Annette Dickinson saw a lot of changes in the dietary supplement industry as the Council for Responsible Nutrition’s executive director from the trade group’s launch in 1973 through 2005. She remains active in the industry as a consultant for CRN.

Dickinson and her successor at CRN, Steve Mister, recently talked with “The Tan Sheet” about how the trade group and the supplement industry have changed over 40 years, from CRN’s start with three founding member companies to more than 100 today with an annual budget around $4.5 million. The following are excerpts from the interview.

“The Tan Sheet”: What would you say were the association’s priorities when you started, and how have they changed?

Annette Dickinson: At the time CRN started, which was in 1973, it was a period of great controversy with FDA. FDA had been trying for almost 10 years to establish a standard of identity for vitamin and mineral supplements, which would have severely limited both the quantity and the combinations of nutrients that could be sold, and the industry was uniformly opposed to it. In 1973, FDA was expected momentarily to issue the final rule, and many parties were primed to file legal objections to it as soon as it was issued.

So CRN’s founders … had been thinking for a long time about the fact that there needed to be an association that was science-based, that took a rational approach to issues, that did not view regulators as necessarily the devil incarnate. But that recognized that reasonable regulation was necessary, and was willing to step up and work with the agencies to resolve some of these difficult issues that had been pending for quite a long time.

Annette Dickinson, Council for Responsible Nutrition past president

Photo courtesy of CRN

The initial objectives, the philosophical objectives, were to establish an association that took a responsible science-based position on issues that affected the industry, and that tried to take a cooperative approach to the agencies in which we could reasonably work through various issues. And the practical issues were the need to combat this particular regulatory proposal, both through any administrative means that were available, but also through legislation.

So the objective was to create an association of companies backed up by a group of highly respectable consultants on the outside – law firms, PR agencies, legislative agencies – to help us through that process.

Q: What happened to put the proposal on the table in 1973?

Dickinson: The American Medical Association took a jaundiced view of the products that were available and of the need for supplements at all, and had actively lobbied the agency in the late ’50s, early ’60s, to limit the quantities and the combinations of products that were available. So FDA had been responding over a period really of about 10 years, through various phases of this regulatory proposal, to an impetus that really came from the medical community.

There had been public hearings in the early ’70s and … FDA had issued a tentative final rule. So they were expecting, certainly before the end of 1973, the issuance of a final rule. And that would present the opportunity to challenge it in court.

Q: How would the industry be different today if that rule, in the most extreme way FDA proposed, remained in effect?

Dickinson: It would not be recognizable at all. The limits on quantities were about 150% of the RDA. So to put that in practical terms, we could not have sold vitamin C at levels higher than about 90 mg. And today, most products are in the range of 500 mg or more if it’s vitamin C by itself. In fact, even the RDAs are higher now than 60 mg, which is what they were at the time. It would have meant very low levels of nutrients. Plus, you could only market single nutrients or combinations of the whole set, or some limited combinations like B vitamins. So a highly restrictive assortment would have been available.

The final rule was actually overturned by the courts in 1974. And legislation passed that essentially backed up what the courts had said, and prevented FDA from establishing that kind of standard in the future in 1976. … The agency took a while to get over the shock of having been overruled by the courts … and of having legislation passed which actually restricted what FDA could do in this area. Or backed up what the court had already said and forbade them from establishing this kind of standard.

Q: With that accomplished, what became the priorities for the association?

Dickinson: FDA wasn’t just going to turn their back on it and forget about it at that point. It seemed there was going to be some kind of follow-up from the agency in terms of a new proposal or a series of new proposals. So our effort was to work on the legislative side to keep our contacts on the legislative side in case they were needed, but also to work directly with the agency to explain their position, to talk about alternatives, and to develop and highlight information about the benefits of supplements.

I would say that the basic philosophical objectives of the association have not changed. The objectives continue to be to bring scientific expertise and legal expertise and public relations expertise to all of the issues that affect our industry and that affect our company’s ability to do business in a responsible way. And to try to explain ourselves, both to the public and to the federal agencies, and that includes not just FDA but the Federal Trade Commission, the Consumer Product Safety Commission, the Department of Agriculture, which issues dietary guidelines. All of the agencies and administrative organizations that have an effect on what companies are able to do and what they’re able to say about the products that they market.

