Global overview for probiotics: Trends, markets, and harmonization – Regulatory Focus

| 20 September 2022 | By George Paraskevakos, MBA | This article discusses current diverging regulations for probiotics as ingredients in foods and dietary supplements and the trends and translational science that have demonstrated probiotic benefits. It emphasizes how aligning a global probiotic harmonized regulatory framework can help navigate the confusion around the regulations to ensure global consumer access to beneficial products of quality.Keywords Codex, harmonization, regulations, probiotics, probiotic foods, supplementsIntroductionBackground Probiotics are one of the more intensely researched dietary ingredient categories, and their benefits have been supported in translational science. However, current diverging global regulations present challenges to ensuring consumer access to safe probiotic products of quality, highlighting the need for clear, harmonized regulations and claims to facilitate delivery of foods and dietary supplements with probiotics to consumers worldwide.In 2001 and 2002, the UN Food and Agriculture Organization (FAO) and World Health Organization (WHO) published two joint reports with guidelines and recommendations for governments around the globe for the evaluation of the safety and nutritional aspects of probiotics.1 These recommendations are widely respected and have been extremely helpful to governments, shaping regulations for probiotics internationally. The regulations set a baseline for the probiotic industry but have been interpreted independently, creating gaps as governments developed different requirements at the national levels.These guidelines and the definition shaped the future trajectory of the industry and the global probiotics market is now dynamic and diverse. Continued growth, coupled with increasing consumer demand over the years, offers many opportunities for food, beverage, and dietary supplement organizations. The guidelines and FAO-WHO definition have resulted in a complex mosaic of diverse global regulatory frameworks, which presents challenges when commercializing probiotic products but may also be seen as opportunities.Current landscapeThe global probiotics market continues its upward ascent. A 2021 report noted that the total probiotic market was worth more than US$48 billion (Figure 1).2 The market grew 8% globally from 2020 to 2021, supported by the research and science tying probiotics to gastrointestinal-related issues and immune support, coupled with an increasing public demand for products for health promotion. Probiotics offer many opportunities both in food, beverage, and dietary supplement applications.Figure 1. Global retail value of probiotic supplements2Source: Euromonitor InternationalDuring the past 2 years, while facing the COVID-19 pandemic, consumers were looking to minimize vulnerability to disease and illness, with an increased focus on disease prevention, health, and overall well-being. Optimizing health goals, including supporting immunity and digestive health and helping with allergies and weight management are a few areas consumers have been researching on-line. Figure 2 shows the proportion of consumers reporting that they have become more conscious about the relationship between a healthy lifestyle and preventing health issues. Another 2021 report, evaluating opportunities for probiotics in a postpandemic society, outlined how consumers seeking probiotics for prevention far outweighed interest in treating illness.3Figure 2. Consumer perceptions of probiotic supplements3Source: FMCG GurusThe ever-increasing e-commerce markets cannot be ignored when discussing market and consumer demand for probiotics. Higher demand, coupled with the more free-flowing virtual commerce space, bring a sense of urgency to the regulatory environment. Probiotic regulations are reasonably aligned within the none-commerce space, but when discussing e-commerce, regulatory oversight is evident. The EU is a good example of this. No probiotic claims are allowed on the food supplements on store shelves, but more than US$120 million of probiotic products still enter the EU via e-commerce platforms, and a majority of these products have claims on the package (Figure 3).4Figure 3. e-Commerce market size for probiotic supplements4Source: Lumina IntelligenceIt is important to also outline the largest global dietary supplement markets. The US leads, the way followed by China and Italy (Figure 4). At its current 11% year-on-year growth rates, China will be making significant gains as a global player. APAC as a region continues to grow across all probiotic segments and represents more than 55% of the global probiotic category.2Figure 4. Global market size of probiotic supplements2Source: Euromonitor International, for IPAWhat about the science?Probiotics have become one of the most researched supplements both by scientists and by online consumers. Probiotics are recognized as having strong supporting evidence amongst the large amount of ingredient supplements available to consumers.5 Furthermore, an online PubMed search reveals over 38,000 publications as of July 2022 (Figure 5). There is a significant amount of scientific research into the crucial role of probiotics and their beneficial effects on a variety of indications. In addition to classic indications, such as gastrointestinal and immune health, other areas addressed include the gut-brain axis, metabolic syndrome, rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis. Dronkers and colleagues have reported more than 1,600 human clinical trials from two databases they reviewed and they are now analyzing more than 700 indications noted from those clinical trials.6Figure 5. Results of PubMed search for probiotics, July 2022Source: International Probiotics AssociationSystematic reviews combine results looking at all studies performed for a certain indication. These can be useful tools, giving overviews of the amount of research performed in a given area (Table).The amount of research is widespread in many areas of human health. The meta-analyses, reviews, and published articles highlight new targets in emerging areas of health that may be supported with probiotics in addition to the core historical applications. Zommitti et al published a detailed overview of select probiotic clinical studies and their specific effects on human health.17The published science for probiotic applications is abundant. Nonetheless, probiotics used in the researched applications have to meet minimum criteria before a micro-organism can be deemed probiotic. IPA18 and IPA EU19 have published comprehensive papers on the topic. Moreover, when using probiotics for specific conditions in humans, the products must have sufficient study with the specific strain and are required to be sufficiently researched for their intended use, as outlined by Sanders and colleagues.20 Global policy on probioticsThe FAO-WHO collaborationIn view of the growing popularity of probiotics and the lack of international consensus on the methodology to assess their efficacy and safety, the FAO and WHO began collaborating about 20 years ago to examine the scientific