Functional foods at a crossroads

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Related tags: Functional foods, Nutrition

Functional foods at a crossroads
Do functional foods work?

Watching recent actions by scientific agencies, regulators and industry players themselves of late, one might be forgiven for thinking that the functional foods dream is falling a little short of the reality.

We’re talking about the biggest food companies in the world being told the claims that help sell some of their foods are deceptive and misleading. Nestlé. Mars-owned Wrigley. The Kellogg company. Danone. General Mills. And them agreeing to change or withdraw the claims.

Nestlé and Kellogg’s of late have had their wrists slapped by the increasingly active US Federal Trade Commission over immunity claims aimed at kids. Both issued statements saying in essence, ‘We did nothing wrong, stand by the claims, but will change the claims as the FTC wishes.’

Er sorry… but why go along with it if you stand by the science? Are the claims false or not? Is the science there or not? Do these products (a probiotic drink and an antioxidant-boosted cereal) work or not?

If Dannon’s probiotic yogurts boost gut health and immunity why settle a class action by agreeing to change the claims and set up a $35m fund for unhappy consumers to drain? Ditto for Wrigley’s bad breath-beating gum ($7m fund and withdrawn claims).

It is well known that fighting class actions can be more detrimental than trying to win them and a settlement is not necessarily an admission of guilt, but it doesn’t look good does it from a PR point of view however you dress it up?

Same with last week’s FTC- Nestlé settlement which was a big story in the mainstream press including the New York Times.

Claims scrutiny

Remember, we’re not talking about rogue players operating from an oil rig somewhere in the deep Atlantic making spurious internet claims about a thermogenic nutrient extracted from the bowels of an unpronounceable Icelandic volcano that can cure cancer, enhance sexual performance, increase lifespan by 47 per cent and facilitate levitation.

These companies have spent many millions on the science and the marketing of that science.

The problem for this business model is that around the world product claim-making is coming under ever-closer scrutiny, with a new and highly strict health claims regime in the European Union highlighting the new status quo. Functional food and ingredient development has almost ground to a halt as a result. If you can’t market a food on its supposed added health benefit why bother developing the ingredients at all?

But critics of Europe’s new system insist the claims are failing because the European Food Safety Authority (EFSA) is interpreting the science in a medicinal way that is inappropriate to nutrients designed to promote health and wellness, not prevent disease.

In the US, the recent FTC actions coupled with those of the US Food and Drug Administration which in February issued warning letters to 17 food companies including pomegranate leader, POM Wonderful, over various health claims, signals a tighter claims environment in the US.

How much science is enough?

So what’s it to be then? Do these foods (and supplements) have health benefits or not?

Does the problem lie with the nutrition science itself (not enough clinically backed, human intervention trial-demonstrated, positive associations), or the way the science is being interpreted by regulators and companies that wish to express some of that science in their marketing materials?

As is the case with most scientific conclusions, they are rarely 100 per cent conclusive, so you then reach a point where difficult questions arise: ‘How much science is enough?’ and ‘What kind of science is appropriate to prove a nutrient-health relation?’

In its settlement with Nestlé last week the FTC entered into the, ‘what is significant scientific agreement?’ debate by insisting that for future claims-making Nestlé must possess, “at least two adequate and well-controlled human clinical studies of the product”.​ Any claims must also be pre-approved by the Food and Drug Administration for the first time.

These requirements relate only to Nestlé but are expected to be cited by the FTC in future cases. It will be interesting to see the application of that.

In the meantime, given the substantial body of nutrition science that does exist, the reasons for, and consequences of, any breakdown in healthy food messaging should be examined and soon.

Because while the cynical will argue the kind of messaging the FTC, FDA and EFSA have cracked down on is exploitative and purely profit driven, there is much evidence backing the contribution functional foods and supplements can make to public health.

But how can that science be understood in the law and the market place?

Shane Starling is the editor of NutraIngredients and writes for NutraIngredients-USA.com. He has written extensively about health claims around the world.

Related topics: Regulation

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3 comments

Functional Foods: Masquerading therapeutics or healthier snacks?

Posted by Peter Leighton,

As an outgrowth of the nutrition industry, many companies have been working hard to aggregate nutrition, taste, convenience and targeted functionality into food and beverage products. While these so called “functional foods” are not a new class of products, because of their tremendous popularity we have created this moniker to distinguish them from conventional or processed foods.