We’ve moved enormously far since the 1970s. The Nutrition Labeling and Education Act of 1990 … authorized not only a complete revision of nutritional labeling, but also introduced the ability to make health claims for certain products, which eventually evolved into having qualified health claims and structure function claims under [the Dietary Supplement Health & Education Act]. There’s been a sea change in FDA’s view of how these products should be regulated and what companies should be able to sell, to tell about them, to say about them on their labels, both for supplements and for functional foods and conventional foods.

Steve Mister: The basic tenets have never really changed at CRN. We’ve always had this strong commitment to science, evidenced by the fact that the first full-time employee at CRN was Annette. You have someone with a great pedigree and expertise in the science.

Council for Responsible Nutritiion President Steve Mister

Photo courtesy of CRN

There’s always been a recognition that this is an industry that needs some amount of regulation. If we’re going to have the confidence and the respect of the health care practitioners and consumers, there has to be some kind of a framework of regulation around it, but it shouldn’t try to mirror what FDA has done for drugs, because we are different than drugs.

We have more of a consumer focus today than we did in the early days of CRN, just because as resources have grown. It’s allowed us to have more of a conversation with consumers, where in the early days it was much more focused on the Congress and the regulators and the courts.

Q: How do more consumer-focused activities make a difference for the industry?

Mister: One of the obvious things is what we do with “Life…supplemented,” and that’s the program through our foundation that really does try to have a conversation with the consumer about the importance of good health and incorporating supplements into that wellness regimen, along with having a good diet and exercise, and also using your supplements to fill in the gaps.

That’s one of the most obvious ways. But what we’ve done recently with the National Advertising Division and our voluntary advertising program is a recognition that we, as an industry, have to monitor the kind of claims that we’re making to consumers. If we make claims that are not substantiated and are too good to be true, our consumer will start to lose confidence in what we do say that’s correct. So we have to monitor the marketplace and self-police ourselves. So that’s another example of how we interact with consumers.

All of the work that we do with the consumer media in response to studies that come out … is a very important part of what we do to make sure that consumers are getting accurate information about the science, and that when people publish studies that have their own agendas or they’re misinterpreted in the press, that we have our opportunity to have our say on what those studies really show.

Q: Which companies started CRN?

Dickinson: The companies no longer exist, all three of them. The primary founder was Bill Thompson, who was president of the WT Thompson Co. … The second one was Nolan Draney, who was a vice president at Plus Products. …The third one was a company that was actually newly formed at the time, … Archon Pure Products Corp., which was formed by a guy by the name of Dan Ritchie. And [Archon’s] representative was a vice president by the name of George Crawford.

Q: What was the impetus for DSHEA?

Dickinson: After FDA’s standard of identity was overturned in the ’70s, then in 1992, I guess it was, FDA’s commissioner created a committee and instructed the committee to take what they called a blue sky approach. That was [then-Commissioner] David Kessler’s approach … to the regulation of dietary supplements, because he saw that they really had not gone back to that subject following the court decisions, and that it needed to be thought through again.

He created this committee, and the committee came up with a report, which was published by FDA in 1993 as an advanced notice to proposed rulemaking, which unfortunately sounded a whole lot like the notions that were behind the standard of identity back in the ’70s. The idea that they did not approve of higher doses of vitamins and minerals, and that maybe they should put limits on those. The idea that they moved into other categories then, such as botanicals, and said that they kind of thought that they were inherently therapeutic and maybe were not supplements at all, but were really drugs. Several conceptual attitudes of that sort came through that advanced notice.

That’s when the industry decided that this restrictive attitude had not gone away, and that it needed to be dealt with. A group of people came together and drafted a series of bills that eventually became DSHEA, to basically cover all of those categories. Not just vitamins and minerals, which had been the subject of the 1970s activity, but also proteins, amino acids, botanical products and other ingredients.

Q: When did Congress take an interest?

