Nutraceuticals World: Under what circumstances was CRN founded? How would you characterize the dietary supplement industry at that time?
 
Steve Mister, president & CEO: Annette Dickinson was our first full time employee at CRN, and I actually spoke with her about this a lot. She was subsequently president of CRN immediately before I was. She retired, and that’s when I got the spot. So, I’ve spoken with her about the beginnings of CRN. CRN, was founded in 1973 and was a reaction to some efforts that were going on at FDA to try to limit the amount of vitamins that could be sold to consumers without it being considered a drug. If you were above a certain potency FDA said that you were necessarily a drug. That led a small group of companies to decide that they needed to fight this, but in a different way than was being addressed by the rest of the industry. There was an understanding among these companies that there needed to be some kind of regulation around the industry. We could not expect the industry to grow, and yet dodge all kinds of regulation and say that we should not be touched by FDA. So these companies were looking for a reasonable compromise that allowed for some kind of regulatory framework without treating the industry like pharmaceuticals. Secondly, there was an understanding that there needed to be good science underpinning those decisions. And so there was a real attention to developing an association that valued science. And thus, the logo that we still use—‘The Science Behind the Supplements.’
 
That effort eventually led to Congress passing the Proxmire Amendment a couple of years later, which then enshrined in the law that FDA could not declare something to be a drug that was a vitamin simply because of its potency. And that’s why now we can sell many vitamins and minerals at levels that are higher than RDA. We know now looking back that this was a very important thing, because we sell, for example, vitamin C, and we find benefits for vitamin C at several times RDA. The same goes for vitamin D, where many people recommend now that you should be getting 1,000, maybe 2,000 IUs of vitamin D, yet the RDA is much less than that. So I think that that was a critical turning point for the industry.
 
Annette also tells me that at that time the industry was very fragmented.
 
Nutraceuticals World: What have been the most important milestones for the industry over the last 40 years? What impact have those milestones had on business and consumers?
 
Mr. Mister: So we’ve got the Proxmire Amendment, which were very important early on, because they were one of the first times where Congress told FDA what the limits as to what their regulations were, and that they could not treat these products like drugs just because of the level of the ingredient. If it was safe for consumers to use, they should have access to it.
 
Secondly, we had the Nutritional Labeling Education Act in 1990—what’s known as NLEA. And that set up the basis for labeling the nutrition in foods, so then four years later when DSHEA [The Dietary Supplement Health and Education Act] passes, that becomes kind of a model of what the labeling of supplements should look like. It also set up the ability to make health claims. Which even today, the ability to make claims about supplements—such as calcium, vitamin D, the reducing the risk of osteoporosis, things like fiber reducing your risk of heart disease—those continue to be very important drivers in the marketplace.
 
And then 1994 was another watershed year with the passage of DSHEA, which finally laid out a framework by which FDA should regulate supplements separate from either drugs or food.
 
Judy Blatman, senior vice president, communications: I’ve been here since 2001, and a lot of what I’ve seen since I’ve been here, and I think with all industries, has been that there are a lot of things that are cyclical. But one of the important watershed moments in our industry was the situation with ephedra. This was really the first time since DSHEA was passed that FDA opened up its toolbox and looked inside to see what was available to them in terms of regulatory authority and enforcement activities. And in fact, I remember Dr. Mark McClellan, who was the commissioner of FDA at the time, saying something to the effect of,  ‘We can’t continue to say this law doesn’t work until we try to make it work.’ Through DSHEA they were able to remove ephedra from the market. I think this was an important milestone for our industry.
 
What we’ve seen since then is even more increased activity certainly within the last few years, starting with Dr. Sharfstein, and now with Dr. Fabricant. They’re really making use of what’s available to them under DHSEA.  
 
