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“Quality” seals for probiotic products? New paper formulates plan to ensure transparency on the growing market

A global logo or seal to communicate the quality of probiotic products could be on the cards, following the publication of an expert opinion in Frontiers in Microbiology. The paper has set out recommendations for the probiotics industry to bring transparency to consumers about what their probiotic products contain. As well as products undergoing third-party evaluations, labels could communicate genus and species names, strain designations and quantities for all strains present, a use-by date, storage instructions and company contact information. As the probiotic market continues to proliferate, improving transparency – even in the absence of regulatory requirements to do so – is paramount, the researchers note.

“Various published assessments of probiotics have found that some commercial probiotic products fall short of what they declare on the label,” says study co-author and ISAPP Executive Science Officer, Mary Ellen Sanders. “Although regulatory standards exist, enforcement is uneven and is understandably focused on safety concerns rather than accuracy in labeling. But it’s important for consumers and healthcare professionals to have certainty about what’s in a probiotic product that they intend to use for a specific purpose.”

There has been a more than 40 percent rise in NPD when global launch numbers with a probiotic claim are compared from 2012 to 2017, Innova Market Insights data show. This rapid growth has led to a wide range of different products being available on the market.

Although in the EU there are strict regulations around using the term “probiotic” on products, these labeling suggestions are in line with them.“Some of these are high quality and well-labeled. Others are not. This is an opportunity for products that are high quality to get an independent certification of this, and have this communicated on the product label,” Sanders tells.

The use of seals and logos on products offered to consumers can serve to communicate transparency and trust. Such messaging on packaging should be as simple as possible, as well as scientifically substantiated, found an earlier from this year. The four-year EU-funded research project, CLYMBOL – Role of Health-related Claims and Symbols in Consumer Behavior – studied consumer understanding of health claims and symbols on packaging.

Responding to the study, the potential logo or seal that could differentiate “quality” products can be compared to non-GMO certification, Iris Hardewig, Head of Consulting & Strategic Innovation at Analyze and Realize, tells. “Like the non-GMO certification, it is up to the manufacturers to make use of it. In the end, it will be a matter of price. The higher priced premium products will be certified; commodities may stay in the market at lower price points without a certification.”

Although in the EU there are strict regulations around using the term “probiotic” on products, these labeling suggestions are in line with them, adds Hardewig.

A seven-step process for quality
The review paper is by ten authors who are all members of an expert panel convened by the US Pharmacopeia (USP) and who represent private and public research bodies. These include the National Institute of Standards and Technology (NIST), the US Pharmacopeial Convention, the International Scientific Association for Probiotics and Prebiotics (ISAPP) and several major probiotic manufacturers.

The authors recommend companies producing probiotics undergo third-party evaluations to certify the probiotic quality and label accuracy, as well as establish validated methodologies for all aspects of quality assessment.

The paper describes the steps necessary for setting up such a certification; these include the development of methods and standards for identity and purity, which can be aided by recent scientific advancements: whole genome sequencing and PCR-based identification techniques, as well as quantification of live cells at the end of shelf life.

The authors specifically highlight a seven-step process, which is used by already-established certification bodies, that manufacturers would undergo in order to be certified. The process would require documentation of facility statistics, a Standard Operating Procedures Index, an Analytical Methods Index, a Quality Manual Index, a Hazard Analysis and a Critical Control Point Plan, as well as Allergen Control Plans. Consumers could then look for a logo or seal that assures them the company has taken these measures.

What happens next?
Regarding the next steps, Hardewig notes that as the paper suggests voluntary third-party certification, it will need certification agencies to develop such a process. According to the paper, there are already organizations that offer such certifications. So, if there is strong interest from manufacturers, then agencies will have to react and offer a certification process swiftly.

“Companies would have to take the initiative to embark on this approach. This third-party auditing is not required; it is voluntary. But once undertaken, it would allow communication of certification of quality on probiotic product labels,” concludes Sanders.

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