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 legislators—the 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 that’s 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 don’t 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.
