Foods masquerading as drugs have become a $160 billion business.
ProBugs, a yogurtlike beverage for kids, is tasty, fun and good for your child's digestive system, if claims from its maker, Lifeway Foods, near Chicago, are to be believed. Sold at high-end stores like Whole Foods, it comes in flavors like Sublime Slime Lime and contains a hefty dose of 7 billion to 10 billion good bacteria that "inhibit the growth of harmful bacteria" in the gut, according to Lifeway's website. The label promises ProBugs will give bad germs "a time-out" and adds: "You can never have too many good bugs."
You'd never guess from the breathless marketing that when Lifeway tested ProBugs in a clinical trial, it failed spectacularly. In the study a daily dose of ProBugs did nothing to reduce the incidence of antibiotic-associated diarrhea in 125 young kids. Nor did it impact measures like stomach pain or missed days of school, according to the results published by Georgetown University researchers in a medical journal last August. Only the sickest kids showed a hint of a benefit.
When a drug flops doctors prescribe it less and insurers stop paying. But Lifeway continues to tout ProBugs' digestive benefits as if nothing has happened. It put out a press release about the failed study, claiming ProBugs "may have a positive effect on reducing antibiotic-associated diarrhea."
"Probiotics can help so many children," swears Lifeway Chief Executive Julie Smolyanski, referring to products containing protective bacteria. Her company, with $58 million in annual sales, doesn't have enough money to do another trial, she says. She accuses Georgetown of botching the study by confusing which patients got ProBugs and which got a placebo. Lifeway has refused to pay any more bills for the study. Georgetown stands by the findings and says Lifeway had no complaints until the results came in.
Foods masquerading as drugs are the hot spot in the packaged-food business. The world's biggest food companies are stuffing ostensibly beneficial bacteria, omega-3 fatty acids and other additives into packaged foods. They are funding clinical research in order to justify health claims--often deliberately vague--that blur the line between nutrition and medicine. The foods promise to boost immunity, protect your heart and digestive system or help you sleep. In some cases, like the ProBugs kefir, manufacturers aren't adding new ingredients but merely repackaging old foods with bold new health claims.
More than 2,000 so-called functional food brands generated $31 billion in U.S. sales in 2008, up 14% from 2006, according to the market researcher Packaged Facts. Globally, it is a $160 billion business. Sales are growing at a 7% annual clip. This includes $4 billion spent on yogurt with high doses of "probiotic" bacteria; $1.8 billion on breads and other foods with added omega-3 fatty acids; $1.5 billion on fortified cereals and snack bars; $900 million on "energy" (i.e., stimulant-containing) drinks with additives like the amino acid taurine or the herb guarana.
"We're going through a revolution in food," says Thomas Pirko, president of Bevmark consulting, whose clients include Coke, Kraft and Nestlé. "It's a whole new consciousness--every product has to be adding to your health or preventing you from getting sick." If you find the perfect additive, he adds, "you get rich."
But most of the claims "are completely unsubstantiated," says Steven Nissen, head of cardiology at the Cleveland Clinic. "Medical attention does not come from a Cheerios box." Designer foods can be a way for clever marketers to lure people away from real health foods--fresh fruits and vegetables. "It plays on our psychology," says Michael Pollan, author of The Omnivore's Dilemma. "We want to consume sugar; we want to consume fat; we want to consume salt. These products give us an excuse to binge."
Added omega-3 fatty acids don't make Sara Lee's Soft & Smooth Plus white bread into a health food. Extra bacteria don't cancel out the sugar in the yogurt. "People should be getting nutrition from real foods, not from foods that are artificially modified to give supposed health benefits," says University of Wisconsin cardiologist James Stein.
Georgetown's Daniel Merenstein wants to know which yogurt health claims are valid.
Some of the new products are far-out indeed. Nestlé sells its supplement drink Glowelle for $42 a six-pack at Neiman Marcus. It "is clinically proven to help protect skin" from moderate sun exposure, boasts its website, citing an unpublished 56-patient study. DreamWater, from Sarpes Beverages in Charlotte, N.C., is touted as "the first water that helps you relax and fall asleep." But an independent group, the Natural Standard, concludes there's "insufficient evidence" that one of its main additives gets into the brain. Sarpes Chief Executive David Lekach says the drink works for him. "All I'm doing is delivering very, very commonly bought supplements in a liquid form," says Lekach.
A minority of food additives, like dietary fiber, have solid evidence behind them. But those are the exceptions. The European Food Safety Authority started reviewing food health claims in 2006 and has rejected 80% of more than 900 proposed claims to date. Only 9 of the most recent 416 food claims passed muster. The latest loser is the French multinational Danone, maker of Dannon yogurt, which recently withdrew its application for yogurt health claims that it had been making for years.
