The research couldn't be more promising. Consumer awareness is proliferating in both Europe and the United States. Now it's industry's turn. Joysa Winter explores the question: will manufacturers embrace the new standardisation programme?

When the International Probiotics Association (IPA) announced in March that it was issuing a 'quality seal' for probiotics products, to many in the industry it was news a long time coming.

In recent years, a growing number of products in a growing array of formats have begun touting the addition of health-supporting bacteria, and consumers have had no way of measuring those claims. Among the requirements for the new seal is proof that the bacteria survived the manufacturing process and are viable (the CFU count), as well as a clear identification of the probiotic strain contained in the product.

"We strongly support IPA's effort to standardise the labelling of products," says Rob Hurlbut, CEO of Attune Foods, a manufacturer of probiotic wellness bars. "We believe it will only help the consumer to have more information as to the type of strains, the count and the clinical support behind probiotics claims."

Attune sells two varieties of bars in 10 flavours across the United States, and in its process of product development, learned just how challenging issues like viability and clinical support can be.

"Working with a living ingredient like probiotics poses several challenges," Hurlbut explains. "For us, it was a challenge to balance between the desire to achieve certain attributes in the bars vs limitations presented by the ingredients themselves, as well as technical challenges in the manufacturing process. When you are trying to juggle all that and still create a great-tasting product with unparalleled efficacy, it is tricky.

Manufacturers using heat processing, in particular, face challenges because they have to keep the probiotics alive."

Attune went to great lengths to try to ensure the efficacy of their products. They selected a blend of four different kosher and GRAS-certified probiotic strains chosen for their clinical efficacy and demonstrated stability. And the company ensures every bar delivers a minimum of 8.5 billion colony forming units (CFUs) throughout its shelf life, and that each strain is dosed at the same or greater quantity as they were administered in successful clinical trials.

"We also keep the products refrigerated through the entire supply chain," Hurlbut says. "This allows us to deliver an efficacious dose to our consumers."

A matter of substantiation
The problem is, not all product manufacturers are willing to go to such lengths, and consumers have had no way of really distinguishing the industrious from the indolent.

"We are really at a crossroads right now because the industry and its products are in a situation where there is not validated efficacy," says Mary Ellen Sanders, PhD, a consultant to the probiotics industry, who also serves as executive director of the International Scientific Association for Prebiotics and Probiotics (ISAPP). "It's a real problem.

"There are a lot of people using the term 'probiotics' where they don't have strong efficacy data to support the strength they are touting. It has become a bandwagon term, the way 'organics' used to be. Now there is a legal definition for it. There isn't one for 'probiotics' yet, so people are using it to mean different things."

The ISAPP's definition for probiotics is 'live micro-organisms, which when administered in adequate amount confer a health benefit on the host.' Speaking about the myriad new products touting probiotics — including cereals, pizza and salsas — Sanders says it is often not clear whether any given product meets that definition.

"You must have clinical evidence that the specific microbe being used has health benefits," she says. "You can't just throw microbes into a product and call it a 'probiotic.'"

But while labelling and standardisation might be wanting, at the same time Sanders sees an exciting state of global research into probiotics.

"We are entering a five- to 10-year period where we will be gaining better appreciation for how microbes are important to our health — not just to disease but to health," she says. "It's an exciting time to be in the field."

State of the science
Founded in 2002, the ISAPP is an organisation of industry scientists whose mission is to advance the science of probiotics. In the US, this science has often lagged behind Europe, in part because of how the regulatory system operates.

"In the US, the regulatory distinction between foods and drugs is very clear, but this can limit the kind of research we can do," Sanders explains. "Take as an example a very interesting controlled, double-blind study published in 2007, which showed the ability of a fermented dairy drink, Actimel (sold in the US as DanActive), to decrease diarrhoea and Clostridium difficile in the elderly in three London hospitals. I looked at this study and thought: 'This is a really interesting and important use of a food product! These people have to eat something, so why not have them consume a fermented dairy drink that may reduce their risk of illness rather than a non-fermented one?'¹

"In the US, the Food and Drug Administration would view a study like this as a drug study, not an appropriate use for a food."

European studies have yielded other promising findings in recent months.

In July, the results of a University of Copenhagen study were announced in which piglets fed infant formula with Bifidobacterium animalis and four Lactobacillus strains had a 20 per cent lower occurrence of necrotising enterocolitis, a serious gastrointestinal disease that frequently affects premature newborns.

