Having dodged the most serious attack on the bill’s substance, we switched gears from defense to offense, and turned to the challenge of steering it the rest of the way through Congress. Though we looked to be in fine shape in the House, our concern was the Senate, and the possibility that industry trade groups might block it there. Senator Howard Metzenbaum, an Ohio Democrat, had introduced a measure similar to ours that had stalled in committee. Because senators have the power to place a hold on a bill, it is much easier to stop legislation in the Senate—outside groups need only convince one of them to do so.
Once the bill had passed the House Energy and Commerce Committee, we decided to sit down with representatives from several of the largest trade groups and see if we could strike a deal. Both sides had concerns that impelled them to the negotiating table. The food industry had three options: try to stop the bill, live with it as it was, or accept that something would pass and try to negotiate concessions in exchange for withdrawing opposition or even supporting the compromise. From our standpoint, the strong support in both chambers did not guarantee that a bill would make it through the Senate. Striking a compromise on the House bill, however, would all but assure victory in the Senate, since the industry groups would be ethically bound to honor any agreement they struck now. As summer arrived, both sides plunged into weeks of negotiations.
RESIGNED TO THE IMPENDING LABELING STANDARDS AND LIMITS on health claims, the food industry returned to the issue of preemption. Undermining Proposition 65 was, of course, out of the question; but disparities between FDA and state labeling standards remained a costly headache, from which manufacturers now sought relief. Whenever state requirements differed from federal standards, companies had to tailor their packaging to a niche market. Rectifying this struck me as a reasonable enough request. With the Nutrition Labeling and Education Act poised to supply the information consumers needed, the patchwork of state standards was no longer a necessary bulwark.
But reaching compromise required more than just winning me over. First in the House, and later in the Senate, a series of obscure region-specific obstacles had to be overcome to placate lawmakers or industries that might block a deal. Most people imagine Congress as grappling over weighty matters of state, but it is not always so. Our first challenge was Vidalia onions. Unbeknownst to me, these pungent little bulbs, a vital component of certain popular Southern cocktails, are often sold in liquor stores. Roy Rowland of Georgia did not think it fair that liquor stores, which do not offer much in the way of foodstuffs besides Vidalia onions, be required to post food labels solely to apprise their clientele of the nutritional merits of cocktail onions. We granted an exemption.
The next hitch was small mom-and-pop vegetable stands, which couldn’t easily comply with the proposed labeling standards. These, too, earned an exemption.
The Senate demands seemed similarly arbitrary, though important to rectify given a senator’s ability to stop a bill. One of the many federal-state disparities was the legal standard for what constitutes maple syrup. The FDA required a product to contain at least 80 percent maple syrup in order to be labeled as such. But Vermont, which regards maple syrup in the same way Germans regard beer, had a standard of 100 percent that was evidently a matter of ferocious state pride—Senator Jim Jeffords of Vermont threatened to block the legislation unless an exception were made for Vermont maple syrup. We relented to avoid that sticky situation.
A trickier impasse was whether dietary supplements would be subject to the bill’s constraints on health claims. Senator Orrin Hatch of Utah, home to many of the largest supplement manufacturers, insisted there be separate—and more lenient—standards, since claims to prevent or cure disease are the primary reason most people take dietary supplements. Here we were not willing to concede because supplements were largely unregulated and in many cases posed a real danger to users’ health. To save the bill, we agreed to insert a provision that directed the FDA to adopt a standard and procedure for evaluating and approving claims on dietary supplements, and to issue a binding recommendation one year after the law’s enactment.
The most vexing problem, however, turned out to be candy. To prevent unscrupulous manufacturers from burying information in microscopic type, the bill stipulated that nutrition labels must be a certain size. A box of Milk Duds could simply print the label on the outside of the package. But a box of assorted candies could not, since each variety differed in nutritional content. Nor could the manufacturer adhere to the law by labeling individual candy wrappers without running afoul of the size requirement. Here was a problem that, I’ll concede, none of us had foreseen. But it was of gravest concern to the Chocolate Manufacturers Association, and therefore needed addressing. Trade groups are unusually well funded and possess a hair-trigger willingness to try to block legislation they opposed. We could imagine the ads: “Congress is trying to take away your candy!” With some effort, we crafted a fix for variegated boxed candy.
Strange as it sometimes can be, haggling over obscure particulars is not at all unusual in the latter stages of the legislative process. Even sensible, well-written bills can’t possibly anticipate every contingency, and there will always be a good case for making certain exceptions. The art of legislating is figuring out how to accommodate them without undermining the larger purpose. This can be difficult. No matter the issue, outside groups always tend toward purist positions. But for the legislative process to work, lawmakers need to make compromises that outside allies dislike. Some of the public interest groups that had been instrumental in bringing the issue of food safety to the fore opposed any deal preempting state standards. But to my mind, the benefits of doing so outweighed their objections. After several arduous weeks, we struck a deal.
