Written and compiled by the UNPA staff
[Photo of Bill Clinton signing DSHEA]
After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.
— President Bill Clinton, upon signing the Dietary Supplement Health and Education Act into law, Oct. 25, 1994
In 1993 and 1994, there was a growing, national dialog about improving healthcare, so from both political and consumer perspectives, healthcare was a topic of increasing importance. President Bill Clinton had recently taken office, and he put First Lady Hillary Clinton in charge of his healthcare task force to address reform. This ultimately led to the proposed Health Security Act (HSA).
Sen. Orrin Hatch, R-Utah, was a key voice on health issues as one of the few Senate members who sat on both the Labor Committee and the Finance Committee; these two committees have jurisdiction over all healthcare programs. Hatch was a leading critic of the HSA, and as a former chair of the Labor Committee, he was recognized by his colleagues for his public health acumen. By August of 1994, the Utah senator and his Republican colleagues had driven a stake in the heart of the Clintons’ effort.
At the same time, however, in the minds of consumers, dietary supplements were strongly linked to the concepts of improving healthcare and taking personal control of one’s own health to stay healthy longer and potentially avoid the onset of chronic disease and the side effects of pharmaceuticals. Statistics at the time indicated that at least 100 million Americans regularly used vitamins and minerals to improve diet and health. There was also increasing scientific studies appearing about the benefits of dietary supplements.
In addition, there was a growing awareness by many consumers, those in the industry and then Congress, that the Food and Drug Administration (FDA), the government agency that has regulatory jurisdiction over the vast majority of consumer products, including dietary supplements, had been heavy-handed with its regulatory approach to supplements for more than three decades.
This contributed to a growing grassroots fear of FDA overaction and prompted media campaigns and petitions in health food stores across the country. One public service announcement featured well-known actor Mel Gibson and called attention to troubling events, such as the armed FDA raid on Dr. Jonathan Wright’s medical clinic in Washington state.
The efforts of consumer groups and industry to bring these concerns to the attention of Congress paid off. Legend has it Congress received more correspondence about maintaining access to dietary supplements than at any other time except for letters regarding the Vietnam War.
1962: FDA set minimum/maximum levels for dietary supplements, but the proposal was withdrawn.
1980: FDA again tried to place potency limits on vitamins and minerals, but the proposal was withdrawn.
1990: Congress enacted the Nutrition Labeling and Education Act, giving FDA the authority to approve disease prevention claims for foods, including dietary supplements. The passage of the act prompted FDA Commissioner David Kessler, M.D., to try to regain what he felt was regulatory ground lost to the supplement industry. His ongoing policy was a key factor in mobilizing the grassroots efforts to maintain supplement access and led to passage of DSHEA.
1991: FDA proposed regulation stating that herbs are not eligible for health claims because they are not nutrients.
1992: Sen. Orrin Hatch, R-Utah, introduced a one-page bill that would permit claims for supplements with no safety requirements. This legislation became the Health Freedom Act of 1992, which later served as a placeholder to keep FDA at bay until DSHEA passed. Hatch also authored a provision, enacted as Title II of the first Prescription Drug User Fee Act, to delay bringing dietary supplements into the NLEA regulatory scheme Congress had set for foods.
1993: FDA Commissioner Kessler announced he would pursue action against any dietary ingredients—including botanicals—other than essential vitamins and minerals, calling them illegal food additives. However, that year, two unanimous Federal Appeals Court decisions strongly rejected FDA’s attempt to ban black current oil through Kessler’s “food additive theory.”
The Dietary Supplement Health and Education Act of 1994 (DSHEA) passed because the climate was right. It passed twice in the Senate by unanimous consent and once in the House by unanimous consent.
The Clinton administration’s emphasis on healthcare reform helped to bring the issue of access to supplements into the limelight, which was quickly recognized as a non-partisan issue for consumers. It was seen as a matter of fairness and of allowing the American public access to safe dietary supplements and information about their benefits. These strongly held public beliefs prompted unprecedented grassroots support leading up to DSHEA. The mail from consumers concerned about losing access to supplements was crushing, according to congressional staff members who worked on Capitol Hill at the time. Nearly all consumers that shopped at a health food store were asked to sign a petition to Congress in support of DSHEA.
Perhaps as a result of this widespread consumer concern, the passage of DSHEA could be considered a study in bipartisan politics. Sen. Orrin Hatch, R-Utah, working with Sen. Tom Harkin, D-Iowa, and lead House sponsor Bill Richardson, D-N.M., were successful in showing other members of Congress that FDA was out of control in its bias against dietary supplements. Sponsor by sponsor, Hatch grew the roster of cosponsors for the bill, working closely with Richardson, until ultimately, a majority of the House and Senate committees of jurisdiction, and the House and Senate themselves, agreed that FDA lacked a clear regulatory system for supplements and, as such, cosponsored DSHEA.
The initiative was clearly bipartisan from the beginning because the central authors realized that with a Democratic Senate, House and president, the only chance of enactment was through a bill that was solidly represented on both sides of the aisle.
In the end, the key to speedy passage of the final bill may be that it was negotiated directly by the principals, working off the Hatch draft. Reps. Henry Waxman, D-Calif., John Dingell, D-Mich., along with Richardson, Hatch and Harkin were all there at the table in Richardson’s Capitol Hill office on the very last day of Congress in 1994. As Hatch had predicted, it came down to the wire. Chairman Waxman in the House brought up the final bill, and Hatch brought up the bill in the Senate.
Passage of DSHEA was both a legislative victory for Hatch, Harkin and Richardson, but more importantly, it was a tremendous win for consumers. The solid support for it was indicated by the fact that the bill passed by unanimous consent in both the House and Senate. And the solidness of the compromise negotiated is indicated by history, with relatively few problems over the last two-plus decades and no major amendment or legislative challenge to its structure in more than 20 years.