IN THE MID-1980S, A HEALTH CRAZE SWEPT THE COUNTRY. For the first time, large numbers of Americans became aware of the importance of proper diet and exercise to good health, and in an effort to prevent heart disease, strokes, and cancer, many tried to cut down on their intake of cholesterol and sodium. More than most new national enthusiasms, this one reached Congress. One reason may have been that we were always the first to see reports on public health, like the ones issued during this period linking sodium and hypertension. But my own hunch is that the profile of those most at risk bore an uncanny resemblance to the members of the U.S. Congress: paunchy, middle-aged-and-older men whose diets and health regimens would not have elicited the surgeon general’s approval.
As someone who has always battled weight problems and dieted constantly, I was no exception. Along with some colleagues, I started making regular visits to the House gym, and over the years have tried to stick with a program. I’ve discovered that staying healthy has more in common with legislating that one might imagine: Both demand years of perseverance and effort without any assurance that the payoff will resemble anything like what you had originally envisioned. And as the chairman of the House subcommittee on health, I was more acutely aware than most of my shortcomings in this area.
One frustration soon encountered by anyone trying to watch his diet in those days was the difficulty of finding even basic nutritional information about most foods—information like calories, sodium, and cholesterol content. Food manufacturers had a spotty record of what they chose to reveal on product labels, if they chose to reveal anything at all. No law required them to do so. Some products offered comprehensive nutritional details, some only limited information, and others nothing at all. The result was haphazard and confusing. Recognizing a marketing opportunity in the new awareness about diet, food manufacturers started including health claims on their labels (“Low Cholesterol!”), while simultaneously downplaying or ignoring important information that might discourage sales of a product, such as high levels of fat and sodium. This made life even harder for health-conscious consumers: No one could make sense of the labels. Anyone attempting to watch what he ate, including many congressmen, soon realized that he could not really do so until food makers began providing basic nutritional information.
By the end of Ronald Reagan’s presidency, the problem of food labeling had grown acute, owing not only to the inconsistency of what was being disclosed but also to the administration’s passion for deregulation, which created the additional problem of exaggerated and misleading health claims. The trouble began with a breakfast cereal, Kellogg’s All-Bran. In 1984, Kellogg’s launched a multimillion-dollar marketing campaign for All-Bran that included the claim, printed in bold letters on the cereal box, “The National Cancer Institute believes a high fiber, low fat diet may reduce your risk of some kinds of cancer.” Kellogg’s repeated the claim in full-page ads in major Sunday newspapers and magazines. This was the first time a company had ever claimed a direct link between a food product and cancer prevention, and the implied endorsement of a highly respected governmental medical organization like the National Cancer Institute caused sales of All-Bran to skyrocket. Other cereal makers quickly responded with claims of their own.
Since 1906, federal policy had held that any product claiming to treat or prevent disease had to be tested and regulated as a drug. All-Bran had not been, so the ad campaign appeared to violate federal rules. The Food and Drug Administration, which oversees the safety of the country’s food, considered stopping the ads and even seizing boxes of All-Bran, until Reagan appointees intervened and let Kellogg’s continue.
This touched off a stampede among food makers to issue ever more aggressive and outlandish claims about the nutritional benefits of their products, claims that were often misleading and soon lost any grounding in scientific fact. Skippy touted its peanut butter as having “less sugar than other leading national brands,” but its label didn’t state how much sugar Skippy contained. Del Monte claimed its canned vegetables were as nutritious as fresh ones, but didn’t mention that they contain three hundred times as much sodium. Campbell’s Soup did away with specifics altogether and began referring to itself as “health insurance,” though its products, too, contained staggering amounts of sodium.
