Eating Your Medicine
The Battle Over Superfoods
Michelle Stacey, Simon & Schuster, New York, London, Toronto, Sydney, Tokyo, Singapore, 1994
Humans have optimistically looked for medicinal value in foods for millennia: garlic as an antibiotic, yogurt for longevity, various herbal teas as cure-alls. Researchers can now foresee a more perfect answer: foods that are almost indistinguishable from drugs. A super-beta-carotene carrot might fight lung cancer; specially formulated sausages fortified with large amounts of omega-3 oils or other natural substances might prevent heart disease. But such rejiggering of nature’s basic recipes has ended up raising some unexpected and fundamental questions about the identity of food itself.
What, exactly, is the true definition of food? What do we want from it? Is it simply fuel, or medicine to prolong life? What happens when we attempt to redefine food, to designate other uses that extend far beyond sating and pleasure? Even superfoods’ keenest promoter, a man who is working to make such hybrids legitimate, betrays a sense of what is lost when food and medicine become one.
Dr. Stephen DeFelice has been trying to pin down the meaning of the word “food” for more than ten years. In 1983 DeFelice, a specialist in drug research and development, organized a conference at the University of Medicine and Dentistry of New Jersey called “Natural Substance: When Nutrition, When Drug?” in which a group of doctors, scientists, and attorneys attempted-and failed-to come up with a precise definition of food. Three years later he wrote about his search in From Oysters to Insulin: Nature and Medicine at Odds, a book in which he urged greater research into the medical uses of natural substances. He has combed dictionaries, and he has taken into consideration the legal definition of food established by the Food and Drug Administration (which is a combination of the obvious and the unexpected: “1: articles used for food or drink for man or other animals; 2: chewing gum; 3: articles used for components of any such article”). None of these efforts has yielded an answer. Instead, says DeFelice, most experts are ambushed by circular reasoning: Food consists of nutrients; nutrients nourish; to nourish is to provide with food.
Correcting this fuzzy thinking has become something of an obsession with DeFelice, especially since March of 1991, when he began actively trying to change the official identity of food; or, to be exact, of some foods-those formulated to prevent or cure disease in the eater. These might be called foods of the future-others have called them superfoods or designer foods-and DeFelice contends that their existence demands a new way of thinking about what food really is.
He described this idea to me over lunch, pausing at one point in midthought to consider how to improve the taste of the escarole before him. Knife in one hand, he carefully placed a substantial dollop of butter onto a forkful of escarole cooked in garlic and chicken broth. “Here, try this,” he said, holding out the loaded fork. “Now, with more garlic, I can make it better than this. . . mm, love it!” We were sitting in a booth at Aperitivo Restaurant, on West Fifty-sixth Street in New York-the kind of midtown Italian restaurant that looks like it hasn’t changed in twenty years: comfortable banquettes along the wall, pink linen tablecloths, artwork of dubious pedigree highlighted on the walls, waiters in white aprons who finish off pasta dishes in a movable chafing dish pulled up to your table. DeFelice has been coming here since the week the restaurant opened in 1968.
An energetic man in his fifties, DeFelice brings a lot of enthusiasm to things gustatory. “For me, eating is the total experience,” he said. “This place may not have the absolute best Italian food in town, but eating isn’t just the food. It’s the ambiance, the people, the whole experience of being there . . .” And, in fact, the process of ordering from the expansive menu so enchanted him that after we had made our choices he proclaimed, “I love to eat and drink!” He ordered a bottle of Pinot Grigio, and soon we had worked our way through the asparagus parmigiana (“They put a lot of butter, parmigiana, and bread crumbs on it-it’s good!”), and began to seriously address our spaghetti carbonara (eggs, bacon, cheese), sole sauteed in bread crumbs, and the escarole. DeFelice, after advising me on how to eat my pasta (“Take it from the edge, where it’s cooler-that’s where all the good stuff collects, too”) and telling the waiter to grate more cheese over it, reminisced about the family dinners of his childhood in an Italian enclave of Philadelphia. “Big meals-soup, meat, potatoes, salad, vegetables,” he said. “It varied every night. We had red meats, fish, liver, kidneys, everything. We didn’t worry about it. So now, when people talk about pork without fat, chicken breast with no skin. .. I like the dark meat! What do they serve in every restaurant? The damn breast, the dullest part of the chicken. It drives me nuts. And I want the skin-good stuff! I’m not a laborer, I don’t eat just to survive-I eat for pleasure. Guys who don’t eat any meat-we used to call those men sissies in my old neighborhood. My friends in Italy, when they have a pork chop they eat the whole chop-the fat, the whole damn thing. And the rate of heart disease in Italy is much lower than it is here. The argument against meat is so weak. I eat one steak, am I in jeopardy? Where’s the data to say that? What people don’t take into account with this worry about food is happiness. Everybody talks about heart disease, but there’s a thing called happiness. I like living. I get up each morning, and I look forward to my work, to eating, talking to people. So I eat my cholesterol, and maybe I’ll die four months earlier. I’d rather die four months earlier-four years earlier-than be a vegan, who doesn’t eat meat or even dairy products, all my life. Life is wanting to live! Hey, I bet if you do a survey and ask people, ‘If you could enjoy the pleasures of food and die three years earlier, or not enjoy the pleasures of food, which would you take?’, they’d probably give up the pleasures of food, but I wouldn’t.”
As a scientist, and as an eater, DeFelice is a man of some ambiguities. Professionally, he is working to push food into the next century; personally, he’s more steak and fries than New Age. Yet he appears completely sanguine about any contradictions between his championing of superfoods and his desire to see food purely as a source of pleasure. His work has made him literate in the new language of selfdenial-low-fat, low-cholesterol, high-fiber-but it has also introduced him to an arena where science collides with folk medicine, and where the desire to rethink food impinges on the simple act of enjoying eating it.
