Dannon's national debut of Activia in February 2006 was one of the most successful new-product launches in recent history, a feat made all the more remarkable given the fact that Americans have never been big yogurt eaters. In its first year, sales soared to over $130 million, more than three times Dannon's original forecasts. The launch not only created a new powerhouse franchise for Dannon in the States, it helped springboard one of the hottest new functional food categories: those containing probiotic ingredients.

If competitors and other food marketers were quick to notice Dannon's probiotic success, so were lawyers who are questioning the science underlying the marketer's health claims for Activia and DanActive, the probiotic yogurt drink launched in 2007, on the heels of Activia's popularity. Earlier this year, California resident Patricia Wiener sued Dannon, claiming financial injury due to deceptive advertising -- based on a lack of clinical proof to support claims made in Dannon's marketing -- that duped her into buying the product. This week, a U.S. District Court judge will rule on whether to expand Wiener's complaint to encompass a class; either way, a trial is scheduled for March 17.

Coughlin, Stoia, Geller, Rudman & Robbins -- the plaintiff's San Diego attorneys who previously won more than $7 billion for Enron shareholders -- says Dannon has been one of the most blatant in flaunting Federal Trade Commision and Food and Drug Administration guidelines regulating health claims. But the marketer hasn't been the only one to allegedly push the boundaries: The trial next year is sure to cast a wider shadow over the functional food claims of mainstream marketers who increasingly are making the kind of promises traditionally associated with dubious dietary supplements.

According to research firm Mintel, the market for functional foods jumped 42 percent, adjusted for inflation, between 2002 and 2007, driven in part by product introductions increasing tenfold during that time. American consumers are getting a crash course in what critics contend is the faux science of food marketing as they are bombarded by a dizzying range of food and beverages touting benefits from omega-3, probiotics, prebiotics, fiber and antioxidants. Some of the country's biggest marketers have seen their health benefits questioned, including Coca-Cola and Kraft with vitamin-enhanced drinks, Tropicana orange juice, Quaker Oats, Eggland's Best eggs and Sara Lee Whole Grain White Bread.

Health considerations help drive Americans' food purchase decisions, especially those of aging boomers'. In addition, the tastes of U.S. consumers have been increasingly influenced by the mainstreaming of organic and natural options, and greater public acceptance of preventive medicine. The media over-reports -- credibly or not -- every new fad ingredient making health claims. For marketers, claiming such benefits offer not only a potent sales tool for differentiating a brand in a crowded marketplace -- and supposedly justifying a price premium -- they also help secure loyalty during hard times like these, when cash-strapped consumers might consider store-brand alternatives to offset soaring food costs. Those efforts seem to be working: In a survey conducted earlier this year, Mintel found that 48 percent of respondents said they purchased a functional food or beverage in the previous three months, up from 34 percent in 2006 over the same period of time.

Increasingly, however, critics are questioning whether consumers are getting what they're paying for -- or whether they're actually eating more calories, chemicals and additives under the guise of promised benefits in processed foods.

"This is all about hype, not about health," argues Marion Nestle, the Paulette Goddard Professor of Nutrition, Food Studies and Public Health at New York University. "There's so many food products out there that [marketers are] killing themselves to try to make their products stand out."

In the case of Activia, it certainly worked. Citing Dannon sources, plaintiff's attorneys CSGR&R said the success of the Activia launch was a result experienced by "less than one-tenth of one percent of all product launches." Working with Young & Rubicam, which declined to comment for this story, Dannon used a TV-heavy campaign targeting women. (The plaintiff's lawyers say that Dannon has spent more than $100 million to advertise Activia and DanActive.) The advertising itself has been unremarkable: An initial Activia campaign used two students who talked about "bloating" and "irregularity," and in subsequent work with Jamie Lee Curtis, authoritative in librarian glasses, who underscores that it's the only yogurt containing "Bifidus Regularis," which is "clinically proven" to regulate the digestive system.



DanActive ads feature harried moms in need of a healthy lift, who also fret over their children's health. DanActive claims the probiotic dairy drink "has been clinically proven to help naturally strengthen the body's defenses."

To further wrap its message in scientific overtones, Dannon uses a faux-Latinate twist in trademarking the cultures in each product. Activia, as mentioned, plays up its Bifidus Regularis, while DanActive prominently promotes its L. casei Immunitas bacteria. It also packages it in a 100 millileter daily dose, with suggested usage in the morning. The products retail for about 30 percent more than regular yogurt.

"The claims are very strongly worded and the real problematic material is where Dannon says the claims are 'clinically proven,'" claims CSGR&R partner Tim Blood. "That is simply false."

On Web sites for Activia and DanActive, Dannon lists peer-reviewed studies about its claims for the products, but some critics are questioning whether that research is relevant to the people depicted in the company's advertising.

"People are being misled when Dannon says 'clinically proven,'" contends David Schardt, senior nutritionist, Center for Science in the Public Interest. "Dannon exaggerates and misrepresents the research for Activia, although there is some science behind the claims, and with DanActive, they have no studies to show that the people in the ads are protected for immunity."