One of the amazing things about legislation is that you can rewrite an entire bill in the middle of the process, which is what we did with the House measure between the committee and the floor vote, adding the concessions for candy, Vidalia onions, and some other odds and ends. We moved to place the bill on the suspension calendar, a fast-tracking system in which legislation that at least two-thirds of House members support is voted on with limited debate and no allowance for amendments. In late July, the House passed the measure by a voice vote, sent it on to the Senate, which tackled maple syrup and a few other issues, and we finally passed the joint version in late October. On November 8, 1990, President Bush signed the Nutrition Labeling and Education Act into law.
BUT THE FIGHT TO PROTECT CONSUMERS AGAINST MISLEADING health claims wasn’t nearly over. Buried within the NLEA like a ticking time bomb was the deal we’d struck with Hatch to let the FDA decide how to regulate dietary supplements. The agency was given one year after President Bush signed the law to examine the issue and recommend a course of action. In what must have seemed an extraordinary stroke of luck to Hatch, his own former aide, David Kessler, became commissioner of the FDA on the same day the NLEA became law.
That made it all the more stunning when, in November 1991, Kessler released the agency’s findings: Rather than the lighter regulations Hatch anticipated, the FDA announced that dietary supplements posed a serious health risk and ought to be regulated exactly like the NLEA regulated food. The FDA had already convened a task force on dietary supplements to study the dangers. We could scarcely have imagined a better outcome. But Kessler’s findings sent supplement manufacturers into a tizzy, and the $4 billion-a-year industry quickly mobilized a wide-ranging campaign to fight back. To my surprise, I found myself in the crosshairs.
The industry devised a clever two-track strategy. The first part entailed having Hatch introduce a Senate bill, the Health Freedom Act of 1992, and New Mexico’s Bill Richardson a counterpart in the House, to establish the lax oversight they desired. Both bills precluded FDA regulation of dietary supplements as drugs, denied the agency the power to approve them before they hit the market, and removed the NLEA’s requirement that “significant scientific agreement” back up any health claims, giving manufacturers unfettered
ability to assert whatever they wished about their products, including that supplements could cure cancer and AIDS. The second part of the strategy involved an enforcement bill I had recently introduced to strengthen the FDA’s historically weak powers of oversight by granting it, for the first time, the ability to issue subpoenas, force the recall of dangerous products, and, if necessary, confiscate such products. The bill sought to shore up broad deficiencies and was not aimed at dietary supplements specifically—indeed, did not even mention them. But the supplement industry seized on it to make the claim that the government intended to outlaw most supplements and require prescriptions for the benign few, like vitamin C, that might still be allowed on store shelves. “Don’t let them take our vitamins away!” became the industry’s rallying cry.
This cynical portrayal had not the slightest basis in reality. But it was effective nonetheless. People who use dietary supplements tend to feel passionately about them, and by scaring these customers into believing that the government was going to take them away, the industry was able to mount an enormous grassroots lobbying effort. Every health food store in the country set up a booth with preaddressed postcards that outraged customers could send to their congressman. Some even had posters on the wall identifying me as the culprit trying to force them to get a doctor’s prescription for their vitamins. But the highlight of the industry’s campaign of scare tactics was a television commercial starring the actor Mel Gibson. In the ad, Gibson is seen wearing a bathrobe and standing in the kitchen of an enormous mansion late at night. He is about to take a vitamin when suddenly an army of machine-gun-wielding agents in black “FDA” jackets bursts into the house. “Guys—it’s only vitamins!” Gibson cries helplessly, his hands raised in the air. The agents grab him anyway, and a message flashes across the screen: “Write Congress Now. Protect your right to use vitamins and other supplements.”
The Gibson commercial, and the broader campaign of which it was a part, tapped into a strain of populist paranoia in the country that crosses every geographic and political boundary. This paranoia centers on the belief that a vast conspiracy is at work between doctors, drug companies, and the federal government to try and force people to use expensive pharmaceuticals, which might even make them sicker, while at the same time denying them access to “natural ingredients” like Chinese herbs that have been used for thousands of years to keep people healthy. It all boiled down to the belief that doctors and drug companies needed people to get sick in order to make money—and that any measure seeking to strengthen FDA enforcement powers was clear evidence of congressional complicity. The supplement industry made very clever use of these passionately misguided beliefs about “the system” and how it operated. By conflating two bills, it managed to create a phony threat (my enforcement bill) and at the same time rally its customers behind an industry-friendly “solution” (Hatch-Richardson) that stripped away even the most basic health and safety provisions.
As chairman of the health subcommittee, any supplement bill had to get past me before it could become law. The industry’s initial foray in 1992, the Health Freedom Bill, arrived too late in the year to get through Congress. So Hatch tried to attach a rider to an appropriations bill that was sure to pass that established a one-year moratorium on applying NLEA standards to dietary supplements. Though his amendment passed the Senate by a 94-1 vote, we managed to kill it in the House-Senate conference. But we could not stop his next attempt, which he attached to a prescription drug bill in the closing weeks of Congress. Aware of the deep suspicion with which supplement users regarded the FDA, Hatch’s amendment fanned the flames by directing the Department of Health and Human Services to produce a report on the FDA’s enforcement practices, and determine whether the agency discriminated against dietary supplements. (The report would conclude it did not.)
