Partisanship aside, well-tended friendships, education and vigilant attention from the natural industry make for good relations inside the Beltway.
Introducing the participants:
• Robert Craven, CEO, FoodState (MegaFood)
• Daniel Fabricant, PhD, Executive Director and CEO, Natural Products Association (NPA)
• Mike Greene, Vice President, Government Relations, Council for Responsible Nutrition (CRN)
• Risa Schulman, PhD, President, Tap~Root
It is vital for those in the natural products industry to work with government legislators and regulators to ultimately provide consumers access to safe, healthy products. Nutrition Industry Executive magazine discussed the state of affairs with natural product leaders whose goals are to foster and maintain those connections inside Washington.
NIE: Where does the supplement industry stand with the U.S. government today?
Craven: I think as an industry we’re in the process of growing up, and as such there are some very real challenges that we need to face head-on in the near future, primarily the confusion surrounding our industry in Washington. The biggest threat I can see at the moment is that we are not used to getting really kicked around—after all, our industry began out of a very sincere desire to help people. So we as an industry need to adjust to the new norm and do a much better job of explaining ourselves in Washington quickly.
In an uncertain world people are looking for what’s real—and we can help them find it by establishing and driving trust and certainty. And not just with consumers, but with Washington as well.
Greene: We’re at an interesting time in the industry because, as you know, DSHEA (Dietary Supplement Health and Education Act) is 21, and we have lots of new friends and new faces that we’re working with. Of course Senator Hatch (R-UT) is still here and still a champion of the industry. We’re working with Senator Martin Heinreich (D-NM) and Tim Scott (R-SC). From my experience with CRN in the past 15 years, we’re moving in the right direction. We’re doing what we can to enhance and fully enforce DSHEA and we’re looking toward the future. And I think that’s what we’re really optimistic about.
Fabricant: We have to look across all branches of government—legislative, executive and judicial. I think we’ve got challenges on all three fronts, at the same time we’ve done a good job of building relationship with the agencies—it’s very good. They are listening and working with the industry to correct any problems. With Congress, there’s been so much turnover that the clock is really ticking. We’ve got a lot of work to do to bring people into the fold. It may not be the way it was before. I don’t think anyone in Congress is going to be in office for 30 plus years. Senator Harkin was [an ally] and Senator Hatch still is. We may want to focus less about personal interest and more about business interest and how these businesses are in their congressional district and how this industry is part of their constituency.
With the judicial side, if things don’t go right on the other two sides, you fight it out in court. There are some pretty significant cases on the table right now. There’s Bayer and the federal government’s enforcement of cGMPs (current good manufacturing practice). There’s a lot of good dialogue at the court level, but we have to remain vigilant on all three fronts. Government is changing and the industry is changing, so you have to be plugged into those changes on all levels, and it’s not always easy.
NIE: Who in Washington can now be listed as “allies” of the industry?
Craven: There are several trade groups working to make sure our voice is heard in Washington, and they’re doing a great job bringing folks to the table, but one person in particular I’ll mention is Congressman Tim Ryan (D-OH), author of The Real Food Revolution. He has a similar viewpoint about the core role that food can play in wellness, and I think he could be a very powerful ally to our industry because he thinks the way we do. To me it’s not so much about finding someone who will champion supplements as it is finding someone who will champion overall health and wellness and eating right.
Fabricant: We have some of our old friends still. Obviously Senator Hatch is our greatest champion. Martin Heinreich has been named as potential there. Joe Manchin (D-WV), Senator Alexander (R-TN) and Senator Heller (R-NV) have been very helpful there, as well.
In the House we’ve got a lot—Jared Polis (D-CO), Jason Chaffetz (R-UT), Frank Pallone (D-NJ), Erik Paulsen (R-MN). That’s just to name a few; that’s not everybody, and we’re working on some of the new folks and how to bring them into the fold and get them excited about the industry.
