It is clear . . . that we as a society and we as health professionals must address the sodium issue, and we must do it now.
—Arthur Hull Hayes, MD, FDA commissioner, 19821
Much of the key scientific research on salt has been conducted in the United States and sponsored by the National Institutes of Health (NIH). But while some countries are taking the findings of that research seriously and lowering sodium in their food supplies, the United States has moved at a snail’s pace. Consumers can help themselves by reading labels and visiting websites in their quest to consume less sodium, but our salt-filled food environment—a toxic food environment—makes it almost impossible to eat packaged or restaurant foods and still limit sodium.
We each should certainly eat more unprocessed foods, use Nutrition Facts labels, and put our saltshakers in the cupboard. But we consumers shouldn’t have to bear the entire responsibility for coping with a high-sodium food environment. As the Institute of Medicine (IOM, now the National Academy of Medicine) has emphasized, “it is unlikely that the average consumer will be able to successfully reduce sodium intake without changes to other components of the food environment.”2 The only way to achieve healthy sodium intakes on a national scale is through public health actions.
Official committees going as far back as the historic 1969 White House Conference on Food, Nutrition, and Health have urged industry and government to take steps to reduce the sodium content of foods—starting with baby foods—to help prevent hypertension. (See box 8.1 for a timeline of significant policy activities.) The conference’s final report stated:
Evidence has been accumulating that high intakes of dietary salt from infancy onward may be an important factor in initiating and aggravating hypertension. . . . More informative labeling of food as to salt content is needed. . . . Food processors should be encouraged to minimize the amount of salt.3
The conference did not recommend a specific sodium intake, and it had no power to force action. But in the same year, the NIH advised that “stringent sodium restricted diets (less than 2,000 mg a day) bring about some reduction in blood pressure in about one-third of those with hypertension.”4
Partly because of the 1969 report and public criticism, the baby food industry started to clean up its products. In 1975, Frank Nicholas, the savvy chief executive of Beech-Nut, a smaller competitor of Gerber, saw a great sales opportunity. He purged the salt from all the company’s baby foods.5 That action generated huge, favorable publicity for the company and forced Gerber and Heinz to stop adding salt to at least some of their baby foods.6
In 1968, the Senate created the Select Committee on Nutrition and Human Needs, which was chaired by Senator George McGovern (D-SD), who worked collaboratively with Senator Robert Dole (R-KS). The committee initially focused on poverty and hunger and spurred major expansions of the food stamp and school nutrition programs, but it then expanded its focus to include nutrition for the general public. After numerous hearings featuring testimony from leading nutrition experts, in 1977 the committee issued a groundbreaking report, “Dietary Goals for the United States.” The report focused on diet’s contribution to heart disease, cancer, and other chronic diseases. It expressed concern, among many other matters, that “millions of children and youth are moving toward hypertension.” The report concluded:
The evidence indicates that a systematic effort to reduce dietary sodium chloride intake and increase dietary potassium intake would result in the amelioration of much suffering among those who are prone [to hypertension] and would increase both duration and quality of life for many millions of people.7
The committee then bit the bullet and made one of the world’s first specific recommendations for sodium intake: people should consume about 2,000 mg a day.
The Senate report ignited a firestorm of controversy about what Americans should be eating. Fortuitously, the publication of the report coincided with the beginning of President Jimmy Carter’s administration, which sought to reduce the toll of diet-related disease. But “Dietary Goals” was still a report from just one Senate committee and did not have the force of law. To move the ball forward, in 1980 the US Department of Agriculture (USDA) and Department of Health and Human Services (HHS) made the centerpiece of their diet-improvement efforts the publication of a slim pamphlet called “Dietary Guidelines for Americans.” The report helped shift public attention from deficiencies of vitamins and minerals to excesses of foods that promote chronic diseases. It gave official endorsement to a diet with fewer calories and less sugar, saturated fat, and salt. It connected high-sodium diets to high blood pressure and said that Americans “take in much more sodium than they need.”