DeFelice refers to the confusion that currently engulfs the whole business of food and health as nutribabble, and it is tempting to see him as an embodiment of that confusion, or at least of some paradoxical thinking about food. Nutri-babble has a certain resonance when it comes to DeFelice’s personality as well. He talks fast, almost telegraphically, words and ideas jumping ahead of each other, leaping into completely different subjects without pause, and as he speaks he leans in close to make his point. In the manner of a politician, he can sometimes manage to answer a question that has not been asked while skirting one that has been but the irritant quality of that habit is tempered by an occasional wry self-awareness and frequent booming laughs. Full of theories and full of opinions, DeFelice operates along the edges of government, science, and the food and drug industries, both in his primary occupation as a consultant to drug companies and in his work with superfoods, which is an avocation-something he believes in but that brings in no money. His goal is, simply, to make superfoods legitimate, in the eyes of both the government and the scientific community, and to encourage their development by private industry.
Describing what exactly superfoods are is not easy, partly because not many of them exist yet. A superfood might be a vegetable juice formulated to prevent reproductive cancers in women, or a salad dressing or a bread made with ingredients that help prevent heart attacks. The identity of superfoods is so broad that DeFelice has come up with a new word for them: “nutraceuticals.” His coinage grew out of his impatience with the existing definition of food. “You cannot define the difference between a food and a drug; it’s impossible,” he told me. “The Food and Drug Administration defines it legally: Food is something you eat, but once you make a claim that it works medically, it becomes a drug. What we have now are dietary supplements, brews, teas, extracts-all with claims for medical benefits. Are these foods?”
Not surprisingly, the solution to this problem-not a medical or scientific solution, but a linguistic one-occurred to DeFelice as he was lingering over a meal. “1 was in Rome on business a couple of years ago,” he said, and I was drinking sambuca and thinking about this: Here we have nutrition but with a pharmaceutical use. Let’s call it a nutraceutical. Let’s create a word for this huge market, because the food and drug industries are going to be blurred in the future; people are going to eat their medicine. Everything from designer foods to dietary supplements to juices to ginseng tea. So I wrote an article about this new word, and now it’s in the lexicon. There are nutraceutical meetings. It was in Food and Wine, as a new food buzzword. You know what that tells me? It’s a need; people see it.”
Having invented the word, DeFelice has earned the privilege of defining it, which he does as follows: “Any substance that may be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease. Such products may range from dietary supplements, diets, and isolated nutrients to genetically engineered ‘Designer’ foods and processed foods such as cereals, soups, and beverages.” He offers as examples of substances that he feels already qualify as nutraceuticals or potential ingredients in nutraceuticals such nutrients as niacin (shown to help prevent subsequent heart attacks in coronary patients), calcium (to treat hypertension or osteoporosis), vitamin A (to treat measles), and garlic (to reduce atherosclerosis). Those substances might be consumed in supplement form, incorporated into a food mixture (like a sausage), or concentrated in an existing food by means of biotechnology; DeFelice’s example of this is “an engineered carrot, a fortified carrot.”
DeFelice exhibits enough media savvy to understand the appeal not only of new words but of officialsounding names and acronyms. He has designated his effort to legitimize nutraceuticals the Nutraceutical Initiative, and in furtherance of it he has created NAG-the Nutraceutical Advisory Group-made up of what DeFelice calls “top legal and medical experts” from the Harvard Medical School, Tufts University, and Memorial Sloan-Kettering Cancer Center, and including two former general counsels for the Food and Drug Administration. The specific goal of the Nutraceutical Initiative is to convince Congress to create a special regulatory agency-a Nutraceutical Commission, or NUCOM-to oversee the licensing and marketing of nutraceuticals. Taking them out of the purview of the FDA, DeFelice believes, will encourage innovative scientific research into the potential of health-promoting foods. His contention is that FDA regulations are holding back such research. “Basically, the FDA is protecting people from knowing the truth,” he said. “They’re nice people down there, but they can’t handle nutraceuticals.”
The FDA attracts DeFelice’s wrath for its bureaucratic caution, even while it has attracted applause from others for its latest effort to reform food regulations. That effort took the form of the Nutrition Labeling and Education Act of 1990, a broad mandate passed by Congress but left to the FDA to implement. The agency issued detailed proposals for how to fulfill the act in November of 1991, and after a yearlong period for review and public comment and an internecine skirmish between the FDA and the United States Department of Agriculture (which, in representing meatindustry interests, pushed for weaker regulations), the proposals were approved by the White House. The food industry has until May 1994 to relabel its products in accordance with the new NLEA rules. Those rules are designed to close loopholes in current foodlabeling regulations that have allowed marketers to exaggerate the healthfulness of their products. Thus, for example, under the NLEA rules the words “light,” “low-fat,” “reduced,” and “fresh” would be tightly defined for use on product labels; serving sizes for the purposes of nutrition labeling would be made uniform; and saturated fat, often a hidden contributor to high cholesterol levels in humans, would be required to be listed separately from other fats. And-of greatest concern to DeFelice-the FDA, after evaluating ten broader health claims for use on food labels, suggested approving four of those for general use: manufacturers could say that calcium intake may prevent osteoporosis, that sodium may contribute to hypertension, that dietary fats may contribute to cardiovascular disease, and that dietary fats may be implicated in the development of cancer. By the time the proposals were reviewed and approved, two more claims had been added: that fiber from fruits, vegetables, and grains may help prevent cancer and heart disease, and that antioxidants (such as vitamins A and C) may reduce the risk of some cancers.
“Historically, the NLEA is probably the worst thing that could happen in the field of nutrition for years, from my point of view,” DeFelice said. “The people at the FDA feel that they’re solving the problem of how to regulate food health-claims, but what they have done is to cement it. They’re closing the door to research, to innovation. They’re saying that you can make certain general claims, in certain categories-say, about low-fat diets preventing cancer. But anybody can make those claims. So if I’m a food company, I’m not going to do any research; I’m going to wait for somebody else to do the research. I’m going to spend my money on promotion instead-on selling my products. They just killed R and D. Killed it!”