NIE: What are the biggest threats to the industry or DSHEA?
Craven: The biggest threat to our industry and our existing regulatory framework is a lack of trust. We must build trust—with our consumers, with the media, and with Washington—for continued credibility.
What can we do to build trust? The issue of “self-regulated” has been around since DSHEA was crafted in 1994, and that perception persists over 20 years later. So I think we can and need to take this even further. You hear a lot about transparency these days, but I think we can be more than transparent: we can be transformative—transforming the way we do business and what people see when that curtain is pulled back.
This is exactly why we’ve implement a few changes at MegaFood recently as part of our Big T Transparency initiative, including open access to facilities, new product development plans, and even audit and testing results. The end goal of all of it is to help people understand what’s real, what’s true, and what to believe when it comes to supplements.
Schulman: We are currently living with the biggest threat to the industry: loss of consumer trust. We all know this, and there are steps being taken by many bold and courageous individuals and companies to develop transparency and accountability in sourcing and manufacturing. There is, however, an additional area that is an equal threat to trust, and that is efficacy. Developing products and benefit claims that are truly evidence-based is a prerequisite to transparency. If the product doesn’t have real efficacy, it doesn’t matter how and from what it was made. While many companies, to their credit, strive to be science-based, fewer have the deep scientific and regulatory know-how and the ability to synthesize the two in order to develop a strong and solid platform for their products.
Greene: I think the biggest threat right now is probably from industry becoming intransigent—saying that Congress isn’t going to do anything, or nothing is going to happen in the states. We always have to be vigilant, and we have to recognize that there are potential issues that can come about from any corner that could cause problems for the industry, the consumer, and with the way we’re regulated. Our traditional detractors, like Senator Durbin (D-IL), and Senator Blumenthal (D-CT), who has joined Sen. Durbin, in the past has introduced amendments that focused on dietary supplements, but of course we’re expecting the reintroduction of the Dietary Supplement Labeling Act (their legislation). That could come in a couple months.
In the House of Representatives, we saw the retirement of both Henry Waxman (D-CA) and John Dingle (D-MI). We haven’t had many detractors there, in fact I believe this is the result of great education, but some of the work we’ve done with the Dietary Supplement Caucus is the primary way the trade associations, and the industry in general, educate Congress. I believe that has had a lot to do with it. We have had great access to representatives, we share good information and we do our best to remind everyone on the Hill that dietary supplements are regulated. We’re not regulated like drugs, but we are regulated.
Fabricant: Our biggest threat is us, and our biggest threat is apathy. I’m not a naysayer, but I think that most people who were around during DSHEA wouldn’t know how to operate now. It’s so different. Grass roots are still important, and NPA does a lot with grass roots. Politics are so financially driven now—that’s really a threat. I think the natural and organic industries don’t think they have to operate like other industries do. They think, “That’s for big tobacco. That’s for people like big petroleum. It’s not for us because, we’re healthy, we’re good.” That’s fine, but realize that for every consumer that thinks the industry is good and healthy, there’s a politician in Washington that says “something about this doesn’t sit right with me.” If we’re not constantly in their ear telling our story, (and not giving to their campaign) they will say, “I really have no incentive to help you guys out.”
NIE: What is the biggest misconception about the supplement industry that needs clarification in Washington?
Craven: I would say the biggest misconception about the industry is that it’s simple and unregulated. We all know we’re a very complex industry and that the tendency for the government and media to oversimplify or paint with a broad brush across the industry is a huge misconception. This oversimplification leads to situations like what we have in New York, where the attorney general is skipping the regulatory process and forcing change through investigations and agreements with specific companies, or the belief that one DNA test can tell you what’s in a botanical.