Dickinson: Even before the ANPR, as soon as the committee’s report came out, which led in that direction. And Sens. [Orrin] Hatch and [Tom] Harkin and others started working on some legislation that would point FDA in somewhat of a different direction. Rather than having them look backward to that period of the 70s, have them look at a science-based approach to supplements, and to recognizing the benefits. That was also in the period right after the passage of the Nutrition Labeling and Education Act, so all of the activity over health claims was in full play at that point. The final health claims regulation for foods had been published.

All of that was still a matter of discussion, and FDA had proposed to authorize a number of claims for conventional foods, but not for supplements, like for fiber and for antioxidants, for example. All of that added to the feeling that FDA still wasn’t looking at supplements in the same way that it looked at nutrients in foods, and that it should be doing that.

Q: At what point did you start to realize this was a watershed moment that could lead to something that would define the industry, as opposed to creating a bill responding to the crisis of the day?

Dickinson: I don’t think we saw a difference between those two things. I think we saw the whole FDA, ANPR and the legislative response to it as being a watershed thing from the beginning, because it was huge. I mean, it would redefine FDA’s approach to the whole supplement category. I think we always saw it as a defining moment.

The legislation actually moved very quickly. I think it was first introduced in about late ’92 or early ’93, and it passed in ’94, so that’s incredibly fast for a major piece of legislation. And also, the number of co-sponsors, both in the Senate and in the House, was just immense. I have heard it said that two thirds of the Senate and one half of the House were on the bill as co-sponsors.

So it was not something that was just the brainchild of a few people, but something that Congress just recognized that people wanted. And they were getting a lot of lobbying from individual consumers in their districts on this issue, and not just phone calls and emails but people actually coming and grabbing their lapels in the hallway.

So there was a lot of activity going on. Sen. Hatch was able to get the thing out of committee even over [Sen. Edward] Kennedy’s objection, which didn’t happen very often with issues that Kennedy took a position on. So it was highly controversial and it moved very fast. … As chairman of the committee, [Kennedy] was not in favor of the bill moving. But he did agree eventually to have hearings on it, and Sen. Hatch basically ran those hearings. … And on the House side, Congressman Bill Richardson was very instrumental in the hearings.

Q: Did the DSHEA negotiations bring about or make apparent CRN’s capabilities?

Dickinson: I would say that actually DSHEA was a time when, at the insistence of Hatch and Harkin and their staff, the industry worked together. …Not for the first time, but we got the message loud and clear that we weren’t supposed to be off doing our own thing; that we were all supposed to be pointed at the same direction; and that whatever conflicts might exist among companies … had to take second place.

Q: Some argue that the way DSHEA structured FDA’s regulation of supplement manufacturing enables companies that do not intend to comply with the rules to market and sell products.

Dickinson: No, because DSHEA, as well as the Food, Drug & Cosmetic Act generally, requires that everything that a company puts on the label or that it says about the product must be truthful and not misleading, and that the product must meet the quality standards that it is expected to meet. So there’s nothing in the act that permits a company not to do those things. It is an attitude of risk-taking on the part of a handful of outlier companies, combined with FDA’s inability to be everywhere at once, and to enforce against those kinds of actions that still allow those things to exist.

Mister: One of the things that we see as we look back over the history of the regulation is that in the years immediately following the passage of DSHEA there just was not a lot of activity by FDA to enforce it. Now I think that has changed dramatically. … We have seen a much more robust FDA and a willingness to issue warning letters and to do all of these inspections and things.

But in the mid, late ’90s, after DSHEA, which was during the period of the great explosion of new companies coming into the market, there was certainly a framework for regulation that FDA wasn’t doing a whole lot to enforce. So you did have this sense that companies could come into the industry, for good or for bad. There were very low entry barriers, and not a lot of regulation of companies in terms of actual enforcement activity.

Dickinson: Let me say that there had not been that activity before, either. It isn’t that DSHEA created a situation where there was little regulatory activity, so much as there had never been a lot of regulatory activity, except focused on this standard of identity, for example. It wasn’t a gap that suddenly opened up. It was a gap that had existed for a long time.

Q: In which areas would you say the industry perhaps is not seen favorably by consumers or by Congress?

