Following many months of industry lobbying and grassroots activism, Congress passed the Dietary Supplement Health and Education Act in late October 1994 and President Clinton signed it into law Nov. 12. The dietary supplements industry, no longer fettered by overzealous U.S. Food and Drug Administration enforcement actions, experienced explosive growth for a handful of years.

Now, on the 10th anniversary of the bill, the industry has come full circle. How did DSHEA pass in the first place, what did its passage mean for the industry and what does the future hold, for the industry and for the often-misunderstood bill that saved it a decade ago?

How FDA lost control

"The predicate to DSHEA was a long, slow burn," said Loren Israelsen, executive director, Utah Natural Products Alliance, based in Salt Lake City. Israelsen worked closely with Sen. Orrin Hatch, R-Utah, and others in Congress in drafting the legislation that, through much give and take, eventually became DSHEA.

"The basic principle of the Health Freedom Act, which was introduced by Sen. Hatch in June 1992, was that supplements aren't food additives, they aren't drugs and they need to be defined," Israelsen said.

FDA thought otherwise. The agency wasn't about to let go of its market preapproval and was willing to go to extreme lengths to show it was in control. "FDA was feeling really aggressive, like they could roll us whenever they wanted to," Israelsen said.

FDA's primary weapon was the argument that all supplements without a defined nutritional value were food additives. "This was an argument that FDA seized on to restrict new supplements on the market," said Marc Ullman of the New York-based law firm Ullman, Shapiro & Ullman. "They were able to keep many herbal formulations from coming to market. You could sell bags of herbs and [customers could] mix them up at home, but you couldn't mix them together in a single product."

FDA undertook a series of enforcement actions that served as a flash point for public outcry against the agency. Some of these enforcements eventually led to judicial defeats for the agency, as the courts figured out how tenuous FDA's arguments were (see sidebar below). But the case that mobilized consumer opinion most against FDA was the Jonathan Wright case.

Wright was a natural physician in Washington who continued to prescribe L-tryptophan to patients after FDA had banned the substance. On May 6, 1992, FDA stormed Wright's clinic with armed sheriffs who terrorized patients and seized vitamins, equipment and medical records. "The raid made no sense," Israelsen said. "There was no rational explanation. People began to think, 'Wow, what are they prepared to do to stop us from using vitamins?'"

The birth of DSHEA

Eventually, in early 1992, industry groups based in Utah came together to figure out how to respond to FDA's actions. Although a legislative fix seemed like a long shot, Israelsen said, "There was a sense that we had nothing to lose by trying this."

The bill was cosponsored in the Senate by Hatch and Sen. Tom Harkin, D-Iowa. Hatch's involvement was based on his Utah constituency and his political beliefs. "He said, 'Here we have another out-of-control federal agency looking to grab power where they don't have it and strip people of choices they should be entitled to make,'" said Ullman. "FDA made itself extremely vulnerable to that kind of critique."

Harkin's involvement might seem less obvious, given that the bill's strongest opponents were other liberal Democrats, including Reps. Henry Waxman of California and John Dingell of Michigan, and Sens. Richard Durbin of Illinois and Edward Kennedy of Massachusetts. But Harkin was a believer; bee pollen had helped him with his allergies when nothing else had. "Harkin was the guy we needed in the Senate because he could carry water to the Democrats," Israelsen said. "He did a masterful job."

As a result of congressional negotiating, the bill eventually had 66 cosponsors in the Senate and 261 in the House—enough that it would pass if it came up for vote. Grassroots activism continued after the bill was introduced, keeping pressure on the Democrats who opposed the bill on the grounds that it rolled back FDA's regulatory power and contained too few safeguards regarding supplements safety.

But as the fall session neared its end, the bill was stuck. It passed the Senate unanimously, but was blocked in the House. Neither Waxman, who chaired the House Subcommittee on Health, nor Dingell, who chaired the commerce committee, seemed to have any intention of letting the bill go to the floor for vote.

Then the miracle happened. "It was really a result of the unforeseen politics of the national election in 1994," said Israelsen. Though the Democrats controlled both House and Senate, polls showed that a number of Democrats were in trouble, and the Democratic leadership didn't want to be the bad guys in the eyes of the millions of consumers who supported the bill. "If they were the ones seen as blocking the bill, they would likely pay for it on Election Day," Israelsen said.