While we can debate what products are “functional foods”, the U.S. market for functional foods is greater than $30 billion in sales a year — about 5 percent of the total U.S. food market, and it’s growing at up to 10 percent per year, far more than the 1 to 4 percent forecast for the conventional food market. The U.S. functional foods market is predicted to be worth around $43 billion by 2013.

Consumers are finding functional foods attractive for a host of reasons. Most consumers are more proactive about their health, especially baby boomers that are witnessing the health issues of their parents and vainly refuse to succumb to the demise of aging. Many are recognizing the need for reintroducing the many “lost” nutrients that are proving to be beneficial for optimal health. Advances in food science have helped bring a far superior taste and mouth-feel to the integration of some otherwise nasty tasting bioactive ingredients. And while consumers have accepted the need for vitamin supplementation, 55% would prefer to buy foods for nutritional benefits than supplements. But to be successful in marketing functional foods one must remember that science tells and emotion sells. In other words, successful functional foods are based in science but purchased for taste and convenience; they are not medicines.

What are functional foods?
There are three different types of functional foods. First, there are those products which are inherently healthy. This includes products that do not add any bioactives, but intrinsically contain nutritional compounds that have scientific data to support functionality. For instance, Welch’s grape juice sales increased 33% following the release of clinical data supporting antioxidant activity and cardiovascular benefits; Gardenburger sales increased 25% in the two months following FDA approved health claims for soy; Cranberry juice sales increased 20% after the results of a 1994 Harvard study demonstrating health benefits; and General Mill’s Cheerios sales jumped 11% after being marketed for heart health benefit.

The second category of functional foods is those which add a researched bioactive compound to provide a health benefit. The classic example here is Tropicana Pure Premium orange juice which reformulated its line with added calcium fortification, growing sales 173% and building a new category. This category of functional foods addressed the reintroduction of orphaned phytonutrients which provide a validated functional benefit as discussed previously.

Finally, engineered functional foods are those formulated specifically to deliver a desired functional benefit. Whether you knock back a Red Bull for an energy lift, a PowerBar for sports performance benefit or a Gatorade to replenish electrolytes, these products are based upon scientific research to deliver to the consumer a desired benefit.

Functional Foods are not a panacea and are certainly a product category bound to be “abused”, just as dietary supplements have been. What do I mean by abused? In controlled dosing, such as pills, one can specify the amount of certain bioactive compounds such as vitamin A. But when these compounds are in a food product, it is a bit more difficult to manage the dosing, especially when a good tasting snack product is involved. Maybe one just wasn’t enough and soon the consumer is doubling or tripling the amount of vitamin A, possibly reaching a potentially toxic level. Remember General Mill’s Cheerios? Well the FDA recently claimed that Cheerios were being marketed as a drug, since the company promoted cholesterol reduction of 4% in 6 weeks.

Another valid concern is the encouragement of additional caloric intake. Functional foods “delude people into thinking that [they] are healthy,” says author and New York University food scientist Marion Nestle. And many of the foods marketed as functional are not particularly “healthy”, aside from the bioactives involved.

Considering that over half of households are using food or beverages to treat or manage specific health issues, it is important to recognize the burden that must be carried by companies marketing these products. If consumers are eating medicine like its food, they will get too much of a good thing. And the consumption of additional calories simply feeds a real health pandemic: obesity. So it is very important that manufacturers think very carefully about what they are formulating and how they are marketing these functional food products. The key take away is this: functional food success will be defined by wellness, not disease treatment.

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Future of nutritional science

Posted by John Nichols,

We need to explain why single substance RCTs don't work for nutrients (nutrient interdependance) and five year studies are too short. We need to explain that the nested case-control study with 20-30 year follow-up is important in nutritional science. There is a vision along these lines for nutritional science but the scientific establishment will need some convincing to share this vision.

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Drugs, not dietary supplements

Posted by Steve Baugh,

“at least two adequate and well-controlled human clinical studies of the product”.

Clinical Trials for dietary supplements? Sounds like we are pretty far down the slippery slope already. At least when we are done we can drop the current disclaimer, because when we are done these products will have been shown to treat diseases!! Is this the end of dietary supplement claims period?
Perhaps we could have the FDA nullified, their strategy of single compound therapies (with the force of the national guard) died along with combinatorial chemistry (guess we don't know as much as we thought!!). Now its back to plants, so how come they get to lead the way? They drove us away from plants so they are eminently unqualified to lead us back. And their clinical trials models don't work for dietary supplements, so where are we going here?

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