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Decoding a Probiotic Product Label

/in Consumer Blog /by KC

By Mary Ellen Sanders, PhD

Interested in knowing what’s in your probiotic product? Unfortunately, there are many ways that probiotic product labels can fall short.

First, not all items labeled as “probiotic” truly meet the scientific criteria for a probiotic product. See here for information on what qualifies as a probiotic. Some fermented foods are marketed today claiming to be ‘probiotic’. But these products often have undefined microbial content and lack any studies documenting health effects, criteria that are required for a probiotic. Instead, such products could legitimately be labeled as containing ‘live, active cultures’. Dietary supplement products formulated with untested microbes should similarly not be labeled as probiotics.

Also, a label might not provide adequate information on what types of microbes are contained in the product. Genus and species may be listed, but no strain designation. Maybe only “bifidobacteria” or “lactobacilli” are listed.

They might not disclose the potency of individual strains in the product. Some may provide a total count of colony forming units (cfu)/dose or serving, which in the case of a single strain product is informative. But in the case of a multi-strain product – products may contain a couple or up to 30 strains – you don’t know if equal amounts of all strains are included, or perhaps the bulk of the count is made up of the strain in the formulation that is least expensive to manufacture rather than the one that will make the probiotic more effective. Some products may provide one count for “Lactobacillus” and another count for “Bifidobacterium”, a slightly more informative approach than just total count, but still lacking in detail. Many challenges exist for multi-strain products, including the lack of robust methods to quantify different strains once combined, especially viable ones. This topic was one that was covered in an ISAPP webinar, Current issues in probiotic quality: An update for industry.

The label may state that the count is “at time of manufacture”, a number that is no doubt inadequate if you purchase the product close to the end of its shelf-life. Most probiotic strains suffer cell count decline over the course of shelf-life, with some strains more susceptible than others. This situation almost guarantees that by the pull-by date for a multi-strain product, the ratio of cfu of strains to each other is likely much different than at the time of formulation.

Surveys of probiotic product labels

Additionally, it is difficult for consumers to know what products are backed by studies documenting a health benefit. If a product is not labeled sufficiently, it is impossible to link it to evidence. Two studies surveyed commercial probiotic products in the Washington DC area, Retail Refrigerated Probiotic Foods and Their Association with Evidence of Health Benefits and More Information Needed on Probiotic Supplement Product Labels. Results showed that 45% of retail dietary supplement products did not provide strain designations and an equal number did not provide a measure of potency through the end of shelf-life. Only 35% of products could be linked (based on strain and dose) to evidence of a health benefit. Food products fared a bit better, with 49% of refrigerated probiotic food products being linked to evidence of a health benefit. One clear indication from this study was that if your food product discloses the strain designation, it is likely to have evidence of a health benefit. An overall conclusion was that product labeling – at least in this region – needs improvement.

Historical context on guidelines for probiotic product labels

According to the FAO/WHO 2002 Working Group on Guidelines for the Evaluation of Probiotics in Food (page 39 of this combined document), the following information should be on probiotic labels:

– Genus, species and strain designation for each probiotic strain in the product.

– Minimum viable numbers of each probiotic strain at the end of the shelf-life, typically expressed in colony forming units (or cfu).

– The suggested serving size (or dose) must deliver the effective dose of probiotics related to any health benefit communicated on the label.

– Health claim(s) (as allowed by law and substantiated by studies)

– Proper storage conditions

– Corporate contact details for consumer information

These principles are developed and reiterated in “Best Practices Guidelines for Probiotics” (2017) developed by the Council for Responsible Nutrition and IPA.

Additional information

ISAPP created an infographic to explain the information on a probiotic labels. Our example portrays an imaginary dietary supplement for sale in the United States. Labels on foods containing a probiotic or a probiotic produced in another country would be labeled differently from this example to comply with applicable regulations. For those interested in probiotic labels in the EU, see the infographic ISAPP created for a probiotic product in the European Union. Also of interest, USP.org created an infographic on “How to Read a Dietary Supplement Label” for U.S. products.

‘Probiotic’ on food labels in Europe: Spain adopts a pioneering initiative

/in ISAPP Science Blog, News /by KC

By Silvia Bañares, PhD in commercial law, attorney Barcelona Bar Association, Spain; and Miguel Gueimonde, Departamento de Microbiología y Bioquímica de Productos Lácteos, IPLA-CSIC, Villaviciosa, Asturias, Spain. 

The word ‘probiotic’ has been absent from food products in most countries in Europe for years. Authorities there concluded that the word is an implied health claim, which is a reasonable position based on the probiotic definition: live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. The argument proceeds: since there are no health claims approved for probiotics by the European Union, the word is not allowed on food labels. However, the logic fails since in 2010 ESFA actually did approve a health claim for probiotics – although they didn’t use the term ‘probiotic’. This claim was for yogurt cultures improving lactose digestion. But nonetheless, restrictions on using the word ‘probiotic’ have endured.

Recently, akin to positions taken by Italy (here and here) and ostensibly the Czech Republic (as stated here), Spanish authorities have determined that the term ‘probiotic’ may be used.