Every subsequent edition of the “Dietary Guidelines for Americans,” which by law is updated every five years, has recommended limiting sodium intake, with the 1995 edition supporting a limit of 2,400 mg of sodium per day. In 2005, the report dropped the recommendation slightly to 2,300 mg for most healthy people under about 50 years old. But for individuals with hypertension, African Americans, and middle-aged and older adults—that’s more than half the population—it lowered the limit to 1,500 mg per day. In 2015, the “Dietary Guidelines” narrowed that advice to people with prehypertension and hypertension, which also is well over half the population.
My organization, the Center for Science in the Public Interest (CSPI), fired its opening salvo in the salt wars in 1977. It started with the hiring of a recently minted nutritionist with a master’s degree from Cornell University, Bonnie Liebman, and a crash project of reviewing the evidence on the health effects of high-sodium diets. Some of the research was equivocal or did not find a problem, but much of it indicated that high-sodium diets were harmful. Some of the nation’s leading hypertension experts were deeply concerned about Americans’ sodium intakes. For instance, Edward D. Freis, a senior investigator at the Washington, DC, Veterans Administration Hospital, wrote, “The evidence is very good, if not conclusive, that reduction of salt in the diet to below [800 mg] a day would result in the prevention of essential hypertension and its disappearance as a major health problem.”8 Jeremiah Stamler, the Northwestern University School of Medicine hypertension expert, said that habitual salt intake sets the stage for hypertension. “It therefore,” he wrote, “makes good sense to encourage the American people to eat less salt and encourage the food industry to help by reducing the salt that is so ever present in commercial products.”9
With sentiment like that from medical leaders, in 1978 the CSPI formally petitioned the FDA to implement a suite of actions that would begin solving the sodium problem. We asked the FDA to:
In 1981, the CSPI filed another petition that called on the FDA to require a notice (an admittedly rather wordy one!) on canisters of salt:
The Surgeon General has determined that, for many people, a diet high in sodium or salt may produce high blood pressure. High blood pressure increases the risk of heart attack and stroke. The public is advised to limit salt consumption by cooking with only small amounts and refraining from adding salt to food at the table.12
Small packets of salt could state: “The Surgeon General has advised the public to eat less salt.”
Those petitions marked the first time that someone called on the FDA to fulfill its public health mandate and adopt specific policies to solve the sodium problem. Little did we know at the time that those petitions were only the first step of a journey that would last more than four decades—and that journey still continues. As an indication of what the FDA’s receptivity to our petitions might be, shortly before we filed our petitions, the agency’s acting director of nutrition, John Vanderveen, told me that the large amounts of salt in processed foods might be beneficial, because they protect very active people from sodium depletion.13 Coincidentally, at about the same time, Sanford A. Miller, the director of the FDA’s Center for Food Safety and Applied Nutrition—and Vanderveen’s boss—told me that high levels of salt in packaged foods were a major nutrition problem and should be limited.14
Let’s now take a little detour back to 1969. That was not only the year of the White House conference on diet and health, but also the year that the FDA banned cyclamate, an artificial sweetener suspected of causing cancer. Cyclamate was not an official food additive, but rather an ingredient considered by the FDA to be “generally recognized as safe,” or GRAS. GRAS substances were supposed to be familiar ingredients that everyone “knew” were perfectly safe, like vinegar, vitamin C (ascorbic acid) . . . and salt and sugar. Because of the public uproar over a synthetic and probably dangerous chemical like cyclamate being considered safe, President Richard Nixon ordered the FDA to review the safety of all GRAS substances.15 To conduct the review, the FDA asked the Federation of American Societies for Experimental Biology, a consortium of scientific societies with mostly academic members, to establish a Select Committee on GRAS Substances, or SCOGS.
The committee took a decade to review the safety of over 370 substances and concluded that almost all were safe. But in 1979, the year after CSPI’s initial petitions to the FDA, SCOGS shook the food world by concluding:
It is the prevalent judgment in the scientific community that the consumption of sodium chloride in the aggregate should be lowered. . . . The Select Committee agrees and favors the development of guidelines for restricting the amount of salt in processed foods.16
It went on to say in its linguistically convoluted way that the evidence was not sufficient to determine that the adverse effects reported from current usage of salt were not deleterious. In other words, current uses of sodium could not be considered “generally recognized as safe”—exactly what CSPI’s petition contended.