In many cases, the clear intention was to deceive consumers. Bertolli Extra Light Olive Oil may have looked like a healthy, low-calorie product—that was certainly the idea—but its “light” claim derived not from a calorie count, but from the color of the olive oil itself. Sara Lee Light Classics French Cheesecake boasted “only 200 calories per serving,” even though a serving contained more calories than Sara Lee’s regular cheesecake. Confronted by an FDA task force, the company claimed the term “light” referred to the cheesecake’s texture. Wonder Lite Bread boasted that it contained “no cholesterol,” without noting that few types of bread contain any cholesterol whatsoever. Food manufacturers scrambling to cash in on the health trend wanted only to convince consumers that such products were good for them—even when they were not. Simply claiming to be healthy usually got people to buy them.
JOE MOAKLEY, A MASSACHUSETTS DEMOCRAT WHOSE FAMILY HAD A history of hypertension, became the first member of Congress to try to elicit standard nutritional information when he introduced a bill requiring food makers to disclose sodium content on their product labels. Jim Cooper, a Tennessee Democrat, twice put forth a Lite Food Labeling Act that would have defined “light” as meaning “one-third the calories, fat or sodium that would be in the food without alteration.” Both measures died after manufacturers complained that the requirement would impose too great a cost, confuse people with too much new information, and, for a host of other specious reasons, could not possibly be made to work. In Congress, the most commonsense ideas are often the ones that draw the most heated protests.
There is an inherent tension to the subject of government regulation that centers on knowing when it is necessary for the government to intervene and when it is not. How does Congress know if it has gone too far or hasn’t gone far enough? My own belief is that people always deserve whatever information is necessary to make responsible decisions, especially about important matters of health. If government decides not to regulate such matters, it ought to provide the information and let consumers decide for themselves. Food labeling was clearly an area where government needed to play a role, first in establishing a way for consumers to get basic nutritional information, and second in stopping the spread of dangerous and misleading health claims.
By the time Reagan left office, even some food manufacturers had begun to realize the need for federal labeling standards. By the late 1980s, the FDA had descended into chaos, the result of a toxic combination of factors, including severe budget cuts under Reagan imposed even as the agency’s responsibilities were multiplying and pressure on it mounting to approve drugs faster, due largely to the exploding AIDS epidemic. Agency morale was at a historic low. The Reagan administration had undermined enforcement of many basic food and drug laws, and then, in 1989, the FDA was rocked by scandal and Commissioner Frank Young forced to resign after several officials were convicted for falsifying safety and effectiveness data for drugs that the agency had approved. The crisis was such that President George H. W. Bush, encouraged by Republican senator Orrin Hatch, nominated as his FDA commissioner Dr. David Kessler, a tough, enforcement-minded pediatrician and lawyer (and former Hatch aide) who had taught food and drug law at Columbia Law School.
The trouble from an industry standpoint was that when the Reagan administration stopped enforcing the laws, many state attorneys general stepped into the void, suing companies like Campbell’s, for claiming its soup decreases the risk of heart disease, and Kellogg’s, for claiming that Frosted Flakes made a healthier snack than bananas, oranges, or apples. The threat that any number of states could take action fostered enormous uncertainty among food manufacturers. No one was entirely sure about what was or was not permitted under the law.
It fell to me, as chairman of the subcommittee responsible for overseeing public health, to try and remedy these shortcomings. In July 1989, I introduced a bill proposing the Nutrition Labeling and Education Act (NLEA), which required all processed foods to carry labels listing the amount of calories, saturated and unsaturated fat, cholesterol, sodium, complex carbohydrates, sugar, protein, and dietary fiber. The bill also established uniform federal definitions of terms like “light,” “lean,” and “low fat,” and stipulated that any claims of disease prevention had to be backed by “significant scientific agreement” rather than just the wishes of the marketing department. Our intention was to make the law as comprehensive as possible, so that ultimately every food product, including fresh fruit, vegetables, meat, and poultry, would carry nutritional information.
Unlike many other legislative efforts, this one did not sort out neatly along party lines. Food industry trade groups like the Grocery Manufacturers of America and the National Food Processors Association opposed the bill, particularly its curb on health claims. And though Republicans are usually attentive to what industry desires, here some were not. Louis Sullivan, the secretary of health and human services in the new George H. W. Bush administration, declared, “The grocery store has become a Tower of Babel, and consumers need to be linguists, scientists, and mind readers to understand the many labels they encounter.” Ed Madigan of Illinois, the health subcommittee’s ranking member, also liked the idea and agreed to work with us on legislation.
