It was a scene reminiscent of "The Untouchables." While David Kessler—the squeaky-clean new head of the U.S. Food and Drug Administration—rose to address a group of industry lawyers in Palm Beach, Florida, one April morning, his agents, halfway across the country, were moving in. "I am here today to tell you that I place a high priority on enforcing the law," Kessler reportedly told the skeptical lawyers.
But they weren't skeptical for long. Kessler informed them that, armed with a seizure action filed on the FDA's behalf by the U.S. Attorney's Office in Minneapolis, Kessler's inspectors were going after Cincinnati-based Proctor & Gamble, manufacturers of Citrus Hill Fresh Choice Orange Juice. The inspectors seized 2,000 cases of the juice, which is made from concentrate, while reporters looked on. Two days later, the company dropped the word fresh from the brand name, as did other offenders such as Ragu Foods, until then makers of Ragu "Fresh" Italian pasta sauces. Three weeks later, Kessler's FDA struck again—this time ordering manufacturers of vegetable cooking oils to remove the words no cholesterol from their labels.
Basking in lavish press praise and virtually unanimous approval from federal policy makers, Kessler is a hot commodity. In Washington, image is everything. Your public profile largely determines your power.
Kessler's good rep (Washington wags call him "Eliot Knessler") is no accident. When he came to the FDA last November Kessler knew that his 200-pound-plus body wouldn't help his image as the federal government's primary food policeman. So the 5-foot-10-inch Kessler began dieting and jogging, and by his first big public splash—the orange juice case—he was a trim 155 pounds. A fawning profile of him by People Weekly led off with the story that Kessler's 40th-birthday present from his 6-year-old son, Benjamin, was a handmade poster of Kessler in a wrestling ring facing a large carton of orange juice labeled "fresh."
In fairness, Kessler's goal doesn't appear to be self-aggrandizement . He simply understood that a high-profile campaign against a large company would help to inspire his staff and upgrade his agency's standing in the more-boring-than-usual Washington political landscape. It worked.
But the truth behind the FDA's new activism is hardly as good-vs.-evil as Kessler's rhetoric or the Eliot Ness analogies would suggest. The vegetable oils labeled "no cholesterol" had, well, no cholesterol. The FDA says the claim is still misleading because consumers might mistakenly get the impression that "no cholesterol" means "no fat" or "no risk of heart disease."
Even the Citrus Hill orange juice case isn't so straightforward. What does the word fresh actually mean? Maybe it doesn't apply to concentrate, but in the strictest sense nothing in a grocery store is fresh. Besides, the words from concentrate also appeared on the label.
At its heart, the FDA's new crusades aren't intended merely to ferret out fraud or to give consumers more-accurate information about the foods or drugs they buy. Instead, they are designed to give consumers less information, by limiting what manufacturers can say in labels or advertising. This is OK, though, because the FDA will decide what is safe, healthy, or effective on behalf of consumers. Or, at least, that's what the FDA wants you to believe.
Kessler's FDA isn't just going after food labeling. On a host of issues, ranging from prescription-drug ads to health-food regulation, the FDA is taking an activist, pro-regulation stance. The usual suspects are crowing about the end of Reagan-era deregulation (though the loved ones of AIDS patients and others who fell victim to the FDA's slow drug-approval process in the 1980s would challenge the existence of "deregulation"). In many cases, the new crusades are direct throwbacks to FDA policies of the 1960s and '70s that emphasized the inability of consumers to judge health and safety claims. Some of the most prominent issues include:
Vitamin and Food Regulation. Tryptophan is an amino acid used as a nutrient supplement by many Americans—until taken off the market by the FDA when a batch of tryptophan killed 31 Americans and made many more ill. After an investigation, the U.S. Centers for Disease Control concluded that the deaths were caused by a contaminant in a single batch of tryptophan manufactured by one company—Showa Denko—and not by tryptophan itself. But, as yet, the FDA hasn't allowed the product back on the market.
In fact, say tryptophan supporters Durk Pearson and Sandy Shaw, authors of Life Extension, the FDA is cracking down on other amino acids and foods sold as nutritional supplements. According to the FDA's definition, any food product sold with specific health claims—i.e., x will reduce your risk of heart attack, or cancer, or chronic insomnia—will hereafter be regulated as a drug.
That may sound like meaningless bureaucratese, but whether a product is considered a food or a drug makes a big difference. "If it's considered a drug, then it is almost impossible to market it," says Jack Calfee, a professor of marketing at Boston University and former Federal Trade Commission official. A manufacturer of a "drug" must conduct clinical trials costing up to $100 million per drug, produce detailed labels for the package including dosages, and survive a lengthy and expensive regulatory process. "Any nutrient is a drug under [the FDA's] definition," says Shaw, so even truthful claims about a common food product will take manufacturers into a dangerous area.
Prescription Drugs. Kessler has indicated that he will more stringently police direct-to-consumer advertising for prescription drugs, such as those for Nicorette (quit-smoking) gum and Minoxidil (the antibaldness treatment). Paul Rubin, former chief economist for the Consumer Product Safety Commission and a professor at Emory University, points out that these ads have an important health benefit—letting consumers know about new or promising treatments or even informing them about symptoms of disease they might otherwise not recognize—without any health risk. Doctors must still prescribe these drugs, after all, and they can't do so unless their patients come in to complain of symptoms or ask about new treatments.
