Jack Martin became one of the principal lobbyists for the dietary supplements industry after a stint with FDA and as a staff member for Senator Orrin Hatch. As one of the people actually involved in the passage of DSHEA, and still representing our interests on Capital Hill, his recollections of the past and his advice on the present and future are singularly well informed.
1. How long have you worked on behalf of the supplements industry and in what capacities?
Most people who are raised in Utah are familiar with the supplement industry. It is a large and important part of the Utah economy. During college I became friends with Ken Murdock (former owner of Nature’s Way) while working in student government. Ken left school to attend to his family business, which he built into one of the supplement industry’s premier companies. Ken later played a key role in the passage of DSHEA.
In 1978 I went to work for Sen. Orrin Hatch as his Utah press contact. During the six years that I worked for the Senator I became more familiar with the industry and the role it plays in helping to keep people healthy. I also saw the great affection that the Senator has for the industry and the people in it.
I left the Hatch staff in 1985 to work for President Reagan at the Food and Drug Administration. While at FDA I learned a great deal about the industry and the way the agency regulates it. During my seven years at FDA, new legislation passed by Congress changed the way the agency could regulate the supplement industry, probably the most notable being the Nutrition Labeling and Education Act (NLEA). The regulations being written by the agency would have essentially taken away the ability of the industry to let the public know about the benefits of its products. This was one of the rallying points for the industry to pass DSHEA. At that time, the agency was going after the industry using the food additive clause. It seemed that NLEA would have given FDA a new approach to regulating the supplement industry.
During my tenure at the agency, I had the opportunity to meet with Ken Murdock and Loren Israelsen and others from the industry. Most of the concern of the industry at that time was the way the agency was regulating the industry.
I left FDA in 1992 to join the lobbying firm of Parry & Romani Associates. The first issue I worked was to work with the staff of Sen. Hatch to get legislation introduced to protect the supplement industry from over-regulation by the FDA. We were working on behalf of Utah Natural Products Association. While at Parry & Romani I also represented Nature’s Way, Twin Lab and NNFA.
In 2002 I became partner in the Firm of Walker, Martin & Hatch, LLC. We currently represent the Natural Products Association (formerly NNFA), one of our first clients, and The Coalition to Preserve DSHEA and continue to work for the supplement industry.
2. What were your roles and responsibilities at FDA?
I worked at FDA from 1985 to 1992. I was a Reagan political appointment as Associate Commissioner for Public Affairs and held that position for four years. The Associate Commissioner for Public Affairs is in charge of all agency interactions with the media, agency publications and the Freedom of Information office. The press office handles in excess of 25,000 press inquiries each year. The Freedom of Information Office receives in excess of 40,000 FOI requests annually, and the publications office is responsible for publishing the FDA Consumer and all public information programs.
Under President George H.W. Bush I was the Special Assistant to the Commissioner for Policy. During this time, I organized the Office of Small Business and Trade Affairs to directly interact with the business side of FDA regulated industries.
3. Is it true that FDA “has it in” for our industry, as some people think?
It seemed to me that the people who worked for the agency were not “after the industry.” The problem was that there were no really definitive regulations that dealt with the industry at that time. FDA had had its regulatory hands tied when it tried to regulate the potency of vitamins and minerals and was told by the passage of the Proxmire Amendments that it could not do that. When I was at the agency, there were still people who remembered that legislative lesson.
Remember, FDA is a regulatory agency and it is much easier to regulate if you write a specific set of regulations to follow. So the supplement industry found itself in a regulatory gray zone as far as some at the agency were concerned. Because of this situation, the agency had to look for ways to enforce what it felt were violations of the FDCA. This led to the use of the food additive clause as a tool the FDA felt it could use to accomplish its mission.
