The new initiative was announced during a speech Dr Gottlieb gave yesterday at a conference in Washington, DC organized by the Food Drug Law Institute that focused on compliance. In his speech, Dr Gottlieb announced the formation of a Dietary Supplement Working Group within FDA.
Call for new authorities
Dr Gottlieb said the purpose of the group is, “[T]o take a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures — and what new authorities might make sense.
“We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements,” he added.
Dr Gottlieb placed the risk that some products marketed as dietary supplements pose in the broader context of risk posed by all products regulated by FDA. Other problems mentioned by Dr Gottlieb included companies making illegal opioid treatment claims, compounding pharmacies and foreign based manufacturers of active pharmaceutical ingredients.
Spiking, GMPs, claims listed as concerns
As far as supplements are concerned, Dr Gottlieb said, “We’ve encountered a range of problematic conduct in this space as well. Some products marketed as dietary supplements contain dangerous and illegal ingredients, often without identifying them to consumers. Some contain lawful ingredients, but their manufacturing processes fall far short of GMPs that are needed to assure a quality product. And others make illegal and unproven claims about their ability to treat serious diseases.”
As Dr Gottlieb noted, the dietary supplement industry has changed radically since the inception of the Dietary Supplement Health and Education Act, which was signed into law in 1994. In the intervening quarter century, the category has grown from $4 billion in sales and fewer than 500 products to more than $40 billion and upwards of 50,000 SKUs.
“I’m concerned that the industry has gotten bigger and riskier faster than our policies and our capacity to manage this risk. That needs to change,” he said.
Stakeholders in the dietary supplement industry were cautiously optimistic that Dr Gottlieb’s aims on how to take the industry into its second quarter century married with their own.
“If you take his speech in order, he mentioned spiking of products, GMP compliance and illegal claims. These are three things that we have all been working on together,” said Loren Israelsen, president of the United Natural Products Alliance. “They have been persistent issues for us and the FDA.”
Daniel Fabricant, PhD, president and chief executive officer of the Natural Products Association, said that more vigorous and focused enforcement by FDA is something his group has long advocated for.
“While I don’t agree with him that things have gone too far too fast and that has opened up the storm drains for everybody and anybody, we do want to see FDA taking the lead on things like CBD,” he said.
“The agency can’t get everybody, but you can send a strong message to the bad actors,” Fabricant added.
A regulated category–like any other
Michael McGuffin, president of the American Herbal Products Association, said it was welcome that FDA finally seems to have come around to the view that supplements are just another category of regulated products and aren’t some slew of weird concoctions foisted upon the agency by activists.
“[I]t’s clear that supplements were not singled out but were simply recognized as another class of FDA regulated goods. After so many years of the myth of the ‘unregulated industry,’ FDA and this Commissioner are now consistent is sending the message that this is not the case,” McGuffin said.
Steve Mister, president and CEO of the Council for Responsible Nutrition said the initiative is part of a welcome breath of fresh air that Dr Gottlieb has brought to the agency.
“Since Dr Gottlieb’s arrival at FDA, we have seen increased enforcement against bad actors that mismarket drug ingredients as dietary supplements, the implementation of the Program Alignment initiative to make FDA inspectors stronger experts in the product facilities they inspect, and a willingness to work with the industry on Supplement Facts label changes. We applaud these efforts,” he said.
McGuffin said Dr Gottlieb’s announcement of the working group is consistent with the message stakeholders have been sending to the agency, recognizing that the time may have come to consider some changes to the overarching regulatory structure.
“The news here of course is that the Commissioner has now made public that FDA is reviewing its existing policies and considering new and more effective approaches to best regulate supplements. This seems particularly timely given that it was just this year that AHPA and other industry organizations submitted comments to the agency to share our suggestions for regulatory reform. Hopefully this newly identified Dietary Supplement Working Group within FDA will be considering these ideas, and we have every expectation that this process will unfold in a transparent manner with appropriate engagement by industry stakeholders,” he said.
It was not immediately clear from Dr Gottlieb’s speech whether the internal working group would be soliciting input from industry.
“I would hope so, and we are going to ask,” said NPA’s Fabricant. “We are here to act as a resource.”
What might come of the initiative
Dr Gottlieb didn’t specify what kind of new authorities FDA might be seeking, other than to say, “You’ll be hearing more from us on that front very soon.”
But one issue that has been mentioned in connection to these sort of discussions in the recent past has been whether some sort of mandatory product registry could be part of a new regulatory scheme. In communications about the NDI Draft Guidance, the agency has said that system represents the only point at which the agency can vet the safety of products before they go onto the market. And at other points, the agency has signaled its unease with not knowing exactly what’s on the market. The figure of at least 50,000 dietary supplement products on the market mentioned by Dr Gottlieb is just a guess; no one knows the true figure.
“The creation of a working group will, I assume, create recommendations to take to Congress. That would presumably be for the purpose of amending DHSEA. If that included mandatory product registration, I am open to that conversation as a way for FDA to have a better idea of what’s out there,” Israelsen said.
“Of course, bad actors are probably not going to register their products. But not having been registered might make them more obvious,” he said.
High time for a change?
Israelsen said that the changes in information technology have made considering a new regulatory scheme a pressing matter.
“I do agree with the urgency of the problems they have listed. It’s important to remember that DSHEA and the internet were born almost on the same day. Spiking and the technical ability to create a black market for products that regulators would have a hard time tracking down is in large part driven by this technology,” he said.
“It is appropriate that FDA periodically re-evaluate its regulatory tools and procedures," CRN's Mister said. "CRN has encouraged FDA to engage in more enforcement and to make use of the Supplement OWL, the dietary supplement industry’s online registry of products that provides the agency with new transparency. CRN will analyze any new proposals from the Working Group through the lens of DSHEA and the critical balance it strikes to protect public health while assuring consumer access."