Duffy MacKay, ND, vice president, scientific and regulatory affairs: The story continues and takes us up to 2006, where we saw for the first time an industry that had matured significantly to the point where it realized the benefit of additional regulations for securing the future of safe product distribution, and really putting the consumer first, by supporting the Adverse Event Reporting (AER) Law. By definition, the law is really the post-market surveillance for dietary supplements. It provides FDA with information about potential serious adverse events, as well as requires companies to have a record keeping system in place, so that if there were to be a signal of a safety issue the tools are available for FDA to do an investigation and make a decision. What was unique about this was that it was really supported by the industry, recognizing that as the law and the industry evolved new tools may be necessary.
 
Another significant event was in 2007 when the GMP [Good Manufacturing Practice] final rule was written. This was significant in the sense that we’re seeing DSHEA—the law from ’94—mature, and that the regulation is fulfilling its intended direction. The GMPs were very significant because it allowed FDA its first eyes inside of the facilities as it did inspections, which started in 2008 and were phased in to 2010. GMPs are still a significant issue today as companies come up to speed and make sure that they are compliant with the law. As we know, it’s an important issue for FDA, and it’s an important issue for the industry. We’re doing what we can to educate and make sure that all companies, not just representatives that are part of the trade associations, become compliant.
 
Finally, our most recent and very significant change was the Food Safety Modernization Act (FSMA). And while not directly enacted for supplements, it has a lot of implications for supplements, including things like facility registration, so where we’re going to get a nice, clear picture of how big the industry is and where it’s players are. FDA has new tools like mandatory recall authority and facility registration suspension. So it really gives a new layer of regulations for people to think about. We’re still seeing some of the regulations for food safety creep into place and we’re watching that closely.
 
Nutraceuticals World: Are companies today in the supplement industry at large ‘responsible’? What more can be done to weed out ‘bad actors’?
 
Mr. Mister: The brief answer to your question is yes, I think the industry is responsible. I think the overwhelming majority of companies within this industry are committed to the health of their consumer and putting out quality products.One of the things that’s always struck me with this industry is that people who are in the industry absolutely believe in their products, and believe in the value of supplements as a way to maintain good health. This is often illustrated by the number of people in the industry who take the products themselves.
 
But, we do have this fringe element of companies who do try to seep into the corners of the industry and market products they call ‘supplements’ when they’re not. That’s the whole tainted product issue. So we do have these small fringe elements who disregard the law, and as an industry we need to continue to marginalize these folks. Companies need to be able to step up when they know somebody out there is putting out a bad product, whether it’s reporting it to FDA, or calling out the company if they know who it is.
 
I do want to distinguish here between intentional misconduct—which is what I’m talking about with regard to tainted products—and the other part of the industry that’s still getting its house in order responding to the changes that have happened as a result of Adverse Event Reporting, GMPs, and now the FSMA changes that are coming. We do have some people in the industry who, though well intentioned, have been slow to respond, and so that calls for a different reaction from mainstream industry. In this situation, these are not people who are doing something intentional. But they need to be pulled up by their bootstraps and educated. We need to continue to educate those in the industry as to what compliance entails, and what the benefits of complying are. Not only does it mean you’ll put out a better product, but satisfy your regulatory burdens you’re less likely to have FDA coming into your plant repeatedly doing repeat inspections. So there are lots of benefits to companies really understanding the regulation, and fully complying with it. 
 
I think this is the more mainstream challenge for the industry as compared to dealing with these ‘bad actors’ who will always be out there in the shadows. We have to just keep marginalizing them.
 
Ms. Blatman: I think that consumers have a role to play too, because ultimately consumers can speak with their wallets to help weed out these bad actors also. It’s really important that we do what we can to educate consumers. For example, at CRN one of the things that we do is maintain our RSS feed so if you sign up you can know when FDA is putting out warnings.
 
Dr. MacKay: From the scientific perspective, there is always concern that the pipeline for good investments into science is at risk, whether it be federal funding or in general if the economy takes a bad turn. That the money that helps us unravel the relationship between dietary supplements, vitamins, minerals and various botanicals and other ingredients, and its impact on health.
 