4. How did you come to work on Capitol Hill as a lobbyist?
Every now and then in your professional life you reach a point where it is time to move on. In May of 1992, I was in that situation at the FDA. I had inquiries from several PR firms but I really wanted to do something other than PR after 17 years. I met with Tom Parry and Romano Romani and they invited me to join their firm. They offered me the opportunity to use the things I had learned while working with both Sen. Hatch and the FDA. It was a golden opportunity to expand my horizons, which sounded great to me so I accepted.
After ten years with Tom and Romano I joined Laird Walker and Scott Hatch to start Walker, Martin & Hatch.
5. It seems that the number of people and organizations claiming to have been pivotal in passing DSHEA gets bigger every year. As one of the people actually involved, please talk about the passage of DSHEA including who was REALLY involved, and who REALLY wrote it.
The catalyst for DSHEA was the enforcement activities of FDA and the possible impact of the regulations that were being written for NLEA. As I recall, there was an enormous uproar over the Black Currant Oil action taken by FDA, but I think the final spark was a direct result of the regulations being written for the NLEA. These regs would have made it almost impossible to educate any consumer about the benefits of dietary supplements
Any piece of legislation is written by the Senator who sponsors it. DSHEA was written by Sen. Hatch and his staff, including Trish Knight, who still works with us on the Senator’s behalf. It is important to know that the written construction of any legislation comes after the sponsor(s) meet with stake holders, those with an interest in the legislation, so there was industry input.
After a bill is written, the fun begins; negotiating a final bill. We went through a total legislative process after Sen. Hatch introduced his bill. I found it interesting that parts of the industry told me the day after the bill was introduced that they could not support it. They felt they had been excluded from the process and had been working on their own bill. There were actually people who said they would oppose the legislation. One segment of the industry said that even with all that was going on at FDA which would have seriously hampered the ability to communicate product benefits, no legislation was necessary!
Despite all the industry bickering, Sen. Hatch and his staff pressed forward with the legislation. We had a lot of work to do in a short time, as we were in the last half of the second year of the Congressional session and the NLEA regulations were due. We had to pass something. Sen. Hatch convened industry in his office and laid out the path for success.
Trish and Sen. Hatch and everybody put together a little bill that actually exempted the dietary supplements industry from the NLEA. It passed at something like 5 AM after Trish literally walked it to the House. This bought us time to get the legislation that was ultimately DSHEA written and passed.
When the next Congress convened we started the process over again and there were a lot of industry people involved, including trade associations and supplement companies. National Nutritional Food Association (now Natural Products Association), Utah Natural Products Alliance (now United Natural Products Alliance), Council for Responsible Nutrition and other groups like the National Health Alliance met almost daily. Some of the associations came in kicking and screaming. Since some had said they would not support the bill, they were afraid that if they did not participate, they obviously would have no say in the final product.
When the bill was first introduced, I contacted the then Executive Director of the NNFA to invite the association to participate in helping push the bill through Congress. I was told “NNFA did not do Washington.” Fortunately, Ken Murdock, Loren Israelsen and others made sure that NNFA became an integral part of the lobbying effort along with UNPA, CRN and NHA. The associations provided both legal and lobbying expertise to work on the legislation.
The first major problem we had was that too many people wanted to be involved and run the process. At one of the early meeting we had about 50 people. We had to trim the numbers to include mainly the trade associations and some of the companies that were funding the effort. Even with fewer numbers, it was still a problem keeping on task as a group without someone or some group trying to cut a deal without the others being involved. Patricia Knight, who was the point person for Sen. Hatch, said it was like “herding cats” trying to keep people on target.
As the bill picked up momentum, it required legal input from all the associations as points were negotiated. The legal players were Scott Bass, NNFA; Loren Israelsen, UNPA; Steve McNamara, UNPA; Kevin McGuiness, NNFA; and Tony Young, with help from others like Gene Lambert. I remember this group because we were on the hill almost every night.
Ken Murdock, Hal Drexler, Jerry Kessler, Jim Beck along with Tree of Life, Twin Labs, Weider and many other companies spent a lot of money to cover legal, lobbying, PR and grass roots efforts to help pass the legislation. Without people of vision like Ken Murdock and others who were willing to spend both time and a lot of money to pass this legislation, the industry as we know it would not exist.
