Probiotic Foods and Supplements

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Probiotic Foods and Supplements

Saturday, June 12, 2010

The New York Academy of Sciences

Presented by the New York Academy of Sciences, the US Food and Drug Administration and the US Office of Dietary Supplements, NIH, the goals of this symposium are to facilitate the exchange of ideas regarding labeling and substantiation of claims for probiotics among academic, industry and regulatory professionals and to discuss ways to translate and communicate research results in a trustful way to the consumer and to health professions such as MD's, pharmacists, dieticians etc.

Target audience includes academicians interested in conducting research on health benefits of probiotics; scientists, communications personnel and regulatory specialists from companies involved in, or interested in, marketing of probiotics; US government regulatory experts tasked with oversight of probiotic foods and dietary supplement products; other experts in the field interested in the development of probiotics for the US market.


Related Publications

Annals

The Science and Regulations of Probiotic Food and Supplement Product Labeling
By Mary Ellen Sanders (Dairy and Food Culture Technologies, Centennial, Colorado) and Dan Levy (U.S. Food and Drug Administration, College Park, Maryland)

Annals

Probiotics: From Bench to Market
By Marguerite Klein (National Institutes of Health, Bethesda, Maryland), Mary Ellen Sanders (Dairy and Food Culture Technologies, Centennial, Colorado), Tri Duong (Texas A&M University, College Station, Texas), and Howard A. Young (National Cancer Institute, National Institutes of Health, Bethesda, Maryland)

eBriefing

Probiotic Foods and Supplements: The Science and Regulations of Labeling

eBriefing

Probiotics: From Bench to Market

Podcast

More than a Yogurt Cup


Presented by

  • US Food and Drug Administration
  • US Office of Dietary Supplements at the National Institute of Health
  • The New York Academy of Sciences

For a complete list of sponsors, please click the Sponsorship tab.

Agenda

* Presentation times are subject to change


Saturday, June 12

8:15 – 8:45 am

Registration and Breakfast

8:45 - 9:00 am

Opening Remarks
Brooke Grindlinger, PhD, The New York Academy of Sciences
Mary Ellen Sanders, PhD, Dairy and Food Culture Technologies

Dan D. Levy , PhD, US Food and Drug Administration

9:00-11:20am

Session I: Structure/function claims for probiotic foods or dietary supplements
Moderated by Mary Ellen Sanders, PhD, Dairy and Food Culture Technologies

9:00 am

Approach for Substantiating a Claim of Digestive Health for Probiotics
Yehuda Ringel
, MD, University of North Carolina at Chapel Hill

9:20 am

Probiotics and Label Claims: Communicating The Health Benefits of Foods That Can Promote Health
Elizabeth B. Rahavi, RD, International Food Information Council 

9:40 am

Substantiating Structure /Function Claims Made for Dietary Supplements
Kenneth M. Taylor, PhD, Center for Food Safety and Applied Nutrition, United States Food and Drug Administration 

10:00 am

Substantiation of Health Claims in Advertising
Richard L. Cleland, JD, Federal Trade Commission

10:20 am

Panel Discussion

Mary Ellen Sanders, PhD, Dairy and Food Culture Technologies
Yehuda Ringel , MD, University of North Carolina at Chapel Hill
Kenneth M.Taylor, PhD, Center for Food Safety and Applied Nutrition, United States Food and Drug Administration
Richard L.Cleland, JD, Federal Trade Commission
Neville Bamji, MD, Mount Sinai Medical Center

Linda Duffy, PhD, National Center for Complementary and Alternative Medicine, NIH

Elizabeth B. Rahavi, RD, International Food Information Council

11:20 – 11:40 am

Coffee Break

11:40-12:40 pm

Session II: Nomenclature for probiotic microorganisms and strains
Moderated by Dan D. Levy , PhD, US Food and Drug Administration

11:40 am

FDA Ingredient Labeling Regulations
Geraldine A. June, MS, Food Labeling and Standards Staff, FDA Center for Food Safety and Applied Nutrition

12:00 pm

Probiotic Nomenclature for Product Labels: Recommendations from Lactobacillus and Bifidobacterium Nomenclature Committees
Charles Franz, PhD, Max Rubner-Institut, Federal Institute of Nutrition and Food 

