This week, as revelers around the world make their New Year's resolutions, one item is at the top of just about everyone's lists: "This year," we tell ourselves, "I'm going to eat right." The truth, though, is that we don't want to eat right. What we want is to eat whatever we feel like, in whatever quantity we want, without gaining weight or clogging up our arteries. And food producers are delighted to cooperate: supermarket shelves overflow with diet soda, sugar-free candy and, in recent years, fat-free cookies, crackers and snacks of all descriptions. Some of them may taste like chemical-flavored cardboard, but for millions of diet-conscious consumers, they're better than practicing self-control.
Olestra, however, could make guilt-free eating a pleasure. It doesn't just substitute for fat. It is fat, with all the flavor-enhancing, palate-soothing smoothness of corn or canola oil. And unlike any of the half a dozen or so fat substitutes currently available, olestra doesn't break down when it's used for frying. That means fat-free potato chips, French fries and maybe even Cajun feasts that taste like the real thing could someday be available to the general public.
They could become available, that is, if the U.S. Food and Drug Administration lets Procter & Gamble put products cooked with olestra on the market. This month, after decades of study and deliberation, that decision should finally come down. Last spring a group of senior FDA scientists concluded that olestra could safely be used in chips and other nonsweet snacks. In November, after four exhaustive days of meetings, most members of an FDA-appointed food advisory committee agreed.
Now there's just one more hurdle: FDA commissioner David Kessler has to give final approval before olestra-based snacks can be sold to the public. But while commissioners almost always go along with their scientists' and advisory committees' recommendations, Kessler is weighing this one with special care. Olestra could become a staple in the diets of tens of millions of Americans, so it's crucial that it be safe. Moreover, nearly a third of all Americans are obese, and the combination of high-fat diets and extra weight contributes to heart disease, high blood pressure, diabetes and several types of cancer. If olestra could help drive down fat consumption, it could literally save lives.
The financial stakes are enormous as well. P&G has already invested $200 million in developing, studying and testing olestra. If the FDA approves, the company plans to use the fat in its own chips and snacks under the trade name Olean and sell it to other food producers as well. The annual market for all these olestra products could be worth $1 billion within 10 years.
But olestra isn't totally benign. It can trigger intestinal cramping, flatulence and loose bowels. It keeps the body from absorbing some carotenoids, nutrients that may lower the risk of cancer and heart disease. In its original formulation, it also reduced the absorption of vitamins A, D, E and K and caused a condition delicately referred to as "anal leakage." And while most other artificial food additives are eaten by the milligram, olestra would be gulped grams at a time, making it what nutritionists call a "macroingredient"--it would, for example, account for about one-third, by weight, of every potato chip.
For all these reasons, many consumer and health groups--including the American Public Health Association, the National Women's Health Network, the American Academy of Ophthalmology and Ralph Nader's Center for Science in the Public Interest have come out against approval. Despite scores of clinical trials in animals and humans and hundreds of thousands of pages of studies, they argue that no one can be certain that olestra won't be a danger to public health. Besides, says Michael Jacobson, cspi's executive director, "we don't need olestra potato chips. It's crazy to add a substance to the food supply that makes people sick."
Whether olestra is needed isn't the FDA's concern, however. Like all food additives, fat-free fat falls under the federal Food, Drug and Cosmetic Act of 1938 and the food-additives amendment of 1958. According to those laws, olestra can be approved if it carries a "reasonable certainty of no harm" when used as intended. If olestra really makes people sick, as Jacobson and others assert, the agency might well reject it. But after much fretting over the precise definition of harm (and diarrhea as well), a majority of advisory-committee members decided that while the gastrointestinal and nutrient-blocking effects may be inconvenient and even unpleasant, they're almost certainly not harmful.
Even so, Kessler is taking no chances: he is currently having FDA scientists go over data one last time before he issues his decision. Drugs are generally used for a prescribed length of time by sick people who are willing to take some risks to feel better. Food, by contrast, is something everyone consumes every day for life. Thus, says the commissioner, decisions on food additives "are among the most important the agency makes. There's an enormous responsibility to be thorough and to be vigilant." Acknowledges Wayne Callaway, a George Washington University nutrition expert who chaired P&G's scientific review council on olestra: "I'm very sympathetic to the FDA. They're in a very tight position because if they're wrong, everyone knows about it."
THAT'S ONE REASON WHY THE process of getting olestra approved has taken nearly a quarter-century, a pace some in the food industry consider outrageously glacial. It was way back in 1959, in fact, that biochemists at P&G's Miami Valley research campus, near Cincinnati, Ohio, began trying to understand how the body digests fat. In particular, they were trying to identify a kind of fat that premature infants might digest more easily.