Marty Whittikin, who was President of NNFA at that time, spent a great amount of time in Washington, which meant that her business suffered. When NNFA hired Michael Ford as Executive Director, some of the pressure Marty was experiencing was removed, although she still spent a lot of time in DC.
During the DSHEA battle, the industry put together a grass roots effort that kept pressure on Congress to support the bill. Alexander Schauss put together the grass roots group Citizens for Health, which sent a lot of letters to members of Congress asking them to support the bill. Since more than 100 million people were taking supplements everyday, the grass roots group had a lot of people in every state to mobilize.
Most of the retail stores around the country sponsored petitions under the “Save Our Supplements” grass roots campaign. They also provided information to customers regarding the progress of the bill. Everyone who entered a health food store was encouraged to contact their Senators and Congressman to ask them to support the industry.
Jerry Kessler’s lobbyists worked closely with Cong. Richardson, who also sponsored legislation in the House. Since that legislation was different from the Hatch version, we actually gave away some points during our internal negotiations that we should have let Trish Knight handle.
Working with the staffs of the members of Congress consumed an incredible amount of time. Many nights each week we were in the Senate, meeting with Trish and staff from other members.
At the same time, we (the lobbyists) were visiting members of both the House and the Senate to ask them to co-sponsor the bill. As hard as everyone worked, it really pales in comparison to what Sen. Hatch accomplished. The week before Expo East (Baltimore), Sen. Hatch contacted every member of the Senate and picked up about 45 co-sponsors. That was amazing!!! This would never have happened without him.
As we moved the bill along, Sen. Harkin came on-board and really helped to solidify the final effort. The final bill was negotiated in the Nation’s Capitol by Sen. Hatch, Sen. Harkin, Cong. Richardson, Cong. Dingell and Cong. Waxman.
All in all it was a great effort by a great group of people. The industry really should be grateful for the expertise of Bass, McNamara, McGinness, Israelsen and many others. Also people like Ken Murdock, Hal Drexler, Jerry Kessler and a lot of companies put a lot of time and money in this effort. The trade associations were the glue that helped push it over the hill along with the grass roots effort, which at times shut down the faxes and phones of members of Congress. The one negative was that some people were overzealous and actually made threats to Congressional members.
6. Here we are 13 years since the passage of DSHEA. Has it worked the way you envisioned? Where has it failed?
At this point, I would say it is working the way we envisioned, but a lot of the law has yet to be implemented. As you know, the Good Manufacturing Practices document has now been published. I believe this part of DSHEA will give the industry a lot more credibility. It will take from the media its constant misinformed accusation that the industry is not regulated. Also the AER bill should help in this effort. By the way, David Seckman and I were recently at FDA and were told that FDA is on schedule to implement AER’s.
I think that, so far, the biggest test for DSHEA was the ephedra issue. As the controversy continued over several years, it really did not matter if the product was safe or not safe, because the media had convinced the public that ephedra was a dangerous product. When FDA finally removed the product from the market, it was obviously in the best interests of the industry. Now the controversy is “Did FDA step outside of DSHEA to remove the product?”
Actually, DSHEA seems to be working well. The products are great and the industry is working with both the Congress and the FDA/HHS regarding legislation and regulation. Trade associations like Natural Products Association, Council for Responsible Nutrition, Consumer Healthcare Products Association, United Natural Products Alliance and American Herbal Products Association all work the Hill.
7. What is most frustrating and most satisfying about passage of the Act?
I am most frustrated about the fact that the FDA has not yet been able to fully implement the law. A lot of this is not the fault of the agency. Congress needs to give FDA enough resources that it can perform its function. It took 13 years to publish GMP regulations. This should have happened much more quickly.
It is satisfying to see the changes in the industry. The amount of growth in the industry is impressive, with a lot of new companies and new products coming in each year. The fact that the industry has a set of laws which oversee it is good for the continued health and growth over the upcoming years.
