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Dan Fabricant's FDA Insights

Dan Fabricant's FDA Insights

In April, Daniel Fabricant, PhD, ended his three-year tenure as FDA’s Director of the Division of Dietary Supplement Programs. Fabricant has since returned to the Natural Products Association (NPA; Washington, DC), where, prior to joining FDA, he served as vice president of global government and scientific affairs. (FDA has named William Correll interim head of Dietary Supplement Programs. Correll hails from FDA’s Center for Food Safety and Applied Nutrition.)

Nutritional Outlook and industry members will be watching with interest to see how Fabricant’s inside experience at FDA with policy issues such as New Dietary Ingredients and Good Manufacturing Practices (GMPs) informs his work at NPA going forward. Upon Fabricant’s departure from the agency on April 18, 2014, FDA said: “Dr. Fabricant worked hard to strengthen the FDA dietary supplement program,” noting that, during his time there, the agency took several court enforcement actions and issued numerous warning letters to companies, including for adulteration, mislabeling, and GMP violations.

Now firmly back at NPA, this time as its CEO—succeeding John Shaw—Fabricant spoke to Nutritional Outlook’s James Gormley about a range of issues, from the future of the NPA, to emerging champions on Capitol Hill, GMPs, and more.

 

Gormley: Thanks so much for taking the time, Dan, and congratulations on your return to the NPA.

Fabricant: Thanks, appreciate that. Looking forward to everything we can accomplish here. It’s a great association, great history, great story, so I’m excited by the opportunities.

 

What is your vision as to where the NPA and the industry should be next year? Five years? Ten years? And how can we get there as a responsible industry?

Sure, I think with NPA, it’s a great organization with wonderful volunteer leadership throughout the organization. What we’re really going to do is focus on how we can harness that. How we can make sure that those volunteers that are tried and true NPA members have access to members of Congress that are from their districts. Making sure their voices are heard, and heard appropriately, and that things are being done reasonably. This is an important time to build a lot of new relationships with two of the biggest industry champions [potentially leaving]. One is definitely leaving in two years [Sen. Tom Harkin, D-IA], the other [Sen. Orrin Hatch, R-UT] has indicated that he may be gone in four years. There are a lot of relationships that need to be built.

I think we’re really going to focus on building those relationships on the Hill, but also I think one of the things we can offer that the other trades [associations] can’t offer: we understand on a level how the agency [FDA] thinks to a much greater degree than anybody else right now. We’re certainly going to look to use that to our members’ benefit, but also to the consumers’ benefit, to make better products, to make sure things are fully compliant [and] that there aren’t any challenges with regulators.

The point of the trade associations is to serve the industry, not to serve themselves. I think that’s really where we’re focused.

 

Are you planning fundamental changes to the membership, like the recent NPA bylaw amendment membership vote, which was not passed, to expand the definition of retailer to include online e-tailers, such as Vitacost and iHerb?

I think it’s a good question. That was a very close vote. I think it’s [expanding the definition] is a very good concept, since the industry is changing. At the same time, we’re always going to stay true to our roots, if you’ll pardon that pun. I think that the NPA has been, for so long [and] in a lot of ways, the voice of the independent, and it will remain the voice of the independent. But, I think as businesses are changing, we, too, have to look [and ask], ‘Is our model still the most effective for that?’ and pull off the challenge of ensuring that we stay true to our roots—but, at the same time, making sure we’re situated in a capacity where we can really serve the industry to the maximum degree possible.

I think it goes back to the earlier part of our conversation. The most important thing that we can do is make sure our members have access—whether it’s the independent members or whether it’s the big manufacturers—[to make sure] that they have access and their voices are heard on the issues. I think people like to factionalize the industry within the industry, circling the wagons and shooting inwards. I don’t think that that’s something we’re focused on. I think, by and large, most people in the industry have way more in common than they have in the way of differences. So I think that we’re going to choose to put our focus there.

Where there are differences, we will seek to resolve those with some pretty healthy discussions and look to compromise in a way that’s best for all parties involved.

 

Something I’ve heard a couple of times over the last couple of years from suppliers is that they feel that they’re funding the organization and that there’s some resentment in that regard because retailer memberships are free, or almost free, and yet retailers have the same voice. Obviously, retailers need to have a voice and a vote. But could address the suppliers’ concern about whether they’re being put on equal footing with retailers, although they’re bearing the large portion of moving the organization forward and funding it?

Right. What I think you’re asking is, ‘Is there a disparate trait?’ I think really the crux of this organization is that we do have to cover a lot of territory; we do have to listen to all voices. I think that, in a big way, there’s a natural marriage between the suppliers and the retailers. I think that’s a big part of what we hear. There are those discussions between groups and they do understand what is important to each one of them.