Mister: I think the problem that the industry wrestles with, and they have wrestled with this for years, is this notion that the majority of the industry, which is mainstream, really wants to provide consumers with something that improves their life, gives them better health. Then you have the outliers. And whether it was the folks that were selling much higher doses of ephedrine back in the late 1990s, higher than they could justify safety-wise, or it’s the people that we have now that are spiking products with analogs of prescription drugs, you have this small minority of companies that, for our critics, they define the industry, as opposed to the majority of the industry which really is trying to do the right thing.

You even see that in the area of these warning letters on GMP. There are certainly a number of them, you can’t deny that. But that does not represent the majority of the products in the marketplace. But yet, when you look at those warning letters, it’s very concerning that there are companies out there that, to this day, are not testing their incoming ingredients, and they’re not testing their finished products to the specifications that they’re supposed to.

So you kind of have this tale of two different industries. And that’s the negative for the industry, is that this minority has the potential to define who we are instead of the majority of the industry defining what is the dietary supplement marketplace.

Q: What can CRN do about that?

Mister: One of the things we can continue to do is we can highlight the differences between the good guys and the bad guys. We can continue to talk to consumers about their role in supporting good companies, being savvy about the purchases they make, looking for brands and labels that they know and trust.

All the things that we say to consumers [about] not succumbing to claims that are too good to be true. Because we have this mouthpiece for consumers, we have the ability to remind them on behalf of the industry how to be smart purchasers of these products.

Dickinson: Also, all the work that we put into initially drafting and then working through a period of 10 years on the good manufacturing practices, was an effort to give FDA the tools, and give the industry the tools that they needed to evaluate whether a company was performing up to scratch. Although as Steve said, there are companies who still aren’t there, the vast majority of the companies and of the bulk of the products produced in the industry are abiding by those. We supported, conceptually and on paper in terms of real work put into the effort, the existence of strong GMPs.

Q: Which areas of CRN’s work would you consider the strongest?

Mister: I think one of the things that has really been the hallmark of CRN’s 40 years has been the integrity with which we address the science. Because even our critics, even the people that we battle with on Capitol Hill, even the people that disagree with us sometimes in the consumer press, I think for the most part they respect the fact that we are true to the science. We’re not going to go out on a limb if that’s not where the research is. We’re not going to take positions that are politically expedient or convenient for the industry if we don’t think that the nutrition science backs that up.

That has given us a level of credibility even with the people who are very critical of the industry, that allows us to continue to have these conversations and advance our policy agendas. Because they can’t just write us off as being, that’s just the industry talking.

Q: Areas where you would d like to get stronger?

Mister: Well, I think if we had more resources, we’d certainly like to increase our consumer presence. I think we’d like to do more conversations with consumers about using products responsibly, being savvy purchasers.

At the other end, if we had more resources, I think we’d like to do a lot more actually initiating and sponsoring additional science and research. Because we are a trade association, we can be a hub of the industry where companies who have common concerns can come together to investigate particular issues. But that takes more resources than we have now.

Q: What would you say was the most important thing CRN did for the industry at the start, and does today?

Dickinson: I think the most important thing at the start was what it was founded to do, which was to pursue legal action against the regulations that FDA had finalized. … CRN was not the only one. There were 16 companies or organizations that filed suit against the regulations, and those were all consolidated in a single court case.

The second most important action at the beginning was to get legislation that would confirm what eventually became the court’s decision, and also prevent FDA from having that kind of restrictive standard of identity in the future.

I guess the most important things today continue to be to keep Congress involved about our issues and to keep developing congressional supporters who understand our issues. But at the same time, to work with the agencies, with FDA, with FTC, with CPSC, with whoever else gets involved in our issues, including some of the states. California, of course, is very active on regulatory issues, and we have a number of activities that we monitor at the state level.

Q: How has CRN changed since the start?

Dickinson: The obvious thing that’s changed is that it’s grown in membership, and it’s also grown in staff. Those two things together have allowed it to do many more things than what we were able to do in the beginning with just a skeleton staff and with some companies that put in a lot of time and effort. We still have companies that put in a lot of time and effort on CRN’s committees and the board and other activities, but in the beginning, that’s really all we had. So it has been a really wonderful thing to see how CRN has grown and has been able to bring on additional staff and expertise.

CRN At 40 Years: Pre-DSHEA To Supplement GMPs And NDI Notifications

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