Probiotics as a case study comparison of Health Claims regulatory approaches

By Helen Mair    

© Lawmedia Pty Ltd, February 2013

In this article, Helen Mair, who is Dairy Australia’s health and nutrition policy advisor for product innovation, considers the availability of information about probiotics in relation to substantiation of such claims under the new Nutrition, Health and Related Claims Standard. The article examines evidence that is available and the treatment of probiotics in the health claims regulatory schemes across different jurisdictions.

WHO/FAO defines probiotics in the case of foods as “Live microorganisms which when consumed in adequate amounts as part of food confer a health benefit on the host”, and prebiotics as a “non-viable food component that confers a health benefit on the host associated with modulation of the microbiota”.

Since ancient times microbes have been exploited in foods for palatability, preservation, providing essential nutrients, making nutrients more bio-available, and safety. Currently mainstream medicine recommends probiotics to patients for various health related conditions for example, gut, immune, urogenital, skin and infant health.

With the common use of pre/probiotics therapeutically and in foods, it is to be expected that the regulatory and policy frameworks around the world include the management of and reference to pre/probiotics. However there is significant variation between jurisdictions in how this is done. In elucidating the most recent science in this area, there appears to be a lack of consistency or a lack of recognition of the continuum between health and disease, food and drugs, and what type/level of evidence is appropriate to support an association at various points on that continuum. As a result, substantiation and the weight of evidence to support pre/probiotic and health association requirements across international jurisdictions is the subject of a number of journal articles.

Australian policy and regulation provides some recognition of beneficial associations between dairy fermentation microbes and health. The FSANZ standard for Fermented Milk Products includes requirements for type and number of microorganisms and the Australia New Zealand Food Regulation Ministerial Council Policy Guidelines on Nutrition, Health and Related Claims, Policy Principles provides a ‘probiotic’ example of a ‘General Level Claim’:”Yoghurt high in X and Y as part of a healthy diet may reduce your risk of stomach upsets”.

With the implementation of the new Food Standards Australia New Zealand (FSANZ) Health Claims Standard, the process for pre-approval of health claims will include the translation of health claim opinions of relevant international jurisdictions (particularly the EU). Apart from listed pre-approved claims, facility is also provided for an application for a ‘High level health claims variation’ or ‘process of systematic review’.  Pre/probiotic claims are relevant to all three pathways.


Japan - Ministry of Health. Labour & Welfare manages food related health claims including Foods for Specified Health Uses (FOSHU). FOSHU applications are voluntary, so approval for every probiotic with health benefits is not required. However the standardised FOSHU health claim for probiotic products is limited to  improvement of gastrointestinal conditions and includes references to ‘good bacillus’, ‘reduce bad microflora’ and ‘promotes the maintenance of a good intestinal environment and regulates gastrointestinal conditions.’ Statements like ‘keep the intestines healthy’ and similar are also permissible.

Guidelines for evaluation of FOSHU applications outline test requirements for efficacy confirmation. For example, evidence supporting ‘improved GI conditions’ by probiotics should demonstrate through data, improvement of intestinal flora balance, increase in faecal bifidobacteria and, ideally decrease in Clostridium perfringens, lower bacterial metabolite production, and increased defecation frequency in humans. Claims should be backed by proof of probiotic viability in the GI tract. Trials should be on humans in the form of a randomised, double-blind placebo-controlled study, normally as a crossover design with 3- by 3- week intake periods.

Health Canada provides a: Guidance Document – The Use of Probiotic Microorganisms in Food. The document suggests a systematic review of evidence that supports the claimed effects of each of the probiotic strains at their claimed intake levels. Markers used to support the claim should be recognised as being valid and biologically relevant. Function claims are scientifically supported if the evidence is based on therapeutic effects in healthy rather than sick populations. “Probiotics’ or similar terms/representations including Latin species names modified to suggest a health benefit, are considered health claims.

