Probiotic Standards

As the growth of probiotics continues in the food/beverage and supplement markets, concerns have surfaced including lack of a public standards for the identity and authenticity of probiotic microorganisms. The U.S. Pharmacopeia (USP) and Institute of Food Technologists (IFT) teamed up to host a workshop to address this issue of probiotic standards, and questions about genotype, function and other critical characteristics. INSIDER talked to USP's Markus Lipp, Ph.D., director of food standards, and Kristie Laurvick, M.S., scientific liaison, about the issue of probiotic standards, including what will be addressed in the May workshop.

INSIDER: Why are genotype and phenotype important in probiotics use in foods and supplements?

Lipp and Laurvick: Genotyping a microorganism is akin to taking its genetic fingerprints;" it uniquely identifies the microorganism on the genetic level. By knowing the genotype, a manufacturer can infer what the microorganism of interest is capable of doing under the right conditions. A phenotype determines what the microorganism actually does under specific conditions, i.e., its functionality. For example, does it exude lactic acid under the proper conditions? Knowledge of both genotype and phenotype are useful when utilizing probiotic ingredients and are particularly necessary when tying ingredients to health claims.

Often, the identification of a specific probiotic strain is performed through genetic testing, but useful identification information may be obtained from phenotypic analysis as well, depending on the uniqueness of the characteristics of the strain and its functionality. Proper identification of a strain is essential from a safety perspective, as safety studies are most often based at the strain level. As such, it is imperative for manufacturers to know exactly which microorganism they are incorporating into their product. Identification also is important in supporting purported health claims, which are also mostly based at the strain level. For any claimed health benefit, manufacturers should be able to confirm that what they are using in a probiotic product is, in fact, the strain tested.

INSIDER: What are the challenges to defining identity and authenticity?

Lipp and Laurvick: It is highly challenging to differentiate one bacterium strain from another given that strains from the same genus and species will have a high degree of similarity. To do so, it is necessary to sequence the full genetic code of the microorganism and identify the small differences that are uniquely identifying the specific strain. Finding this unique codethat is, the genetic code that identifies microorganisms that are otherwise very similartakes time, technology and money. This information is very helpful to companies that formulate products using probiotic ingredients; however, to ensure its proper use for strain-level identification, extensive training is often required. Many challenges exist when it comes to identity and authentication of probiotic ingredients. How much does function define identity? Will the microorganism survive processing conditions? Does it get to the locus of action? Does it do what it is supposed to do in the body? Developing test strategies is consequently difficult, and educating formulators and consumers about the uniqueness of microbial strains that are considered probiotic" is key to the success of any standards developed.

INSIDER: What are the challenges in developing standard methods for functional assays?

Lipp and Laurvick: The desired effect of probiotics is often determined in vivo through clinical trials. There is not always enough understanding on how to translate in vivo results into in vitro tests. Hence, developing tests that measure a parameter relevant to the in vivo effect that can be conducted at a laboratory bench continues to be a challenge. To begin with, there is not always enough agreement on what actually matters in the functionality of the microorganism as it interacts with the host who consumes it. And there seems to be insufficient agreement regarding what physical, functional characteristics are critical to effectively describe efficacious probiotics. Additionally, there is also not widespread agreement on how to best balance the need to protect the intellectual property (IP) amassed by the innovator through costly experiments and the need to share information that is relevant to develop public standards by disclosing part of said IP.

INSIDER: Do regulatory requirements for probiotics used in foods and supplements reflect the latest standards and knowledge base? What more can be done?

Lipp and Laurvick: Regulators and industry understand the need for sensible, transparent and meaningful regulation. Consequently, a number of regulatory agencies have embarked on the challenging task of formulating a framework for governmental oversight of probiotics that, on the one hand, protects the consumer from harm and misinformation, and on the other, promotes the freedom to innovate for industry. To find that balance is not an easy endeavor, and it is one that is ongoing. Independent public standards may play a helpful role for regulators as well as for industry. As an independent standard-setting organization, USP has the unique ability to operate in the space between regulators and industry in order to foster the sharing of information and technologies by bringing together experts from academia, industry and regulatory environments. The discussion around probiotics and their purported health benefits is a very dynamic one, as innovators develop novel microorganisms and delivery mechanisms for new and different applications at a rapid pace.

INSIDER: How can the upcoming workshop help sort out these issues and generate solutions for the future of probiotics in foods and supplements?

Lipp and Laurvick: Probiotics are clearly an area of interest to food manufacturers and suppliers, regulators and consumers because of their purported health benefits. With more manufacturers incorporating probiotic ingredients into a wide array of foods, public standards provide important tools to verify the authenticity of these ingredientscritical to fostering honesty in the marketplace and preserving the reputation of these products. As public standards generally do not exist, USP and IFT are co-hosting a workshop May 9 to 10, 2012, in Rockville, MD, to discuss how to develop standards suitable to verify the identity and authenticity of probiotic microorganisms. Central questions include: what genetic criteria are suitable and needed, and what functional criteria are required to define the identity and authenticity of a probiotic microorganism? The workshop will bring together a variety of stakeholders to help generate consensus on key questions and point to a path forward for standards development for probiotics.

Find out more about the regulatory side of probiotics in the SupplySide Marketplace education session, "Probiotics, NDIs and Species Identification," with speakers Cristine Farrance, Ph.D., senior application scientist, Accugenix; and Anthony L. Young, Esq., partner, Kleinfeld, Kaplan and Becker LLP, on Thursday, May 10, 2 p.m. to 4 p.m. at the Javits Center in New York.

And find out more about the probiotic market and get a list of probiotic suppliers with INSIDER's "Probiotics & Prebiotics Buyer's Guidebook."