The FDA usually responded “reasonably quickly” to SCOGS reports (most of which required no real response), but because of “significant controversy” over the salt decision the FDA needed to prepare strategy documents, according to Miller.17 The FDA needed to consider “a great number of legal, technical, and administrative issues.” Changing the regulatory status of such a ubiquitously used ingredient, and possibly other sodium-containing ingredients, certainly would be complicated, but FDA probably also feared that the food industry would try to block action, including by suing the agency.
And, indeed, industry fervently wanted to stop the FDA from limiting salt in foods, including in potato chips. One example involved Frito-Lay—the nation’s biggest snack-food maker, which even back then had sales of more than $1 billion a year.18 Dr. Robert I-San Lin was the chief scientist at Frito-Lay between 1975 and 1982. Now in his mid-eighties and living in California, he still has a memory that would put an elephant to shame. He told me that his supervisor wanted him to testify at a public meeting convened by the SCOGS committee and deflect or deny health concerns about salt. But he refused because he believed that Americans were consuming too much salt. His supervisor told him “testify or pack up and leave,” but he managed not to do either. Instead, another Frito-Lay employee, along with two academic consultants to the snack-food industry, spoke at the meeting. One of those consultants, John Laragh, a professor at Cornell University Medical Center, testified: “We don’t know what the ideal intake of sodium chloride is. But we do know that . . . compromising the intake can be dangerous.”19 In other words, don’t mess with the salt in foods. Lin says now, “We could defeat the FDA and stop them from taking action on SCOGS’s advice. . . . I could whack them down easily,”20 though at the time he told his supervisors that he was “very reluctant to put up a fight with the Committee on salt . . . [because] none of the following arguments [against using less salt] are invincible.”21
In 1981, the Reagan administration appointed Dr. Arthur Hull Hayes to head the FDA. Because Hayes headed the hypertension clinic at the Hershey Medical Center in Hershey, Pennsylvania, I was hopeful that the agency would act boldly to tackle the sodium problem. But in the context of an administration that was philosophically opposed to regulation, Hayes and FDA adopted a largely voluntary plan that encouraged companies to drop salt from cooking instructions, label sodium on packages, reduce sodium levels in processed foods, and produce more low-sodium foods.22 The key word there is “voluntary.” Then-congressman Al Gore (D-TN), who had held a hearing in 1981 on a bill to require labeling of sodium, predicted that the voluntary approach was “almost certainly doomed to failure.”23 And he was right, partly because it is impossible to get several hundred million consumers to read labels carefully before they buy a bottle of salad dressing, bag of chips, or can of soup, and companies did not experience much pressure to lower sodium levels. Stronger medicine was needed to help cure the sodium problem.
At Gore’s hearing, Representative Robert Walker (R-PA) objected to a labeling bill, telling me when I was testifying, “I’m a little concerned about a process that has a Big Brother approach.” I responded, “I don’t like Big Brother any more than you do. But I find when I want to eat processed foods that the salt content is dictated by another Big Brother—or Big Aunt—Betty Crocker.”24
Even Commissioner Hayes said at Gore’s hearing, “I have made it abundantly clear [to food industry executives] that if sufficient positive action is not forthcoming, I would feel compelled to pursue a mandatory solution.”25 (Jumping ahead for a moment, in 1986 the FDA found that only about half of foods had sodium labeling;26 I’m not aware of any report that measured changes in the number of new lower-sodium foods or the sodium content of existing products.)
Representative Gore’s bill attracted broad support from fellow Democrats and such groups as the American Heart Association (AHA), American Association of Retired Persons (AARP), and American Medical Association (AMA). But to get a vote on the House floor, the bill first had to be approved by the Health and the Environment Subcommittee of the Energy and Commerce Committee. Chairman Henry Waxman and Gore thought they had the votes, but then the food industry turned the screws.27 A congressional aide reported that the AMA’s resolve dissolved when “the food industry reminded the doctors that the AMA didn’t like being regulated any more than it did.” And industry lobbyists expressed their displeasure directly to members of Congress. In particular, Campbell Soup and Procter & Gamble reportedly persuaded two key Democratic congressmen (James Florio and Thomas Luken), who represented the districts in which those companies were headquartered, to drop their support. Waxman acknowledged the obvious: “We are having difficulty getting the votes to pass this legislation because of industry pressure.”28 The bill was withdrawn in 1982.
