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'Pixie-dust' dosing threatens to erode consumer confidence

Functionally fortified products still dominate the functional market.



Fish oil in our peanut butter. Probiotics in our cereal bars. Lutein and glucosamine in our water. Thanks to strides in technology and product formulation, which have allowed for better-tasting functional ingredients with a longer shelf life, the offerings in the functional food and beverage category continue to expand. In fact, Mintel reports that 770 new U.S. products were launched in 2009 alone.

But just how “functional” are these products? It's a question being asked with urgency by many in the functional food and beverage industry, as some grow concerned about companies using less-than-efficacious amounts or varieties of ingredients in order to boast them on their labels and charge a premium. The practice, which some refer to as “pixie-dust” dosing, has prompted an array of regulatory actions in the past year and is prompting some ingredient companies, such as Cognis Nutrition & Health, to establish mandatory guidelines for their clients on just how much of an ingredient must be used in a product and how it must be portrayed on the label. Meanwhile, manufacturers, including The Hain Celestial Group and Next-Foods, are calling on their peers to be more clear and consistent in their labeling, and consumer watchdog groups are asking the government to force the industry to do so.

“The food industry says it is interested in functional foods because it wants to deliver products that are more healthful to the consumer; but the fact is they also allow for higher profit margins and allow companies to make more money,” said Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest (CSPI), a consumer watchdog group that called on the U.S. Food and Drug Administration (FDA) in December to “crack down on false and misleading food labels.” “If the product has so little ingredient in it that it doesn't matter, or if it makes exaggerated claims on the label, it hits the consumer pocketbook hard, and it debases the integrity of the entire food label,” Silverglade added.

In addition, noted Kantha Shelke, PhD, principal of Corvus Blue, a Chicago-based food research firm, such tactics can create “big problems” for the industry itself because they lead to jaded consumers who stop believing in the efficacy and health benefits of functional foods and beverages.

Claims Crackdown

CSPI's 158-page report to the FDA pointed to Minute Maid orange juice with glucosamine hydrochloride “to help protect healthy joints,” Carnation Instant Breakfast to “help support the immune system,” and Thomas Hearty Grains English Muffins “made with the goodness of whole grain” as classic examples of products that either under-deliver on efficacy, or overstate it on the label.

CSPI is just the latest to call functional food companies out on product claims. In December 2008, the FDA sent a letter to The Coca-Cola Co. requesting that the beverage giant change the label on its now-defunct vitamin-and-mineral-enhanced Diet Coke Plus soda, because it didn't contain enough of those nutrients to legally use the word “plus” on its label. (Only products containing at least 10% more of the Reference Daily Intake (RDI) of a certain nutrient than other similar products can use the word “plus.”) In May 2009, the FDA slapped General Mills with a warning over the long-used cholesterol-lowering label claims used for its Cheerios cereal.

Anger over ingredient content and claims use has also resulted in legal disputes. In September, Dannon settled a $35 million class action lawsuit from consumers who alleged its labeling on Activia and DanActive yogurts was vague and misleading. And in January 2009, CSPI sued Coca-Cola for making what it called “unsubstantiated claims” for its Glaceau Vitaminwater drinks, which contain trace amounts of zinc, ECGC, theanine and ribose amid 33 grams of sugar and 125 calories per bottle.

“At the end of the day, putting pixie-dust amounts of vitamins in sugar-laden, high-calorie drinks is doing nothing to benefit the consumer,” said James Tonkin, president of HealthyBrand Builders, a functional beverage consulting firm. “Consumers feel hoodwinked.”

Not-So-Functional Beverages


Tonkin has spent 37 years in the beverage industry and has been watching the functional beverage market since its birth in the 1980s. He blames stiff competition and, in turn, ever-decreasing profit margins for tempting beverage companies to scrimp on ingredients and engage in label hype. (According to Mintel, the number of enhanced waters, energy drinks and functional teas on the market has tripled in size over the last five years, with companies launching 239 new products in 2009 alone.)

Tonkin characterized the efficacy of products on the shelves today as “mostly pathetic,” with some functionality in maybe 50% of them. He pointed to the introduction of Vitaminwater as the beginning of a troubling trend that has infiltrated the functional beverage market. Although functional ingredients such as ribose (for heart health and energy), lutein (for eye health and skin) and lycopene (for brain health), hold great promise for the beverage market in the future, Tonkin said that promise rests in responsible, efficacious doses that will earn the trust of consumers. “Now companies put as minimal a dose as they can in there to be able to make some kind of claim,” he said. The focus, Tonkin added, is often on “developing a brand but not necessarily on creating a product that works.”