In October 2020 the Spanish Health Authority (AESAN) delivered a new decision related to the use of the term “probiotic” in foodstuffs. According to it:

“until  a uniform criterion is generated on the part of the Member States of the European Union, it is considered that it could be accepted that the term probiotic/s  on the label of foodstuffs, both of national manufacturing as well as from other countries of the European Union. In all cases, these products must meet the safety requirements. However, it should be noted that the use of this term cannot be accompanied by any health claim, unless expressly authorized under the Regulation of the European Union  -Regulation EC 1924/2006–” [1], [2]

This new decision completely differs from the previous one (February 2020), which forbade the use of “probiotic/s” term in food products. Surprisingly, both documents are extremely similar in their reasoning.

However, the new Guidance contains some points that might be relevant for the future:

  • First, there is a clear statement related to the EU Commission Guidance of 2007 [3]; such Guidance had always been invoked as the rationale in order to forbid the term probiotic in foodstuffs, since according to it, the reference to “probiotic/s implies a health benefit”[4]. But the AESAN communication points out for first time that such Guidance is not binding since it has no legal force.
  • Secondly it recognizes the lack of harmonization at the EU level regarding the “probiotic” term:

 “From the discussions that have been held within the European Commission’s group of experts on nutritional and health claims, it is found that there are different interpretations by State Members regarding the use of the term “probiotic”, which, in turn, implies a non-harmonized situation in the European Union market”[5].

  • Third, there is a clear reference to mutual recognition principle; that is to say, any product legally marketed and sold in any EU country might be, in its turn, marketed in any other European Union Member State. For instance, any foodstuff labelled as “probiotic” in Italy might be legally sold in Spain as far as it fulfils the aforementioned criterion in its country of origin. The AESAN communication recognized such fact, pointing out that:

“In this sense, infant formulas and follow-on formulas are marketed which, as a voluntary added ingredient, contain different live microorganisms. The presence of these live microorganisms is indicated on the product label in the ingredient list. In the field of food supplements, it has been found that there are a large number of food supplements on the market, which include the term “probiotic/s”. These products come from different EU countries, where they are allowed to be marketed under this name and, therefore, they could not be prevented from being marketed in Spain, in application of the “principle of mutual recognition” established in the European Union Treaty”[6].

This statement is clearly aligned with Regulation EU 2019/515 [7] (related to mutual recognition principle) and a recent Commission Regulation (Implementing Regulation 2020/1668), which develops the previous one [8]. According to these dispositions, any competent authority suspending market access should notify the legitimate public interest grounds for such suspension. Therefore, Spain would find quite difficult to reject a foodstuff labelled as “probiotic” in another EU country when it is legally sold as such. Hence, it can be said that Spain has adopted a pioneering initiative that maybe could be followed by other EU Member States.

Italy and the Czech Republic have allowed use of the term ‘probiotic’ on foods – perhaps simply because they considered it to be the right thing to do – but they did not make the convincing legal argument made by Spanish authorities. The rationale presented by Spain could likely be easily adopted by other EU countries as well. Perhaps the Spanish initiative will motivate the EU Commission and EFSA to reach a consensus about this word.

Two decades ago, with a rapidly growing list of probiotic-containing products reaching the market worldwide, there was increasing concern by consumers about how to distinguish among the different probiotic strains available and how to know which products have evidence for different health benefits. This, together with the interest of scientist and industry for clear rules and fair competence, prompted the EU Commission to regulate the area and the Regulation EC n° 1924/2006 on nutrition and health claims made on foods was developed. In its preamble this Regulation states, “to ensure a high level of protection for consumers and to facilitate their choice, products put on the market must be safe and adequately labelled” and recognises that  “general principles applicable to all claims made on foods should be established in order to ensure a high level of consumer protection, give the consumer the necessary information to make choices in full knowledge of the facts, as well as creating equal conditions of competition for the food”.  Therefore, consumer protection and facilitating informed purchase choices was in the forefront of the Regulation, in an attempt to satisfy the concerns and demands that consumers had leveraged.

Subsequent interpretation of the Regulation EC n° 1924/2006 led to the conclusion that the term “probiotic” was a health claim and, as a consequence, should not be used in product labelling. Different countries, such as Italy or the Czech Republic, reacted to this by developing national regulations allowing the probiotic food labelling. Now Spain, on the basis of mutual recognition principle, accepts its use as well.

However, this new situation makes relevant again the challenges that consumers had identified two decades ago:  how to differentiate among the different available probiotic products and make an informed, purposeful purchase. This unsolved issue should now be addressed. In this context, we advocate for the development of easy-to-use guidelines targeted to regular consumers, not to clinicians or scientists, to provide consumers with the necessary tools to make their choice.

Related article: Spanish agency approves use of term ‘probiotic’ on food and supplements

References:

[1] https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/subdetalle/probioticos.htm

[2] Translation by the authors

[3] https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition_claim_reg-2006-124_guidance_en.pdf

[4] Guidance on the implementation of Regulation n° 1924/2006 on nutrition and health claims made on foods conclusions of the Standing Committee on the Food Chain and Animal Health /14/12/2007

[5] Translation by the authors

[6] Translation by the authors

[7] Commission Implementing Regulation (EU) 2020/1668 of 10 November 2020 specifying the details and functionalities of the information and communication system to be used for the purposes of Regulation (EU) 2019/515 of the European Parliament and of the Council on the mutual recognition of goods lawfully marketed in another Member State.

[8] Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 march 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing regulation (EC) nº 764/2008