplements, such as Dr Victor Navarro, direction of the national Drug Induced Liver Injury Network, said it is very difficult for clinicians under current circumstances to get accurate, timely information about the ingredients in many dietary supplements, complicating the care for patients presenting with liver distress. Some sort of high-profile, one-stop shop for information on products that are on the market would be an improvement, he has said.
George Pontiakos, CEO of botanical ingredient supplier BI Nutraceuticals, said he believes it’s high time that the industry consider this step.
“It doesn’t really affect BI; what would be be far more important would be for GMPs to extend to ingredient suppliers and I don’t know why we didn’t do that in the first place,” he said.
“But I believe the industry needs to take steps to regain credibility and if one of those steps is premarket notification I think we need to take a look at that. It was premarket notification that was discussed, not premarket approval. I don’t know why we don’t do it already and I don’t understand what the objections are.
“I know a number of manufacturers (at the meeting) embraced the idea and number wanted to know more,” Pontiakos said.
DSHEA is not be all and end all
In the past the notion has received a fairly cold reception, according to industry insiders. The idea was that DSHEA addressed industry’s needs in such an elegant fashion that it would be a mistake to open up a potential Pandora’s box and start an amendment process that might be steered out of control by industry opponents. But that view is obviously changing, observers said.
“There was a change in the vibe. There is a cadre of executives who for many years have been part of this discussion about the status of DSHEA and where do we stand as an industry,” said Loren Israelsen, president of the United Natural Products Alliance.
He said that for most of past 20 years executives felt that DSHEA adequately addressed the industry concerns, and the problems, like how the industry has struggled to establish a high common standard of GMP compliance, have remained more or less the same from year to year.
“But now we have FSMA (the Food Safety Modernization Act) coming at us next year and we don’t really understand how big that is going to be. And we were surprised by the NYAG investigation and the continued negative media attention that has ratcheted up to a higher level and what feels like a rising level of consumer concern about the industry,” he said.
“There was a different sense at this NBJ that we would be remiss as industry not to consider the events of 2015 as indications that it is time to rethink the issue set with the ultimate goal of creating a stronger industry,” Israelsen said.
Willingness to change
Michael McGuffin, executive director of the American Herbal Products Association, said that too much can be made of the dietary supplements industry’s willingness to stand pat on DSHEA. From his point of view, the industry has always been willing to consider new legislation and new regulatory frameworks when they make sense and will benefit the consumer without unduly burdening the manufacturers.
He said this most recent discussion was a step in that process, and didn’t approach in his view the watershed status that some other observers were according it. McGuffin said the legislative history of the dietary supplements business, going back to the days of the Proxmire Amendment and before and extending through the addition of the adverse events reporting requirement in 2006 shows that the industry can help direct meaningful regulatory reform when the time is ripe.
“I don’t know that there is a banner and and a movement afoot to demand such a change in the law now. We are always open to discussions about the best way to regulate this class of goods. Maybe one of those discussions might be some kind of registration process. We have to think about how that would help FDA and how it would help the consumer,” he said.
“The industry seems more open to considering potential shifts that would strengthen industry regulation and ensure companies have accountability to their consumers; however there’s a wide gap between what we have now and pharmaceutical pre-market approval. The key is to find something in between that not only addresses quality concerns but also helps rid the market of those companies that are completely ignoring the rules,” said Judy Blatman, senior vice president of communication for the Council for Responsible Nutrition.
Where does consumer fit in?
Dan Fabricant, executive director and CEO of the Natural Products Association, said keeping the consumer in mind could help inform the discussion of whether it is time to consider such a step.
“What does the consumer think of product registration? Do they think products are already being registered? One of the the issues I remember from my time at the agency was, hey, we don’t know who is out there. So would premarket approval help with that? Is it something that could boost industry credibility? This is a long way from being finalized by I think it is a discussion worth having,” he said.