According to the lawsuit, Dannon claims Activia and DanActive are "clinically" and "scientifically" "proven" to provide consumers with health benefits that other yogurt products cannot deliver and that the company's ads say these exclusive health benefits result from its proprietary strains of "probiotic" bacteria that are unique to the products. But CSGR&R argues those claims are "false, misleading and reasonably likely to deceive the public. Dannon's own studies fail to support this advertising message, and a number of them flatly contradict Dannon's claims. It is not proven that Dannon's proprietary strains of probiotic bacteria deliver the unique health benefits claimed in its advertising campaign."

Dannon representative Michael Neuwirth declined to comment on the suit, but asserts, "We are a science-based company. Activia and DanActive were studied for more than 10 years in double-blind, placebo-controlled research. We stand behind the science."

While DanActive promotes the fact that each small bottle contains 10 billion of its L. casei Immunitas cultures, the product does not carry the "Live & Active Cultures" verification seal given by the National Yogurt Association. (Activia does have the seal.) Neuwirth says that is because DanActive is a dairy drink, not a yogurt.

Sources say the government is looking into Dannon's claims. Reps for the FTC -- which has oversight for advertising, the FDA, labeling and, by extension, Web sites -- do not comment on ongoing investigations.



Both agencies have struggled with budget and staffing cuts, and, it would appear, are more focused on food safety issues these days. (In 2005, however, the FTC went after Tropicana over its Healthy Heart orange juice claims and, in 1996, similarly went after Promise margarine, also for unsupported heart health claims.)

Non-profit watchdogs like Schardt's CSPI have been among the most aggressive in stepping into the breach by threatening their own lawsuits against marketers or drawing the government's attention to questionable claims. The CSPI, for instance, has gone after egg producers like Eggland's Best with its omega-3 eggs. CSPI says the company uses unapproved nutrient content claims and that its "25 percent less-saturated fat" boast amounts to less than half a gram, which the FDA considers trivial in nutritional labeling. (Eggland execs did not return calls for comment.)

Threatening lawsuits, last year CSPI also got Quaker Oats to tone down its cholesterol-lowering claims and, earlier this year, made Sara Lee change the labeling on its Soft & Smooth Made With Whole Grain White Bread to make clear that the product contains 30 percent whole grain. Its previous label suggested it had as much fiber as 100 percent whole wheat bread.

"Immunity" is one of the hottest marketing buzzwords right now. Companies like Green Giant are an example of the "silly label claims touting magical immunity-boosting properties," according to a CSPI report. Last fall, the General Mills unit launched a special "Immunity Boost" selection of frozen vegetables (along with "Healthy Vision" and "Healthy Weight" options). While the inherently healthy vegetables aren't fortified, their selection is intended to support immunity claims by containing broccoli, carrots and red and yellow peppers with antioxidants and vitamins A and C.

"These were not developed so much around a 'functional food strategy,' but around consumer insight that improving and maintaining health is the number one concern of boomers," explains Pam Becker, a General Mills representative.

Given the success of boutique green-tea drinks and Glaceau offerings like Vitamin Water, deep-pocketed marketers are also rushing into the enhanced water and energy drinks categories. Among the drinks companies like Kraft are marketing are Crystal Light Immunity Berry Pomegranate with vitamins A, C and E that claims to "maintain a healthy immune system." CSPI says there's "little evidence" to suggest the drink will have any impact on the average consumer's immune system, there's little fruit benefit -- less than 2 percent of the drink is its "natural flavor" -- and many of the rest of the ingredients are not contributing to good health: artificial sweeteners, preservatives and food dye.

"Vitamin-fortified water is just water with a handful of the cheapest nutrients thrown in," says Elizabeth Somer, a Salem, Ore., registered dietician and author of books including The Essential Guide to Vitamins and Minerals. "Nutrients work as a team. If you're going to take a supplement, you're much better off taking a good supplement where you know just what you're getting and how much rather than helter-skelter in a poorly formulated food."

Counters Kraft rep Bridget MacConnell: "There's substantial scientific evidence that vitamins A, C and E play an important role in immune function, and many of the country's leading nutrition experts agree. This is why we fortified Crystal Light Immunity Berry Pomegranate flavor with these and other vitamins. Our Crystal Light Immunity label clearly states that one serving provides at least 10 percent of the Daily Value of [those] vitamins. So, in the context of an overall diet, this beverage should be considered one source -- but not the only source -- of these important nutrients."



Last fall, CSPI urged the FDA to look into claims made by Coca-Cola, which bought enhanced juice and tea manufacturer Fuze last year. (Coca-Cola also bought Energy Brand, the manufacturer of Glaceau, in 2007.) CSPI cited Fuze's claims on its site that the Vitamin B3 in the four flavors of Fuze Refresh is "known to improve circulation and reduce the cholesterol level in the blood."