The scientists already knew that fats belong to a class of compounds known as esters, which are made from acid molecules linked with alcohol molecules. So they started tinkering with the number of fatty acids that could be attached to a molecule of alcohol. In the process, they made an unexpected discovery. In laboratory animals, an ester composed of an alcohol and one fatty acid was pretty well digested and absorbed. But two fatty acids were better, and three were better still. The chemists reasonably assumed they could keep adding more.
Wrong. As soon as the scientists added a fourth fatty acid, the digestibility and absorbability of the compound decreased. Five fatty acids decreased it further still. And six fatty acids, attached to a molecule of sorbitol, a sweetish alcohol used in food products, made the compound completely indigestible.
That seemed pretty interesting, so the scientists started casting about for cheaper off-the-shelf compounds that had characteristics similar to their rather expensive sorbitol construct. They eventually came up with sucrose polyester, a class of compounds that sports as many as eight fatty acids crowded around alcohol groups that hang, in turn, off a ring of sucrose molecules. By contrast, the naturally occurring fats known as triglycerides include just three fatty acids.
Why does the body digest and absorb triglycerides but not a sucrose polyester such as olestra? Both types of molecule, explains P&G chemist Ron Janacek, are too large to pass unaltered through the mucous membrane of the small intestine and into the bloodstream. With triglycerides, an intestinal enzyme known as lipase acts as a kind of molecular scissors, fitting into slots between the fatty acids and snipping them apart. But when there are too many fatty acids clumped too close together, as happens with olestra and other types of sucrose polyester, these slots are concealed and the enzyme cannot do its job.
Although olestra passes through the intestines undigested, its effect in the mouth is like that of any oil. Oils have a strong chemical affinity for the aromatic compounds that give food its taste and smell; they extract these substances, spread them around the taste buds and waft them up to odor receptors in the nose. Oils derived from plants sometimes have aromatic compounds in them to start with, which is why olive oil, for example, has a distinctive flavor. Others, such as canola oil--and now olestra--have no taste of their own.
Like natural oils, olestra also has a creamy, tongue-pleasing texture. "From a sensory standpoint," observes Adam Drewnowski, director of the Program in Human Nutrition at the University of Michigan, "foods that are rich in fat are pure taste and pleasure." The fact that humans get such pleasure from fat-filled food is believed to have its roots in evolution. Primitive hunter-gatherer societies had unpredictable food sources; those with a taste for calorie-rich fat were thus more likely to survive.
In the beginning, remembers P&G's Janacek, "there was certainly not a groundswell to develop olestra as a product. It was more like, 'This is a curiosity. Let's see what we can do with a zero-fat fat that has the look, taste and feel of normal fat. Can we make chocolate ice cream with it? What else can we do with it?'" Plenty, as it turned out. "We tried out all kinds of foods, and this material was just a perfect substitute for fat," says Fred Mattson, a member of the original research team and now a professor emeritus at the University of California at San Diego. "It made cakes very nicely. It made pies. And when we heated olestra and added potatoes, we got fine French fries."
The company soon realized it had a potential blockbuster product. So in 1971--the year Procter & Gamble took out its first patent on sucrose polyesters as substitutes for fat in foods--the company started talking with the FDA about filing a formal petition to approve its use. Officially, a review of a food additive is supposed to take 180 days. In fact, most take three to six years, partly because the FDA has an informal policy not to reject an application out of hand. The FDA requires exhaustive studies before it will approve a new food additive. But, says William Schultz, its deputy commissioner for policy, "petitions sometimes come in very unsatisfactory shape, and we tend to work with the companies and tell them what studies they need."
With olestra, the process was even more complicated because no one had ever come up with a food additive that would be used in such large quantities. Normally, for example, the agency requires toxicology tests in which animals eat 100 times as much of the stuff as humans ordinarily would. But that would have required rats to eat a diet composed entirely of olestra--and would have killed them by malnutrition.
So instead of 180 days or even six years, the agency and the company have batted olestra back and forth for the past 21/2 decades. At one point early on, P&G switched to calling olestra a drug rather than a food; it seemed to lower blood cholesterol in test subjects, and the company thought it might have a better chance at getting the go-ahead that way. As it turned out, the oil didn't do a good enough job to win approval as a medicine, so P&G went back to its original strategy.
In 1987 the company submitted a formal food petition. P&G's initial application proposed using olestra not just in chips and other salty snacks but also as a major additive in commercial cooking oils. The petition set off FDA requests for more studies. Finally, to expedite the process, the FDA in 1990 asked P&G to narrow its request to such snacks as chips.
The company agreed, partly because it would have been prohibitively expensive to market the oils along with the snacks, and partly because the FDA tends to be most comfortable taking one step at a time. Aspartame, for example, the sweetener better known by the trade name NutraSweet, was first approved for use as a table-top sweetener. As new petitions were filed, other uses were added. "There is always the potential to go back to the FDA," observes Chris Hassall, P&G's associate director of regulatory and clinical development. And indeed, that is precisely what industry observers expect the company to do.