Function claims are permissible regarding physiological effects of probiotic organisms in food (e.g. promotes regularity) but are limited to a role in maintaining or supporting the function of the body associated with good health or performance. Acceptable function claims state a specific and scientifically supported effect (as opposed to the type of claims supported in Japan such as a general effect like ‘improves gut health’). Premarket approval is not required unless the food meets the definition of a drug. However manufacturers are expected to hold evidence substantiating the claim. It is recommended that the Guidance Document for Preparing a Submission for Food Health Claims is consulted regarding substantiation requirements.

United States Food and Drug Administration (FDA)

Probiotic claims to date have fallen under Structure/Function Claims, whereby it is not permissible to explicitly or implicitly link a claimed benefit to a disease but must focus on ‘maintaining’ or ‘supporting’ body structures of functions or general wellbeing. In the case of food, the active ingredient must be: ‘Generally Recognised As Safe (GRAS)’; truthful, not misleading and based on appropriate scientific criteria; must be contained within the food; and the benefit should be derived from the nutritive value of the active ingredient.  No FDA approval, notification or disclaimer is required.

 ‘Health Claims’ are considered to describe a relationship between a food/component or dietary supplement ingredient to a disease or health-related condition. In practice, the FDA considers that these claims be limited to reduction in the risk of incurring the disease or condition by the currently healthy population and must be approved by the FDA or a scientific body of the US government or the National Academy of Sciences. Significant Scientific Agreement (ssa) claims are based on the Evidence Based Review system and are not likely to be reversed by new and evolving science. Currently there are no established pre/probiotic ‘Health Claims’.

‘Qualified Health Claims’ are where the quality and strength of the scientific evidence falls below SSA. These claims must be qualified to assure accuracy and non-misleading presentation to consumers, and are assigned a rank based on the strength of data A – D (A = SSA, D = little scientific evidence). Currently there are no established pre/probiotic ‘Qualified Health Claims’.

European regulatory approach

Particularly topical is the European Food Safety Authority (EFSA) approach where approved claims under the three types of claims include criteria and wording. Of note, the term ‘Probiotic’ is considered a ‘Health Claim’ and is not permissible after 14th December 2012.

 EFSA provides Scientific and Technical Guidance for the Preparation and Presentation of the Application for Authorisation of a Health Claim which outlines the hierarchy of pertinent data (excluding non peer-reviewed studies) and focuses on human, intervention, then observation, then mechanistic and bioavailability studies, and lastly animal data. Guidance on the scientific requirements for health claims related to gut & immune function EFSA Journal 2011 is also available. This guidance is not specific to pre/probiotics and indicates relevant human studies are essential; however studies in unhealthy populations such as Irritable Bowel Syndrome sufferers may be considered suitable. Study methods should be ‘generally accepted’ and questionnaires validated. Examples of the level of evidence required suggest demonstration of reduced risk of infection should be similar to that of vaccination, and for reduced inflammation, changes in inflammation markers are not a beneficial physiological effect unless it can be demonstrated that alteration associated with a specific dietary intervention reduces the incidence of a disease. 

 ‘Article 13.1’ refers to claims on body function effects based on existing science. A body function effect is considered to be the role of a nutrient or other substance in growth, development and functions of the body, or psychological and/or behavioural functions, or slimming, or weight control, reduction in the sense of hunger or increase in the sense of satiety, or to reduction in the available energy from the diet. Claims are based on ‘generic’ generally accepted scientific evidence. The only approved probiotic claim relates to improved lactose digestion.

‘Article 13.5’ encompasses claims on body function effects based on emerging science. Assessment on a submitted scientific dossier is made on a case by case basis. The applicant must supply the totality of the available data and can include proprietary data. The food and constituent must be defined and characterised. The claimed effect must be defined and must be a beneficial physiological effect, and be biologically plausible. A cause and effect relationship must be established between the consumption of the food/constituent and the claimed effect. No probiotic claims have been approved at this stage.

‘Article 14’ claims are disease risk reduction claims and claims involving children and are assessed in the same way, with the same requirements as ‘Article 13.5’ claims. However the claimed effect must relate to the reduction or beneficial alteration of a risk factor for the development of human disease (not a reduction in the risk of disease). Predictors may be established from intervention and/or observational studies. Again, no probiotic claims have been approved as yet.