In 1982, Hayes spoke at a conference sponsored by the AMA. “It is clear,” he said, “that we as a society and we as health professionals must address the sodium issue, and we must do it now.”29 In a formal statement, the FDA acknowledged that it “agrees with [the SCOGS GRAS review] that ‘a reduction of sodium chloride consumption by the population will reduce the frequency of hypertension.’”30 It also acknowledged that setting limits on sodium “would accomplish the desired goals” of reducing hypertension. But the agency rejected setting limits “because the Commissioner believes that a voluntary program will produce the desired results with less regulatory burden.” The FDA issued an ultimatum: “If no significant progress occurs toward these goals in a reasonable time, the agency will consider additional regulatory actions.” But the FDA did little over the next three decades.
The FDA, under the leadership of a hypertension expert, had an opportunity to save thousands of lives, but in 1982 it denied both CSPI’s labeling and “limits” petitions.31 The FDA said it would defer any action on the GRAS status of salt until it saw whether labeling and voluntary actions would reduce sodium to safe levels. As a consolation prize, however, in 1984 it at least required any foods with nutrition information on their labels or foods that were fortified with extra nutrients—about 30 percent of the dollar value of foods regulated by the FDA—to include sodium along with calories and other information.32
In the face of the FDA’s denial of its petitions, in 1983 CSPI, represented by attorneys at the Georgetown University Law School, sued the agency. We contended that the FDA failed to fulfill its legislative mandate by not requiring sodium labeling and not setting limits on sodium in processed foods. The next year, however, the FDA persuaded the court to set aside the lawsuit so the agency could see whether sodium labeling did, indeed, lead consumers to choose lower-sodium products and companies to lower sodium levels.
The food industry wasn’t going to just sit around when salt was in the crosshairs of the public health community and the FDA was expressing concern about salty diets. In the 1980s, Frito-Lay, a division of PepsiCo, tried a new strategy: shift blame from too much sodium to too little calcium. In a memo labeled “Frito-Lay’s confidential information,” Frito-Lay’s Bob Lin reported that David A. McCarron (a key figure in chapters 3 and 6), then a professor at the University of Oregon Health Sciences Center, had asked for funding for work aimed at showing that calcium, not sodium, was the key dietary culprit in causing hypertension. Lin wrote, “An effective promotion of ‘Calcium Antihypertension Theory’ may release the pressure on sodium for the time being.”33
Lin recommended giving McCarron a grant of $10,000 to $20,000 ($26,500 to $53,000 in 2020 dollars) and cooperating with the Salt Institute, thinking that the resulting research could provide “powerful ammunition” for the company. But Lin presciently warned, “I don’t believe proper calcium intake can prevent/ameliorate most types of hypertension, so even if the ‘Calcium Theory’ campaign is successful, the [sodium] issue will come back in the long run.” Lin also criticized McCarron’s own research: “From [a] scientific point of view,” he said, “there is much to be desired. . . . There are potholes.”34 And, in fact, during a phone call Lin told me: “I doubted that McCarron was a real expert on salt and hypertension, and knew that he downplayed the link between them.”35 Lin did not recall whether McCarron actually conducted a study, but McCarron certainly publicized the notion that calcium, not just sodium, was a major cause of hypertension.36 (McCarron did not respond to my requests for an interview.)
Speaking more broadly, Lin believes that industry has fought so hard against effective government actions to reduce sodium consumption because of a basic philosophical principle. PepsiCo (and presumably other industry giants) “fight against any government intrusion into business freedom.”37 That would apply to salt reduction, food labeling, pollution controls, and many other matters. But internally, Lin was trying hard to reduce salt in Frito-Lay products. He tested techniques including using finer salt crystals and using electrostatically charged salt particles that would spread more evenly on chips and increase the salty sensation.
