Nutrition Action Healthletter
April 1999 — U.S. Edition

Cover Graphic
Millions of Americans already eat functional foods. They routinely start their day with folate-enriched toast (to prevent birth defects and protect their hearts) washed down with calcium-fortified orange juice (to strengthen their bones). Sometime soon, they’ll be able to slather that toast with a margarine that lowers cholesterol.
   For lunch, some may have a bowl of pea soup spiked with St. John’s wort (hoping to prevent depression) and a glass of apple juice with echinacea (hoping to ward off the sniffles). In between, they may chew on a gum made with phosphatidyl serine (hoping to slow memory loss).
   What’s wrong with adding vitamins, fiber, herbs, and extracts to foods that ordinarily don’t contain them?
   Maybe nothing...if research shows that they’re safe and that they work. Unfortunately, there’s no guarantee of either.
Functional Foods
By Beth Brophy & David Schardt

In a sense, functional foods have been around since the 1920’s, when iodine was added to salt to prevent goiter. That begat vitamin D milk, which begat “flour,” which begat kava kava snack chips, soups with added enriched echinacea, teas with added ginseng, and gummy bears with added vitamins.
   Functional foods are one of the fastest-growing segments of the food industry, especially among affluent baby boomers.
   In Japan, England, and some other countries, functional foods have already become part of the dietary landscape.
   Are we also slated for a future filled with Brain Gum and Nantucket Nectars Ginkgo Mango Juice?
Super Nectars    “In 1992, the U.S. market was close to nonexistent,” says Thomas Aarts, executive editor of Nutrition Business Journal, a trade publication that tracks functional foods.
   Aarts says that retail sales now top $10 billion a year, and he predicts an annual growth rate of eight to ten percent for at least the next five years, especially for milk with added vitamins, yogurt and yogurt drinks with added cultures, and juices and teas with added herbs. The typical growth rate for most food products is about one percent a year.

Food or Pharmacy?
“Within ten to 15 years, it is conceivable that people will be able to get their blood pressure medication within a food,” says Gene Grabowski, spokesman for the Grocery Manufacturers of America, a trade association. “We’ll be able to put medicine in a hot dog bun or aspirin in cake batter.
   “But we don’t want to go there,” he adds. “How would cake be regulated as a medicine?”
   Even so, Grabowski is on to something. He cites surveys by the grocery industry showing that consumers prefer to get extra nutrients in their food rather than from supplements. Some heavyweight food manufacturers agree. Kellogg, Unilever, and Pillsbury are developing—or have already started marketing—functional foods.
   For example, Kellogg has announced plans to unveil its Ensemble line of 22 functional foods in Illinois, Indiana, Kentucky, Michigan, and Ohio. The line includes cereals, pastas, frozen entrees, and breads that are made with natural soluble fiber from psyllium husk, which helps lower cholesterol.
Ginkgo Biloba Rings    But a future in which every other food in the supermarket contains a supplement doesn’t appeal to everyone.
   “My concern is that functional foods will distract people from eating healthy diets and encourage companies to market absurd products as health foods just because they contain one or another single nutrient,” says Marion Nestle, chair of the Department of Nutrition and Food Studies at New York University.
   “Let’s face it,” she adds, “functional foods are about marketing, not health. Fruits and vegetables are already perfectly adequate to help prevent cancer and heart disease.”
   Others agree. “I want my food to be food,” says Joan Gussow, professor emeritus of nutrition and education at Columbia University Teachers College in New York. “Eating should be a pleasure, not an intellectual exercise.”