BY LAST FALL, P&G HAD GENERated some 150,000 pages of studies--12 shopping carts' worth--and in November most of the FDA's 23-member food advisory committee holed up in a Holiday Inn in Alexandria, Virginia, to sift through the results. During a four-day marathon session, committee members and outside experts considered scientific reports from P&G and from the independent cspi and heard presentations on toxicology, nutrition and labeling. They grilled P&G's representatives. They interviewed outside consultants. And they listened to consumer and public-health activists. Says panelist Fergus Clydesdale, head of the food-science department at the University of Massachusetts at Amherst: "Every corner was heard from, every study was looked at and everyone had an opportunity to speak." Kessler himself was there for the last two days, peppering the panel and the witnesses with questions and reminding committee members more than once of what they were and were not there to decide.
A few points were settled without much argument. The panelists agreed, for example, that olestra is nontoxic. They agreed it has no effect on the body's absorption of vitamins B and C. They agreed it does not significantly interfere with the action of most medications.
Early in the testing process, however, P&G had uncovered some potentially disturbing side effects, including one that could have sunk olestra all by itself. "We had a great deal of trouble," says the University of California's Mattson, "with what we called anal leakage." In its original formulation, olestra was so light and liquid that it went straight through the digestive tract and out the other end, staining the underwear of those who ate foods made with it.
Mattson had also realized the novel concoction could cause vitamin deficiencies. While vitamin C, for example, is water soluble, vitamins A, D, E and K all dissolve in fat and enter the bloodstream by hitching a ride on the fat molecules that are naturally present in food. These vitamins latch on to olestra just as easily, though, and when that happens they sail through the digestive system.
P&G argues that it has addressed both of these problems. To counteract anal leakage, company scientists tinkered with olestra's molecular structure, making it a bit more viscous. That didn't eliminate leakage entirely, but that's not surprising, since a small number of people have the same problem when they eat too much fat of any kind. P&G dealt with vitamin blockage simply by pumping extra vitamins into olestra-based foods. Its molecular appetite thus sated, the olestra cannot absorb additional vitamins from food.
The majority of committee members found P&G's answers persuasive, even after cspi's Jacobson took the floor to describe a hypothetical college athlete who finds his boxers stained and as a result is subjected to the gibes of his comrades in the locker room.
Things got trickier when the group got to carotenoids. Usually found in carrots, cantaloupe and such leafy, dark-green vegetables as spinach, this family of more than 500 nutrients may help keep the immune system healthy and prevent prostate cancer, lung cancer, heart disease and macular degeneration, a common vision impairment in the elderly. Some carotenoids are fat soluble, just like vitamins A, D, E and K, and olestra vacuums them out of food just as efficiently.
Yet P&G isn't planning to fortify olestra with carotenoids. Its reasoning: the link between the chemicals and disease prevention is merely suggested, not proved (and a recent Finnish study hinted that beta carotene, the best-known carotenoid, may actually promote some cancers). Besides, says the company, depletion can happen only when olestra and carotenoids are consumed at the same time. People don't usually eat potato chips with broccoli or crackers with cantaloupe. Although some panelists were troubled by the carotenoid question, citing a single recent study on sucrose polyesters that says eating as little as 3 g of such fat substitutes can deplete some of the body's carotenoid levels by up to 40%, the majority agreed that it isn't likely to be a health problem as long as olestra is confined to snacks.
Ultimately, though, the experts spent much of their four days of meetings focused unflinchingly on the intestines. They discussed legal definitions of the harm that might be caused by diarrhea. They talked about excess gas. They discussed the "tactile properties at the sphincter." Some panelists even shared their own bowel habits. A few days later, at Thanksgiving dinner, recalls Mary Wang, a senior scientist with the California Department of Health Services, "everybody gave me a bad time when I told the story of all those competent scientists who spent two days talking about diarrhea."
But olestra's final approval may hinge on just such scatological questions. Clinical diarrhea is a potentially dangerous condition accompanied by loss of liquids, loss of important electrolytes (chemicals that help electric signals move through the nervous system) and, often, gastrointestinal inflammation and poor absorption of proteins and carbohydrates. P&G asserts that olestra clearly does not cause diarrhea in that sense, and after hearing from several gastroenterologists, most panelists agreed.
It's equally clear, though, that the fake fat can trigger cramps, flatulence, bloating, loose stools and a condition called "fecal urgency"--the need to go right now. Unpleasant? Yes. Annoying? Absolutely. But harmful? Again, P&G says no. The company trotted out a study in which 3,357 men, women and children, all heavy snackers, were encouraged to nibble as much and as often as they wanted. Half got olestra-based snacks, the others got conventional junk food. The result: 2.5% reported gastrointestinal problems with olestra, while 2% had trouble with ordinary snacks. In a parallel study of 904 kids under age 10, 1.7% had digestive symptoms with olestra and 1.5% without it. Not only are these differences statistically insignificant, but those who felt some discomfort on olestra didn't reduce their intake as a result.