Having the support of the committee’s top Republican created a collaborative, rather than an adversarial, process that limited what industry groups could do to stop the bill. At an August hearing on the legislation, food industry representatives argued against a new law on grounds that it would be too costly and difficult to implement. The real reason they opposed it, which they couldn’t air publicly, was that many of the products touted as “healthy” were clearly not so, and they worried that educated consumers would stop buying them. But Madigan’s inclination toward the idea prevented them from pressing this claim too strongly even in private, since they required his goodwill in many other areas. In October, the bill passed the subcommittee on a voice vote.
Sensing that they could not kill the legislation, the industry groups switched tactics and instead sought to use the bill as a vehicle to escape state food safety requirements, a longstanding desire of their members. Their primary focus became ensuring that any new federal law would preempt a California measure known as Proposition 65, which required warning labels to be placed on any foods that contain a carcinogen. California voters had passed what was formally the Safe Drinking Water and Toxic Enforcement Act of 1986 as a ballot initiative to protect themselves from toxins. Food manufacturers hated the law because it presented them the choice of eliminating, at some cost, even trace amounts of carcinogens or else slapping a label on their product that read, “WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.” The less than robust sales potential for carcinogenic foods prompted most manufacturers to ensure that whatever they sold in California was free of hazardous substances—in other words, Proposition 65 worked exactly as intended.
Not every legislative battle is decided in a dramatic showdown on the House floor. Some are won quietly through the clever drafting of a bill, and victory seized before the matter can ever come to a vote. This became our strategy. Despite the country’s newfound interest in health and fitness, there was hardly a public clamor for better nutrition labeling, and none at all to preempt state food safety laws, except among industry trade groups. Consequently, few congressmen or senators felt strongly enough about the matter to spend political capital defending these laws—they simply didn’t resonate with their constituents in nearly the same way as issues like clean air and tobacco. No groundswell was going to arise in our defense.
This meant that while many members were inclined toward our bill, they would also be willing to give away a great deal to achieve compromise. What food makers most wanted was to preempt Proposition 65, and there was reason to believe they might get their wish. Though Ed Madigan supported our push for uniform nutritional labeling, he made clear that he would support the industry’s desire to override Proposition 65. So from the outset we anticipated that Madigan, or some other Republican, would put that option before the committee by introducing an amendment—and we doubted our ability to defeat it.
But winning a vote is not the only way to stop an amendment. Should a chairman determine that an amendment is not germane to the bill before his committee, he will rule the amendment out of order and dismiss it. With the nutritional labeling measure headed to full committee, its chairman, John Dingell, would be the one to decide.
Once we had identified the likeliest threat, we set about plotting to avoid it. Here was a situation where a thorough knowledge of the rules and deft use of language could work wonders. When Bill Corr, from the subcommittee staff, had sat down to draft the bill, he had in mind the possibility that there might arise a germaneness argument over an amendment to preempt Proposition 65, and had devised a clever linguistic trick to counter it. He wrote the Nutrition Labeling and Education Act to pertain specifically to “nutrients” rather than “food.” The distinction might at first appear puzzling—until one remembers that “food” can contain both “nutrients” and “carcinogens,” and therefore an amendment concerning carcinogens, such as any that would repeal Proposition 65, might not be germane to a bill dealing only with nutrients. In effect, the bill set a trap for our opponents.