To say that progress was slow in the 1970s and 1980s would grossly overstate the pace of change. One likely reason was that the FDA was afflicted by a severe case of conflicts of interest. The revolving door between the food and drug industries and the FDA spun faster than a carousel on amphetamines: a commissioner left for the drug industry, a deputy commissioner became the vice-president of the food industry’s major trade association, the head of the foods division came from a food manufacturer and left to become an industry consultant, another head of the foods division joined the soft-drink industry’s trade association, the head of nutrition left for a major candy company, and one chief lawyer went to the vegetable-oil industry while another came from and went back to a law firm representing food and drug companies. Such officials molded the mind-set and decisions of the agency.
After the court put CSPI’s sodium lawsuit in abeyance, and the voluntary labeling program was in place and without apparent effect, CSPI sought other ways to educate people about sodium. We began a decade-long effort to win passage of a law that would require more informative food labeling with fewer deceptive health and nutrition claims. Thanks especially to Representative Waxman and Senator Howard Metzenbaum (D-OH), that effort culminated in the 1990 Nutrition Labeling and Education Act, the law that requires nutrition labels on almost all packaged foods. The list of labeled nutrients includes sodium. The restaurant industry, however, “vociferously opposed” the legislation unless restaurants were excluded, which they were (unless they made deceptive health and nutrition claims).38
Nutrition Facts labels have been invaluable to millions of consumers who are watching their intakes of sodium, calories, cholesterol, or other nutrients, but they have not led to the kinds of improvements we had hoped to see, either in the nutritional quality of foods or in shoppers’ choices. A decade after it became law to label processed foods with Nutrition Facts, Americans were still consuming the same amount of sodium. So in 2005 CSPI focused once again on sodium. We published a report, “Salt: The Forgotten Killer,”39 and sued the FDA for never taking final action on our 1978 petitions to revoke salt’s GRAS status and limit sodium levels in foods.40 Back in 1984 when the court denied CSPI’s initial lawsuit, District Court Judge June L. Green ruled that the FDA “must make a decision on the GRAS status of salt” after its voluntary programs “have been in effect for a reasonable period of time and FDA has had an opportunity to assess their impact.”41 Twenty years certainly gave companies and the FDA that “reasonable period of time,” yet over those years, sodium consumption hardly changed. Unfortunately, the court ruled that our petition had gathered 27 years’ worth of dust and we would have to file a new petition with the FDA, which we did later in 2005.42 The new petition highlighted the voluminous medical research that had accumulated in the intervening years. This time the world seemed more ready to listen. (Except, of course, the irrepressible Salt Institute, which told the FDA: “There is no justification to change the GRAS status of salt. . . . Prudence dictates that we tread very carefully in any consideration of a change in the regulatory status of salt to ensure that we do not do the population more harm than good.”)43
Though the scientific evidence of salt’s harmfulness had become even more decisive, federal officials continued to avoid taking bold actions to protect the public’s health. Amazingly, in 1990, long after the “Dietary Guidelines for Americans” and other authoritative publications stated that too much salt increases blood pressure, the FDA’s Vanderveen (who had become the full-fledged director of nutrition) said, “There is no conclusive evidence that salt consumption causes hypertension. It’s only a hypothesis.”44 And when the officials took any action, it was minimal and had no effect on consumption. Mounting effective regulations and hard-hitting educational campaigns was beyond the pale for FDA officials. The basic reasons were obvious: industry opposition and costs.
FDA officials were not the only ones who failed to tackle sodium. The USDA regulates the labeling and safety of meat and poultry products ranging from pork chops to frozen pepperoni pizzas, which contribute about one-fifth of the sodium we consume. To encourage action in that arena, I met with several top officials in 2005 to express my concerns about sodium.45 But when I said that salty USDA-regulated foods, and implicitly the USDA, were responsible for thousands of premature deaths every year, it was like waving a red cape in front of a bull. Dale Moore, the Secretary of Agriculture’s chief of staff, was outraged and stormed out of the meeting. Richard Raymond, the Under Secretary for Food Safety, responded dismissively, “people will eat what they’re going to eat” and should just read labels. So much for action by the USDA.
But, as Alexander Pope wrote almost three hundred years ago, “hope springs eternal in the human breast.” I continued to harbor hope that the United States government would protect the public. The next chapter explains the latest developments.