12:20 pm

The Role of International Biological Resource Centers in Identifying and Curating Bacterial Strains for Commercial Use
Brian J. Beck, PhD, American Type Culture Collection

12:40 –1:40 pm

Lunch

1:40 pm

Delimiting the Boundaries of the "Strain" in an Ever-Evolving Bacterial World
Eric W.Brown, PhD, US Food and Drug Administration 

2:00 pm

Naming and Marketing of Strains - An Industry Perspective
Duane Charbonneau, PhD, Procter & Gamble
 

2:20-3:20pm

Panel Discussion
Duane Charbonneau, PhD, Procter & Gamble

Dan D. Levy, PhD, US Food and Drug Administration
Geraldine A. June, MS, Food Labeling and Standards Staff, FDA Center for Food Safety and Applied Nutrition

Eric W.Brown, PhD, Molecular Methods and Subtyping Branch, FDA Center for Food Safety and Applied Nutrition
Charles Franz, PhD, Max Rubner-Institut, Federal Institute of Nutrition and Food
Brian J. Beck, PhD, American Type Culture Collection

3:20-3:30pm

Closing Statement
Dan D. Levy , PhD, US Food and Drug Administration

3:30 – 5:30 pm

Networking Reception

Speakers

Organizers

Linda Duffy, PhD

National Center for Complementary and Alternative Medicine, NIH

Dr. Duffy, previously a Professor of Pediatrics and Preventive Medicine for 15 years, trained in preventive medicine and infectious disease epidemiology and has research interest in translational models and validation standards. She participated in the review of NIH Roadmap initiatives, including microbiome projects and other trans-agency initiatives, and currently serves as a Program Officer in the NCCAM Natural Products Branch. She oversees the clinical translational probiotics portfolio and is a member of the NIH Trans-agency Probiotics and Prebiotics Group.

Tri Duong, PhD

Texas A&M University

Dr. Duong’s research interests focus on the use functional genomic techniques to understand the probiotic functionality of Lactic Acid Bacteria and their application in health and food safety. He received a PhD in Functional Genomics from North Carolina State University under the direction of National Academy of Science member, Todd R. Klaenhammer, and underwent postdoctoral training at Washington State University. Dr. Duong is an Assistant Professor at Texas A&M University in the Department of Poultry Science.

Marguerite Klein, MS

Office of Dietary Supplements, NIH

Ms. Marguerite Klein, whose academic training is in nutrition, health education and clinical trials methodology, had a 15-year career primarily in cardiovascular disease prevention followed by 9 years in research of complementary and alternative medicines. In 2008, she joined the NIH Office of Dietary Supplements. Currently, she is expanding the ODS Analytical Methods and Reference Materials Program and is working to address challenging issues (e.g., soy clinical studies; probiotic safety) in order to improve the integrity of dietary supplement research.

Dan D. Levy, PhD

Center for Food Safety and Applied Nutrition, U.S Food and Drug Administration

Dr. Levy supervises pre-market safety review of new dietary (supplement) ingredients for the FDA and chairs the FDA Ad hoc Inter-Center Workgroup on Live Microbial Ingredients. His research interests in the molecular genetics of FDA-regulated products are rooted in his background in DNA mutagenesis and repair starting from doctoral work at the NYU Sackler Institute, postdoctoral research at the National Cancer Institute in Bethesda MD and the Center for Nuclear Studies in Grenoble, France and 15 years of research and regulatory experience at FDA.

Mary Ellen Sanders, PhD

Dairy and Food Culture Technologies

Dr. Mary Ellen Sanders, through her business Dairy & Food Culture Technologies, consults on all aspects of probiotic applications in the food and supplement industries. She believes probiotics will flourish only if available products are scientifically validated, responsibly produced and accurately labeled. She strives to balance the potential consumer benefits of probiotics with an understanding of the emerging science. Based on her extensive work with manufacturers, academicians and regulators, Dr. Sanders offers a comprehensive perspective to those interested in the continued emergence of the probiotic industry.