In his memoir Square Peg, Hatch writes about what happened next. "Unwilling to acknowledge defeat, I sent a final letter to Dingell and Waxman outlining what I needed in the bill. To my amazement, they called back later that afternoon and asked to meet. Something had happened."

Over the course of several hours, Hatch, Kennedy, Harkin, Waxman and Dingell hammered out a compromise bill with some new additions to satisfy the safety concerns of the Democratic opponents. For example, the disclaimer on structure/function claims—that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease—was the final piece of the puzzle.

The bill never went through committee and was never voted on, contrary to popular myth. "It went from a zero, a nothing in the House to being a bill flying through by unanimous consent in the middle of the night," Israelsen said. "I think FDA absolutely thought this bill would never pass, and when it did they couldn't believe it."

So, the dietary supplements industry had its bill, much to everyone's surprise. The next question was: What would the industry do with it?

The post-DSHEA world

For a few years after DSHEA passed, the industry experienced incredible growth while FDA, seemingly beaten, did nothing. "When DSHEA passed 'utter liberation!'" said Ullman. "Realistic, utter liberation for the herbal industry and the perception of utter liberation for the rest of the industry." But in retrospect, it seems clear that both the industry and FDA failed to live up to the powers invested in them by DSHEA.

In spite of the fact that DSHEA granted FDA powers it hadn't had before, including the creation of industry standards for good manufacturing practices, and the ability to pull products from the market if it deemed them unsafe, FDA claimed that, because it no longer had market preapproval, the dietary supplements industry was now unregulated. Unfortunately, some in the industry believed this. "This is a regulated industry, and not everybody should be in it," Israelsen said.

"I think the numbers show that DSHEA caused a big bang expansion followed by a contraction," Israelsen said. "The industry has had some clear successes—glucosamine, fish oil. But there have also been some gigantic busts, though each for different reasons—kava, ephedra, ginkgo, St. John's wort. Quality scandals hurt us, [as do] questions about herb/drug interactions."

In addition, the FDA has finally awakened and begun to seize the regulatory power explicit in DSHEA. This new regulatory muscle can be seen in the banning of ephedra products because of safety concerns, and the current discussion on citrus aurantium and other products. "It sure took them a long time—as though to give the industry enough rope to hang itself," said Robert Ullman of Ullman, Shapiro & Ullman.

The question is, what happens next? Some in the industry see FDA's more active role as a first step toward reclaiming market preapproval. Others think FDA should have acted more quickly on products like ephedra and believe that a more active FDA will reveal as untrue the claim that the industry is unregulated.

But if the industry is to live up to both the burden and the promise of DSHEA, it first has to understand the law. "When the law passed, the vast majority of the industry had no idea what it said," said Israelsen. "And to this day, the vast majority of the industry still does not know."

Mitchell Clute is a free-lance writer, poet and musician in Crestone, Colo.

Black currant oil paints indelible stain on FDA

One of the driving forces in the push toward DSHEA was public perception that the U.S. Food and Drug Administration was incapable of regulating the supplements industry fairly. In the years just before DSHEA was passed, FDA strengthened this perception by embarking on a series of heavy-handed enforcement actions against retailers, manufacturers and health care practitioners who provided certain products to consumers—products FDA considered either illegal food additives or misbranded drugs, since there was as yet no official regulatory category for dietary supplements.

But the supplements industry began to fight back in court, winning a series of cases that challenged FDA's enforcement approach. One key victory was the Traco Labs black currant oil case. FDA seized two barrels of black currant oil from Traco President Sid Tracy and sought a court order to destroy the product on the grounds that it was an "unsafe food additive." Robert Ullman, of the New York law firm Ullman, Shapiro & Ullman, represented Traco Labs in challenging the FDA's position.

"The black currant oil that Traco Labs sold was encapsulated," Ullman said. "FDA's position was that the capsule was a food and the black currant oil was an unapproved food additive."

Steven Shapiro, also of Ullman, Shapiro & Ullman, sums up the FDA's position on food additives with this analogy: "Their position was, peas are a food, carrots are a food, but if you put them together in a bowl, you have a new food called peas and carrots. Now peas are a food additive and carrots are a food additive."

