Function by the rules – regulating functional foods

In years gone by, many dietary mantras were based on restriction, with calorie counting and fat reduction often seen as the bedrocks of healthy eating. More recently, however, the tide has turned away from this kind of asceticism - which often led to a high consumption of artificial ingredients - and towards a nutritional ideal based on what is 'natural' and nourishing.

This can be seen clearly in the 'clean label' trend, as companies market their products as simple, real and minimally processed. It can also be seen in the rise of so-called functional foods, as consumers seek to add key ingredients to their diet rather than just cutting things out of it.

Food functions

Poised somewhere in between food and drug, a functional food is a product that provides health benefits above and beyond basic nutrition. For instance, probiotic yogurts can improve the balance of a person's gut flora and caffeinated drinks can enhance cognitive performance.

While definitions vary, they tend to emphasise ingredients' quasi-medicinal properties. For instance, the Institute of Food Technologists (IFT) describes functional foods as "substances [that] provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically active components that impart health benefits or desirable physiological effects".

Meanwhile, the US Department of Agriculture's Agricultural Research Service (USDA ARS), says they "are designed to have physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions, and may be similar in appearance to conventional food and consumed as part of a regular diet".

Appetite for these ingredients, which are also known as nutraceuticals, is currently at an all-time high. The functional foods market is growing slowly but surely, at a rate of around 8% a year, as consumers seek the benefits of preventative healthcare.

According to data from Leatherhead Food Research, this trend is particularly notable in the US, where consumers are turning towards functional foods to combat their perceived dietary shortcomings. By the end of the decade, the US is expected to overtake Japan as the largest functional foods market on the planet.

"We have noticed that functional food products have increasingly attracted attention in recent years," says Dr Jin Ji, executive vice-president and chief technology officer at Brunswick Laboratories. "The market is growing rapidly because of the increasing consumer awareness towards the unhealthy qualities of most packaged foods and beverages.

"Our consumers are becoming more educated, health centred, environmentally conscientious and socially responsible. This, along with the push by the media and healthcare interest groups, has led to the demand for new functional foods and supplements. It has been a decade-long growth pattern."

As Ji explains, the most popular ingredients are those that have been clearly demonstrated to improve consumers' health, and have a weight of research behind them.

"Some are known ingredients that have been investigated for some time," she says. "These include turmeric (curcumin and other related ingredients for their anti-inflammatory properties), probiotics and fibre (for gut health), flaxseed (containing omega-3 and fibre), aloe vera and spirulina. Newer ingredients, such as the antioxidant ataxanthin and fucoidan extracts from seaweed, are also starting to gain momentum."

Regulation matters

All this said, growth is not going unchecked. Manufacturers must now deal with tighter legislation than ever, requiring them to provide clear scientific evidence for any health claims. You can't simply state your product improves digestion or clears the skin: you must have a robust body of evidence.

To date, Japan is the only country in the world with a formal definition for functional foods - the country coined the term in the 1980s, creating a legislative food category (Foods for Specific Health Uses, or FOSHU) a few years later. Elsewhere, the situation is more ambiguous: should these foods be held to the same regulatory standards as drugs, requiring randomised controlled trials to back up their health claims, or should the rules be laxer?

Take the case of pomegranate juice manufacturer POM Wonderful, which has been sued numerous times for allegedly overstating its products' health benefits. Most recently, it found itself in a disagreement with the US Federal Trade Commission for claiming they could prevent cardiovascular disease, erectile dysfunction and prostate cancer. While it had conducted studies, these had not been randomised controlled trials, and its claims were ultimately found to lack 'a substantial basis'.

This verdict seems to suggest that, if you're a food manufacturer who wants to make a specific disease-prevention claim, you'll be subject to the same scrutiny as a drugmaker, though what it means for general health claims as vague as 'this juice is good for you' is open to question.

Clinical trials and testing

In Europe, meanwhile, the European Food Safety Authority (EFSA) provides guidance for the labelling of approved products with health claims. There have been concerns that the rules are overly strict, though, barring thousands of manufacturers from entering the functional foods market.

"The lack of a clear, cohesive definition may be leading to over-regulation of health claims in the EU, impeding functional food development," wrote Danik M Martirosyan and Jaishree Singh of the Functional Food Center in a 2015 paper.