The authority on germaneness, and other matters of rule and precedent, was the House parliamentarian. The job of parliamentarian is believed to have originated in 1857, when Speaker James L. Orr of South Carolina appointed a “messenger” named Thaddeus Morrice whose knack for remembering Orr’s decisions made him an invaluable repository of institutional knowledge. Over the decades, others filled the role, and in 1927 Congress formalized the nonpartisan Office of the Parliamentarian, and later published a multivolume compendium of House precedents. Today, the parliamentarian is the figure who sits just to the right of the speaker whenever the House is in session, and holds enormous power in this capacity. It is the parliamentarian who reads the thousands of bills, resolutions, and executive communications introduced in the House each year; who decides which committee or committees those bills are referred to; and who commands unrivaled authority as an expert on all matters of legislative procedure and detail—including whether or not a nutrition bill could be drafted in such a way that a chairman might find cause to dismiss an amendment concerning carcinogens. With chairmen, as with everyone else, the opinion of the House parliamentarian carries great sway.
The value of having this nonpartisan arbiter was not, I must confess, initially clear to me. When, as a new congressman, I first encountered some obstacle in a rule, I appealed to Tip O’Neill, the ultimate authority as House speaker, to decide in my favor. In the California Assembly, the speaker determined the rules, and Jesse Unruh had maintained power by routinely using them in exactly the partisan fashion I envisioned. But O’Neill deferred to the parliamentarian and declined my entreaty. It came as a surprise to me that Tip O’Neill, the leader of my own party, couldn’t just make the decision. But later on, when the Republicans gained control of the House, I came to appreciate the importance of having an honest broker to follow the rules. In the meantime, I drew a lesson from what I’d observed. Since having the speaker on your side is a great advantage, and the speaker always consulted the parliamentarian on issues of rules, it occurred to me that the parliamentarian held tremendous power that I might use to gain an edge. My staff and I became devoted students, consulting the parliamentarian on all matter of law and procedure, mastering the rules in our own right, and eventually pioneering, with his guidance, all sorts of legislative tactics and maneuvers.
When consulted about the drafting of the NLEA, the parliamentarian agreed that the distinction between nutrients and carcinogens was a meaningful one, and he ruled in our favor. This was a great advantage, for it enabled us, if the expected amendment on Proposition 65 materialized, to introduce a point of order and seek to have the amendment dismissed on grounds that it wasn’t germane. But invoking such a ruling can sometimes involve an elaborate pas de deux. Though influential, the parliamentarian’s ruling is an advisory opinion that ultimately takes a back seat to the decision of the chairman or speaker. While it’s important to have, letting it be known that you have it is something of a delicate matter. I couldn’t very well announce it before the committee, since doing so would openly challenge Dingell’s authority, with whom we were then in the midst of the heated final stages of the Clean Air Act struggle and not on the friendliest of terms. Instead, my staff discreetly conveyed to his that we’d raised the question and the ruling had gone our way.
In May, Dingell called the bill for markup, and, sure enough, Madigan introduced an amendment directed at Proposition 65. I immediately made a point of order and explained the crucial distinction between nutrients and carcinogens. I never found out whether Dingell himself learned of the parliamentarian’s ruling, but he gave every outward appearance of making up his own mind on the matter, right there before the committee. With theatrics befitting a powerful chairman, Dingell called for a dictionary, and an aide wheeled out one of the largest I had ever laid eyes on. Dingell looked up “nutrient” and read the definition aloud to the committee, then riffled through the pages until he got to “carcinogen” and did the same. That seemed to satisfy him. He dismissed the amendment after a brief debate, and our bill, thankfully intact, moved out of committee by another voice vote.
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, the 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?”
For two brutal years, I had struggled with paltry support, and to little evident effect, in what everyone could now see was a losing fight. Dispirited and exhausted, I did something uncharacteristic: I agreed, right there at the table. From the looks on their faces, I could see that my staff was taken aback. The secret to successful negotiations is never answering right away. Over the years, we’d won numerous important concessions on all sorts of bills by following a disciplined routine when presented with these sorts of proposals. Experience taught me to ask for a recess, talk to the experts on my staff, and then offer a counterproposal, or, if necessary, simply decline. This careful approach provided a negotiating advantage over the many members who would “get ahead of their staff,” as the phrase had it, and cut deals without pausing to consider the larger ramifications, as I had just done.