Dan Murray, vice president of business development at ingredient distributor and marketing firm XSTO Solutions, said he prefers to give manufacturers the benefit of the doubt. Although he conceded that the market is full of those who want to “steal the science without paying for the right dose,” he also noted that there are other factors that lead companies to use less than the clinically proven dose in their products. For example, companies conducting clinical trials of nutrients and other compounds often use high doses in order to get their money's worth out of the research — or, in other words, positive results — when in reality, lower doses may also have an impact.

Also, Murray added, beverage companies have to keep in mind that some consumers will drink more than one of their products each day. “If the data shows they should be using 500 mg of ingredient X and they are using 5 mg, that is clearly an underhanded misrepresentation,” he said. “But if someone puts in one third of an effective dose, or a quarter? We shouldn't treat it as a bad thing just because it is not enough of a good thing.”

But then there is the flip side: The complaint from healthcare professionals that some new drinks may contain too much of a certain ingredient. For instance, after the release of the new $3-per-can grape-flavored Drank, an “extreme relaxation beverage” spiked with valerian root and melatonin, some health professionals complained to the media that the concoction might pose a health risk. The allegation mirrors a situation that arose years ago, when companies started sprinkling kava kava into teas, causing the FDA to cry foul because of the warnings associated with the botanical. “The company's defense was that they added so little kava that the FDA had nothing to worry about,” recalled CSPI's Silverglade. “But we asked, ‘If so little is added to the product, then how can they promote it on the package?’”

Rob Paul, PhD, is a neuropsychologist with a private practice in St. Louis and a formidable research background. When he started formulating his new canned brain-health drink, Nawgan — which includes hefty, trial-based doses of lycopene, d-alpha tocopherol acetate, alpha-glyceryl phosphoryl choline and Kyowa Hakko USA's Cognizin brand citicoline — he followed a different formulation tact so that the end result would actually benefit consumers. Said Paul, “It is about understanding the science — the outcomes and the mechanism of action for each of the ingredients — so you can reach a dose window that is not too low and not to high.”

Consumers Left Confused

When it comes to functional foods and beverages, FDA nutrient content labeling laws clearly specify when and how a manufacturer can use words such “high” (requires 20% of recommended daily value) or “good source” (10% to 19% of daily value). But critics contend that the alphabet soup of RDAs, DRIs and recommended daily values is confusing for consumers, ill-enforced and full of loopholes.

To complicate matters further, some functional beverages and snack bars label themselves as dietary supplements, rather than food, which means they can use terms such as “proprietary blend” and refrain from listing specific ingredient amounts at all. (FDA discussions currently underway could do away with this loophole).

CSPI said it would like to see the end of vague structure/function claims, such as “supports immunity,” and wants to see all products with statements such as “made with whole wheat” or “contains cherries” be required to specify how much in legible print.

Even more concerning to some ingredient manufacturers is the fact that labels are not required to distinguish between different varieties of probiotics and omega-3s, allowing companies to use cheaper versions but boast similar outcomes as those connected with studied ingredients. “Unfortunately, the current regulations leave too much room for ambiguity, and there is a great deal of consumer confusion,” noted Jon Getzinger, chief sales and marketing officer for Ocean Nutrition Canada (ONC), which boasts roughly 200 consumer products containing its patented Meg-3 EPA/DHA fish oil ingredient. “The way things are structured, all omega-3s get lumped together when, in reality, they behave really differently in the body.”

Although ONC's ingredient has enabled manufacturers to infuse foods such as baked goods and peanut butter (Jiff, for example, contains Meg-3) with DHA from fish oil without ruining the taste, many companies still opt to use the cheaper ALA omega-3 fatty acids derived from flax in their products, even though ALA has been shown to have less of a health impact. “We are troubled by the trend of other sources of omega-3s trying to ride the coattails of studies using fish or fish oil,” said Getziner. The ONC executive said one solution to this problem could come from the federal government establishing a clear recommended daily allowance for DHA and investing in educating consumers about the different forms of omega-3s available and their proven health benefits.

How Much Is Enough?

One 2008 report by Consumer Labs noted that Silk Soymilk Plus Omega-3 DHA touted 400 mg of beneficial omega-3 above its Nutrition Facts panel, but only at the bottom of the other side of the carton did it note, in tiny letters, that just 32 mg of these 400 mg is made up of the omega-3 DHA. When contacted for this story, White Wave officials said that 32 mg of DHA per serving — which is also the amount found in the company's Horizon Organic DHA Omega 3 milk product — is “recognized by the FDA as an excellent source of DHA.”