This means that functional ingredients companies might find themselves in an interesting position. On one hand, their potential consumer base is larger than ever before, as is the range of potential applications. On the other hand, they need to be increasingly careful about whether their health claims stand up to scrutiny, or risk finding themselves in hot water.

In her role at Brunswick Laboratories, Ji has worked extensively with manufacturers to help them surmount some of these hurdles. Since 1997, the Massachusetts-based testing and research lab has helped companies develop functional and medicinal products, with clients including Johnson & Johnson, PepsiCo, Kraft Foods and Campbells. The mission is twofold: to help these companies make healthier products, and to substantiate their health claims.

"For the past 20 years, Brunswick Labs has been undertaking in-depth testing and research of phytonutrients for functional foods and dietary supplements," she says. "These in-depth investigations provide a more thorough understanding of the quality of a food product, providing guidance for formula development and optimisation."

The company started out by developing tests that could measure a food's antioxidant properties, alongside other assays such as fractionation (a technique to isolate specific groups of chemicals from a substance) and active-ingredients identification.

More recently, it has been responding to demand for tests that measure actual biological relevance. To meet this demand, the company has been providing sophisticated clinical studies that measure the effects in the human body itself, rather than just compiling a list of chemicals.

"We carry out these studies in live human cells (bioassays) and human participants (clinical studies), and look into a wide range of health functions, including oxidative stress reduction, anti-inflammatory properties, weight management, metabolic health, cardiovascular condition improvement, and so on," says Ji. "We have noted that this area of biological investigation work is becoming more significant in the industry."

Health awareness

This trend is tied to a growing awareness of the complexity of food chemistry. As many studies have demonstrated, a single micronutrient, taken out of context, doesn't always act in the same way as a naturally occurring micronutrient in the diet. This has troubling implications for vitamin pills, which work on the basis that the vitamin C in a supplement is no different from the vitamin C in an orange. But in fact, a growing body of research suggests that multivitamin supplements may do more harm than good. Studies have consistently shown that they fail to prevent disease, whereas others have suggested they may actually increase mortality risk.

For a functional food manufacturer, the take-home message is clear: don't treat your product as merely the sum of its ingredients, but look at how the ingredients interact.

"The health function of a formulated product is not a simple addition or subtraction of the health functions of individual ingredients," points out Ji. "We often see synergistic and cancellation effects in products formulated with multiple ingredients. One direction is to find the synergistic effects and cultivate them. This can be guided via properly designed bioassays."

Of course, the difficulty with performing clinical studies is that they can be expensive, beyond the reach of a small functional foods manufacturer. Ji says that many clients prefer to focus on bioassay studies, which typically cost between $5,000 and $20,000 - drastically lower than the $100,000 required for a small pilot clinical trial.

"Although bioassays do not offer solid claim support, they provide biologically relevant information for consumer education, and the most importantly, the results of bioassays help to guide a successful clinical study," she explains.

For those larger clients that do have the means to go further, Ji recommends that the trial takes place in stages.

"The first stage is a small pilot study designed to include more health parameters, investigation on a limited number of study participants, often with an open-label study; the second stage is a larger study designed to focus on a selected few health functions on a larger number of study participants, often with a placebo-controlled study. We found that this logical approach to clinical studies provides higher success rate," she says.

While the industry is still dominated by large manufacturers - for which functional foods form a small but significant part of their overall range - Jin sees important opportunities in store for speciality ingredient manufacturers. Many of these are investing heavily into manufacturing processes, clinical trials and intellectual property to advance their products and protect what they've discovered.

"Marinova, in Australia, is a good example: they have become the leader in the small category of fucoidan manufacturers in just over seven years by following this pattern," she says. "Usually, a breakthrough occurs when the media picks up on a new clinical trial that shows profound or interesting positive results. Fucoidans are gaining traction with consumers looking for a safe, complementary medicine to help cancer patients, as research has also shown fucoidan to boost immune function and reduce systemic inflammation."

Ji thinks that, despite the challenges, functional foods and nutraceuticals have promising times ahead. With chronic diseases on the rise, consumers are turning their attention to prevention rather than cure, and many see their diet as playing an integral role in keeping them healthy.

"We feel the industry for functional and nutritional foods will continue to show high growth for years to come," she says. "This market has a true demand, as its products can potentially mitigate the negative health trends of increased levels of inflammation, diabetes, obesity and other metabolic disorders associated with high stress levels."