DeFelice has little patience for the new crackdown on spurious food-content claims. “These regulations about the words ‘fresh’ and ‘lite’-they’re insignificant,” he went on. “That’s not the issue, that’s peripheral stuff: chicanery, hookerism! It’s always been around. So clamp down on it. Why does something like that get front-page coverage? What I want to know is what do the does say, what do the experts say, about a particular kind of cereal, and what it might do for me. What the FDA is doing is saying, ‘Shut it down; we can’t handle it. Certain categories you can make a claim, anything else we’re going to shut down.’ The people at the FDA don’t realize that the action is right before their eyes: vitamin A and measles, magnesium and diabetes, it’s happening right under their goddamn noses. Every day: cranberry juice and urinary-tract infections, in the New England Journal of Medicine. And they’re fighting this knowledge. they want to smother it. Folic acid and neural tube defects in kids-we have a new era in medicine. The FDA is not involved in innovation; they’re anti-innovation.”
Trying to influence public policy is not what DeFelice was trained to do, but he has found, over the course of a varied career, that he has something of an affinity for it. He often refers to himself as a “drug man,” and it was his work on drugs that eventually led him to superfoods, and to his public campaign on their behalf. Trained as an endocrinologist at Jefferson Medical College in Philadelphia, he entered clinical pharmacology, becoming chief of clinical pharmacology at the Walter Reed Army Institute of Research, where he worked in lieu of going to Southeast Asia after being drafted during the Vietnam War. “They pulled me out of the Army computers because I was recognized as having drug knowhow,” he said. “I was part of a whole group of doctors who’d been drafted, and I was the only one who didn’t have to go to Vietnam.” At Walter Reed he developed antimalarial and antiradiation compounds for the Department of Defense, and began his education in the big business of drug research. After Walter Reed, he spent several years as the medical director at Pfizer pharmaceutical company, learning about the industry side, then started his own research company in New York City, called BioBasics. Pharmaceutical companies would come to him to arrange testing of new drugs they were developing, and DeFelice did everything from designing the studies to having them peer-reviewed. By the midseventies, he had built his business into what he calls an “empire” at the corner of Thirty-eighth Street and Madison Avenue, employing a hundred people.
But by the early eighties, said DeFelice, “It was no fun anymore-research had become more of a legal, bureaucratic thing, all paperwork. I wanted to get back to working with ideas.” He scaled down and started working on his own as a consultant to drug companies in this country and in Europe, helping them to develop new drugs and get them approved-a style of work he says he prefers. “A drug marketer comes to me and says, ‘I want to expand in Europe and increase my sales by five hundred million in ten years); or, ‘I’m trying to deal with this company and I can’t get through to the old man’; or, ‘My research is bogged down; how can I rev it up?’ So I help them out.” DeFelice now maintains a small New York office and another in Cranford, New Jersey, near his home in Westfield, and employs only two assistants.
DeFelice’s first brush with health policy began with a research project in 1964, while he was pursuing a fellowship in clinical pharmacology at St. Vincent’s Medical Center in New York, on the effects of carnitine on hyperthyroidism. DeFelice quickly became fascinated with carnitine, a compound that occurs naturally in the human body and is vital to cell metabolism. After several years of clinical testing in animals and humans, often conducted on his own time and with his own money (most of it borrowed), DeFelice became convinced of carnitine’s efficacy in treating several health problems, from shock to angina pectoris and other heart ailments. The most debilitating of these was a littleunderstood and difficult-to-diagnose condition called simply carnitine deficiency, which affects children and is usually fatal if untreated. But when DeFelice attempted to obtain FDA approval for the use of carnitine as a drug, making it available by doctors’ prescription, he came upon a bureaucratic snafu: Because carnitine was a natural substance already available in health food stores as a dietary supplement, no pharmaceutical company would fund DeFelice’s new-drug application for its clinical use. There was no economic incentive for obtaining a patent to produce and market carnitine for prescription only when anyone could already buy it on the cheap. DeFelice was surprised to find that he would have had better luck with a completely new, artificial drug molecule that a company could easily patent and to which it could retain exclusive marketing rights; as it was, the FDA required just as stringent testing of a natural substance for approval as a drug, but without the promise of exclusivity.
DeFelice’s long struggle with the drug-approval process eventually made him an activist. In 1976, still working on carnitine, he created what he calls “a nonprofit educational organization” that he named the Foundation for Innovation in Medicine. Its first focus was to help push for passage of the Orphan Drug Act, so called because it gives economic incentives to encourage research on drugs that combat rare diseases and are thus unprofitable to develop and market. The act was passed by Congress in 1984, and in 1985 carnitine was approved as an orphan drug, based on an application prepared by DeFelice and funded by an Italian company, Sigma Tauw, which now dispenses carnitine by prescription (carnitine is still available in health-food stores, but Sigma Tauw has the exclusive right to offer it by prescription and is the only company authorized to make health claims on its behalf). The Foundation for Innovation in Medicine still serves as a backdrop for DeFelice’s policy efforts, and until now has run mainly on his own money and on contributions from friends both in and out of the health industry. “Mostly European industrialists,” DeFelice said. “The people who’ve contributed to the nutraceutical push had no vested interests in it-they’re friends, contributing as a favor to me.” That may change, however; DeFelice is thinking of seeking commercial sponsors of his nutraceutical initiative.
