In October 1994, Congress passed the Dietary Supplement Health & Education Act (DSHEA), creating a definition and regulatory paradigm specific to dietary supplements. Lobbying efforts, retail blackout days, consumer letters to legislatorsthe industry pulled together in hopes of protecting consumers right to choose safe, efficacious dietary supplements, and saw a boom of business as the impact of DSHEA took effect.
Recognizing the 15th anniversary of this event, Natural Products INSIDER is asking industry insiders to share their recollections of the events leading up to the passage of DSHEA, as well as their insights on where the dietary supplement industry is headed.
This month, Loren Israelsen, executive director of the United Natural Products Alliance (UNPA.com), shares his thoughts.
INSIDER : Why was DSHEA a priority for the industry and consumers in the early 1990s?
Loren Israelsen: It is cliché, but true. You had to be there to understand it. The depth and intensity of mutual distrust and antipathy between FDA and the dietary supplement industry was palpable. There were several triggers that preceded DSHEA and, to a large degree, crystallized the need for DSHEA. These included an armed raid on the clinic of Jonathan Wright in Washington State. The issue was vitamin B injections. Imagine a SWAT team breaking down the front door of a little clinic in flak jackets and guns, telling patients to hit the floor. Then there was the notorious FDA supplement task force report, nicknamed the Dykstra Report, which suggested, if not stated, that amino acids, botanicals and most other non-nutrients should be drugs or food additives. That did not go down well. Raids on companies selling such things as black currant oil, evening primrose oil, stevia, etc., were seen as nothing short of totalitarianism. The big one, however, was a regulation that came out of the Nutrition Labeling and Education Act (NLEA), which passed in 1990, that would have essentially banned all benefit/health claims except those approved and petition by FDA. In other words, we would have been out of the claims business altogether. In the early 1990s, it seemed clear to many of us that something had to be done, or we were on the road to extinction.
INSIDER : Has DSHEA accomplished what you had hoped?
Israelsen: To a large degree, yes. The definition of dietary ingredient in Section 201 is huge. It is expansive by design and remains a central pillar of DSHEA and unique in the world. GMPs (good manufacturing practices) are now becoming a reality; this is something we badly wanted. We cannot consider DSHEA implemented and effective unless we have an active, regulatory partner that is both competent and willing to enforce DSHEA in a disciplined but practical manner. What I am seeing now suggests this is happening.
The other key provisions of DSHEA, i.e., the new dietary ingredient (NDI) process and structure/function claims, have worked out pretty well. In hindsight, I can now see a more elegant way to design these procedures, but thats life. The one thing we really missed was the power of the Internet and how that would change everything. Remember DSHEA passed just as the Internet was beginning to reveal itself as a force. Again, I dont know how we could have taken the Web into account in drafting DSHEA. In the end, it was a question of timing. For me, the central and abiding accomplishment of DSHEA is that it reestablished the populist movement for natural self care in this country and gave birth to a new generation of leaders and visionaries. In short, DSHEA helped us reconnect to our heritage and traditions.
INSIDER : What have been DSHEAs greatest successes, and in what areas has it fallen short by the greatest degree?
Israelsen: Preserving access to ingredients and products is clearly the greatest success. This could only be done if supplements remain a class of foodsnot drugs, not food additives. That seems simple enough, unless you are trying to sell Congress on that idea, and this remains a unique feature of DSHEA, seen nowhere else in the world. I think GMPs will turn out to be a big success. Painful, yes, but an essential and necessary step for this industry to mature and strengthen its relationship to consumers. For me, the most enduring success of DSHEA was the skill and craftsmanship with which it was drafted. Technically, it has an elegance and robustness you seldom see in important legislation of this kind. Much of this is due to a small group of lawyers including Scott Bass, Peter Barton Hutt, Tony Young, Kevin McGuiness and, in particular. the exceptional work of Steve McNamara, one of the finest food and drug lawyers ever. We had the varsity team on the field.
Where have we fallen short? I have three principal disappointments:
Product Quality: Commitment to quality. There is way too much lip service and way too little willingness to pay for quality or invest in quality. Unfortunately this is happening because many seem to hold the view that DSHEA gave them a free pass of some kind. This is an area that I will personally be working on.
Intellectual Property (IP) Incentives: We just could not figure out a way to build in IP incentives. This remains a problem.
Research Focus at the Office of Dietary Supplements (ODS): I really wish we could have found a way to be more specific about the kind of research that would be done by ODS and collaborating centers at the National Institutes of Health (NIH). I have been disheartened to see major studies on dietary supplements fail that need not have failed had there been clearer cooperation and guidance between industry and academia.
INSIDER : What are the current threats to DSHEA, and what opportunities lay ahead because of this?
Israelsen: I see four principal threats:
Politics. There is a powerful group of Congressional leaders that want to settle an old score. In political battles, there are always winners and losers. We were winners in 1994. The losers are still looking for a winand, they are now in positions of power to do something about it.
Renegade Players. We have been very lucky not to have a melamine meltdown or a peanut implosion inside the supplement industry. Renegade players pose a direct threat to DSHEA. If something serious were to happen, all bets are off. I could not predict an outcome that would be positive for the industry.
Industry Executive Indifference. There are too few industry executives who see it as part of their high position to invest in the industry infrastructure or to invest their personal time to create a sustainable community of suppliers, manufacturers, publishers, retailers, researchersall of which are needed for our industry to meet the challenges and opportunities of the next generation.
Spiking. Is it unconscionable and intolerable that anybody would intentionally spike our products with drugs, synthetic chemicals, steroids or agents to fake lab tests, deceive customers and put consumers at risk.
INSIDER : What would DSHEA look like now if we knew then what we know now?
Israelsen: It would look remarkably similar. There are a few things I would have done differently. First, mandate a hard deadline for a GMP regulation.
Next, create an IP mechanism to encourage research, exclusivity and an adequate return on investment. In hindsight, we should have added a provision prohibiting the use of proprietary science and research as the basis for substantiation of a product that was not the subject of those studies. It would also have been helpful to have a more clear definition of what a new dietary ingredient is. The problem was that we were simply running out of time and didnt have the means to talk this one through and reach consensus on a clearer and more comprehensive definition.
Finally, knowing what we know now, we should have mandated that ODS allocate a substantial part of its budget toward analytical method development, authenticating reference materials and providing the analytical tools that the industry so badly needs. ODS has done a good job in the past five years of advancing this agenda. We should have mandated this be done right from day one.
Having said this, DSHEA remains a remarkable piece of legislation, both from a technical drafting perspective as well as a document expressing the will of the people and preserving what many see as a fundamental right, which is access to products in support of their own health. In this respect, DSHEA may never be surpassed.
Editors Note: Look for more on DSHEA @ 15 on NaturalProductsINSIDER.com and in the Nov. 4, 2009, issue of INSIDER. We also welcome your comments on the topic; e-mail Heather Granato, Group Editor, [email protected]
Want to hear more about the passage of the Dietary Supplement Health & Education Act (DSHEA) and the future of the dietary supplement industry? Join Loren Israselsen for the session DSHEA: 15 Years Later on Nov. 13, 2009, at SupplySide West. Get more details at SupplySideShow.com/West.