American authorities are far more permissive. The 1930s law that created the Food & Drug Administration exempts foods from pharmaceutical-style regulation. A 1994 law allows food companies to advertise how their products affect the normal "structure and function" of the body but not treat disease. Even the FDA admits that the difference is murky: Only drugs can treat Alzheimer's, but preventing absentmindedness is a food claim. Foods can regulate digestion so long as they don't treat chronic constipation.
If drug companies made so many claims with so little evidence, "they would be fined," says Georgetown University physician Daniel Merenstein, who did the study of Lifeway's good bacteria. The FDA is starting to crack down; it went after General Mills last spring for saying Cheerios can lower cholesterol. But the FDA also makes it hard for companies that want to rigorously test foods, Merenstein says. It often insists that foods already on supermarket shelves be treated like drugs and run through a gauntlet of preliminary studies before large-scale human studies can begin. He says he recently had a drug trial approved in two weeks, while a probiotic one took 20 months.
Merenstein just finished a 638-child, Danone-funded study that showed DanActive, another yogurt drink, reduced infections by 19% in young kids. It had no effect on missed days of day care. "The question is, do these things work?" says Merenstein. Getting the answers could take years. In the meantime, here's the evidence--or lack thereof--behind the claims for some of the biggest food categories.
Even clinical-trial failures can make great marketing copy. POM Wonderful, the privately held Los Angeles maker of pricey pomegranate juice ($5 a pint), has spent $32 million funding scientific studies, including trials in 2,500 patients. "We've tried to bring modern science to bear on this ancient fruit," says POM President Matthew Tupper. "We're not aware of any other beverage supplement that has the same level of clinical research behind it."
In fact, there's not a single definitive result among studies listed on POM's website. The biggest experiment, with 289 patients, used ultrasound on the neck to test whether drinking pomegranate juice reduced hardening of the arteries in heart patients. It found "no significant difference." (The authors hypothesized that the juice may have helped sicker patients.) Other trials in prostate cancer and erectile dysfunction are more preliminary.
In February the FDA warned POM it was marketing its juice as an unapproved drug and demanded it tone down its sales pitch. The FDA cited all sorts of glowing testimonials on its site, including how the juice saved the life of a cancer patient, made mysterious lumps disappear and helped treat a heart-valve infection. POM says it's negotiating with the FDA.
Vitamins have been getting great p.r. ever since Howdy Doodyhost Buffalo Bob Smith crowed, "Wonder Bread builds strong bodies eight ways," in the 1950s. The latest fad: lacing sugar water with vitamins and positioning it as a health drink. The concept was dreamed up by entrepreneur and health nut Darius Bikoff, who started selling Vitaminwater in 1996 and sold the brand to Coke in 2001 for $4.1 billion. Pepsi ( PEP - news- people ) and other beverage companies sell competing versions.
Nutritionists declare that there is no benefit to getting more than your recommended daily allowance of vitamins. "If you ingest what you need, that's fine--and that's it," says Hans Verhagen, head of nutrition research at the Netherlands' National Institute for Public Health & the Environment. Westerners get enough of most vitamins, he says.
Excess vitamins can be dangerous. Supplement guru Gary Null claims he became severely ill after ingesting his own supplement that contained 1,000 times as much vitamin D as it was supposed to. He blames a contract manufacturer and is suing them.
But smaller doses may do harm, too. A 2007 Journal of the American Medical Association study pooled 68 trials of 232,000 patients and observed a 5% higher death rate among people who took high doses of beta-carotene, vitamin E or vitamin A. A 1999 study of 9,500 patients found that taking 400 international units of vitamin E daily raised the risk of heart failure by 13%. Swallowing enough fortified waters, snack bars and breads could edge consumers toward the upper limits for vitamins set by the National Institutes of Health, worries Marion L. Neuhouser, a diet researcher at Seattle's Fred Hutchinson Cancer Research Center.
Water plus sugar plus questionable doses of vitamins. What's Coke's explanation? It says that Vitaminwater has less sugar than soda and that vitamins' role in health "has been thoroughly documented." It says the doses it uses are safe.
Plant sterols derived from nuts and grains are one of the few food additives with a proved health claim. They can lower cholesterol by up to 10%, human trials have found. Cardiology guidelines recommend them. Brands containing sterols include Promise Activ butter substitute (Unilever), Minute Maid Heart Health Orange Juice (Coca-Cola) and Smart Balance Peanut Butter (GFA Brands).