Howard Young, PhD

National Cancer Institute

Dr. Young, a Principal Investigator in the Cancer and Inflammation Program, Center for Cancer Research, National Cancer Institute-Frederick studies the control of gene expression during the development and maturation of the cellular immune system with a special emphasis on Interferon-gamma expression by NK cells. Author/co-author of over 270 papers, Young was President, International Society for Interferon and Cytokine Research (2004-2005) and served as Chair of the Immunology Division of the American Society for Microbiology. He has served as Chair of the NIH Cytokine Interest Group and co-Chair of the NIH Immunology Interest Group

Speakers

Neville Bamji, MD

Mount Sinai Medical Center

Brian J. Beck, PhD

American Type Culture Collection

Brian Beck currently manages the acquisition, characterization and maintenance of more than 19,000 items in the Bacteriology collection at ATCC. He earned his PhD in microbial physiology at the University of Wisconsin-Madison and held applied research appointments at the University of Minnesota and University of Michigan. His interests range from the isolation and description of new isolates that produce natural products with therapeutic potential to targeting the biosynthesis of secondary metabolites such as siderophores in pathogenic bacteria for the development of new antimicrobials.

Eric W. Brown, PhD

FDA Center for Food Safety and Applied Nutrition

Dr. Eric W. Brown is a research microbiologist with the Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN). Dr. Brown currently serves as the chief of the Molecular Methods and Subtyping Branch within the Division of Microbiology-Office of Regulatory Science and is actively engaged in a multi-parameter research program to develop and apply molecular genetic strategies for identifying and differentiating dangerous bacterial foodborne pathogens. Dr. Brown’s expertise lies in the science of evolution and genetics where he has made important contributions toward understanding the evolutionary dynamics of several groups of bacterial pathogens that are significant in the fields of food, biomedical, environmental, and agricultural microbiology. By combining the latest tools of bioinformatics and molecular biology, Dr. Brown has reported on the genetic and systematic relationships that currently exist among numerous genes implicated in bacterial virulence and the pathogens in which they reside. Specifically, his research has focused on the application of phylogenetic techniques in understanding the prevalence and role of horizontal gene transfer in pathogenic bacteria. This understanding of the evolutionary genetic aspects of enteric pathogens has aided in elucidating the etiologies and genetic origins of several emerging pathogens including enterohemorrhagic and enteropathogenic E. coli. Dr. Brown received his B.S. in Biology from Shepherd University (Shepherdstown, WV), his M.S. in Microbiology from the National Cancer Institute/Hood College Joint Program in Biomedical Science (Frederick, MD), and his Ph.D. in Microbial genetics from The George Washington University (Washington, DC). He then accepted a tenure-track faculty position in the Department of Biological Sciences at Loyola University of Chicago. In 2000, Dr. Brown came to the Food and Drug Administration in January and has since carried out numerous experiments relating to the molecular detection and identification of foodborne pathogens. Dr. Brown has published findings in numerous peer-reviewed research journals and has presented data at many national and international meetings. He has been a member of the American Society for Microbiology since 1994 as well as the Willi Hennig Society of Systematics and Evolution since 1996. Recently, Dr. Brown authored a chapter on the molecular differentiation of bacterial strains presented in a book on Molecular Epidemiology published by Oxford University Press.

Duane Charbonneau, PhD

Procter & Gamble

Duane L. Charbonneau is a Ph.D. microbiologist and a Research fellow for Procter & Gamble's global personal health research and development team. With over twenty years of healthcare industry experience, he is an expert infectious agents and antimicrobial technologies for the consumer healthcare industry. In his role as Research Fellow, Duane manages various components of the research and development programs, including in vitro methodology and testing as well as clinical trial design, execution and interpretation, literature review and product research. Duane has authored over 25 published articles and holds several patents. Duane received his Ph.D. from Cornell University. He has a wife and three children and enjoys watching them play sports.

Richard L. Cleland, JD

Federal Trade Commission

Mr. Cleland joined the Federal Trade Commission’s Division of Advertising Practices in 1991. In 1996, Mr. Cleland was appointed Assistant to the Director of the Bureau of Consumer Protection and, in 1998, he was appointed Assistant Director of the Division of Service Industry Practices. He currently serves as Assistant Director of the Division of Advertising Practices. His primary area of expertise is the advertising and marketing of health-related products and services. He also supervises many of the Commission’s health fraud and weight-loss product and service law enforcement initiatives. Current areas of interest include immunity claims for dietary supplements and foods. Mr. Cleland recently supervised the Commission’s review of the Endorsement and Testimonial Guides. Prior to joining the Federal Trade Commission, Mr. Cleland served as Special Assistant Attorney General and Director of the Division of Consumer Protection in the Iowa Attorney Generals Office.