One of the things that we fall victim to is that people who are not experts in the area of our products are defining us in the scientific community. One of the most recent examples is with the report from The National Toxicology Program that examined ginkgo. This is a basic rat and mouse toxicology study on ginkgo that is by no means conclusive as to what this would mean for humans. NTP is not an expert in ginkgo; there are questions about the material they chose to use and how they conducted their studies. But, this is being misinterpreted as meaningful by some people. Unfortunately we see this, where a study may have a small amount of meaning, and then its over interpreted in the mainstream media. Even people saying that the door is shut on omega 3s because you have one study in JAMA and it’s just really important that we develop more sophisticated ways to interpret nutrition science that goes beyond the randomized control trial, and goes beyond where NTP is going. And so I really think that’s a giant gap inside the science area. Organizations like NCAM understand that studying nutrition is very different than studying drugs. Hopefully with the advances in genomics and metabolomics, we’ll be able to work some of this out, but it’s a big threat if we don’t.
 
Ms. Blatman: The overall theme for me is that perception can overtake reality. For example, we’re continuing to see these editorial letters published in some scientific journals that talk about the problems of regulation within our industry, and specifically citing most recently the number of recalls of tainted products. One of the things that really struck me as interesting is that they talked about how 50% of the products that were recalled under a Drug 1 Recall were actually dietary supplements. Well, that says two things to me: First of all, that 50% were technically illegal drugs and therefore not dietary supplements; the second thing it says that if 50% were ‘dietary supplements’, it means the other 50% were drug products, and nobody is out there calling for a change in the way that drugs are regulated. So I think we really need to be careful as an industry as to when perception is overtaking reality, and figure out the different kinds of things we can do to combat that.
 
Nutraceuticals World: What are the biggest threats to industry from your perspective?
 
Mr. Mister: First of all, the tainted products issue is of course one of them. It is this potential for a small cadre of companies that are not really even supplement companies, putting out products and calling them supplements because they think in doing that that gets them under the radar screen, and they’re illegal drugs.
 
Ms. Blatman: I think one thing that is really important is that if we don’t recognize the important role of health care practitioners, we’d be making a big mistake. Certainly we know from our consumer survey that we’ve done for the last 10 years, that when consumers are asked for who they trust for reliable information on dietary supplements, the number one answer is always physicians, followed by pharmacists. And then of course we see important numbers for dieticians and nurse practitioners. Even though our products are considered self-care, so in general you wouldn’t need permission from your doctor, it’s really important that consumers make this part of their dialogue with their health care practitioner.One of the things that we’d done proactively through our Life Supplemented consumer wellness program is to talk about the role of dietary supplements as part of a healthy lifestyle, along with a healthy diet and regular exercise. We’ve worked with a lot of healthcare practitioners on this program, and I think because we have such a responsible message going forward, that it’s really helped us with the healthcare practitioner community. They understand the direction that we’re heading in as an industry is to ensure that consumers are taking supplements as a part of one of their healthy practices, rather than taking supplements as ‘miracle products.’
 
Dr. MacKay: We must maintain a steady stream of investment in science because we need to continue to understand how these products benefit people so that we can expand our portfolio. In areas like probiotics, we really need to begin to understand the potential there so that we can put them in the right place in society, which I think is mainstream. Companies also need to recognize the importance of investing their own profits in to science— such as the science behind GMPs, establishing specifications, and all those other areas of science that are within the walls of the company. The greater scientific community also needs to gain a better understanding of how to interpret nutrition information beyond randomized controlled trials.
 
Ms. Blatman: There’s one other think I’d like to bring up, and that goes back to the idea of industry perception. Sometimes as an industry we’re so stuck on the idea of being right and ‘digging in’ that we lose sight of how we’re perceived. 
 
Mr. Mister: I think you’re right. When we do have a problem with FDA or an issue with science, I think because of the history this industry has had with the kind of criticism we’re faced from both the agency, legislators and from some of our consumer critics, our first reaction as an industry is to kind of dig in and fight. That keeps us some times from thinking what that does to the perception by our consumer. So where we might see other industries whether they really believe that they’re right or wrong on this issue compromise in order to save the consumer perception, we will more often dig in and sometimes I think we need to consider how this will play in Peoria.
 