But sterols have never been proved to avert heart disease. "I don't think anyone knows if they prevent heart attacks," says Cleveland Clinic cardiologist Steven Nissen. "There are basic scientists who are worried they don't." Some preliminary data suggest that sterols might harm arteries. In 2006 a small Finnish human study published in Atherosclerosis found that sterols keep arteries from relaxing, which indicates worsened blood vessel function. In a 2008 study in the Journal of the American College of Cardiology, mice that were fed plant sterols suffered more- severe strokes. The researchers also found evidence that sterols collected in the blood vessel walls of human patients--just like cholesterol. Douglas Balentine, the head of nutrition at Unilever, says the animals in the studies were given massive doses that aren't relevant to humans.
In the wake of these studies, preventive cardiologists at the University of Wisconsin Hospital stopped recommending foods with sterols, says James Stein, uw's head of preventive cardiology. "I don't think a margarine should be considered a health food," he says. For patients who want a cholesterol-lowering margarine, he says, Johnson & Johnson's Benecol is a better choice because it contains plant stanols, which also block cholesterol but aren't absorbed into the body.
Web ads for FRS health energy boast the steely face of cyclist Lance Armstrong with the caption "Tired of being tired?" The liquid concentrate contains quercetin, a chemical derived from the skins of berries and grapes. The ads claim quercetin is "the only antioxidant clinically proven to boost energy."
This bold promise is based on science done in animals and cells, along with some small human trials. One study of 11 elite cyclists found that those who took quercetin for six months were able to complete a time trial 3.1% faster than before, though the difference compared with a placebo was not significant.
Some scientists say quercetin holds promise for fighting fatigue and even infection. "The science is far beyond almost all of the other nutritional supplements on the market," says University of South Carolina professor Mark Davis, who has consulted for the FRS Company.
But last year researchers at the University of Georgia found no benefit from the supplement in 30 healthy volunteers tested on seven different performance measures. (The study was funded by Coca-Cola, which apparently was thinking of launching its own quercetin supplement.) Lead researcher Kirk Cureton has tested 60 more patients since then, with the same null result. He says there is little evidence backing other popular energy additives, including the amino acid taurine in Red Bull. The exception: caffeine.
"It's the marketing folks within these companies that make these decisions, not scientists," says Cureton. "When the marketing people decide what they want to say, they go try and find some evidence to back it up." FRS says the science behind its supplement is "unassailable."
Emerging basic research suggests that imbalances in good gut bacteria may be involved in obesity, diabetes and other ills. Yogurt companies aren't waiting for definitive answers. They're touting all sorts of health benefits to their probiotic yogurts right now.
Danone's Activia ($2 billion in annual sales) contains special bacteria that concentrate in the intestines and, in some studies, decrease the time it takes for food to move through the digestive system. Danone can't claim it treats constipation, but it devised ingenious television ads in which actress Jamie Lee Curtis talks about "digestive issues." "I've just discovered a yogurt that can help," she says in one. An animation--just like the ones in drug ads--shows the good bacteria working in a woman's belly.
Some human trials of other probiotics show they modestly reduce the incidence or severity of diarrhea in young kids. But it depends on which strain you eat. A 201-patient Israeli study from 2005 showed that two strains, Bifidobacterium lactis and Lactobacillus reuteri, reduced diarrhea in infants. But reuteri was far more effective. "Think about probiotics how you think about antibiotics," says Michael Cabana, the chief of pediatrics at UC, San Francisco. Probiotics are "not interchangeable." But food companies aren't required to say how much of which strains are in their yogurts, and many don't.
Researchers once blithely assumed that any amount of probiotics was safe. Dutch researchers definitively disproved this in 2008 when they administered massive doses of good bacteria to the intestines of severe pancreatitis sufferers. Patients who got the good bacteria were more likely to die, according to results published in The Lancet.
Everyone knows that omega-3 fatty acids can protect the heart. Less well known: Not all omega-3 fatty acids are created equal.
Most big studies confirming the cardiovascular benefits of omega-3s have tested either docosahexaenoic acid (DHA), an omega-3 found in salmon, sardines and breast milk, or another fish oil called eicosapentaenoic acid (EPA). But many foods that brag about being "an excellent source" of omega-3 fatty acids instead contain alpha-linolenic acid (ALA), derived from nuts and flaxseeds. Because only a small percentage of ALA is converted into EPA and DHA inside the body, it may not have the same heart benefits, cardiologists say. Kellogg ( K - news- people )'s Kashi Almond Crunch cereal says it contains 500mg of omega-3, but it's all ALA. If you want omega-3s for your heart, read the fine print and look for products with EPA or DHA. Kashi says people don't get enough omega-3 and that it makes no specific health claims.