The carnitine experience spurred DeFelice to expand his thinking beyond the world of drugs. “The promise of nutrition started to hit me-an old drug man,” he said. “The public sees the possibilities, but the does don’t. There’s misinformation out there, but the public really wants to know. What I felt from my experience was that regulation drove out the innovators, the bright guys.” DeFelice’s carnitine experience also gave him the idea to structure his nutraceutical commission on the Orphan Drug Act, which not only loosens somewhat the scientific requirements for a company’s new-drug application, but also grants a seven-year period of exclusivity during which no other company may market the drug. “That act said, look, there is no economic incentive to develop drugs for these diseases, because the regulations for a new-drug application require too large an investment; it doesn’t pay to fund the application. So our nutraceutical commission will diminish the requirements for a new-drug application, and we will give you seven years’ exclusivity for your claim. You don’t have to do all those studies that the FDA requires before a drug can be marketed. You do a few studies, show some reasonable data, we’ll give you exclusivity. In the twenty or thirty years before the Orphan Drug Act was passed, only about twenty orphan drugs were approved. Since the act, over three hundred have either been approved or are in the hopper, the itand-D pipeline. It works, the exclusivity issue.”
DeFelice’s nutraceutical initiative would end up having as much to do with business as with science. According to DeFelice, the problem with nutraceuticals in this country, and the reason he needs to champion them, boils down to this: Food scientists are rapidly approaching the technological capability to create these superfoods, but they are not allowed to market them. Or, to be more precise, superfoods can be sold, but not as superfoods, because the government does not recognize any such entity. A superfood manufacturer is allowed, on his food label, to say what his product is but not what it does; he may not tout its health benefits. And why, asks DeFelice, should anyone go to the trouble of creating such specialized products if he cannot earn an extra dollar by making them special?
After we ordered our dessert at Aperitivo-espresso, raspberries soaked in Grand Marnier, and for DeFelice a cigar, chosen delightedly from a selection proffered at our table-he sat back and laid out for me how his nutraceutical commission would resolve this impasse. “Since the FDA considers any food a drug once you make a medical claim about it, if you want to make that kind of claim you have to enter the drug system,” he explained. “Well, the average cost of getting a new drug approved is two hundred million dollars, because of the extensive testing that’s required. So if I wanted to say that cranberry juice helps cure urinary-tract infections, I’d have to submit a new-drug application, and funding the necessary studies would cost so much that once I had it approved I’d have to charge, say, a dollar for my cranberry juice. Well, the guy next door is going to laugh, because he can charge ten cents. He didn’t spend the two hundred million dollars, but he can use my claim, because I have no protection for it. What we have is a non-research-driven nutrition industry.
“The FDA has created a big vacuum. Look at the drug system. How do we learn about drugs? The pharmaceutical companies sponsor the research, they have it published in the journals, they go to tell the does about it, the does learn about it before the public does. You get rid of the charlatans that way. Well, this is what I want in the food industry. I want a company that does research to be able to submit a claim to a nutraceutical commission made up of experts who review it. If that commission says that your data support the fact that magnesium lowers hypertension in diabetics-two or three clinical trials, something reasonable-then you would get exclusivity on that claim for seven years. This will create a boom, a research-and-development-based nutrition industry. It’s as simple as that. You’ll get the mainstream science out of the laboratories and to the people.”
At a juncture when the FDA is very publicly tightening regulations on what food marketers can say on their packaging about the health benefits of their products, DeFelice is galloping in the opposite direction. But he feels that his timing is on the money: “I’ve sort of hit the right moment in history,” he said. “We’re in a flow where the old systems are breaking down. I’m saying, Hey, let’s create a new thing in medicine like the biotech revolution, or like orphan drugs. We’re at a point in history where people are asking questions. They want the benefits of nutrition. And we have the technology now to move ahead.”
* * *
It is said that Marcus Porcius Cato the Elder, Roman statesman of the second century B.C., was convinced that cabbage had special medicinal effects, and prescribed it for his wife and son when they fell ill with fever (the cabbage did not save their lives, but that did not shake his faith).’ Garlic has been a favorite cure in many cultures, including the Egyptian, Roman, Greek, Chinese, Japanese, and Indian An Egyptian medical text from 1500 B.C. prescribes garlic for headaches, throat problems, and weakness, among other ailments, and folklore holds that the builders of the pyramids were fed large amounts of garlic to keep up their strength. Pliny’s Historia Naturalis suggested a garlic cure for sixtyone different illnesses, including asthma, ulcers, tumors, and consumption; Hippocrates held that it worked against digestive upsets and uterine tumors. Garlic has also been prescribed, in the last two thousand years, to prevent heart disease and rheumatism (in India), to treat high blood pressure (in China and Japan), and as an aphrodisiac (sixteenth-century England). As recently as World War II, the British were using garlic to prevent septic poisoning and gangrene in battle wounds. (2)
Garlic has one of the richest histories of medical use, but many other foods have been credited as therapeutic, including fish (for rheumatism, arthritis, gout, pulmonary consumption, and as “brain food”); ginger (for nausea, whooping cough, fever); grapes (liver and kidney ailments, fevers, tuberculosis, dyspepsia); yams (for rheumatism, arthritis, colic, asthma); and yogurt (for bowel problems, senility, and to promote longevity). (3) An article in the August 1896 North American Review, entitled “How to Prolong Life,” describes how to eat for longevity and has this to say about the apple in particular: “The apple is such a common fruit that few persons are familiar with its remarkably efficacious medicinal properties. Everybody ought to know that the very best thing they can do is to eat apples just before going to bed. The apple is excellent brain food because it has more phosphoric acid, in an easily digestible shape, than any other fruit known. It excites the action of the liver, promotes sound and healthy sleep, and thoroughly disinfects the mouth. It also agglutinates the surplus acids of the stomach, helps the kidney secretions, and prevents calculus growth, while it obviates indigestion and is one of the best preventives of diseases of the throat. Next to lemon and orange it is also the best antidote for the thirst and craving of persons addicted to the alcohol and opium habit.” (4)
Before this century, foods (and herbs as well) were put forward to prevent and cure disease for one reason above all: There was not much else to choose from when it came to easing suffering or warding off infection. The first vaccine-for smallpox-was invented in 1796, but vaccination was not practiced widely until late in the next century. Penicillin, the first antibiotic, was discovered in 1928, and came into use in the United States in 1940. Surgery was a painful and extremely risky affair before about the middle of the nineteenth century, when anesthetics and sterile hospital procedures were introduced. The practice of medicine was in large part guesswork; some would argue that it still is, but at least we have more tools at hand. The drug industry grew explosively in the first half of the twentieth century (aspirin was developed in 1893, phenobarbital in 1903, novocaine in 1905, insulin in 1921, sulfa drugs in 1935, streptomycin in 1944), and as it did the role of food shifted, becoming simpler and more fun. Curing could be left to the pharmaceuticals; food, besides sustaining life, could provide entertainment.
