October 26, 2009
In recognition of the 15th anniversary since the passage of DSHEA, INSIDER spoke to several people who had a hand in some part of DSHEAs creation and/or passage. Patricia Knight is the founder of Knight Capital Consulting LLC and former chief of staff for Sen. Orrin Hatch (R-Utah), one of the main supporters of dietary supplement industry causes. She was instrumental in the development and passage of DSHEA. Peter Reinecke is a principal at Reinecke Strategic Solutions and former chief of staff for Sen. Tom Harkin (D-Iowa), another industry advocate. He has a background in health policy and helped write and promote DHSEA in Congress.
INSIDER: While the passage of DSHEA 15 years ago likely feels like a long time ago, can you still recall all the excitement surrounding its passage?
Patricia Knight : You know, 1994 seems like both yesterday and a hundred years ago. I had just joined Sen. Hatchs staff in 1993 when I was assigned to this bill. It was the first major legislation I handled for him, and in many ways it established the friendship and admiration that Sen. Hatch and I enjoy to this day. Many of the people I worked with on this legislation are close friends and advisors even now, including some of the legends who worked on this bill: Peter Reinecke, Loren Israelsen, Scott Bass, Kay Holcombe, Bill Schultz, Mark Childress, Kevin McGuiness, Jack Martin, Steve McNamara to name just a few.
Peter Reinecke : In terms of DSHEA, while weve seen some recent improvements in its implementationwith inspections underway for the new GMPs (good manufacturing practices) and some stepped up enforcement of clear violationsit is really still a law in its adolescence. It has not reached a mature state of being fully implemented and enforced. Dietary supplement consumers and industry would benefit from the full implementation and enforcement of DSHEA.
INSIDER: How did Senators Hatch and Harkin come to be involved in this fight?
Knight : Sen. Hatch had a long interest in supplement issues for two main reasons. First, he represents a state that has the largest concentration of dietary supplement manufacturers in the country, over a hundred in Utah I believe. And second, he has a tremendous interest in personal fitness and healthy lifestyles, and it is a commitment he takes very seriously.
Reinecke : Sen. Harkin also has a great commitment to good health, especially health promotion and disease prevention efforts. That is a key focus of his work on health care reform and it has really shaped the direction of the current effort in the Senate. He believes a key to changing our current sick care system is to make sure people have tools they need to keep healthy through good diet, exercise, reduced stress and appropriate use of supplements.
INSIDER: What was the motivation for the bill?
Reinecke : It was clear there was a need for a law to protect consumers access to supplements and to provide FDA the authority to appropriately regulate these products. FDA was misusing the authority it had at the time to unfairly target healthful products. One great example of that was black currant oil; this is oil from the same fruit they use to make jelly. FDA actually went to court and argued that the oil was a food additive, added to the gelatin cap, the food.
Knight : Yes, when Senators Harkin and Hatch documented it for Committee members, it was very persuasive.
INSIDER: It was quite a bumpy road that led to enactment of DSHEA. Can you describe some of the highlights?
Knight : It was really a multi-year effort. In 1992, Sen. Hatch sponsored the Health Freedom Act, which was really the beginning of the legislative path. Although that bill wasnt enacted, Sen. Hatch did get a provision enacted as part of the new prescription drug user fee bill in 1992. The provisionthe Dietary Supplement Actblocked FDA from applying to supplements the new rules for health claims for foods.
Reinecke : Sen. Harkin got very active in 1994. He and Sen. Hatch pushed hard for the Labor Committee and its chairman, Sen. Ted Kennedy, to begin action on the legislation.
Knight : We knew Rep. Henry Waxman was pressuring Sen. Kennedy not to move the bill. But our two bosses really kept up the effort. After much persuasion, they won a commitment from Kennedy to hold a hearing on the bill, and later a markup.
Reinecke : That hearing really opened up Committee members eyes about how FDA was acting. Ill remember at one point FDA Commissioner David Kessler held up a supplement bottle and read a claim that was clearly illegal. And Sen. Hatch said, well, Commissioner, why are you telling us? Why dont you take it off the market?
Knight : Ill never forget the Labor Committee markup of DSHEA. It was a decisive victory for our bill. I might add the bill had been significantly improved the night before when Peter proposed a number of strengthening changes that Sen. Harkin wanted. Those changes, such as using the false and misleading standard to judge labeling, really shored up our support in the Committee.
Reinecke : We were then able to get the bill passed by unanimous consent in the Senate.
Knight : At the same time, despite intensive negotiations between the House and Senate, Rep. Waxman did not want to move the bill.
Reinecke : In the end, though, we were able to negotiate a compromise which Rep. Waxman, Sen. Kennedy and our bosses were able to agree on and the final bill passed by unanimous consent in the House and then the Senate.
Knight : Remember, this was 1994, the year the Clintons Health Security Act was defeated. This is really one of the only health care bills enacted into law then.
INSIDER: How do you feel the statute has withstood the winds of time?
Reinecke : I think weve all been pleased at how the laws basic structure has remained in place, with a few notable changes. But as I said earlier, its full potential has not yet been realized due to failure to fully implement and enforce its provisions.
Knight : There was the adverse event reporting for serious problems that our bosses did in 2006, and the new Drug Enforcement Administration for steroid precursor listing in 2004.
Reinecke : And the requirement in the bioterrorism law that all food manufacturing establishments register with FDA, including supplement manufacturers. But overall, the framework that Sen. Harkin and Sen. Hatch established has worked well.
INSIDER: What do you see as future challenges to the law and to the industry?
Reinecke : In the next 15 months there will likely be well-orchestrated attempts to fundamentally change DSHEA. Rep. Waxman has stated his interest in revisiting the law. And we are clearly seeing in the media a concerted effort by opponents of DSHEA to increase the drumbeat for changes. We need to demonstrate if the law is fully implemented and enforcedwith a renewed commitment from both FDA and industry to that endfundamental changes to the laws structure are unwarranted. We need to be educating members of Congress and their staffs about what DSHEA provides for and we need leadership from industry to demonstrate that it is committed to vigorous self-regulation and appropriate government regulation. In addition, FDA needs more resources to go after clear violations of the law. That is largely a function of budget. Both Sen. Harkin and Sen. Hatch have tried to up the budget for DSHEA enforcement, some years with more success than others. But with the growth of the Internet, and indeed of the industry, it is a job that needs to be done.
Knight : Another issue which has emerged recently is the continued marketing of steroid look-alikes to athletes, especially young athletes. The majority of the industry has reached the conclusion that there may have to be changes in the DEAs scheduling authority so they can act more quickly to take these products off the market.
Reinecke : That certainly was the intent of the 2004 law, and if it isnt working, we all want to make sure it fulfills its purpose. But by and large DSHEA has worked well, and I think we both agree it should not sustain any major modifications. It has really helped consumers who want to pursue healthy lifestyles and that is what we aimed to do 15 years ago.
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