In fact, FDA's lawyer admitted that black currant oil itself posed no danger; the problem was that there was no data supporting the safety of black currant oil in a gel cap. "One of the stupidest things FDA did," said Shapiro, "was pick black currant oil, which is probably one of the most innocuous substances in the whole world."

FDA was essentially arguing that the Generally Recognized As Safe list, which was first created to regulate chemical food additives, should be interpreted to include dietary supplements ingredients. This distinction was key to FDA enforcement efforts, because if dietary supplements ingredients were considered foods, it was up to FDA to prove they were unsafe. However, if they were considered food additives, the burden of proof for safety lay squarely on the manufacturer.

During the proceedings, Ullman asked if FDA's lawyer would have any safety concerns about consumers drinking black currant oil straight out of the bottle. FDA's lawyer responded that no one would do such a thing. "I had a couple of bottles of oil on the table," said Ullman. "I opened a bottle and took a swig, and asked the FDA's lawyer to tell the judge what I was consuming. Was it a food? Was it an additive?"

It turned out that, by mistake, Ullman had grabbed a bottle of olive oil, but no one knew that at the time. The presiding judge, Harold A. Baker, found in favor of Traco Labs on April 10, 1991. FDA appealed to the Seventh U.S. Circuit Court of Appeals, but again the court struck down FDA's challenge. The Jan. 27, 1993, decision called FDA's attempt to relabel black currant oil a food additive "an Alice-in-Wonderland end-run around the statute."

A similar case ended with the same result following FDA's seizure of black currant oil from Oakmont Investment Co. On June 8, 1992, the U.S. District Court for Massachusetts found in favor of Oakmont, saying the FDA argument that adding black currant oil to a capsule turns it into a food additive "defenestrates common sense."

What, ultimately, was the impact of these rulings? "As predecessors to DSHEA, these cases served as very good examples of the extreme lengths the agency would try to go to misregulate the industry," Ullman said.

As a result of overreaching, FDA eventually lost the very market preapproval for dietary supplements that it was fighting so hard to protect. To the extent that these cases bolstered both public and congressional support for a bill such as DSHEA, they had a direct impact on the current regulatory situation. "FDA is still trying to undo what they did to themselves over a decade ago with the Traco and Oakmont cases," said Shapiro.

Retailers and DSHEA

If any one factor convinced Congress to pass DSHEA, it was the enormous groundswell of public support. Congress received more mail from constituents in support of DSHEA than it had for any other single piece of legislation in history.

Natural products retailers were a key element in mobilizing this public outcry against FDA's heavy-handed tactics. "It's the only time I've seen all the different naturals store formats come together on a single issue," said Cheryl Bottger, currently corporate vice president of natural foods sales for Tree of Life. At the time she was a retailer with Nature's Fresh Northwest and president of the northwest region of the National Nutritional Foods Association. "It didn't matter whether they were a small independent, a sports-nutrition store or a fabulous food store that sold a few dietary supplements."

Of course, there was some self-interest involved: Supplements were a high-margin product, and losing the entire category would have put many stores out of business. But the driving force behind retailers' activism was the belief that consumers should be able to make their own health choices. "When FDA published its proposed rules on dietary supplements in the Federal Register," said Bottger, "buried in there was language that would have removed virtually all dietary supplements products from the market. Vitamins with anything above the [recommended daily allowance] would no longer have been for sale. Herbal products would have been gone, unless used as an herb or spice."

Retailers became activists to protect consumer health freedom. Sandy Gooch, founder, owner and director of marketing for the Southern California-based naturals supermarket chain Mrs. Gooch's, was a key figure in this nationwide education campaign. "We had our staff totally educated and informed, so they were able to make phone calls, write letters and send faxes to other stores around the country," Gooch said. "The staff was so educated about DSHEA that they could explain it to customers, even in the meat department—why it was important, what power the government would have over supplements if it didn't pass, how expensive supplements would become."

"It was the customer who had the most to lose had those FDA regulations been passed," Bottger said. Few people, especially in FDA, thought this grassroots movement had any chance of achieving its agenda through legislative means. But the natural products industry has always been an industry of true believers. "Was I worried it wouldn't pass? From the standpoint of being a positive person and an entrepreneur, I just thought, 'Let's get this done,'" said Gooch. "We have to. We must."

Natural Foods Merchandiser volume XXV/number 10/p. 33-34, 36