Nutraceuticals World: DSHEA is nearly 20 years old. Will it survive another 20 years in its current form?
 
Mr. Mister: I think it’s important to remember that DHSEA today is not identical the way it was originally passed. It has already been amended twice, and we forget that. Both times it was changed with the industry’s blessing. In 2006 when we passed the Adverse Event Reporting Law that absolutely was an amendment to DSHEA. Then again in 2011 when the Food Safety Modernization Act passed it amended the Food Drug and Cosmetic Act, but it also affected some parts of DSHEA because it did change the regulation for supplements as well as the food industry. So DSHEA has in fact been amended, and I do think we’ll continue to see an evolution with it. DSHEA will not look the same 20 years from now. I think the important thing is for the industry to maintain its political clout so that it can influence the ways it does get amended, and that it doesn’t become a matter where our critics are running the table on us to change DHSEA in ways we don’t want it changed.
 
Twenty years ago we agreed that we would not use disease claims. Structure/function was ours, but we could not talk about diseases. As science is evolving we’re beginning to see some very credible science that demonstrates that supplements can have an impact on disease. So we may very well need to revisit that line between structure/function and disease in the future. But the important thing is for us to maintain our clout on Capitol Hill so we can positively influences these changes to DSHEA.
 
Ms. Blatman: One of the really important roles of our trade organization is to make sure that our industry is able to continue to responsibly manufacture and market dietary supplements and nutritional ingredients that consumers want access to. That’s one of the reasons why it’s so important for companies to belong to trade associations—so that they can have a seat at the table. We bring together many voices.
 
Nutraceuticals World: Several long-time industry allies in Congress are getting set to retire. What efforts are underway to find new supporters?
 
Mr. Mister: We started a process several years ago in order to expand our influence on Capitol Hill by my seeking out new allies. It’s not like the recent announcements from Senator Harkin and Senator Hatch that they’re not going to be seeking reelection was the first time we’ve thought about this. We’ve been giving this thought for several years because we knew that this day would come. So there is, in fact, a strategy at CRN underway to identify new potential champions and allies for the industry, and then to start working with them to make sure that the people we’ve initially identified are in fact like-minded members of congress who share our concerns for the industry whether it’s because they have a personal interest in supplements in their own health regimen, or because they happen to represent a constituency that believes very much in the value of supplements. Or perhaps supplements are a big economic base for this district, as it is in Utah, because of the amount of manufacturing there. We want to make sure we identify the right people who share our concerns, and then work with them and cultivate those relationships. The strategy is a little different with the Senate, than with the House, because of the nature of the two bodies. But we absolutely have an internal strategy in place to make sure that we have continued friends, allies and champions in both houses.
 
Nutraceuticals World: What other issues are top of mind for CRN and its member companies? What are your principle goals moving forward?
 
Ms. Blatman: Often the traditional goal of a trade association is to be reactive, and it’s really important that you also engage in proactive activities because otherwise you’re just always on the defensive.To speak about CRN specifically, we do a really good job of both. I think that you see that we’re always the first trade association that’s out there when there is a scientific study that comes out if we feel that it needs to be addressed from a different perspective, or maybe the science has not been interpreted correctly. CRN is interviewed by mainstream press consistently day after day, so we’re very good at our rapid response.
 
But we’ve also done a lot of proactive things, such as the Life Supplements initiative I mentioned earlier. This was originally a consumer wellness education campaign that was communications oriented. It started as a way for us to fill what we call the ‘education gap’ so that we weren’t always being defined in the media in a way that was different from who we knew the industry to be, and who we knew our consumers to be. We’ve done the campaign for 5 years and it’s morphed the way that the media has changed, from traditional media to social media to digital media, and now we’re looking for the next transition in the campaign. We plan to continue to be very proactive with our message.
 