Where there may be some differing opinions, I think that’s a big function the association serves—to see where those points can be resolved and discussed. We can speak with one voice, and I think that’s something the association has done very well through the years—rally everyone together to speak with one voice on the issues—and I know we’ll continue to do that. Anytime you’re dealing with different scales of economies, there may be some challenges like the one you brought up. But, I think, by and large, the association is focused on doing its job and providing access according to the needs of its members. In a lot of ways, as to the needs of the suppliers, some of what we’re going to be offering in terms of education is going to be very beneficial for them—for example, doing more in-depth GMP training, similar to the way the agency [FDA] does it. I think that that’s a benefit that I would imagine many suppliers are interested in. So I think we’ve got something unique for all the constituencies.

 

So it boils down to one member, one vote. Is that really a level playing field?

Well, I think that’s a good question. I think, though, where we’re seeing the shifts in business, I think that affects both the manufacturers and retailers alike. I think as we’re seeing different models emerge for consumers to buy from, there may be different business models that are selling to them, selling them products, supplying them with products.

I don’t think the discussion is binary, where it’s either a 1 or a 0. I think there are a lot of different layers there. I think one of the issues that we really want to bring about is discussion of those issues. What are the best policies? What are the best positions for that marriage between the groups going forward?

 

Okay, great. From your standpoint now, what are the biggest problems and challenges the natural products industry is facing that it needs to fix?

I think we talked earlier about losing two very dear friends to the industry soon, in terms of their leaving Congress. I don’t know if that’s something you fix, but I think there’s a great opportunity now to foster new relationships and really educate members of Congress about the industry.

There’s so much turnover in Congress, too. There’s got to be an ongoing, very intense effort to do that. I think that’s certainly priority one. I think anytime you get to the end of an administration, you always run into the legislative process slowing down, for better or for worse, [compared to when] there are regulations, and things like that, that “flying out,” and being able to have a handle on that. [I’m referring to] not just the FDA or the FTC process, but also the OMB [Office of Management and Budget]. I think those are some front-and-center issues that we think we have the finger on the pulse of and, so, we’re going to move very assertively to make sure we’re doing quite a bit in those areas.

 

If you had a crystal ball, who do you think might be potential very important industry champions going forward? Someone like Rep. Darrell Issa [R-CA] or Rep. Jason Chaffetz [R-UT]?

There are so many potentials. People you’ve already mentioned, like Jason Chaffetz. I think Heinrich [Martin Heinrich, D-NM] is somebody in the Senate that’s been looked at.

We also have to focus on who’s on the committee for jurisdiction in the Senate. That would be Health, Education, Labor, and Pensions. On the House side, it’s Energy and Commerce. Obviously, we’ve had some great relationships with them over the years, with people like Rep. Frank Palone [D-NJ]. I think we’ll be continuing those discussions with some of the friends we already have. It’s not like nobody knows us up there. We do have some exposure, but I think there’s certainly an opportunity to keep getting the message out.

 

What words of advice would you offer the next director of FDA’s Division of Dietary Supplement Programs? I realize there’s an acting director now [William Correll].

I think one of the best things I was able to do was to really work with the districts, work with the field. The field, in so many ways, is the heartbeat of the organization. They’re out there conducting the inspections. I’m a firm believer—I said this while I was at the agency, and I’ll say it here: The best thing the agency does is test and inspect.

Some of the other issues, I know people dug in on them and thought that they were really very important, and I can appreciate that. At the same time, that’s really the basis of the Federal Food, Drug, and Cosmetic Act. The agency locates something troubling through testing or inspecting. That’s generally where the majority of their efforts are spent. So I think that whoever gets in that chair next, I think if they maintain that focus, it certainly makes for a reasonable platform to have a robust program.

 

In follow up to your answer then: FDA’s Hazard Analysis and Critical Control Points (HACCP) system is really more of—you may correct me—an algorithmic approach to food safety, in that inspection sites are visited only if that site or product meets a certain risk or hazard threshold based on data analysis. Is that really physically “going out there in the field”? Would you like to see less of a HACCP model and more of an “out in the field” model?

I like GMPs. I’m a GMP guy. I think that consumers want it, and I think the industry wants it. That’s how you know. It’s kind of like how you can’t teach your kids to play softball or soccer by talking about it. You’ve got to be there, you have to get a flavor for everything that’s going on and get an understanding of whether kids gravitate to team sports or not. We all want to teach our children those sorts of lessons and have that sort of environmental contact.

If you’re going to manufacture products, there’s a real benefit to being under a GMP environment. It is how you document it; it is how you did it. It is that you’re tracking and trending how you did it. GMPs offer the concept of continuous improvement, which I know you can get on an algorithmic basis, but I don’t always think it’s so clear-cut.

 

This leads me to my next question. Where are the funding or resources shortfalls at the FDA that really need to be propped up or funded better?

Where to begin? I think there’s a few challenges for the agency to having [a] robust dietary supplements [program] going forward. I think that there are a lot of questions as to how much is actually allocated to the commodity [the natural products marketplace] and to doing robust inspecting and testing of the commodity. I was always very frustrated during my time at the agency—that [the natural products industry is] a big commodity, a $32 billion commodity, and we had between 22 and 25 people in the office really responsible for regulating it.