The following year, Hatch and Richardson tried again. Their bills soon became the focus of public attention, aided by the uproar that greeted the June 1993 release of the task force on dietary supplements report, which concluded that some ingredients in popular supplements should indeed be regulated as drugs. A few weeks later, I held a subcommittee hearing in an attempt to bring some balance to the public debate by providing facts to counter the industry spin. I announced my hope of finding a legislative solution that would guarantee the availability of safe dietary supplements as long as they made no unproven claims. Testifying in support of this goal, Kessler reiterated that the FDA was “not concerned about [vitamins and minerals] as long as the potencies are reasonable, their health claims are scientifically valid, and they are manufactured under appropriate quality control standards.” He reminded the committee of the significant health issues at stake, referencing the new FDA report that found “hundreds and hundreds of dietary supplements that claim to cure, treat or reduce the risk of a variety of health problems, some as serious as cancer and AIDS.”
But all this was to little avail. Not long afterward, retailers organized a national blackout day on which stores draped their supplement shelves in black so consumers could “see” what products Congress intended to outlaw. A massive mail and telephone campaign swamped Capitol Hill. Supposedly, more people wrote to Congress about dietary supplements that year than about any other issue.
Throughout my career, I have regarded myself as the good guy fighting the special interests. But this time, the public outcry hit close to home, and I found myself cast in the unaccustomed role of villain. Los Angeles lives up to its health-conscious stereotype, and everywhere I went I seemed to encounter angry constituents. Letters poured into my office. Wives of Hollywood studio executives called me to complain. While visiting a synagogue, a man stood up and berated me for the bill. I vividly recall one community meeting at which a bodybuilder in a red tank top, veins bulging from his neck, screamed at me for what he mistakenly imagined was my crusade to deny him muscle-building supplements. Most people, without screaming about it, took the well-intentioned position that these were “natural products” that they should be able to use, not realizing the extent of the misinformation they’d absorbed.
THE FIGHT TO REGULATE DIETARY SUPPLEMENTS HELD MANY SIMIlarities to others in my legislative career: We found ourselves in the customary position of underdog, facing a larger, better-funded opponent with many powerful allies. This time, we did enjoy considerable media support, as most major newspapers editorialized against the Hatch-Richardson bills and did a good job of explaining the risks posed by many supplements. But the press was no match for the intensity of the opposition, and ultimately did not rally much support to our cause. People often believe the worst about public officials. And when voters are mad enough, those officials usually listen.
Early in 1994, efforts to reach a joint House-Senate compromise fell apart, as did a subsequent attempt between Hatch and Ted Kennedy, who chaired the Labor and Human Resources Committee through which the Senate bill had to pass. In the end, the pressure was so great that the bill passed over Kennedy’s objection.
The industry trade group worked to stoke a similar mutiny among supporters in the House, where I had steadfastly refused to call up the Richardson bill (even though more than half the House—261 members—had co-sponsored it). We tried heading them off by introducing our own bill, which aimed to counter the industry’s most effective scare tactic by forbidding government from requiring prescriptions for vitamins. But lacking credibility with the other side, this gambit failed. Meanwhile, pressure to move Richardson’s bill mounted to the point that our opponents began laying the groundwork for a discharge petition—a rarely invoked rule that allows a majority of House members (218 votes) to override a chairman and forcibly “discharge,” or remove, a bill from committee and place it for consideration on the floor.
It was clear where the momentum was heading. My staff and I understood that a moment of reckoning was nearly at hand, and recognized further the grim irony of our predicament: Just as the prospect of near-certain defeat had forced industry groups to negotiate on NLEA, th
e fight over supplements that originated in the same legislation had now reached a similar point, only this time with the roles reversed. Rather than forfeit our last chance to make a bad law slightly better, we sat down to negotiate with Hatch, Kennedy, and Dingell.
Hatch’s bill had passed the Senate, so it became the vehicle for our discussions. The debate initially centered on the issue of safety. Though the FDA would not be able to approve or regulate supplements, everyone agreed that if a safety issue were to arise, the agency needed to have the ability to act. Beyond that, we split. The endless contention over health claims remained the key point of difference: industry’s desire to escape any limitations at all versus our refusal to accept unproven claims for curing disease. The negotiations eventually narrowed to the precise question of how the claims could be worded.
Finally, Hatch’s side proposed that rather than direct claims to treat diseases or conditions (“Product X lowers blood pressure”), manufacturers be permitted to make more general ones regarding a product’s purported effect on the body (“Product X will bolster your immune system”). This, too, concerned me. In 1994, practical measures to strengthen the immune system held great interest owing to the prevalence of AIDS (acquired immunodeficiency syndrome), and the suggestion that a dietary supplement lacking FDA approval might make any meaningful difference seemed sure to cause harm. I expressed my skepticism. They wouldn’t budge. Then someone said, “What if we added a disclaimer stating that FDA had not validated the claim?”
The Waxman Report Page 12