Charles Franz, PhD

Max Rubner-Institut, Federal Institute of Nutrition and Food

Dr Franz is a microbiologist at the Max Rubner Institute (MRI), Federal Research Institute for Nutrition and Food, in Karlsruhe Germany. Dr. Franz earned his PhD at the University of Alberta, Canada, before moving to Germany to take up his position at the MRI, where he has been active in research and heads a laboratory for the last 12 years. Dr. Franz is a specialist on lactic acid bacteria, their physiology, genetics, taxonomy as well as probiotic aspects. He is currently a member of the International Committee on Systematics of Prokaryotes, Subcommittee on the Taxonomy of Bifidobacterium, Lactobaciollus and Related Organisms.

Geraldine A. June, MS

Food Labeling and Standards Staff

Ms. Geraldine June is the Supervisor of the Product Evaluation and Labeling Team, Food Standards and Labeling Staff, Office of Nutrition, Labeling and Dietary Supplements (ONLDS), FDA. She began her career at FDA in 1987 as a research microbiologist developing methods for detecting enteric pathogens in foods. In 1996, Ms. June joined the Office of Food Labeling (reorganized into what is now ONLDS) where she worked on issues such as common or usual names, ingredient labeling, warning and safe handling statements, and use of non-nutritional claims such as “fresh” on foods. Currently, she supervises a team that develops policies and regulations on issues such as allergen labeling, irradiation labeling, warning and safe handling statements, labeling of bioengineered foods, and food standards of identity. Ms. June received her B.S. degree in microbiology from Howard University in Washington, DC and her M.S. degree in microbiology from George Washington University in Washington, DC.

Dan Levy, PhD

US Food and Drug Administration

Dr. Levy supervises pre-market safety review of new dietary (supplement) ingredients for the FDA and chairs the FDA Ad hoc Inter-Center Workgroup on Live Microbial Ingredients. His research interests in the molecular genetics of FDA-regulated products are rooted in his background in DNA mutagenesis and repair starting from doctoral work at the NYU Sackler Institute, postdoctoral research at the National Cancer Institute in Bethesda MD and the Center for Nuclear Studies in Grenoble, France and 15 years of research and regulatory experience at FDA.

Elizabeth B. Rahavi, RD

International Food Information Council

Elizabeth Rahavi specializes in providing science-based communications about nutrition, health and wellness. She has extensive knowledge in consumer understanding of nutrition and food safety and serves as the Associate Director, Wellness at the International Food Information Council (IFIC). Elizabeth is responsible for monitoring and tracking media trends on nutrition issues, developing communication materials and promotion plans, and facilitating IFIC’s outreach to opinion leaders. Elizabeth is an active member of the American Dietetic Association, Food and Culinary Professionals practice group and is currently the Regional Networking Coordinator Liaison for the Dietitians in Business Communications practice group. She is also a member of the Institute of Food Technologists. She received her Bachelors degree in Dietetics & Institutional Administration from Texas Woman’s University, and completed her internship with Sodexho. She is also a registered dietitian and certified personal trainer. Elizabeth is an avid yogi and runner, recently completed her second full marathon. Prior to joining IFIC Elizabeth worked as a clinical dietitian in the Washington, DC metro area and as an assistant at Understanding Nutrition in Dallas, Texas.

Yehuda Ringel, MD

University of North Carolina at Chapel Hill

Dr. Ringel has been involved in clinical and translational research related to functional gastrointestinal disorders for over 10 years. His research relates to the effect of clinical, physiological and psychosocial factors on the intestinal function and functional GI symptoms. He has been involved in the design, evaluation and conduct of clinical trials evaluating new drugs, food supplements, and other approaches for treatments of these symptoms.