The Claim Game
There’s no doubt that functional foods are changing the food supply. It’s not just that no one has ever put anti-depressants into soup or memory boosters into gum before. It’s that, for the first time in years, companies can make daring claims on their labels without anyone’s approval.
   “Consumers should recognize that no one’s minding the store anymore,” says Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest (CSPI), the consumer group that publishes Nutrition Action Healthletter. “It’s a brave new world of label claims.”
151 Bar
   Until recently, the FDA prohibited labels from claiming that a food could prevent disease. “If a label mentioned a disease, that meant the food was regulated as an unapproved—and therefore illegal drug,— explains Silverglade.
   In 1993, under direction from Congress, the FDA started approving so-called “health claims” on labels. But those claims are tightly regulated.
   “A label can say, for example, that a diet low in saturated fat and cholesterol can reduce the risk of heart disease, but only if it has the FDA’s approval and only if the food isn’t unhealthy,” says Silverglade.
   Since 1993, the FDA has approved ten health claims. But most functional-food-makers have figured out how to short-circuit the rules.
Hains Can    Instead of making a health claim, which mentions a disease, companies make claims that a food can affect the structure or function of the body. The FDA doesn’t have to approve them, and they can appear on any food, no matter how unhealthy. And they’ve gotten bolder.
   “Structure-or-function claims have been allowed on foods for years,” says Silverglade. “But they were rarely used, largely because they were boring statements out of textbooks, like ‘calcium builds strong bones.’”
   But since 1994, when Congress said that dietary supplements could make structure-or-function claims, all that has changed.
   “The supplement industry started making exciting structure-or-function claims, like ‘antioxidants can slow aging’ or ‘maintains healthy cholesterol,’” notes Silverglade.
   “Now the food industry wants to get on the bandwagon.” In fact, some functional foods—like Hain Kitchen Prescription Soups with added echinacea or St. John’s wort—even call themselves supplements, in part to make sure that the FDA won’t disapprove of their claims.
   But to most people, one kind of claim sounds like another.
   Take Kellogg’s new Ensemble line. Sixteen of its 22 foods make a health claim (“may reduce the risk of heart disease”). Others have too much fat to make that claim. So instead, they make a structure-or-function claim (“promotes a healthy heart”). Would most people notice the difference?
   At least Kellogg has evidence to show that psyllium works. For most structure-or-function claims, it’s safe to assume that no one has checked to see if there’s evidence to back them up.
   “Ninety-five percent of functional foods haven’t been clinically tested and are making claims unsupported by clinical data,” says Steven DeFelice, chairman of the Foundation of Innovation in Medicine in Cranford, New Jersey.
   Are functional foods safe? Do they deliver what they promise? You’ve got to evaluate each one on its own merits. Here are four questions to ask:


Benecol Margarine
Active Ingredient: Stanol esters, which are extracted from pine tree pulp.

The Promise: Benecol lowers cholesterol.

Does It Work? In a well-designed study sponsored by the Finnish company that developed the margarine, 102 people with mildly elevated cholesterol (235 or higher) who ate three pats of Benecol every day for a year lowered their cholesterol by an average of ten percent.1 Cholesterol didn’t fall in 51 people who were given a similar margarine without stanol esters.

The Controversy: Last December, Benecol’s U.S. distributor, McNeil Consumer Products (a division of Johnson & Johnson) said that it planned to market the margarine as a dietary supplement. That way, it could avoid having to ask the Food and Drug Administration (FDA) to approve the cholesterol-lowering stanol esters as a food additive. Additives must undergo extensive safety tests before they can be used. McNeil wanted Benecol to hit store shelves before a rival product, Take Charge—a cholesterol-lowering margarine manufactured by Unilever’s Lipton division that uses a stanol-like ingredient extracted from soybeans.
   Not so fast, said the FDA. Benecol is a food, not a supplement. In late January, McNeil arranged with the FDA to declare that stanol esters are a “Generally Recognized As Safe” food ingredient. That would let Benecol be marketed as a food without having to do food-additive testing on the esters.
   So far, the FDA hasn’t gone after other foods that call themselves supplements—Hain Kitchen Prescription Soups, for example. They all appear to be illegal. According to the Dietary Supplement Health and Education Act (DSHEA), a supplement cannot be “represented for use as a conventional food....”

Is It Safe? The company’s studies were far too small to tell. For example, if Benecol caused some harm to one out of every 100 people, the research wouldn’t have picked it up. And the studies didn’t look at what happens to people who use more than three pats a day, either because they think more will lower their cholesterol further or because they run out of other margarine.

The Bottom Line: Benecol appears to lower cholesterol levels. And despite the unanswered safety questions, it has been far better tested than the vast majority of functional foods.

1 N. Eng. J. Med. 333: 1308, 1995.

 Brain Gum
Active Ingredient: Phosphatidyl serine (PS), a fat-like substance extracted from soybeans that is also found naturally in brain cells, where it may help the flow of nerve impulses.

