Functional food makes some big promises

If you believe the claims on various grocery items, you might think that better health is simply a matter of stocking your pantry with many of them: Pomegranate juice will take care of your heart, cereal will lower your cholesterol, and yogurt will fix your constipation.

So-called "functional food," which manufacturers promise will reduce your risk of disease or boost your chances of optimal health, represents the fastest-growing category in the food industry. Food that is fortified with calcium, fiber, omega-3 fatty acids, and vitamins accounts for $20 to $30 billion in annual sales, according to PriceWaterhouseCoopers. It predicts that sales will grow at an annual rate of 8.5 to 20 percent, more than the 1 to 4 percent forecast for the food industry overall.

What's driving the demand? The Academy of Nutrition and Dietetics points to rising health-care costs and scientific research that links a good diet to a lower incidence of chronic disease. The problem? In most cases, the health claims are based on flimsy facts.

The Food and Drug Administration doesn't recognize functional food as an actual food category. As defined by the FDA's Federal Food, Drug, and Cosmetic Act, products with claims that they treat or alleviate disease are considered to be drugs and must meet the agency's regulatory requirements, including proof that they are safe and effective for their intended use. So if you're a manufacturer and you want to claim in ads and packaging that your product has health-promoting properties, there has to be credible science to back it up.

For example, the maker of POM Wonderful 100% Pomegranate Juice and POMx liquid supplement maintains that it has scientific proof to support the claim that its products prevent or treat heart disease, prostate cancer, and erectile dysfunction.

But the Federal Trade Commission cracked down on the company for making what it calls false and unsubstantiated claims. "Any consumer who sees POM Wonderful products as a silver bullet against disease has been misled," says David Vladeck, director of the FTC's Bureau of Consumer Protection. "When a company touts scientific research in its advertising, the research must squarely support the claims made. Contrary to POM Wonderful's advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses."

The company has filed a federal lawsuit contending that the agency is overstepping its authority by setting new standards for advertising food and dietary supplements.

Cheerios Toasted Whole Grain Oat Cereal offers another example of a manufacturer making big promises on its packaging. In 2009 the FDA warned General Mills that its claim on the box—that the cereal was "clinically proven to help lower cholesterol"—was illegal because only a drugmaker can claim such health benefits for a product. See the most recent correspondence between the FDA and General Mills on the matter.

Health claims weren't allowed on food products at all until about 20 years ago. As the FDA saw it, such a link would mean the products were being marketed as a drug. And if food was being promoted that way, manufacturers had to conduct clinical studies to provide evidence of safety and efficacy, something they didn't want to do, says Marion Nestle, Ph.D., a professor of nutrition, food studies, and public health at New York University.

That changed in the early 1990s with the creation of a national system of nutrition labeling (the Nutrition Facts panels now found on food packages). Food manufacturers had opposed the effort, thinking it would reveal negative information about their products.

They then lobbied for the right to promote the benefits of their products, and in response Congress passed another piece of legislation: the Nutrition Labeling and Education Act, forcing the FDA to permit substantiated health claims on food packages. In 1994 Congress passed the Dietary Supplement Health and Education Act, which made it easier to put health claims on vitamins, minerals, and herbal products.

"We expected to see nutritional supplements or dietary supplements making health claims," says Mary K. Engle, director of the FTC's Advertising Practices division. "But then, about five years ago, we started to see those kinds of claims on foods—claims like ‘metabolism-enhancing' and ‘immuneboosting,' or something having to do with brain health or heart health."

Or more recently, digestive health. For example, claims by Dannon that a daily serving of Activia yogurt could help with constipation caught the FTC's attention in 2010, and the agency accused the company of deceptive marketing practices. Dannon said it had scientific proof, but regulators concluded that many of its studies actually found that Activia was no more helpful than a placebo.

Moreover, the probiotics (a type of healthful bacteria) in Activia might help digestion, but only if the yogurt is eaten three times a day—something not mentioned in the ads or on the packaging. Dannon eventually settled with the FTC, but admitted no wrongdoing.

Conventional wisdom suggests that consumers might be tempted to eat functional food instead of taking medication, but a study in the June 7, 2011, issue of Pharmacoepidemiology & Drug Safety found otherwise.

Researchers at the National Institute for Public Health and the Environment in Bilthoven, The Netherlands, found that patients who took cholesterol-lowering medicine didn't substitute food enriched with phytosterols and stanols for statin drugs.

So what's a health-conscious shopper to do? "Know thyself," says Elizabeth Rahavi, R.D., director of health and wellness at the International Food Information Council Foundation, an industry group. "Consumers can ask themselves questions that can help guide their choices, such as ‘Is this a food that I commonly consume?' Often the benefit of a functional food comes through repeated consumption."

Still not sure? Check the website of the Academy of Nutrition and Dietetics and the IFIC Foundation to see if a product's claims are backed up by credible research, Rahavi suggests. And don't just read marketing claims; look at nutrition panels and ingredient lists.

"You should have a healthy dose of skepticism. Don't expect any given food to protect you from disease," says Engle of the FTC.

In general, food that's truly functional doesn't need to have labeling. "I always advise buying real foods, not products," Nestle says. "And stay away from foods that overstate their health benefits. If only eating a sugary cereal would prevent colds or flu. Wouldn't that be great?"