Greene: The whole category of regulation probably would have been my response five years ago. But I think Congress pretty much understands it. Now it’s more about what DSHEA will do and how it works—the question of whether or not DSHEA has been fully implemented and enforced. I think we all recognize that there needs to be more enforcement of bad actors in the industry and we’re looking at how DSHEA is operating—how it’s operating 20 years after it’s been introduced. Twenty years ago, we didn’t have the internet. And the internet is a major way in which dietary supplements are sold, and information is shared. Twenty years later, we’re looking at how DSHEA is evolving and what needs to be changed in the future.
Fabricant: I think the biggest misconception in Washington is that people—Congress members and their staff—who don’t know the industry, read news and they get most of their opinions about the industry from the news. And that’s never a good portrayal of any industry. They hear about [problems with] sexual enhancement, weight loss and bodybuilding products, and that’s not the industry at all. Also, they think there’s no science out there.
NIE: What is the biggest misconception the industry has about Washington?
Craven: I’d say it’s that Washington actually cares about supplements. I don’t think Washington cares a lick about DSHEA or the broader supplement industry. Of course they care about the “bad players” and I support them in that, but I think we would be well served as an industry to elevate the conversation and make it more emotional by aligning with the broader health and wellness conversation. I firmly believe that our industry is a vital part of the solution to the U.S. health care crisis. If we make an effort to elevate our discussions with Washington to this level and we work to explain how we can provide real solutions to this very real problem, I believe we will have more success and build more trust.
I’m not a fatalist. I believe that if we do it right and walk the walk, Washington will come along with us.
Greene: It’s that the industry thinks since Congress is controlled by the Republicans, who are anti-regulations, that nothing will happen to dietary supplements in the next couple of years because Republicans are generally pro-business and don’t want to see added regulations. I think that we’ve got to be vigilant and that we have to keep our eyes open because there are some concerns being raised by folks like the New York attorney general.
Fabricant: People in the industry think that others like us, and we don’t have to play the game the same way big tobacco and big petroleum does. That’s a huge oversight and a recipe for disaster. If you’re not at the table in Washington, you’re likely on the menu. If we’re not giving our time and money, they’re not going to listen to us.
NIE: How will food safety legislation impact the natural products industry?
Craven: Foreign supplier verification programs and minimizing intentional adulteration are good for supply chain transparency and are good for building trust. We welcome attempts to make better, safer, more transparent food. This type of dialogue is probably even more important in the natural products space because our consumers demand it.
The FDA’s (Food and Drug Administration) FSMA (Food Safety Modernization Act) is an opportunity to rise to the occasion. They are working hard on making sure the legislation is scalable and won’t be unfair for the little guys with less capital. FSMA will impact FoodState more so than other companies that don’t work directly with farmers. Some folks are already doing a lot of what the legislation calls for, but formalizing the regulation will standardize the industry. It’s good stuff.
Fabricant: After the peanut butter incidents, the industry needed an overhaul. I think industry has been responsive on comments. One of the things concerning us is that we’re going to need clarification from the agency—we have GMPs that are very strong on dietary supplements, and the industry and the reputable companies have done a good job on implementing them. But there hasn’t been a lot of discussion on dietary supplements from the agency … and we really need that dialogue.
NIE: What about the labeling of GMOs?
Craven: It will be interesting to see where the DARK (deny Americans the right to know) act bill goes now that it’s through the House. A government-backed non-GMO standard and program, though optional, may be a path that could work for many companies who want to verify their products are non-GMO.
It is a shame that this bill negates the state rights because we see this as a path to driving real change in Washington. At MegaFood, we’re taking the stance that the bill will pass so we should all be evaluating it and preparing for its impact.
We have supported both state initiatives and Just Label It, as we are in favor of mandatory labeling efforts. In the end, if the consumer is loud enough, the right bills will get passed.
Fabricant: Everybody’s looking to the Senate since the bill passed the House for GMOs. It was an overwhelming majority that passed, 275 to 150. All eyes are on the Senate and at some point there will be discussion about moving the bill ahead … it’s a wait and see approach. People are starting to see that if the states get involved to require labeling, it will be a challenge because we can’t have 50 different labels for our products. There’s still a lot of split in the industry, but having 50 labeling requirements will be really tough for everybody.