The Promise: Chewing Brain Gum will help most adults, especially “mature” ones, remember names, faces, phone numbers, information, and where they put their eyeglasses or keys.

Does It Work? Research suggests that PS extracted from cow brains or soybeans may help—but not cure—people who have greater than average memory loss for their age. Since age-related memory loss doesn’t strike everyone, and since not everyone with age-related memory loss responds to PS, the company’s claim that most adults would benefit from chewing Brain Gum is bunk.

The Fine Print: In the successful studies, volunteers took 300 mg a day of PS for at least a month (see “Fear of Forgetting,” May 1997, p. 3). Brain Gum’s manufacturer, KR Research Inc. of Reno, Nevada, recommends starting with 250 mg a day—six pieces of gum—for three weeks, then dropping to a “maintenance” dose of 85 mg—two pieces—a day. The bill: $60 the first month and $25 every month after. Unfortunately, no good studies have looked to see what minimum dose of PS is effective.

Is It Safe?: PS is found naturally in the body and in food (though in much smaller quantities). No long-term safety studies have been done, but researchers haven’t seen side effects when people take it as a supplement.

The Bottom Line: The evidence for PS is better than the evidence for any other “memory-boosting” dietary supplement. But it’s only been tested on people who have greater than average memory loss (not on just anybody who wants to think more sharply), it doesn’t help everyone with that condition, and it’s not cheap.

The calcium in calcium-fortified orange juice helps build bone. The folate in enriched flour helps prevent birth defects. Those are the easy ones. It’s much tougher to figure out whether the claims for other ingredients added to functional foods are backed by solid evidence. Even if there appears to be good research, the results may be inconclusive or may not apply to everyone. Take some of the most popular herbs:

. St. John’s wort. Celestial Seasonings St. John’s Wort Tea is a “Mood Mender.” And, in fact, in a dozen decent studies, the herb helped about half of all volunteers with mild to moderate clinical depression (see “Herbs for Nerves,” Oct. 1998, p.8). Of course, that means it didn’t help half the volunteers. What’s more, reliable research has never looked at whether St. John’s wort can bounce you out of a bad mood if you aren’t clinically depressed.

. Echinacea. According to its label, Fresh Samantha’s Super Juice with Echinacea is a “defender of your health.” It doesn’t say a word about preventing or treating colds or infections, since that would be an illegal health claim. So far, the only studies to look showed that echinacea doesn’t prevent colds. It did shorten the duration or help lessen the symptoms of colds in a few studies...but it didn’t in a few others (see “Echinacea,” Apr. 1998, p.8). The bottom line is that most studies weren’t designed well enough to tell.

. Kava kava. “Promotes Relaxation,” says Robert’s American Gourmet Kava Kava Corn Chips. In five good studies, the herb helped relieve symptoms of clinical anxiety like fear, insomnia, or an inability to concentrate (see “Herbs for Nerves,” Oct. 1998, p.8). But only one (so-far-unpublished) study shows that it helps bring relief from the routine stresses and annoyances of daily life.

. Ginkgo biloba. “We have followed the lead of ancient healers who used ginkgo to strengthen the mind,” says the label of Nantucket Super Nectars Ginkgo Mango juice. Unfortunately, there’s no good evidence that the herb helps improve the memory, concentration, focus, or attention of most healthy people. Research on ginkgo and memory has focused on people with dementia, usually from Alzheimer’s disease. According to a recent review of the best published studies, Alzheimer’s patients who took ginkgo for three to six months showed a small improvement in mental function.1
If a food is fortified with vitamins or minerals, the label has to tell you exactly how much or how little has been added. That’s not the case with herbs or other added ingredients. Snapple, for example, refuses to divulge the amount of ginseng it puts into its Ginseng Tea. And even when labels say how much is in each serving, most shoppers have no idea whether that’s a lot or a little.
   For example, according to its label, each cup of Peace Cereal Vanilla Almond Crisp with Ginkgo & Gotu Kola (“an Herbal Brain Power Cereal”) contains two milligrams of ginkgo leaf extract. What it doesn’t say is that two milligrams is just one or two percent of the 120 to 320 milligrams that were used as a daily dose in studies of people with Alzheimer’s.
   How do companies decide how much herb or other “functional” ingredient to add to their foods? Do they evaluate the scientific literature to determine how much is effective...or safe? Don’t bet on it.
   “We added the highest levels we could put in without adversely affecting the taste,” says Andrew Jacobson, president of the natural food division of Hain Food Group, which launched its line of Hain Kitchen Prescription Herbal Supplement soups last October.