That thinking began to change again in the 1960s and 1970s, spurred this time by fear; the emerging environmental movement and the awareness of pesticides and preservatives that accompanied it made the words “all natural” the most popular phrase on food labels. Health food stores began to prosper, as consumers became suspicious of food additives and more open to the notion of certain foods as healthgivers. But the big leap, according to DeFelice, occurred in the mid-1980s, with what he calls, in his shorthand fashion, “calcium-fiber-fish oil.” “Calcium-fiber-fish oil changed the history of American medicine, not because of their particular value but because they made nutrition legitimate,” he said. “For the first time, doctors joined the nutrition revolution Without the doctors, who would believe it? Clinical data were published in reputable journals – The New England Journal of Medicine, The Journal of the AMA – and the health food industry was transformed forever. Instead of this mom-and-pop business- where it was really just the consumer and the proprietor figuring out what to eat-suddenly the doctors were involved, saying calcium may be good for you, fiber may be good for you. That to me was one of the biggest historical changes in medicine.”
It was a change that, in DeFelice’s view, left the FDA playing catch-up. Even as the media abetted this shift in medical knowledge, reporting on study after study that linked food and health- high-fat diets may cause breast cancer, fiber may prevent colon cancer, green tea may block the action of many carcinogens, oat bran may lower cholesterol and thus help prevent heart attacks- the FDA’s official stance on how food manufacturers might use such information remained cautious. But in the context of the FDA’s own history, that caution is not surprising.
The first laws to regulate the marketing of foods offered for sale in the United States were passed almost a century ago, when Congress approved the Pure Food and Drug Act of 1906. That act, enforced by the Bureau of Chemistry of the USDA, did not have as its primary focus health claims on foods; the greater problem with food at that time was purity, while it was the drug business that specialized in false claims for health benefits. The market was flooded with ersatz drugs, often called patent medicines-for instance, syrups for babies that contained narcotics. The food industry, similarly unregulated, was producing adulterated and unsanitary goods: Pickles and peas were often colored with copper salts, baking powder could contain ammonia, vinegar might include sulfuric acid. Conditions in meat-packing plants, described in stomach-turning detail in Upton Sinclair’s novel The Jungle, were filthy. In 1927 the Food and Drug Administration was created within the USDA and took over enforcement from the Bureau of Chemistry; a year later Congress passed a revision of the 1906 guidelines called the Food, Drug, and Cosmetic Act, which remains the FDA’s charter, with amendments added as food technology has evolved. For decades the FDA’s position on health claims for foods was very clear and essentially unchallenged: Making a medical claim for a food item made it legally a drug, and the FDA would demand that either the claims or the product be removed in the absence of extensive testing for safety and efficacy. (5) The agency has the power to issue “cease and desist” orders against violators, or even to seize goods and bring the sellers to court, but usually the offending manufacturer quietly withdrew, unwilling to risk unflattering publicity.
That tidy system collapsed in 1984, in the midst of a general retreat from regulations on business in the Reagan era. In that year, the Kellogg Company started a new marketing and advertising campaign for their All-Bran cereal, featuring the headline: “Finally, some news about cancer you can live with.” The copy, carried in print ads as well as on the back of the cereal package, went on to urge a high-fiber, low-fat diet as a way of preventing cancer, naming as a source the National Cancer Institute; the presumed message was that eating that particular cereal would ward off cancer. Here was a hefty health claim for a food, and the FDA decided to allow it. In fact, the agency decided to use it as a test case, assigning two of its consumer science specialists to conduct a study of “the effects of a health promotion advertising campaign on sales of ready-to-eat cereals.” (6)
The FDA’s compliance was not completely unexpected. The agency had been widely criticized for several years for the strictness of its health-claim regulations-especially in light of a growing body of scientific evidence, some of it the result of decades-long epidemiological studies, of the connections between diet and the prevention of chronic disease. The All-Bran experiment signaled the FDA’s ambivalence, the first loosening of the bonds, but if the agency’s leaders had expected a slow, careful expansion of health claims, what they got instead was an avalanche. The agency had tacitly acknowledged that the old regulations were too restrictive by backing off from enforcement, admitting in the summary of the All-Bran study that its policy of discouraging the use of health claims on food labels was “currently under review by the agency.” But no new rules were yet in place, and marketers responded with a free-for-all-high-fiber doughnuts marketed as health food, cereals with minute amounts of oat bran touted as cholesterol-busters. The FDA’s actions since then have been somewhat confused. The agency has issued new proposals for regulating food health-claims almost every year since 1987. Some excited so much confusion and resistance that they never made it beyond the proposal stage; others led eventually to the passage of the Nutrition Labeling and Education Act of 1990 by Congress, and to the proposed new rules that were hotly debated, almost derailed by the USDA, and finally approved by the White House in December of 1992.
The day after the first NLEA proposals had been released for public comment, in November of 1991, I spoke with Fred R. Shank, the director of the FDA’s Center for Food Safety and Applied Nutrition. “Health messages are new to us, and we’ve opened the door,” he said. “Are we satisfying everyone? Probably not. But at least we’re saying that health messages on food labels are possible today. Eighteen months ago we weren’t saying that. So it’s an evolutionary process. Science is the limiting factor.’,
I asked for his opinion of DeFelice’s idea for a nutraceutical commission to deal specifically with foods that purport to have medicinal value. “Separate commission-that’s ridiculous!” Shank replied heatedly. “I mean, we’ve got foods here, we’ve got drugs here. And therefore, we should have the expertise to deal with the labeling, safety, and efficacy of those types of substances, once they are ready to be marketed. We don’t need a separate commission, we need more science.”