NIE: How should industry work with regulators to provide safe products to consumers?
Craven: I think we should heighten support of efforts and laws currently in place, bringing more awareness through third-party certifications like NSF cGMP. I am in favor of extending cGMP up the supply chain as well, however, there will be complexities as it relates to farmers and this should be thought through carefully. As a brand that buys directly from farms, we don’t want to put an unnecessary burden on this portion of the supply chain. We will continue to use our high farmer standards, audits and ingredient testing to ensure quality, safety and identity from farmers. But for other dietary supplement ingredients, no less than cGMP should be required.
Additionally, I’m in favor of hurdles for the bad players and anything that helps our industry build trust with consumers. Unfortunately, I feel like these hurdles have to be instituted by a third-party trusted entity like the government in order to get past the “self-regulated” misperception. I haven’t thought through all the ramifications or details of how it would be implemented, but I would be in favor if the industry came out strong on items like pre-market product registration or a national label/ingredient database.
Schulman: Self-policing could go a long way to raising the image of the industry in regulators’ eyes. I am talking about an official and gold standard system for certification and assistance. If this could marginalize the 15-20 percent of sellers out there with shoddy and non-compliant products, this would also be a big step toward raising our credibility.
Greene: It comes back down to education and I know it’s somewhat boring and passé, and it’s not active like lobbying. But it’s about education and constant vigilance. We do a lot of great things in this industry. We passed DSHEA, and then we didn’t do anything for the next five years, then we passed the serious adverse event reporting law, because we believed it was right for our consumers, and then nothing gets done for the next couple of years. And then just last year we worked on the Designer Anabolic Steroid Control Act. So we have to be vigilant and we can’t rest on our laurels, and think nothing’s going to happen. We have to do what we can to make sure Congress hears us. We’re not going anywhere. We’re evolving, we’re becoming mainstream and we need to behave like a mainstream industry. So I’m very excited about the future.
Fabricant: Follow the law, especially if it pertains to labeling and quality. Those are the big-ticket items. I’m not saying the FDA is always our friend, but engage them, both on a headquarters level and on a local level. Know what they’re about and let them know what your business is about. Transparency is critical.
NIE: What steps are associations or other entities taking to help industry work with Washington?
Craven: At FoodState we support virtually all of the major associations, and believe they are working hard for our interests in Washington and in the industry. I also think the new Coalition for Supplement Sustainability [trade association] is an important step in collaboratively tackling the challenges facing the industry and to help spread the word about how we can help each other by creating standards that benefit the whole industry.
Greene: CRN does a fly-in every year. Advocacy is very important to us, because our members are the manufacturers and ingredient suppliers in the industry, so we want to make sure that Congress knows that our products are made to high-quality standards, they’re beneficial and they’re safe above all else. So when our members come to town, they talk about what they do. We encourage our members to interact with their members of Congress during Congressional recess when they’re back home in their districts and states, and many of our members do that.
Fabricant: [The NPA] has always prided itself on being the most effective on the Hill. We definitely still are, and we brought that back in a short time. We contribute more than anybody does, whether it’s PACs (political action committees), whether it’s direct lobbying, whatever it is, we’re the first ones through the wall when there’s a fight. You have to have a watchdog at the gate. We work with Congress, work with the regulators and work with the courts to make sure that the industry is getting a fair shake.
NIE: Other comments?
Craven: I think we’re at a point now in this country where people are starting to grasp the concept of overall wellness. People are frustrated with the health care system, and they’re getting older, and the sad truth is that as a country we’re just not as healthy as we need to be. The good news is that consumers are more aware than ever, thanks to the rise in social media in particular, and are increasingly looking for products like dietary supplements, organic and fresh foods, etc., to help them be healthier. The supplement industry needs to claim its rightful position in this movement. NIE