You might say I was an accidental Senate staffer. It was the early 1990s. My job tenure had dwindled to nine months’ duration. Not good.
Working on the House Appropriations Committee was a dream job. But it was cut short when my boss, Silvio O. Conte, a ranking Republican (from Massachusetts) on the House Appropriations Committee, suddenly died.
Returning to the U.S. Department of Health and Human Services (HHS) as a Deputy Assistant Secretary didn’t work so well, either. President George H. W. Bush lost his re-election, and I lost my job.
As luck would have it, on January 21, 1993—the day after President Bill Clinton’s inauguration—I started a new volunteer job at Republican Sen. Orrin Hatch’s office. I didn’t have a desk. I didn’t have a paycheck. What I did have was a fantastic opportunity to be a part of history-in-the-making, learning the legislative process from a world-class master who never stopped his relentless effort to get the job done. And with the Dietary Supplement Health and Education Act of 1994 (DSHEA), Hatch got the job done.
The climate for supplement regulation in the early 1990s was built on decades of foment. A national dialog on health care was well underway with the Clintons’ Health Security Act. Hatch played a key role: he was one of the few members who sat on the two committees with jurisdiction over health care. He was a voice to be heard.
Numerous studies documented the benefits of supplements and their growing consumer use. And Hatch’s home state of Utah was a key part of this dialog, not only because of the numerous dietary supplement companies there, but because of a more libertarian, Sagebrush philosophy that resented unnecessary FDA intrusion.
Step-by-step, Hatch, stalwart advocate Sen. Tom Harkin (D-Iowa) and Rep. Bill Richardson (D-New Mexico) successfully convinced most of their colleagues on the relevant committees, and then in the House and Senate, that FDA had been heavy-handed with supplements for over three decades:
- In 1962, FDA set minimum/maximum levels for dietary supplements, and then withdrew them.
- From 1966 to 1973, FDA proposed regulations on labeling/content. One effort to classify vitamins with more than 150% recommended dietary allowance (RDA) as over-the-counter (OTC) drugs had to be overturned in Congress by Sen. William Proxmire (D-Wisconsin).
- In 1980, FDA again tried to place potency limits on vitamins/minerals, and it was withdrawn.
- 1993 was a low water mark. Two unanimous federal appeals court decisions rejected FDA’s attempts to ban black currant oil through a “food additive theory.” The oil was the additive and the food–the gelcap! One court called FDA’s theory “nonsensical,” while the other described the agency’s approach as “Alice in Wonderland.”
- Also in 1993, FDA issued the infamous “Dykstra Report,” which recommended “improvements” to FDA’s regulatory program for dietary supplements. After a huge public outcry, it was withdrawn legislatively by DSHEA.
- Finally, in July 1993, at a hearing before legendary Rep. Henry Waxman—then chair of the House Health Subcommittee on Energy and Commerce—FDA released a hastily drawn report, “Unsubstantiated Claims and Documented Health Hazards in the Marketplace.” It was so riddled with inaccuracies that Hatch rebutted it with his own staff report—“False and Misleading”—released at a Senate hearing with FDA Commissioner David Kessler, a former Hatch staffer.
A grassroots fear of FDA was growing. Health food stores led campaigns, consumers signed petitions to Congress, Mel Gibson starred in commercials and FDA raided Jonathan Wright’s clinic in Washington state. More letters flooded Congress, the United Natural Products Alliance (UNPA) said, than any time after the Vietnam War. This stirred up action and made a climate ripe for change.
Even so, change didn’t come quickly. DSHEA was introduced in the House and Senate on April 7, 1993. In July, Henry Waxman (D-California) held his hearing. By October, Harkin and Hatch had convinced Sen. Ted Kennedy (D-Massachusetts, normally an ally of FDA) to hold a hearing. Kennedy chaired what is now known as the Committee on Health, Education, Labor and Pensions, which exercises jurisdiction over health care.
It wasn’t until May 11, 1994 that Kennedy’s committee acted on the bill. The legislation was made significantly stronger with Harkin’s additions, such as inserting the “truthful and not misleading” standard for claims.
Hounded by Hatch, yet fearful of Waxman who opposed the bill, Kennedy relented and held a markup on May 11, 1994. Kennedy’s substitute was rejected with few votes. They say it was his first defeat in the committee he chaired, and Hatch/Harkin’s substitute was supported by Democrats and Republicans alike. In August, the Senate approved the revised bill by unanimous consent. And then it sat.
Finally, the day before Congress adjourned in 1994, Waxman signaled he would agree to the Senate position. A hastily called meeting on Oct. 7 in Richardson’s Capitol Whip Office led to a final agreement. It was there that structure/function claims for dietary supplements were solidified. And Waxman added the labeling disclaimer that FDA had not evaluated the product. Because of the concern of Rep. John Dingell (D-Michigan), who chaired the House Committee on Energy and Commerce, the “imminent hazard” standard was added.
Waxman called the bill up in the House at 2:49 a.m. It was approved by unanimous consent, and the Senate agreed to the House action later in the day—again by unanimous consent.
This history might be useful for those who advocate for changes to DSHEA, which has now withstood a quarter century’s test of time with little modification. Strong public outcry, documented government overreach, a motivated grassroots effort and two experienced, committed, well-respected and proven-effective congressional leaders who forged a bipartisan effort all led to enactment of this law.
Do I have regrets? Sure. I’ve never been happy we didn’t have the time to establish a system to codify old dietary ingredient (ODI) status. It would have been great to put more details around the new dietary ingredient (NDI) notification process and motivate FDA to implement cGMPs (current good manufacturing practices) faster than a decade.
Questions over DSHEA persist to this day. Relevant to the current debate on CBD, are there ways the drug/supplement “who’s on first” (investigational new drug [IND]) provision could work better? And how do we rectify industry’s ability to innovate current products for consumers with the “chemically altered” language in the statute?
On balance, though, DSHEA worked well for all. American consumers have been granted wide access to products that make them healthier. The dietary supplement industry has grown so large that many new executives are not even aware of the history described above.
Patricia Knight is a senior political advisor to the United Natural Products Alliance (UNPA), an international association in Salt Lake City representing dietary supplement companies.