That’s not to say that other parts of the agency didn’t work on it. Obviously, there were various resources allocated, but I think for there to be a consistent approach to regulation of dietary supplements, there needs to be a consistent operational platform put in place—and that hasn’t been the case at present.

 

Okay, back to NPA. Where would you like to take the organization going forward?

Politically, we need to have more boots on the ground, in what form that takes. I know you are familiar with the Coalition to Preserve DSHEA. I don’t know if that will come back in the exact same form, but I think that concept is a very good one. We need to be up there telling our story on a frequent basis. So, I think that’s first and foremost: getting that structure back in play. Again, I’m not clear on what form that will take, but I think it’s a real benefit to have that extra touch on the ground.

In terms of programs, I think education—we can offer things that are very consistent with how the agency looks at things, which I think is a real benefit to members, whether we’re talking about claims, ingredient safety, NDIs, GMPs. We certainly have an experience that other groups don’t have, and I think we’re looking to bolster our programs in that capacity.

Other programs that we have, like the Natural Seal, have been very successful. I think consumers have been looking for some guidance in the marketplace, and I think we’re going to continue to offer that. While we’re not a consumer organization, maybe there’s a way we can do that in a more direct consumer fashion so they have that messaging in hand. They clearly have voted with their feet, so to speak, in terms of how they purchase natural products, and so I think we want to keep that trust in the marketplace.

 

Over the last several years, there’s been some ebb and flow with the regions in terms of the regional NPA associations—NPA East, for example. What would you like to see? Would you like to see consolidation of the regions, or would you like to see them have more of a role? What would you like to see in terms of the regional NPA associations?

I think they have a very good role right now. You mentioned NPA East, and we had a call with Paul Kushner, NPA East’s executive director, the other day. There was the GMO bill in Vermont that we’re all working together on. There are some bills in New York that we’re working together on, too. I think the regional structure works very well. We certainly make it a point that we’re all in communication with each other on a continuous basis. I think one thing we’ve learned is that state issues affect people nationally. So we’ve got to work together in a coordinated fashion to make sure things aren’t debilitating to our membership’s ability to do business. I think it’s just that simple.

The California region is actually ours here at NPA National, since we’re in charge of California. So we’ll continue to do a lot of work out there. California seems to be a hub of a lot of potentially challenging issues, not just on a state level, but nationally. So I think, as to the regional system, we’re going to keep aligning our communication and really work together to ensure that consumers have access to natural products.

 

You mentioned GMOs. I know both the association and some industry leaders had some concerns about Prop 37 in California. Industry had some concerns about the Connecticut GMO bill, too. There have been different recommendations over the past couple of months, from “Let’s do it as a voluntary national program” or “Let’s have it be federal” to “Let’s not have a patch quilt of state bills or regs.” What do you think, at the 30,000-foot level, would be best—obviously, with the underlying principle of the consumers' right to know? Do you think a federal law would be best? Do you feel that the states should just go and do as they please? What are the NPA’s thoughts on that?

Well, I think we’re already seeing the states going ahead and doing it. I think that causes some concern. The word you used was patch quilt. I think that’s always our concern, as we’ve seen in other states. Whether it’s something like Prop 65 that affects business nationally, you can’t expect firms to have 50 different labels for 50 different laws. Further complicating the matter, I think there’s a lot of redirect right now, and I think sometimes when there’s a lot of passion, it doesn’t always allow for discussion. What are the pros and cons of mandatory labeling verses voluntary labeling?

NPA has developed principles around GMO, but I think those principles are pretty heavily married up, and I don’t think we would be in a position to support something that didn’t meet all of those principles. At the same time, I think we do have a very strong interest in consumers’ right to know. Mandatory labeling of something containing GMO is, in a lot of ways, to really limit that product in the marketplace. I think that GMO in and of itself scientifically may not be as rock-solid a concept as genetic engineering. People go, “Aren’t they the same thing?” There’s a great bit of education that we have to look to get out there. Because I think there’s a great deal of confusion on the issue, and that’s understandable.

At the same time, we can’t let the confusion engulf us; cooler heads have to prevail, and we have to look at all aspects and how it affects the complete scope of our membership and make sure we’re doing right by them.

 

Do you think that NPA is going to have a Vegas show once again? (It doesn’t have to be in Vegas.)

That’s a great question. Well, it’s not outside the realm of possibility.

 

Do you have any other comments?

I’m just really grateful to be back, if you will, at NPA. It’s a great organization, great story. Some people I know have had strong opinions over NPA in the past few years, but I see that the structure is here and that the association will be around for the long haul. The association may have seen crests and valleys and different waves. But, overall, this association has 78 years of history of advocating and representing this industry in a very professional and effective manner, and we’re going to look to continue that tradition.

 
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