The “safety and efficacy” issue mentioned by Shank is at the heart of the FDA’s approval system. When agency scientists consider a drug for approval, they split their investigations into two categories: tests for safety, and tests for efficacy. Is it safe, and does it work? When those standards are applied to foods that carry a health claim, it becomes clear why the FDA disapproves of DeFelice’s proposals for a special commission to handle nutraceuticals.
“Basically, he would like the best of all worlds with the least interference,” I was told by one FDA scientist. “Drugs require proof of efficacy and safety, but you can sometimes trade off safety against efficacy; for example, a drug like AZT, which is used to treat AIDS, can have serious side effects-that is, it can be less safe than we would like-but the condition it treats is itself so treacherous that the drug is worth approving. But foods must be safe, period. They are not being used to treat someone who has a fatal disease. We have no basis for risk benefit when we approve a claim for a food-it must be safe. But these people would like looser requirements for safety, and looser requirements for efficacy as well. And drugs are administered under medical supervision-something that would not be true of these foods. This idea of a separate system is driven by an unhappiness with having to follow the law in either category that currently exists, food or drugs.” Questions of testing, of risk, and of benefit, are likely to be central to the future of DeFelice’s nutraceutical initiative-and, by extension, to the development and marketing of designer foods in general. The American public may be, as DeFelice claims, eager for the advent of nutraceuticals, but it has also shown itself to be extremely averse to risk; consider, for example, the public response to nuclear power after the accident at Three Mile Island, and to apples treated with Alar. The public support of the FDA’s crackdown on exaggerated health claims on food labels also suggests that consumers may not want to give superfoods a shortcut to respectability.
DeFelice’s rebuttal to the FDA’s reservations relies on what he considers to be common sense. In discussing questions of testing for safety, he pointed out that nutraceuticals are natural substances that man has consumed for centuries; a certain level of safety can be assumed to have been proven. And his standards for efficacy would be looser than those of the FDA precisely because nutraceuticals are not drugs. On the question of how much testing to require, he favors a policy of flexibility. “What’s enough evidence?” he asked. “My commission might say, with regard to one nutraceutical, ‘Give us another study.’ Use the experts, case by case-every case is different, from flaxseed bread to chicken soup to extracts from a lizard’s gizzard. So a food manufacturer will come to the nutraceutical commission with his scientific evidence-you would have some kind of formality for screening the applications-and you send the evidence out to the experts in that particular field, and the experts send back their opinion. The commission can overrule them, if there’s a compelling reason. The commission may say, ‘You must do more work, more studies.’ Or it may say, ‘This is so novel, so new, that it must be treated more as a drug; you’ll need two years’ toxicity studies.’ Because the product is so concentrated, say-or because the animal data doesn’t look good. But handle it case by case.” DeFelice also feels that testing can be less rigorous if the health claim itself is qualified. “Put the qualifications on your label,” he said. “Say ‘There is some evidence that this product may be beneficial.’ ‘May’-that’s all you have to say. ‘This may help prevent lung cancer.’ You don’t have to say ‘does.'”
But there is a problem here-one that even DeFelice acknowledges: It is very difficult to claim results when you are dealing with diseases that take decades to develop and may be caused by any number of environmental or lifestyle factors. Much of the evidence that indicates a preventive connection between diet and disease, for instance, is based on animal research-studies that may or may not be applicable to human beings. The question of whether or not a concentrated extract of celery juice that reduces mammary tumors in rats will do the same for women at risk for breast cancer will take years to answer. And even studies using humans-whether they are long-term epidemiological surveys that look at entire populations or shorter-term clinical trials that look at “markers” for cancer in a group of people at high risk for the disease-are often subject to wide-ranging interpretation. DeFelice himself is wary of epidemiological studies because they are so speculative. But he is nonetheless comfortable allowing a claim for efficacy that seems reasonable, even if all the evidence will not be in until sometime in the next century. What the FDA sees in such a shortcut, however, is a potential policy nightmare-a chaos of claims on everything from cookies to frozen pizza, the kind of thing DeFelice calls “hookerism.” When FDA scientists and spokesmen talk about protecting the consumer, they are talking about protecting people not only from ingesting dangerous substances but from misleading claims from purveyors of modern-day snake oil in the form of super-beta-carotene muffins.
DeFelice reads more than simple protectiveness into the FDA’s actions, however; he sees the agency’s hesitancy in the context of what he considers to be a larger pattern of conservatism and tunnel vision in the scientific community. What we are thinking about food these days, he says, is based on very sketchy and inconclusive research, but that research is being presented as received wisdom. The result, according to DeFelice, is a nation of scientific followers afraid to challenge one another’s thinking, and a nation of fearful and pleasure-starved eaters. “We’re very paranoid and, let’s say, desperate about what we eat,” he said. He sees his nutraceutical commission as a way to throw open the windows and bring in fresh, unbiased ideas about food and health-and perhaps, paradoxically, free us to eat more pleasurably.
This is where DeFelice’s philosophy makes its greatest stretch, leading, improbably, from the superfood revolution back to spaghetti carbonara and pork chops. His reasoning runs like this: the economic incentive provided by the bylaws of the nutraceutical commission will foster, as a byproduct of the rush to create marketable super foods, a much greater volume of research that will eventually answer all of our questions about eating and disease, presumably without the preconceived notions that he feels currently grip the scientific establishment. The ascendancy of nutraceuticals could, in this blueprint, also obviate the need for self-denial-hence DeFelice’s refusal to give up his dark meat and pork fat. Perhaps, in DeFelice’s view of the meal of the future, an appetizer of superjuice to prevent heart disease and cancer will clear the decks for a main course of steak and baked potato with sour cream.
