Labeling of probiotics

How many millions of microorganisms are in each dose of a probiotic? What species and/or strain are they? What is the shelf life of the product? All this and much more should be indicated in the printed text or on the label of a probiotic package if the FAO recommendations on the labelling of probiotics are followed. However, not all manufacturers indicate the information in detail and some even redirect to their website where they provide information that they have not included in their labelling.

Regardless of how each manufacturer does it, the information that should be on the label according to FAO recommendations1 should be as follows:

Genus, species and strain of the probiotic

Although we can find products whose labels indicate a simple phrase such as "contains probiotics" or similar, this is not sufficient information to know the content of the product since it must identify the probiotic or probiotics it contains. This identification should be with the genus, species and ideally with the strain since certain benefits of probiotics are strain-dependent, i.e. only a certain strain has demonstrated the beneficial properties while another strain of the same species does not provide those same benefits.

Minimum number of viable microorganisms

The number of probiotics is usually expressed in CFUs, an acronym for Colony Forming Units, i.e. viable cells with the potential to grow and form a colony. Usually the magnitude of this value is several billion microorganisms per dose.

The label must indicate the CFU value of each probiotic separately. It is not very correct to give an overall value for all the probiotics contained in the product as we then do not know the precise amount that would be in each of them.

Shelf life - Product life

This point is very important since the viability of microorganisms declines over time from the moment the manufacturing process ends to a value that should never be less than the minimum value declared on the product label.

To avoid this situation, stability tests are carried out at different environmental conditions so that it can be established under which conditions the product maintains its CFU number above the value declared on the label. This defines whether, for example, it should be below 25 °C or at a certain humidity or whether it should even have to be kept refrigerated.

It is important to note that some manufacturers declare on the label a quantity of CFU's "guaranteed until expiration date" while others declare nothing or simply refer to the number of CFU's as "guaranteed in manufacture", i.e. what is declared on the label is the initial quantity of microorganisms, when the manufacturing process is completed, but it does not indicate how much will be there when the expiration date is reached. Obviously, the first case is correct since in the second case, the actual amount of CFU's is unknown when the product is close to its expiration date.

Suggested dose or dosage recommendations to obtain the beneficial effect declared by the product.

Although it is actually the specialist or the pharmacist who can indicate the dose to be taken of a certain probiotic, the label usually indicates recommended guidelines based on the amount of probiotic microorganisms present per single dose.

Beneficial properties

During the last decade, numerous clinical studies have been developed focused on confirming a certain beneficial property for a particular pathology. There are some well studied probiotics (e.g. Lactobacillus rhamnosus GG) and also well studied pathologies when treated with probiotics. This is the case, for example, with Irritable Bowel Syndrome or also with diarrhea in its different types: infectious, traveler's diarrhea, etc. In these cases, the beneficial properties of these particular probiotics could be indicated on the label, where generally not only the species but also the particular strain is indicated.

Storage conditions

As mentioned above, the indication of storage conditions is essential to ensure the viability of micro-organisms at the end of their shelf life.

Contact

It must also indicate the name of the company that places the product on the market, which need not be the manufacturer but is responsible for placing it on the market.

In addition to the above indications provided by FAO, the labelling of probiotics is often accompanied by additional information, often with a pictogram.

Some of the statements we can see on the labels of probiotics

GMP Manufactured, GMP Certified o similar

This means that the product has been manufactured according to Good Manufacturing Practices (GMP).

These GMP or NCF are the basic standards that must be complied with by a pharmaceutical laboratory from the point of view of Personnel (clothing, personnel flows), Documentation (procedures), Production, Environmental conditions, Quality, Hygiene and Cleanliness of the equipment, etc. In Spain, GMP certification (NFC) is issued by the AEMPS (Spanish Agency for Medicines and Health Products) and every 2–3 years, inspectors from the agency audit each pharmaceutical plant to ensure that these GMP standards are being met.

Non GMO

Non GMO (Genetically Modified Organism) means that the probiotic microorganisms used in the product have not been genetically modified in any way by any genetic engineering or transgenic process.

Gluten Free

The presence of this declaration means that the product has been manufactured from components which do not contain gluten or its derivatives. This makes it therefore suitable for consumption by people with gluten intolerance.

Lactose Free

Lactose is used as an excipient in the manufacture of many pharmaceutical specialities (tablets, capsules) but has the disadvantage that some people are intolerant to it. If we read on the label "Lactose free" it means that this excipient and its derivatives have not been used in the manufacture of the product. It is therefore a product suitable for lactose intolerance.

100 % Vegan

This text on the label is telling us that the product is suitable for vegans, i.e. it has no animal components.

¹ Probiotics in food Health and nutritional properties and assessment guidelines FAO

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