I could tell right away that my staff believed I had needlessly conceded an important fight. But as Dingell pointed out, I had agreed to the offer of an FDA disclaimer and now had to honor my word. This final barrier cleared, the bill moved rapidly through both chambers, and on October 25, 1994, President Bill Clinton signed the Dietary Supplement Health and Education Act into law.
DESPITE THE SETBACK WITH DIETARY SUPPLEMENTS, THE NUTRItion Labeling and Education Act of 1990 has functioned almost exactly as Congress intended. In a happy case of serendipity, Ed Madigan became secretary of agriculture shortly after the bill passed, and issued an order extending nutrition-labeling requirements to meat and poultry (which were not covered by the NLEA). Today, finding honest, accurate information about the foods we eat has never been easier, and the benefits to health-conscious consumers have been immeasurable.
From a public standpoint, too, the NLEA has been a success. Most media coverage of Washington focuses disproportionately on “big issues,” like the president’s budget, that often have little impact on the lives of most Americans (Congress generally ignores the president’s budget and does as it pleases). Meanwhile, smaller issues like food labeling fly under the radar, but nonetheless have a revolutionary impact on most people’s lives, even if they don’t realize it. Whether strictly adhering to the South Beach Diet or simply trying to keep an eye on sodium or cholesterol intake, it’s a good bet that most Americans make use of nutrition labels every day of their lives. In fact, knowing what you’re eating has become so commonplace that it’s hard to imagine there was ever a time when you couldn’t get basic nutrition information on food labels.
The fact that the law has turned out to be so useful is especially gratifying, since it came about not because of public demand, but rather by congressional initiative. It’s a good example of the leadership that critics so often claim is lacking in Washington. Much as Proposition 65’s threat of a warning label prompted manufacturers to provide healthier food in California, today’s nutrition labels function the same way on a national scale by empowering consumers who want to buy healthier foods and in turn forcing companies to supply them. We’re a healthier country because Congress acted.
The only smirch on our original effort is the Dietary Supplement Health and Education Act of 1994. As a lesson in politics, DSHEA is instructive because it shows how industry can concoct an issue based entirely on misinformation that ultimately allows it to circumvent the law. Sometimes spin trumps fact. When the context is a political campaign, most people understand this and guard against it. But they’re not nearly as used to being deceived in a legislative campaign. The industry’s decision to use health food stores as the vehicle to accomplish this was especially effective since many people instinctively trust them to be an impartial source of information, much like their doctor, and in reality they were not. The vast majority of consumers never realized that the outcry against Congress was being financed by the supplement industry.
As policy, DSHEA has been every bit as harmful as we feared, demonstrating anew that any market lacking regulation or the need to ensure safety quickly sinks to the lowest common denominator. The FDA disclaimer doesn’t seem to have had the slightest impact on how people use supplements. Since the law went into effect, a number of them have proved to have serious health effects. For years, the most popular over-the-counter weight loss supplement, an herbal stimulant called ephedra, was linked to heart attacks, strokes, and seizures. Only the death in 2003 of Baltimore Orioles pitcher Steve Bechler, who had been using ephedra, caused sufficient notoriety for the FDA to finally ban it. Many other dangerous substances are still for sale.
Since the legislative loss on dietary supplements, we have continued to press for changes in the law and, along with getting ephedra off the market, have made slow but steady progress toward that end. After the September 11 attacks, when unscrupulous companies began marketing supplements as “cures” for anthrax and other bioterrorism agents, we were able to get a provision into the Bioterrorism Act of 2002 forbidding this practice and requiring all supplement companies to register with the FDA and track the source of their ingredients. In 2006, we passed a law requiring manufacturers to report adverse reactions, like those caused by ephedra, to the FDA. Other measures made it through Congress, only to be ignored by the Bush administration.
With a new administration in power, that, too, could soon change. In time, bad laws always reveal themselves. And one enduring truth about Washington is that no issue is ever settled for good.