Only one month later, Swedish probiotics specialist BioGaia announced a deal with Nestlé Nutrition to see its proprietary Lactobacillus reuteri strain employed in infant-nutrition products globally — with the first due to hit the market in 2009. The strain is already present in infant-formula products in Asia and Europe.

In May, the journal Nutrition published the results of an Austrian-funded trial involving 271 children with Heliobacter pylori infection, a bacteria known to cause ulcers and cancer. The results suggested that drinking cranberry juice or taking Lactobacillus johnsonii La1 (La1) significantly reduced bacteria levels.

A randomised Taiwanese study reported in the April issue of the American Journal of Clinical Nutrition indicated a similar effect of probiotics on H. pylori.

It is the promising signs of research like this that is spurring further research dollars. In July, Finnish dairy and ingredients player Valio set up a professorship at the University of Helsinki to carry out medical research. Valio's LGG strain probiotic hit the market in 1990, and it has marketed a range of probiotic products under its Gefilus brand in Finland, Sweden, Russia, Estonia, Latvia and Lithuania.

Measuring the market
On the end-products front, probiotics are moving well beyond simply dairy applications into delivery formats that were not possible only five years ago.

The discovery of more stable strains, combined with innovations in processing and packaging technology, has brought probiotics into room-temperature products such as infant formula, cereals and breads, and analysts predict that this diversification trend will continue.²

Frost & Sullivan's Strategic Analysis of the North American Probiotics Markets for Human Nutrition found that the probiotics sector earned revenues of $698 million in 2006. It is expected to reach $1.70 billion in 2013, with a compound annual growth rate (CAGR) of 13.7 per cent. The fastest-growing sector within the market is probiotic beverages, with a CAGR of 24.6 per cent.

"As a result of continued advertising and combined marketing schemes, mainly from processors of finished goods, the level of consumer awareness of the different types of probiotics has improved significantly in the last five years," notes research analyst Maria Januszczak. "This has driven research efforts into the development of alternative delivery formats in the probiotics category that can appeal to a wider range of consumers, and foods and supplements manufacturers are also eager to join the bandwagon and apply probiotics in their existing products."

A comparison of sales among different probiotics-fortified foods has not yet been done, but sales of fortified yoghurts, which have long been the standard delivery system, provide a clue of the broader segment.

According to consumer research by Mintel International, the proportion of respondents who bought pre/probiotic yoghurts grew by eight percentage points from 2006 to 2008 (see figure 1 below).

Just who is buying these yoghurts?

According to Mintel's survey, 19 per cent of adults in 2008 had purchased a pre/probiotic yoghurt in the previous three months, compared to 11 per cent in 2006. Nearly twice as many women as men had consumed the products in 2008, at 24 per cent and 13 per cent, respectively. Individuals in the 45-54 age range were the largest purchasers, at 30 per cent.

Meanwhile, in Europe, consumption of probiotics is equally strong, Euromonitor International reports. Between 2002 and 2007, consumption in Western Europe grew 13 per cent CAGR, and consumption in Eastern Europe increased nearly 18 per cent CAGR.

In 2007, consumption in tonnes in Western and Eastern Europe was 1,125 and 10,151, respectively; the numbers are forecasted to hit 1,747 and 13,205 by the year 2012.

Clearly, consumer awareness is on the rise, and it is for this reason that it becomes all the more important for US product manufacturers to get behind an industrywide labelling scheme.

"In this fast-developing market, the principal dilemma for the industry is how to attract first-time buyers, and how companies can achieve significant market penetration," an executive summary of the Frost & Sullivan report concludes. "It would be in the best interest of all market participants to help promote standardization, (and) police substandard quality and fake products. Consistent, high-quality performance of suppliers to its customers and other stakeholders is crucial for continued market growth.

"The probiotics industry is a complex yet highly attractive market, just as finicky and as tailored as the bacteria itself. Understanding the nature of the business requires an open mind, patience and an almost fanatic trust that a billion cells per day is where success will lay."

References
1. Hickson M, et al. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. British Medical Journal, 29 June 2007.
2. Gotteland M, et al. Modulation of Helicobacter pylori colonization with cranberry juice and Lactobacillus johnsonii La1 in children. Nutrition, May 2008.