Under the FSANZ Health Claims Standard, pre/probiotic claim applications or self substantiations not supported by international jurisdictions, particularly those rejected by EFSA are more likely to be challenged. In this context, the scientific direction for pre/probiotics and learning from the effects of international decisions becomes critical.  

The Gut Microbiome, Food and Health

Recent research has explored the relationship between the gut microbiome and health including gut health, immune disorders, immunity, obesity, diabetes and mental health. Findings demonstrate that bacteria promote nutrient supply, prevent pathogen colonisation, and shape and form normal immunity. Additionally bacteria metabolise proteins, glycoproteins, sugars, polysaccharides, fatty acids from foods and intermediate products of microbial fermentation. This contributes to metabolic processes such as production of hormones for fat storage and energy production, cell differentiation, immune regulation, and protection against infection – through nutrient competition, adherence, and production of bacteriostatic components. In turn, other aspects of health are affected. Of particular note, recent findings indicate that microbes do not have to be alive to interact with the gut and confer a health benefit.

Physiological markers of a healthy gut demonstrate how the gut and immune system work together for effective digestion, defend against toxins and pathogens, and prevent microbiotic cross communication that may trigger inflammation. Surrogate markers to measure a healthy gut include short chain fatty acids, bile salts, thickness of the GI tract, markers of immune function, bacterial composition, pH, viscosity, enzyme activity, nutrient digestion, and state of villi. However there is large variation so it is important to clearly define and consider what is currently known in the current literature to define ‘normal’ gut and ‘health’ markers.

When considering probiotics and health relationships, it is not enough that the probiotic is present, but more important what it is ‘doing’ in the food (and subsequent food components which also interact with the gut to infer health outcomes), and/or the gut. To define these types of food health relationships may not be as simple as contains x which supports y. As in the case of milk, it may be multiple aspects of the food collectively that confer the health benefit – nutrient richness may be key.

Milk is an example that demonstrates food component interactions with the gut and bacteria to confer health benefits. Aside from the richness of vitamins, minerals and amino acids, bioactives such as immunoglobulin enzymes, anti-microbial peptides, and oligosaccharides, relay signals to regulate gut development, reduce infection and help program the developing immune system. Of approximately 400 different milk fatty acids many have shown a range of beneficial effects, for example protecting intestinal integrity, providing chemo-protective effect, reducing allergy markers, and anti inflammatory activity. Lactose derived prebiotics work with probiotics and colonic microbes to reduce inflammation and promote softer stools. Past research established regular lactose consumption influences colonic micro flora in conjunction with other prebiotics, and may promote the maintenance of lactic acid producing bacteria which in turn helps restrict growth of pathogens, stimulates colonic blood flow and fluid and electrolyte uptake.


Policy setters must consider that costs of substantiation increase with difficulty and complexity in the type of studies required to substantiate the claim. Research and innovation to explore and leverage new food/component and contribution to health relationships must be financially viable. The benefit of greater knowledge is to the broader community, and population health, not just industry.

Capitalising on nutrient richness may broaden the options to preapproved claims and those achievable to substantiate, but may have unintended consequences in stifling research and innovation. Consumers eat diets and foods, and we know that foods are far more than macro nutrients, vitamins and minerals. Food Matrix matters; other food components play a role. Food is not a drug and disease risk reduction is different from supporting health.  Policy must reflect this.

The substantiation of functional claims in relation to prebiotics and probiotics might still involve a complex area for food companies seeking to make relevant Health Claims given the differing approaches by various food regulatory enforcement agencies.

Supporting Bibliography and links available from: 



Helen Mair — Health & Nutrition Policy Advisor, Dairy Australia

(+61) (3) 9694 3703  I (+61) 458 037 123  I

Joe Lederman or Charles Fisher — FoodLegal Consultants

(+61) (3) 9606 0022 

This is general information rather than legal advice and is current as of 12 Dec 2015. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.