What's on the label isn't always what's in the product

Do commercial probiotics need better quality controls?

By Nathan Gray contact

- Last updated on GMT

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©iStock
Probiotic products should have a more stringent quality control process with processes that ensure contents match what is on the label, warns a new position paper.

The position paper from a working group of probiotic and prebiotic experts in the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) notes that while an increasing number of commercial products containing probiotics are available there are currently inadequate controls on quality and specification and that a wide array data from Europe, Asia and the USA has previously shown that what is put on a products label does not always match what is actually in a product.

“In those products, irrespective if it is food, food supplement, medical food or drug, the probiotic microorganisms have to be present in a sufficient number by the end of the shelf-life, to pass through the gastrointestinal tract resisting acid and bile, to colonise the gut, and to retain functional properties required to obtain the suggested beneficial effect,” ​wrote the group – led by Professor Sanja Kolaček from the Children’s Hospital Zagreb, Croatia.

The group reviewed and summarised a raft of global studies on probiotics that they say show ‘inconsistencies and deviations’ from the information provided on the product labels “are surprisingly common.”

“Frequently strains are misidentified and misclassified, products are occasionally contaminated, sometimes with even facultative or obligatory pathogens, strains are not viable, the labelled number of colonies cannot be verified or the functional properties are diminished to the extent that preclude the proposed health benefit,”​ they said.

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The IPA says new best practice guidelines will provide an 'A to Z' of quality control.

“Based on the results obtained, we strongly suggest a more stringent quality control process. This process should ensure that the probiotic content as mentioned on the label meets the actual content throughout the shelf life of the product, while no contamination is present.”

New guidelines

Commenting on the position paper, George Paraskevakos, executive director at the International Probiotics Association (IPA) said the group had published best practice guidelines​ that are applicable worldwide earlier this year.

“IPA is working diligently to add to this document,”​ he told NutraIngredients – noting that the current position paper has implications for labelling that are not currently covered.

“We have begun work with our technical committee which will publish best practices for the manufacturing of probiotic strains and blends in finished products, i.e. what is needed to produce a quality finished probiotic product. Additionally we are also working on a standards panel for purity and microbial analysis. There are methods out there but we would like to compare which ones coming from which country would best serve the probiotic sector,”​ he said.

ESPGHAN position

The position paper itself provides evidence on the inadequate quality of commercial probiotic products, and pays special attention to microorganism specification, their numbers, functional properties and the presence of contaminating microorganisms.

More stringent quality control procedures are suggested, which should be mandatory for products prescribed for specific clinical situations, and for use in vulnerable populations such as infants and children.

“Probiotics may profoundly differ in their effects on health. Hence, precise identification of microorganisms to the strain level is required in order to reproduce documented effect on health,”​ wrote the group.

It added that probiotic products intended for use alongside otherwise normal diets in the healthy population should be clearly differentiated from ‘drug-like’ probiotic preparations prescribed for specific clinical situations or indications.

“The later need to be subjected to rigorous clinical trials required for the respective application envisaged,”​ they added.

Furthermore, probiotic products should be submitted to systematic quality control procedures by respective authorities in order to confirm the viability and strain-level identification of the active ingredient – and the results of these evaluations should be made public.

“In view of the rapidly developing technology, the quality control should be performed in certified laboratories utilising validated and standardised methodology,”​ the paper suggests. “Standardisation and validation control should be carried-out by the reference laboratories under the auspices of the respective regulatory agencies.”

Finally, the group suggests that any adverse events that are potentially related to probiotic products should be reported and a register of those events should be maintained by health authorities.

Commenting on the calls, Paraskevakos added that all of the concerns raised in the position paper will soon be covered by the IPA guidance:

“These initiatives are to ultimately create the probiotic book of quality guidelines touching upon all the aspects of our industry; a sort of A to Z of quality for the sector,”​ he said.

Source: Journal of Pediatric Gastroenterology and Nutrition
Published online ahead of print, doi: 10.1097/MPG.0000000000001603
“Commercial probiotic products: A call for improved quality control. A Position Paper by the ESPGHAN Working Group for Probiotics and Prebiotics”
Authors: Sanja Kolaček, Iva Hojsak, et al

Probiota Americas + IPA World Congress 2017

Best practices for probiotics will be one of the many presentations at the upcoming Probiota Americas + IPA World Congress in San Francisco, June 7-9. For more information and to register, please click HERE​.

Probiota Americas 2017

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1 comment

quality requirements for probiotics used as drug

Posted by christina,

please refer to this site
https://www.edqm.eu/en/news/ph-eur-consults-new-quality-standards-live-biotherapeutic-products

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