It's the equivalent of a snake oil debate for the 21st century. Are manufacturers overselling the benefits of probiotics to make a quick buck out of the gullible consumer?
The European Food Safety Authority (EFSA) is taking no chances as it evaluates health claims for the micro-organisms as part of its work towards the EU Nutrition and Health Claims Regulation. 200-plus probiotic submissions have already been refused by EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA), on the grounds of inadequate evidence.
But manufacturers say the full benefits of probiotics are only just becoming clear and are accusing EFSA of stifling the sector with swathes of bureaucracy and cramping the industry's prospects.
So what are the current areas of commercial activity on probiotics and how positive are processors about the future?
Canadian yeast and bacteria operation Institut Rosell-Lallemand says the more we learn about the roles and function of the gut microflora, the more potential for probiotics appears.
"Digestive health represents the primary area of research for probiotics and the one where we have the strongest scientific and clinical documentation," says Isabelle Champié, global marketing director. "Then, a growing area where we now have strong evidences is immunity. Several clinical studies have now been published showing that probiotics can help prevent infections, and scientific studies on the immunomodulatory potential of probiotics are starting to accumulate."
Other benefits of probiotics
The company has performed clinical trials investigating preventing winter infections in children. It's launching a new product in its existing range tackling this area, which combines its clinically documented probiotic formula with Vitamins C and D.
A more recent field of benefits for probiotics is stress and anxiety management. "We have had the first clinical evidences of an effect of a probiotic formula (Probio'Stick) on both physiological (abdominal pain and nausea) and psychological symptoms," says Champié. "Research on the interactions between the gut/brain axis and the digestive microflora backs up such effects."
And emerging fields of research where probiotics could help include obesity, metabolic diseases or cardiovascular diseases: "Here we are at the early step of the discovery process. Products need to be developed and clinically documented."
Innova Market Insights analyst Natalie Tremellen states that research indicates there is great potential for probiotic applications in the future in areas such as intestinal health, lactose digestion, cholesterol reduction, yeast infection reduction, immune stimulation and even control of cancer.
There was a near 20% increase in product launches with probiotic-related immunity claims globally from 2009 to 2010 she says. Phrases used such as "strengthen your natural defences" and "boost the immune system" are typical of such claims. However, Innova says the probiotics sector is facing a massive struggle following the mass EFSA health claims rejection.
Major recent launches in cultures have mainly had technological rather than health functions as manufacturers steer clear of muddy waters, adds Tremellen.
For example, to support dairies making Emmenthal, Swiss and Maasdam cheeses with reliable eye formation and the right sweet, nutty flavour, Chr Hansen launched efficient "propionic" cultures PS-20 and PS-40. It also added two cultures to its special portfolio of kosher solutions for Passover cheese.
And Danisco has risen to one of the biggest challenges in fermented milk drink manufacture, with the introduction of a new culture for a creamy, baked milk product native to Russia and surrounding countries. Yo-Mix TA 460 LYO has been developed to deliver consistent creaminess; flavour mildness, smoothness and viscosity to the ethnic milk drink ryazhenka the third highest selling dairy product in Russia.
Meanwhile, Datamonitor's Joseph Robinson believes significant opportunities exist for probiotics in functional food and dietary supplement applications.
He says that apart from gut health, probiotics may provide other benefits such as improving lactose intolerance, enhancing immunity, lowering blood pressure, reducing diarrhoea and helping to prevent colon cancer.
The probiotics industry should focus on studying and emphasising new benefits such as dental health, he recommends.
A good example of a small player focusing on new health benefits and thus building a niche in the probiotic market is New Zealand based BLIS Technologies. It has created probiotic gums, tablets and powders based on the probiotic K12.
Elsewhere, in expanding mainstream consumption of probiotics, the industry should also seek to provide convenient delivery, while at the same time meeting consumer sensory demands, Robinson says.
Within mainland Europe, Datamonitor forecasts that between 200914 the highest market growth for products purporting benefits for digestive and immune health will come in Italy and Sweden. Both are countries where consumers have indicated a particular interest in the consumption of functional products (across more areas than just digestive and immune health).
However, manufacturers do admit they are hamstrung while they await for EFSA to draw its conclusions on health claims and probiotics. There is also widespread disquiet about the approach that EFSA has taken.
Manufacturers and EFSA
Valérie Delahaye, commercial director for Human Nutritional Food at Institut Rosell-Lallemand, says the goalposts have moved since the beginning of the EFSA process: "At the beginning strain characterisation was not requested by EFSA and producers didn't really know the level of clinical evidence needed to get a health claim when they submitted the dossier. While in principle EFSA's health claims regulation is positive for consumers, the path chosen by EFSA and the process itself is disputable."
EFSA should improve its methods of communication, she recommends. "We need a more open dialogue with EFSA and the opportunity to set up a pre-assessment process for a dossier before submission to understand how to fill the gap between what has been done and its expectations."
At ingredients giant Beneo Institute, manager of regulatory affairs Dr Alexander Schoch is also dissatisfied. "Health claims on the market before 2006 under functioning and effective national jurisdiction and enforcement [by, say, the UK Food Standards Agency or the German Food Control Authorities] are in limbo and already conflict with EFSA opinions."
For example, claims for probiotics are documented in France, Germany and the Netherlands, while EFSA says it does not regard an increase in the bifidoflora as beneficial to human health.
EFSA has applied a 'drug' or medicinal approach to assess claims. As such, it's denying consumers the freedom to make an informed choice, and to access, and benefit from, credible science, claims Schoch. The European legislator should find ways to favour the disclosure over the suppression of claims, he adds.
Dr Juliane Kleiner, the head of EFSA's NDA unit, which deals with questions related to dietetic products, nutrition and food allergies, says: "On probiotics, the majority of claims were negatively assessed because the micro-organism was not characterised or the beneficial effect was not proven.
"In scientific terms, we do not talk of 'probiotics', but rather of health claims related to micro-organisms. When they are characterised and supported by scientific information proving the health benefit, they are positively assessed."
EFSA was set to issue opinions on generic health claims under Article 13 of the EC Regulation on nutrition and health claims by the end of this month. However, it is taking extra time to consider the situation on probiotics, so there's no clear timeline for delivering its verdict.
UK Provision Trade Federation director general Clare Cheney says the delay and uncertainty is problematic. "We are hoping for a positive opinion from EFSA, but it could issue a negative opinion and at least one company has already removed the term 'probiotic' from labels."
So manufacturers face a dual challenge. First prove the science, convince EFSA that probiotics hold the key to anything from immunity to colds to superior teeth and low anxiety levels. Second, don't let the complications of the process of gaining approvals deter you.