Meanwhile, he is keeping his distance from many of the current ideas about food that are being disseminated by what he calls the “Savonarolas” of the scientific establishment (based on the fifteenthcentury Italian monk and religious reformer whose faith never wavered, even when he was burned as a heretic). DeFelice’s Savonarolas are hard-liners whose almost religiously held assumptions would, presumably, be challenged under a more entrepreneurial system. “Take the fat story, because the fat story is an example of what happens under the present FDA system, where entrepreneurial research is not being encouraged,” said DeFelice. “The fat story was created. The does believe it, everybody believes it. If I get up in a meeting and say to my colleagues that the dangers of dietary fat are overrated, they’ll come down on me. Now, I know that they don’t know the data. The data clearly say that we don’t know enough yet about the connection between dietary fat and disease. The data say that there’s an association between fat intake and illness in a small percentage of people. But we’ve made a lot of neurotics over this fat issue. The French eat more fat than we do, and they drink a lot, and they have less cardiovascular disease. Why?
“There’s some really irresponsible medicine out there. Some of these advocates want to start taking fats out of kids’ meals. But what’s a high source of energy? Fat, when you’re young. Fat delivers more calories per molecule than carbohydrates do. So they took bologna out of all the kids’ diets. Bologna! You know, kids are not getting heart disease. We’re finding that about eighty percent of the kids who had high cholesterol when they were seven or eight years old were normal by the time they became teenagers. You don’t see that headline, right? And what are you doing to that kid’s totality when you lower his fat intake? What are you doing to his mood, his energy? They’re experimenting with kids-it’s scary. But the advocacy out there-and the media don’t attack these guys, they join ’em. The does join ’em. It’s becoming an industry.
“Take the cholesterol thing. I could introduce you to three top guys, all widely respected guys in the lipid field, epidemiologists, you couldn’t get any higher than these guys-they will say to you that this fear of cholesterol is ridiculous. Ridiculous to the degree to which the message has been pushed, that is. There might be a certain percentage of people who have trouble with choles terol, but not everyone does. These researchers used to get up in meetings to say this. They’re not doing it anymore, though, because they’ve been blasted. If they go public, they’re crucified. We have an intimidation system: You can’t say anything bad about the cholesterol story, and you can’t say that fat is good. Cholesterol is a very important ingredient in the body, you know-one of the most critical. But no one ever says, ‘Don’t eat too many low-cholesterol foods, because it could be bad for your health.’ Here’s my problem with this. Say there are risk factors associated with a condition like having high cholesterol. The next question is, what do you do about it? If you modify your diet, is that a help? That’s where the data are weak, in fact nonexistent. And if you do lower your cholesterol, does it make a difference in when you die? No one knows this. It may be that only five percent of the population has to worry about dietary intake of cholesterol raising their blood cholesterol levels. But lowering dietary cholesterol is what’s been sold, and that’s what I’m against. The selling of that idea to the media, to academicians, with nonpeer data. This whole epidemiological area-handling large numbers of patients-it’s very tricky. Even the experts disagree. Epidemiologists are like economists; you can look at their data from various points of view. It could be that diet is not that important. There could be other factors-the water we drink, or our emotions . . . the mind’s never considered. All the great philosophies say that mind affects body, but we don’t always look at mind factors. Maybe most of the people with high cholesterol who die from heart disease are the ones with depression. Maybe the French are happier than we are, and high cholesterol doesn’t kill them. We don’t know-that’s what I’m getting at. And we’re never going to find out, unless industry gets in there and starts paying money to do the studies.”
One of DeFelice’s favorite examples of the fallibility of the current theorizing about food and health-and of the way ideas about food quickly become truths in the eyes of the public-involves the Eskimos and heart attacks. The first suspicions that omega-3 fatty acids helped prevent heart disease emerged from studies of Eskimos, who consume large amounts of fat in the form of blubber and yet have much lower rates of heart disease than other Americans. Researchers began looking at the ingredients of the fat that Eskimos consumed and isolated omega-3 fatty acids, which they theorized had a role in protecting the heart. “The thinking is that Eskimos don’t get heart attacks because of omega-3,” said DeFelice. “Well, I could tell you it’s because they don’t have telephones. And that’s not a joke. Have you heard of silent ischemia? Ischemia is lack of oxygen to the heart. Angina pectoris is a lack of oxygen too, but you feel the chest pain, you take a nitroglycerin and it dilates your arteries and does other things, and everything is fine. With silent ischemia you get no oxygen to your heart but you don’t get the chest pain, so there’s no signal. This is more prevalent than so-called noisy ischemia, where you do feel the pain. So they did a study of silent ischemia. When do you get it? Of course, you get it when you’re exercising, but you are more likely to get it under psychological stress. The telephone is one of the major causes of silent ischemia. I’m serious now. The reason Eskimos don’t get heart attacks up there is that they don’t have telephones. Telephones cause ischemia, in our culture. I could say there’s more evidence that telephone calls cause ischemia than that fish oil gets rid of it. But people have just closed their minds.”
DeFelice sat back, empty espresso cup before him. “Nobody talks about pleasure-the need for it,” he said. “The does aren’t telling them, the government’s not telling them. Enjoy yourself. Nothing like good friends, good food, a bottle of wine Don’t say that fat has to be bad. Look at the French, the Italians-they’re doing all right.”
By this time, it felt like we had traveled far from supercarrots, but in DeFelice’s complicated philosophy it is all one. All of these quandaries-the need for superfoods, the intransigence of the FDA, the overselling of the fat and cholesterol stories, Americans’ loss of pleasure in eating-has a common cure: “an R-and-D-based industry,” a phrase DeFelice repeats almost like a mantra. He sees himself not exactly as a guru but as a catalyst, a global thinker who will set the new nutraceutical industry on the right track. “I create, as Thomas Jefferson said, the mighty wave of public opinion,” he declared. “The word ‘nutraceutical’ is out there now, people are using it.” But as we pushed ourselves away from the table and prepared to leave the restaurant, it seemed clear that, despite the food-as-drug implications of his nutraceutical revolution, DeFelice has a keen sense of what is lost when food and medicine become indistinguishable.