Still, many industry insiders believe it's misleading to boast an ingredient such as DHA on a product label when the actual amount per serving does not come close to representing an efficacious dose. “Simply putting 32 mg of a DHA source into milk doesn't mean you have the right to represent that this [product] will improve your health,” Scott Connelly, MD, the founder of MET-Rx and longtime industry executive, told Nutrition Business Journal last fall. The absence of a formally recognized RDI level for DHA and other omega-3s in the United States and other places around the globe — which the Global Organization for EPA and DHA Omega-3 (GOED) is working to have established — contributes to the confusion around what constitutes an adequate amount of these ingredients in functional food and beverage products. In the European Union, GOED is working to have the dietary reference value for omega-3s set at 500 mg or more per day.

In the mean time, ingredient suppliers and manufacturers in the probiotics sector complain that copycat companies often put the word “probiotic” on the label, without divulging anything about the source or levels. “I have seen the word ‘probiotic’ appearing on kid's ice cream bars and granola snacks, and you turn the product over, and you can't even find out what probiotic it is in there, or how many,” said Wendy Goldner, director of marketing for NextFoods' GoodBelly brand of probiotic juices, which uses between 20 billion and 50 billion live cultures per serving of strains LP299V (shown to improve digestion) and Bi-07 (believed to boost the immune system). “I absolutely would love to see that with any probiotic claim, you would have to name the strain and the amount.”

Failure to identify the specific probiotic strains used in the studies supporting health claims was one of the reasons cited by the European Food Safety Authority (EFSA) for its rejection of all probiotic claims dossiers to date. “Almost half of the evaluations with unfavorable outcomes were owing to a lack of information on the substance on which the claim is based, for example, ‘probiotic’ bacteria and botanical substances,” EFSA said in a statement following the release of its first 523 health claims decisions in October 2009.

Policing the Customers

Mike Bush is vice president of business development for Ganeden Biotech, which makes a patented probiotic ingredient now used in roughly 40 foods and beverages. Bush said he believes that part of the solution to pixie-dust dosing and ambiguous labeling lies in the hands of ingredient suppliers themselves.

“They have to police their own customers,” he said, noting that Ganeden tests a sample of every product containing its ingredient to be sure it meets the claims made on the label. Also, the company will not work with customers that refuse to use efficacious doses of its ingredient. “We just had a potential customer request to put what amounted to a drop of our ingredient in their product and make a pretty strong immunity claim,” Bush said. We turned them away.”

Sharrann Simmons, senior marketing manager for Cognis Nutrition & Health, said her company has gone so far as to formally require manufacturers using certain Cognis products to include an amount similar to those studied in clinical trials. For instance, those wishing to use Cognis' trademarked fat-burner Tonalin conjugated linoleic acid must use between 1.7 grams and 3 grams per serving. (Clinical trials showed efficacy at anywhere from 1.7 grams to 6.8 grams per day.)

Biothera, the Eagan, Minnesota-based biotech company behind immunity ingredient Wellmune, requires its customers to use 2 mg per serving of the beta glucan ingredient in their products — the dose used in the company's extensive Wellmune trials. “If you're going to use the Wellmune brand on your product, you must put in that recommended dose,” said David Walsh, vice president of communications at Biothera. “Any lesser dose would undermine our brand and the many research investments we have put in to it.”

Ultimately, however, true change may be up to consumers and the buying power they wield over food and beverage companies. “We need to, as good corporate citizens, continue to press our own industry to take stock of what it is doing and to be more honest with consumers,” said Tonkin. “You can only burn the public so many times before their optimism turns to skepticism. I think that is about where we are now.”

NBJ Bottom Line

During a recent interview with Nutrition Business Journal, Steve Allen, the recently retired vice president of new ventures at global food giant Nestlé, said that he believes “sprinkling an ineffective dose of a novel ingredient in a food to boost the sales is damaging to the long-term brand equity” of that product and its company. NBJ couldn't agree more. The practice of “pixie-dust dosing” may spur revenue growth in the short term; but consumers are becoming savvier and, especially in the current economy, more hesitant to pay a premium for products that do not produce any actual benefit for them.

Those suppliers that have invested in science and in branding their products will be able to require their manufacturing customers to follow specific dosing instructions — just as Cognis Nutrition & Health, Biothera, Ganeden Biotech and numerous other supply companies currently do. In the end, such requirements will benefit suppliers, manufacturers and consumers, who, as InterHealth Nutraceuticals CEO Paul Dijkstra, noted, are demanding “effective, safe functional products that are convenient and taste good.”