Unlike food additives or drugs, the herbs and other ingredients in functional foods or supplements don’t have to undergo tests to see if they cause cancer, birth defects, liver toxicity, or any other serious problem.
   “People say that herbs must be safe because they’ve been used for hundreds of years,” says CSPI’s Bruce Silverglade. “Most probably are. But without proper testing, no one would ever know if an herb occasionally caused cancer, kidney damage, or other problems, no matter how long it had been used.”
   If long-term risks don’t worry you, consider some of the possible more-immediate reactions:

. Allergies. In 1998, a 37-year-old Australian woman experienced burning in the mouth and throat, tightness in the chest, hives, and diarrhea immediately after swallowing a liquid echinacea preparation.2 Her allergist found that 16 of the 84 patients he subsequently assessed with a standard skin-prick test were also sensitive to the herb. Few if any companies test their functional foods for allergic reactions.

. Drug interactions. In 1996, a Georgia man almost died after he began taking kava kava to wean himself off the prescription anti-anxiety drug Xanax.3 His doctors blamed it on the kava-Xanax combination.
   “It’s highly probable that many functional foods either block or increase the absorption of drugs, which could increase their toxicity or block their effectiveness,” says Stephen DeFelice of the Foundation for Innovation in Medicine. “We urgently need more studies on interactions between functional foods and pharmaceuticals.”

. Drowsiness. The National Nutritional Foods Association, a trade group for health-food stores and dietary-supplement makers, warns against taking kava kava if you are under 18, pregnant or nursing, or planning to drive or operate heavy machinery. But you’ll probably never run across that warning on a food label.
   “A child who eats kava chips could fall asleep on his bike and get in an accident,” says Varro Tyler, professor emeritus of pharmacognosy (drugs from natural sources) at Purdue University in West Lafayette, Indiana. “know kava has an effect on the central nervous system.”
   He advocates taking herbs, but as supplements, not in foods. “That way,” he says, “people can keep track of what they are ingesting.”

. Other problems. When you buy a drug, the label tells you not just how much to take, but for how long to take it and who shouldn’t take it. With functional foods, you’re almost always on your own.
   For example, most echinacea supplement labels caution users not to take the herb for extended periods of time. Others warn people with compromised immune systems (like those with HIV or who have undergone organ transplants) or autoimmune diseases to steer clear of it. You won’t find those cautions on Fresh Samantha Super Juice with Echinacea...or on most other foods that contain the herb.

Don’t assume that all functional foods are healthy.
   A glorified candy bar like 151 Bar, for example, may contain decent levels of a handful of its 151 “supernutrients,” but it’s largely sugar, water, fat, and protein. And water and sugar are the first two ingredients in R.J. Corr Ginseng Rush Natural Soda (“The Original Functional Beverage”).
   The bottom line: No matter how impressive-looking a functional food’s name or package claim, check the Nutrition Facts label before deciding whether it’s good for you. Fortified junk foods are still junk.
   And don’t forget Nature’s functional foods. Fruits and vegetables, whole grains, beans, and low-fat milk and yogurt are packed with nutrients or phytochemicals that may cut the risk of cancer, heart disease, high blood pressure, eye disease, and other health problems. Chips, candy bars, and cookies—even if they’re fat-free, low-salt, and contain no preservatives—can’t take the place of foods that come with no label, no advertising, and no gimmicks.

1 Archives of Neurology 55: 1409, 1998.
2 Med. J. Aust. 168: 170, 1998.
3 Ann. Intern. Med. 125: 940, 1996.
Beth Brophy is a Washington D.C.-based freelance writer.
Bonnie Liebman and Stephen Schmidt contributed to this article.
Photos: Nick Waring

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