New position paper calls for transparency in probiotic products

Probiotics are increasingly being researched and marketed as functional ingredients to enhance health. As the market for these products grows, it can be difficult to distinguish between high- and low-quality product. Experts question if it is possible to have certainty about what strains of probiotics are in a given product and at what quantities, and to be confident that product manufacturing adheres to high quality standards, according to a new position paper published in the journal Frontiers in Microbiology.

The paper offers recommendations to the probiotics industry on standards and ways to communicate quality to end-users. The 10 authors are members of an expert panel convened by the U.S. Pharmacopeia, representing private and public research bodies. Including the National Institute of Standards and Technology, the U.S. Pharmacopeial Convention, the International Scientific Association for Probiotics and Prebiotics, and several major probiotic manufacturers.

The authors recommend companies producing probiotics undergo third-party evaluations to certify probiotic quality and label accuracy and establish validated methodologies for all aspects of quality assessment, the paper says. They also stress that one of the biggest concerns for patients and practitioners is whether they can trust that probiotic products are accurately labelled.

To address these concerns, the panel suggests companies undergo unbiased third-party certification. The paper describes the steps necessary for setting up such a certification, which include the development of methods and standards for identity and purity that 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.

Included in the paper is 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, the authors say.

The panel calls for publicly available quality standards and methods: a list of tests, test methods, and acceptance criteria that would provide specifications that define identity, purity, content, and quality in terms of performance or other attributes of the probiotic product. Labels would require genus and species names, with strain designations for all strains present, along with quantities of each, a use-by date, storage instructions, and company contact information.

The authors also panel noted that any statements of probiotic benefits, while not mandatory, must be supported by a human study showing benefit at the dose delivered in the product.