ULTIMATELY, SAYS PANELIST Bruce Chassy, head of the food-science department at the University of Illinois at Urbana-Champaign, "it all boiled down to a semantic question: 'What do you mean by harm?'" As Kessler took pains to make clear, the committee had to limit its ruling to the narrow question of whether olestra could be reasonably assumed to be harmless. And at the end of the last day, each member of the food advisory committee offered his or her opinion. Three recused themselves because of conflicts of interest. Five said no. And 15 said yes, with the understanding that olestra products would be labeled with warnings about possible gastrointestinal side effects.
The outcome disappointed but did not surprise olestra opponents like cspi's Jacobson, who has called it "the first food additive with negative nutritional value." Says he: "It's a very dangerous precedent. It means don't worry if something causes uncomfortable feelings. You have to have permanent, serious damage before the FDA considers barring it."
Jacobson and others also reject the notion that fat-free fat will help Americans lose weight. Says Dr. Michael Hamilton, director of the Duke University Diet and Fitness Center: "NutraSweet was heralded as the great savior for the overweight, but studies have shown that people who eat foods with NutraSweet eat something else to compensate for the lost calories." Indeed, since 1981, when NutraSweet was introduced, the Centers for Disease Control report that U.S. obesity rates have increased. And while olestra-based products will be fat free, they'll hardly be zero-calorie, a subtlety that may be lost on some consumers. Some of Nabisco's SnackWell's cookies are already fat free; as a result, says Thomas Hoban, a professor of sociology and food science at North Carolina State University, "people have a tendency to eat a lot more of them."
What really concerns olestra's opponents, though, both on and off the panel, is that it's impossible to know what will happen when olestra makes the leap from small-lab studies to more than 200 million potential consumers who may eat it daily for years. Among the longest-duration studies P&G submitted was one lasting 39 weeks; its subjects were pigs. "It's appalling," fumes opponent Dr. Walter Willett, chair of the nutrition department at Harvard's School of Public Health. "They want to give something to my kids on the basis of studying pigs."
Even those who favored approval acknowledge that olestra could result in some nasty surprises. The University of Illinois' Chassy, for example, is still concerned about the fat's effect on carotenoids. As long as olestra is limited to snack foods, he thinks it probably won't cause major problems. But he's not absolutely certain. "Three or four years from now," he says, "we might want to review olestra again."
Many experts believe that if Kessler decides to give the go-ahead to olestra, he may stipulate just such a re-evaluation. That's what happened in 1993, when the FDA approved BST, Monsanto's genetically engineered hormone that boosts milk production in cows. It required the company to report back in two years on the chemical's effects. As Kessler puts it, "There is this notion that up until the day we approve a product, the food or drug or device is unsafe. And all of a sudden, the day we approve a product, it's safe forever more. That's not the way science gets the data."
Part of the anti-olestra faction's upset stems from the nature of the FDA's mandate. As Kessler reminded the panelists several times during the proceedings, their only task was to decide whether they were reasonably certain that olestra was harmless. Says the commissioner: "It was very important to me to make sure that everyone on that advisory committee understand that framework. The questions were not, 'Does this product make sense? Does this product contribute to the nutritional health of the nation?' That is not the standard."
But maybe it should be. Panelist Henry Blackburn, a professor of public health at the University of Minnesota, thinks federal standards aren't stringent enough. "Drugs have to produce evidence of benefit, but food supplements do not," he points out. He is also troubled by the fact that the FDA has no money to do its own studies and thus has to rely almost entirely on research done by the petitioners. cspi's Jacobson too is concerned that responsibility for demonstrating a food's safety is shifting to the wrong hands. He notes, "Judging from the FDA's handling of olestra, it appears that to prevent approval, there would have to be absolute proof that a food additive is harmful. It shifts the burden of proof from the company to the public." He also points out that several panel members have worked as consultants to the food industry. (The FDA counters that representatives from industry add important expertise to the committee, and that those with conflicts of interest are required to recuse themselves.) And he wants the FDA to stop cooperating with corporations to get all their petitions approved; instead, he says, the agency should simply reject poorly prepared applications out of hand.
Do Americans really want more protection than they already have from food additives? Or would they rather be free to make their own choices? While Kessler hasn't tipped his hand, it's likely that under the current law, he'll probably have to let P&G bring fat-free fat to market and let consumers decide its fate. Chef John Folse, who runs a food-products company as well as his restaurant, thinks he already knows the answer. "If people have the option of going to the grocery store and choosing from 10 oils, one of which is olestra," he predicts, "olestra will fly off the shelves."