Dr. MacKay: We really are ‘The Science Behind the Supplements,’ and we really do take being part of the scientific conversation very seriously. The CRN scientists continue to identify areas where we think we can contribute to the science, and publish along those lines. This year we’ve published several papers looking at things like the data on calcium, both its influence on health as well as the cardiovascular system. We’re not just standing on the sidelines— we’re participating in these conversations and directly putting out a responsible and balances message. We have a long-term plan that hopes to continue to set aside enough of our resources to publish and be part of the scientific conversation, both on a domestic and international level. For example, the CRNI [the Council for Responsible Nutrition International] held a scientific conference on the topic of establishing reference values for various bioactive constituents like lutein. This is a very important subject to discuss. We know that lutein is good for the eye, but we haven’t set a range of dosage for what the industry should put in their product. So we held a meeting, and then published those proceedings in an internationally read journal so we can get this information out to the greater scientific community, and shape the next 10 or 20 years in scientific advancement.
 
Mr. Mister: Duffy points out a good area here. CRN International, which we created a little over two years ago, was created to develop and promote good science internationally in the same way that we do here. The symposium that he references was actually the third that we’ve done in the last three years, and every one of those has led to published proceedings of those conferences. We’re very proud of the fact that we’re fostering and promoting good science as an association.
 
The last piece I would add is the importance of fostering responsibility in the industry. Going back to what we talked about early on, it was important to the founders of CRN, and we’re continuing to do that today. We just recently put out our recommended guidelines on caffeine, calling on industry to label total caffeine content in products on the label. This is another good example of how we believe you can kind of nudge the industry to go in the direction that it needs to go. A trade association can serve that role by setting voluntary programs, creating educational opportunities, and helping industry understand what compliance really means. All of this fosters responsibility in the industry.
 
Nutraceuticals World: If you could make one prediction for the industry over the next 40 years, what would it be?
 
Ms. Blatman: 40 years! I think there are going to be three areas that are going to be fascinating to watch. The first is how the retail environment will change. Will we ever be leaving our house to shop in 40 years, or will everything come to us? The second is the delivery method of our products. Are we still going to be taking capsules and tablets in 40 years, or are we going to have chips on our arm to get your daily dose of vitamin C? The third of course is the technology, and I don’t know if there is anyone who knows where that is going. I think from my perspective, we’re going to be dealing with intergalactic regulations, so I’m looking forward to working with the Jupiter Times and the Daily Saturn!
 
Dr. MacKay: I think the way that scientific investigation is conducted will look entirely different in 40 years. We’re seeing rapid advances in things like nutrigenomics and metabolomics, and the combining of using computer technology as well as information from the human body to determine if, for example, maybe men and women respond differently to a certain nutrient. Or maybe there is a subpopulation that responds differently. I think we’re going to have better tools to evaluate that, as well as better tools to help dieticians and pharmacists tailor people’s regimens to optimize their nutrition. I think that will look just entirely different.
 
Mr. Mister: As I look out at the future to where I think the industry is going, I think we’re going to see a change in the way consumers and healthcare practitioners alike view supplements, as well as other kinds of health related behaviors. One of our visions for the future is universal acceptance of supplements as contributing to good health. But I do think 40 years from now we will look at healthcare totally differently, and we will look at all these different lifestyle behaviors as a continuum of health. So we won’t have these distinctions between food and supplements and drugs and devices and diagnostics. We’ll understand that food contributes to disease, and both prevention and treatment. Supplements can lead to better health, or when you’re not using supplements it can lead to more likelihood of acquiring a disease. Drugs play a role in all of this. And drugs will have side effects that will prevent one disease but then will create another kind of problem that food or supplements may have the potential to ameliorate. So we will see this kind of whole spectrum of behaviors, including exercise, and what you eat, what you put in your body and how you treat your body, and we’ll have a much better understanding of how that leads to good health. We will view the whole industry differently.