evidence on the functional and safety aspects of probiotics in food. In 2001, the two organizations convened an expert consultation on the health and nutritional properties of powder milk with live lactic acid bacteria in Cordoba, Argentina, and an expert working group was established in 2002 to develop guidelines for the evaluation of probiotics in food.1The FAO-WHO expert consultation evaluated available information on the functional and safety aspects of probiotics in powdered milks and examined the products dietary impact, properties, benefits, safety, nutritional features, adverse effects, and health claims, among other attributes. In addition, it identified priorities for evaluation of safety and nutritional aspects.The FAO-WHO working group followed up with a proposed methodology to evaluate probiotics and defined criteria for health claims for probiotics. As a result of their joint work, the FAO-WHO recommended adoption of the current widely used definition for probiotics: Live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. However, despite the outstanding work by FAO-WHO with expert recommendations, considerable work is still needed to reach global harmonization of probiotic regulations.Codex AlimentariusThe Codex Alimentarius standards and guidelines are the international reference point for food regulations and therefore, have the potential to help in the global harmonization of probiotic standards and regulations. There are Codex commodities standards for food categories, including probiotics, in areas such as fermented milk, food supplements, infant formula, and follow-up formula products. In addition, there are horizontal standards and guidelines for food hygiene, food additives, contaminants, labelling, and nutrition and health claims, that apply to food and dietary supplements in general. However, there are no specific provisions for probiotics. It is in this context that a proposal was presented for Codex guidelines for probiotics for use as an ingredient in foods and food supplements. Codex standards are not obligatory but are used by many national authorities as a starting point to build regulations within their own countries. In the spirit of harmonizing the definition for probiotics, the minimum requirements for their use, as well as specific labelling provisions for probiotics, the IPA proposed the Codex Guidelines for Probiotics initiative in 2017.21The proposal was submitted to the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). A decision on whether to begin developing Codex guidelines for probiotics is expected at the next CCNFSDU meeting in March 2023. Due to a very heavy workload, this committee is required to prioritize its work against specific criteria. These criteria are based on demonstrating impact on public health, food safety, and fair-trade practices, among other considerations. If the committee agrees to prioritize the new work proposal on probiotics, the proposal will be reviewed and the process of exchange and discussion toward harmonization will begin.Probiotics in foods and dietary supplementsAt the national level, we see divergent regulatory approaches for probiotics on aspects such as product classification, definition, permitted probiotic microorganisms, conditions of use and labelling requirements, use of health claims and substantiation requirements, and classification as market access administrative requirements. The same probiotic product can be regulated as a food in one market, a supplement in another, and may require drug type registration in yet another. This makes for an assortment of regulations that oblige industry to navigate regulatory differences to commercialize finished probiotic products globally.Product classification. In most countries, foods and dietary supplements with probiotics are classified under food law. These may also fall under certain categories that have their own specific regulations. Examples of these include, Foods with probiotics (Argentina), Food products with additions (Saudi Arabia, Mexico, Morocco), Foods with function claims (Japan), Health functional food (South Korea), or Dietary supplements (US and/or Canada) to name a few.However, there are some cases in which products containing probiotics are categorized as drugs. This may be because of the form in which they are presented, the microorganisms used, the health claims used or, in some cases, where dietary supplements are regulated under drug law (South Africa and/or Australia).Definition. Despite the existing FAO-WHO definition on probiotics, most countries have not yet adopted a legal definition at national or regional levels. Some countries have adopted either broad definitions, referring to probiotics that confer health benefits based on the FAO-WHO definition, or literally, the FAO-WHO definition in their national regulations. Examples of this can be found in China, Indonesia, Malaysia, Philippines, Singapore, Thailand, Saudi Arabia, Argentina, Brazil, and Canada.Similarly, there are some countries that have adopted a definition of probiotics focused on digestive health. Examples of such countries include Italy, referring to the balance of intestinal flora, or Colombia, with a reference to microbial balance. It is also worth highlighting that in several countries, probiotics are included as an ingredient, and are part of the definition of certain food categories and/or dietary supplements.Permitted probiotic microorganisms. The regulatory approaches taken to permit probiotic microorganisms in foods and dietary supplement will vary from country to country. Some countries, mainly from Asia, have adopted positive lists of probiotic microorganisms that are allowed to be added to foods and dietary supplements. These countries would include China, India, Philippines, South Korea, Taiwan, and Thailand. Others, such as Malaysia, have adopted positive lists only applicable to foods. In yet other countries, dietary supplement regulations include positive lists of permitted probiotic microorganisms in dietary supplements, such as Brazil and South Africa.Conversely, other types of lists include probiotic species/strains rather than an exhaustive positive list to be used by regulatory authorities. An example of this is the qualified presumption of safety (QPS) list in the EU.22 This list includes microorganisms that have been assessed by the European Food Safety Authority (EFSA) as not raising any safety concerns. Probiotic microorganisms included therein are therefore regarded as safe by regulatory authorities in the EU.Although the QPS system was developed within EFSA joint working committees and scientific experts, it is important to discuss the generally recognized as safe (GRAS) guidelines for food additives in the US. These guidelines were developed by the US Food and Drug Administration (FDA) as an amendment in 1958 to the Food, Drug, and Cosmetic Act of 1938 responding to concerns of safety of new food additives.23 QPS and GRAS are often considered as being synonymous, but there are distinctions between them, for example:

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Global overview for probiotics: Trends, markets, and harmonization - Regulatory Focus