Six weeks after our lunch at Aperitivo, DeFelice held a press conference in New York to present and discuss his white paper outlining his proposed nutraceutical commission. The conference was, appropriately, in a room just off the restaurant in the Omni Berkshire Hotel, with a couple of tureens of coffee set up and a view of scurrying waiters preparing for the lunch rush. It was the week before Christmas, and DeFelice’s turnout was small: reporters from three food-industry publications, and an interview scheduled on the Cable News Network later in the day. This is not the “mighty wave of public opinion” DeFelice was anticipating, not nearly the level of interest that had been generated earlier in the year when he had released his new “nutraceutical” word. Then, his press conference had attracted about sixty reporters, and he had ended up being cited in stories in Vegetarian Times, Longevity, and Health, and had fielded calls from the TV show “20/20” and the New York Times.
At this press conference, he launched gamely into his presentation, but as it wound down, DeFelice became candid about the difficulties he is up against, acknowledging that his push is a one-man show. “There are vested interests against this, in the drug companies,” he said. “I went to the supplement people, the vitamin people, to get their support, but they don’t want to get behind this. They’re afraid of change-of what new regulations might mean.” Many of the questions from the reporters present focused on safety and efficacy problems. As the meeting neared its end DeFelice admitted: “If the media doesn’t buy this, I go away. The media’s got to buy this for it to work. But this is my hobby, not my life.”
A few weeks later, I talked again with DeFelice, who was refusing to admit discouragement at the response to his white paper and press conference. “The first press conference got a big reaction, when I introduced the whole nutraceutical concept, but this was just a briefing-almost a rehash, just showing how we can implement the nutraceutical commission. This is all germinating. We got some newspaper stories going-in Dallas, San Francisco; the Wall Street Journal is interested. You see the word nutraceutical all over the place. But it’s in limbo. I want to have a big media event next winter, have the Europeans and Japanese there, a big conference on the promise of natural substances, with audience participation. I’m good at running that, a think tank with the audience and a panel-a Socratic event.” He also talked more about directly lobbying Congress-“not me, I’m not a lobbyist, it’s not my temperament. But we need to find a leader down there, someone who knows his way around the Hill.”
It has occurred to DeFelice that he is ahead of the game, but he sees that only in terms of international competition. “The Europeans and Japanese are competitive with us, and they’re ahead of us in nutraceuticals, but nobody in the drug and food industry sees their head start as a threat,” he said. “They’re beginning to see the danger of lagging behind-they’ll listen now-but they don’t really see it.” He has not extrapolated any further, to question whether the ordinary eater is ready to think of food as a collection of medicines. When I asked him about the future of food by any definition, he responded with a neatly packaged philosophical precis. “This is my theory now-you ready?” he asked. “Food has taken the place of God. Short term, religion is no match for technology. Religion has taken a beating, with the technological revolution. So God is gone, and food has replaced God. These people who are always talking about their diet, they don’t want to die. So there’s a hunger for the medicinal value of food. They want everything-give me pleasure, sex, drugs, food-and they don’t want to die. Everybody’s scared of it. I don’t want to die, either. But I ain’t gonna live my every goddamn day thinking about dying.”
For DeFelice, food has already been transformed; all we can do now is try to catch up to it, and manipulate that transformation into a shape that makes sense to us. As we talked, it became clearer that for him, superfoods will take the shape of a tablet: dietary supplements. Many supplements exist already, of course, composed of substances that some researchers feel prevent cancer and heart disease and other ailments: fish-oil tablets, fiber supplements, calcium pills, even beta-carotene tablets. But their labels cannot contain any claims for potential health benefits, for the same reason that nutraceuticals cannot make claims: a health claim would make the tablet a drug in the eyes of the FDA (dietary supplements are legally considered foods), subject to all the testing necessary for drug approval. (Many supplement-manufacturers step around these restrictions by making what are called `’name claims,” devising product names like Lung Care Tab, Masculine Drive Tab, and Cell Guard.) “Bottom line, it’s not in the meal you sit down and eat,” said DeFelice, “it’s what you supplement over and above a normal diet-like a designer food, but also like vitamin C.”
“When you talk about supplements, it sounds more like a drug than a food,” I remarked.
“See, there you go!” DeFelice crowed. “Forget about your definitions. What is it? Create a new category, don’t get involved with whether it’s a drug or a food. If you read the medical journals, you see that all the action is in dietary supplements- carotene, calcium, vitamin A. That’s where it’s happening. But the FDA is going to release some new guidelines soon on the regulation of supplements, and they’re going to try to put a clamp on any kinds of implied health claims. They want to limit dosing, they want to limit distribution, and this and that. I might get some media impact there, some publicity for the nutraceutical initiative.”
He was already working over some related ideas that sounded like the next challenge for the Foundation for Innovation in Medicine, after nutraceuticals: the need for more freedom to conduct clinical trials (studies using humans rather than animals) for drugs and nutraceuticals. “The other evening I was sitting in a little cabin I own up in the mountains in New Jersey, and I was looking out at the beavers in my pond, and at the deer, and having a martini,” DeFelice said. “And I was thinking, the FDA has really blocked the innovator when it comes to clinical trials. You need big bucks, you need a drug company or NIH to do clinical trials anymore. And you don’t discover anything medically unless you test it in people. Betacarotene, fiber, fish oil-all that means nothing until you put it in people and you show that it works. That’s where the FDA has interfered the most.”
DeFelice was giving himself another year to finish launching nutraceuticals. “Then I’m going to back off,” he said. “Go on to other pursuits. The momentum’s there. It’s on the table. And the word’s in the lexicon. I’m a media guy-I put the message out to people. The nutraceutical revolution has arrived. It’s here. It’s just not legal yet.”
Reprinted from Consumed: Why Americans Love, Hate, and Fear Food, Simon & Schuster, New York, NY. Copyright (c) 1994 by Michelle Stacey