8. If you were involved in developing the Act today, would you do anything differently?
Hindsight creeps in here: I would try to start with a bi-cameral, by-partisan bill. I would also recommend that we start with a smaller group.
9. From your perspective, how has the industry changed since DSHEA passed?
The industry is totally different in some ways, yet in some ways it is still the same. There used to be only two or four big booths at trade shows, not 40 like today. There are now a lot of new players. A lot of old entrepreneurs have gone, sold their companies, retired or moved to difference industries after taking their companies public. So many of the old players who aren’t around anymore would be excited to see what has happened to the industry they saved from demise in the 90’s. It has grown immensely. There are not as many individual creators; they really added a flavor. When I first went to a trade show I was meeting the people who built this from scratch. It is almost all big companies now. That is the way business evolves. There is definitely a wall-street feel to the industry. Yet there are still a lot of “home owned “companies. This is what makes this industry special.
10. How secure is DSHEA?
In its current form, DSHEA is shaky at best. Since the passage of DSHEA, about 50% of Congress and about 85% of the staff with whom we worked are no longer there. I know that David Seckman, who also put together and runs the Coalition to Preserve DSHEA in addition to being Executive Director/CEO of NPA, spends a lot of time every week educating members of congress and their staff.
The Coalition to Preserve DSHEA’s purpose is to fund lobbying efforts, and grassroots and communications campaigns in Washington to make sure the industry can be defended. These all cost money and the industry really can’t afford not to have this protection working in Washington. CRN, CHPA, UNPA, and AHPA all participate in this coalition. The industry really needed this. With his extensive background in Washington politics Seckman has helped build up the industry image in Washington. His leadership has taken us to a whole new level, and just in time, too.
We have Cong. Dingle and Waxman and Sen. Durbin who would like to see this industry much more heavily regulated and who are going to take action. Sen. Durbin has recently restated his belief that supplements should have pre-market safety testing. Cong. Dingell and Cong. Waxman have both stated that they want to get DSHEA changed or get rid of it completely.
Those Congressmen have written letters to GAO, FDA and FTC that lay out a roadmap of where they are heading in terms of more heavily regulating this industry. They want a lot more drug-like regulation. A strategy we see them starting to use is to segment the industry by saying that vitamins are safe but the rest of the products need testing, for example.
Every day there is new legislation. There is a whole bunch of legislation that can have direct or indirect impact on us. We need constant vigilance to watch what is going on in Washington. We also are working to have more champions to help Hatch, Harkin and the others that fight our battle for us.
This is a never-ending process and must be done to preserve the way the industry does business. More people and businesses need to get on board and join the coalition so we can continue to fight the industry’s battles. If we let up, we will eventually lose DSHEA.
11. What do you think the supplements industry needs to do differently?
It is disappointing to see how little support the trade associations receive from industry companies to fund the continuing legislative efforts. And not nearly enough people donate to the campaigns of our champions. It is extremely important that people realize they need to support the members of Congress who stand up for them in Congress. This means contributing to their campaigns. That is just the way it is in Washington. When the head of your trade association calls and asks you to attend a fundraiser for one of our industry champions and bring a check, you are short-sighted not to invest in your future and do it.
When DSHEA passed a lot of people seemed to think “we won, let’s go home.” And they DID go home. Some of them never came back. Washington does not work that way. You can never leave the political fight. I have heard Sen. Hatch say “if you don’t participate in the political process, then the political process will take your business.” It is obvious by the amount of legislation that has been introduced since DSHEA passed. We have been fortunate to remain unchanged so far. The thanks should go to the industry champions like Sen. Hatch, Sen. Harkin, Cong. Cannon, Cong. Pallone, Cong. Burton and others.
For this industry to survive we have to become more involved not only by visiting our Congressional delegations but by contributing. It costs a lot of money in Washington to keep your freedom. It takes a lot of money to win a legislative issue. Anyone who cares about the future of the industry should be funding these efforts.