Coca-Cola rep Ray Crockett says the company revised Fuze labels in January 2007 and is in the process of updating its Web site. As for CSPI's lawsuit over Coke's Enviga drink (a sparkling green tea) that promotes weight loss as it "burns calories" and "speeds metabolism," he says: "The CSPI suit is designed to draw press attention to CSPI and ignores the broad science which supports that Enviga gently boosts metabolism to burn calories. We stand behind Enviga and we continue to defend ourselves vigorously in this meritless lawsuit."

Both Kraft and Coke underscore the fact that their labels are in compliance with FTC and FDA guidelines. Marketers are allowed to make "function and structure" claims -- e.g., promotes brain function -- as long as they don't mention ingredients as a cure for a disease. In the case of Tropicana's Healthy Heart ads, the marketer got into trouble when it claimed that drinking two-to-three glasses a day would produce dramatic effects on blood pressure, cholesterol and homocysteine levels, thereby reducing the risk of heart disease and stroke.

Critics say the government agencies don't have the means to challenge structure and function claims that push the limits.

There were few health claims until 1984, when the tide changed after Kellogg began to market its All-Bran cereal with the claim that diets high in fiber and low in fat reduce the risk of certain cancers. As more marketers followed suit -- and public consumption of cereal fiber doubled -- the government reviewed policies related to food claims. In 1997, Congress passed the FDA Modernization Act, which streamlined the process manufacturers go through in order to make claims. In the decade since, additional legislation has reduced the ability of the FDA and FTC to police health claims, in the view of detractors.

"The law is so broad now. With few exceptions companies can make claims about so-called benefits as long as they don't mention disease," says CSPI's Schardt. "The FDA does not have the mechanics to challenge that."

Harry Balzer, vp at market research firm NPD Group, says health claims are the driving force behind product development at food manufacturers. "Eighty percent of all Americans eat something in a 'better-for-you' version, with the average American eating at least two of those items every day," he says. "Manufacturers are always looking for the newest way to add health [claims]."

Previously they dwelt on eliminating harmful substances -- sodium, sugar, cholesterol, fat. (Even when they didn't have to extract something, marketers found a boast to make: Consider Chiquita bananas' current "fat-free" claim.) Now it's all about adding substances to promote product benefits.



Even so, Americans have their own take on functional foods. "You can have the success of a $100 million brand like Activia in the U.S. and no sales breakthrough for cholesterol-control brands like Benecol and Take Control," says Tom Vierhile, director, Productscan at Datamonitor. "There's not an immediate benefit. In the U.S. we have a pill-popping culture."

Both Activia and DanActive are billion-dollar brands globally (marketed under different names in other markets). Plaintiff lawyers CSGR&R cite these quotes from Franck Riboud, CEO at Dannon parent, Groupe Danone, as indications the company is more interested in marketing hype than health claims:

"When [consumers] eat an Activia, I make more money than when they eat a plain yogurt," as well as, "The success of Activia is not coming from the product itself. The probiotic, everybody knows now about probiotic all over the world. The success is coming from the way you launch the product, how do you enrich the product, the marketing."

Perhaps the most improbable marketing success can be found at Pom Wonderful, an affiliate of the Los Angeles-based company Roll Intenational, which turned a hard-to-eat fruit into a chic ingredient that now finds its way into martinis. Pom Wonderful is the brainchild of Stewart and Lynda Rae Resnick, the latter of whom's early claim to fame was opening her own Los Angeles ad agency at the age of 19. The Resnicks got stuck with 100 acres of pomegranate trees in 1987 when they bought a Northern California farm. Focusing on the fruit's antioxidants, they launched in 2002 with distinctive curved bottles, quirky ads and product giveaways at celeb events like the Oscars to draw attention to the new functional beverage category. Sales of their premium-priced products have jumped from $12 million in 2003 to $91 million in 2006, according to published estimates. Pom Wonderful says it has spent $25 million on substantiating its products claims.

And what claims they turned out to be: One ad promised the juice "can help prevent premature aging, heart disease, stroke, Alzheimer's, even cancer."

Andrea Levine, director of the Better Business Bureau's National Advertising Division (NAD), felt they were the strongest claims she had seen from a food company and got them to tone down their promises.

"If we see dramatic health claims, we're always going to get involved," says Levine about the NAD, the industry's self-policing authority. "There's always the danger of overstating the underlying science when there is just emerging concensus among the scientific community."



Lost amid all the current marketing noise is some genuine innovation that is producing enhanced versions of everyday foods. In June, Dole Food Co. began marketing a portobello mushroom that contains 100 percent of the daily requirement of vitamin D in a three-ounce serving of the vegetable. Mushrooms don't naturally contain the vitamin. Dole exposes the vegetables, usually grown in the dark, to flashing light during the growing process to achieve the result. The change could be a marketing boon, especially to vegetarian consumers who may not want to get their vitamin D from primary sources like milk or salmon. But the company is showing restraint and has opted to price it at the same level as its other portobellos.

"We don't want to make a statement about what vitamin D can do for you," says Gary Schroeder, president, Oakshire Mushrooms, which is a licensee of Dole. "We just want to let people know they have a new source of it. We feel it's not our role to create the hype about it."