The FDA is also cracking down on video news releases prepared by drug manufacturers. In a July letter to U.S. pharmaceutical companies, the FDA demanded to screen any video news releases prior to their use. Kathy S. Bartlett, a spokesperson for Burroughs Welcome Inc. in North Carolina's Research Triangle Park, questions the need to single out video releases when print releases go unscreened. Television stations, she says, can use editorial judgment just as newspapers do.
Food Labeling. The "no cholesterol" vegetable-oil case shows how the FDA is resurrecting a form of the intensive regulation that prevailed in the 1960s. After the American Heart Association originally announced in 1957 that people who consume less cholesterol and saturated fat had less heart disease, manufacturers tried to advertise their products as low in these substances. But the FDA nixed the idea, using the familiar argument that if manufacturers made such claims their foods would be reclassified as drugs and regulated accordingly. Only after more than a decade of battles over whether product labels could use the word cholesterol or even tell consumers to "ask their doctor" about the potential health benefits did the FDA relent.
In its latest crackdown, critics note, the FDA is harming consumers' health. A low-cholesterol diet that still includes some fats is better than a high-cholesterol diet. In general, publicizing medical findings about foods is much more effective on product labels and in ad campaigns than in scientific journals and press releases.
Claims on labels can lead to actual consumer interest in relatively healthy foods. In 1984, Kellogg's began advertising that the high fiber content of its All-Bran cereal could lessen consumers' risk of cancer. The FDA, presumably in a fit of Reaganite salutary neglect, didn't stop the campaign, which All-Bran's cereal competitors soon mimicked.
A 1989 study by the Federal Trade Commission found that cereals launched after 1984 were higher in fiber and lower in fat and salt than before. The All-Bran case demonstrated that, in cereals as in other foods, competition will occur either on the basis of health claims or on the basis of taste.
By limiting what manufacturers can tout about the product, regulators actually reduce the likelihood that there will be something—such as health benefits—to tout. If companies can't promote high-bran cereals because they're good for you, they will sell cereals that taste good, sugar-coated though they may be.
Even with these and other regulatory campaigns underway, Kessler's FDA isn't satisfied. Rep. Henry Waxman (D–Calif.), a big Kessler booster, and Rep. John Dingell (D–Mich.) have introduced a bill to expand vastly the FDA's powers to investigate, inspect, and emargo foods, drugs, cosmetics, and medical devices. Among other things, the bill would allow the FDA to eavesdrop or spy on companies without a warrant and to seize documents, such as personnel records or trade secrets.
Congressional Democrats are important allies in Kessler's campaign to police America's foods and drugs. So are interest groups such as the Public Citizen Health Research Group, a Ralph Nader–created organization headed by Sidney Wolfe which used to sue the FDA regularly. Now Wolfe meets once a month with Kessler for lengthy private discussions; "the protocol of their sessions," states The Lancet, a British medical journal, with all the reverence due a super-power summit, "provides for alternating the meeting sites between their offices."
But food and drug manufacturers are partly to blame for the FDA's new dynamism. During the 1980s, circumspect FDA regulation prompted a number of state attorneys general to go after labeling and marketing practices themselves, sometimes alone and sometimes in concert. Companies asked for comprehensive federal standards to replace this hodgepodge of state laws and rulings. So at first, even the regulated industry welcomed an activist FDA.
Unfortunately, firms have found that federal regulation by the FDA is in practice no less capricious and arbitrary than state regulation was. In a May article on FDA regulation in Advertising Age (whose own editorials welcomed the FDA back into the regulation business), Ken Feather, head of the FDA's Drug Advertising Surveillance Branch, said: "We used to say that if a company made certain changes, then we would probably not take any action. Now, we won't. Now, even if they make the changes, they might end up in court. We want to say to these companies that you don't know when or how we'll strike. We want to eliminate predictability."
Uncharacteristically for a government agency, the FDA may very well have accomplished its goal quickly and easily. No one inside or outside the food and drug industry can figure out what exactly will pass muster. The FDA "seems to be going by instinct," Calfee says. Their main argument—that truthful claims can still be misleading by not telling consumers every relevant fact—sounds reasonable, but there is neither enough space available nor sufficient advertising dollars to let companies inform consumers about every possible effect of every ingredient.
Given these limitations, advertising can still point consumers toward relatively healthy foods or persuade them to ask doctors about new prescription drugs. But apparently Kessler's FDA wants consumers to receive either perfect information or none at all. This goal may coincide with the crusading image Kessler projects, but it really isn't in the best interests of consumers.
This doesn't seem to bother Kessler. "The FDA's enforcement activities have been making headlines," he recently told a congressional committee. "Our record is excellent."
Contributing Editor John Hood is editor of Carolina Journal in Raleigh, North Carolina, and a columnist for Spectator (N.C.) magazine.
This article originally appeared in print under the headline "Washington: Eliot Knessler, F.D.A.".
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