Mary Ellen Sanders, PhD

Dairy and Food Culture Technologies

Kenneth M. Taylor, PhD

US Food and Drug Administration

Dr. Kenneth Taylor helps with developing regulatory policy for dietary supplements and related drug products to reconcile complex scientific matters with statutory requirements. This includes evaluating novel substances for use as potential dietary ingredients and the claims that are made about them for conformity with the Dietary Supplement Health and Education Act of 1994. He has been recognized by the Commissioner of Food and Drugs for his efforts to enhance enforcement activities against dietary supplement products that make misleading and fraudulent claims on the Internet. He received his Doctoral degree in Biochemistry from the Uniformed Services University of the Health Sciences, Bethesda MD.

 

Additional biographies coming soon

Abstracts

Approach for Substantiating a Claim of Digestive Health for Probiotics

Yehuda Ringel, PhD, University of North Carolina at - Chapel Hill

The probiotic concept suggests that supplementation of the intestinal microbiota with the right types and numbers of microbes can improve the microflora characteristics and promote health. Public interest in the relationship between diet and health together with direct-to-consumer advertising contributed to a dramatic increase in the functional food and probiotics market. Probiotic produces are available in different preparations including fermented milk drinks, yoghurts, food products, capsules, pills, and powders. The number, variability and availability of these products are increasing as new products are constantly being developed and marketed with various beneficial health claims.

The issue of probiotics has recently taken on a higher profile as the makers of probiotic and nutritional supplements have launched high-profile marketing campaigns, claiming their products can help relieve and prevent common digestive problems such as constipation, bloating, abdominal discomfort and diarrhea. As a result, people who suffer from these ailments are now taking probiotics or asking their doctors whether or not they should give probiotic products a try. In theory, certain probiotics (at the right dose and in the right formulation) can help restoring the proper balance of the intestinal microbiota, lead to better digestive function and possibly improve gastrointestinal symptoms. However, the current scientific data to support these claims and particularly the benefit of probiotic use in certain disease or illness conditions is limited. Indeed, most of the probiotic products currently available on the market have not been scientifically tested for their effectiveness in particular conditions.

The regulatory authorities regard probiotics as dietary supplements that are not intended to diagnose, treat, cure, or mitigate the effects of diseases and recommend that consumers will consult with a health care professional before using these products. However, studies have shown that despite this recommendation only a minority (less than 30%) of probiotics consumers does so with the advice of their health care provider. Furthermore, the ability of health care provider to provide knowledgeable advice with the regard to the appropriate use of probiotics is very limited due of the lack of high quality evidence based data on the currently available probiotic products.

Further detailed and accurate information on the content, safety, benefits and possibly mechanisms of action of available probiotic products is greatly needed. This information should arise from high quality research. However, the area of clinical and translational research in probiotics is currently facing several obstacles that delay production/delivery of this information. Some of these difficulties relate to the lack of clear guidelines from the regulatory authorities with regard to the needed requirements, lack of available funding from federal resources to support high quality research in this area, discrepancies in endpoints terminology between marketing professionals, researchers, health care providers and consumers.Resolving these difficulties will promote the research in this area and will help providing the needed information to appropriately support probiotics claims, increasing their beneficial effects and customers' satisfaction with their use.

Probiotics and Label Claims: Communicating the Health Benefits of Foods That Can Promote Health

Elizabeth Rahavi, RD, International Food Information Council

Foods that can provide benefits remain a hot food and nutrition topic. The media continues to chronicle trends in food and health and consumers remain enthusiastic about the benefits these foods offer. Research shows that many consumers believe the link between nutrition and health, and are looking for actionable advice. This is especially true for probiotics where findings from the 2009 International Food Information Council (IFIC) Functional Foods/Foods for Health survey shows that nearly three quarters of Americans are aware of the health benefits of probiotics for maintaining a healthy digestive and immune systems, a significant increase from 2007. Recent findings from the 2009 IFIC Food & Health survey also shows that consumers cite the food label as an important factor guiding their food and beverage choices. However, claims on food packages are just one vehicle for informing consumers about foods that promote health. Consumers bring a number of factors into their decisions to purchase a food or beverage, including prior experience, knowledge, and influence from family, friends and others. Therefore, effective communication is a critical element in realizing the public health benefits that probiotics offer, without presenting them as “magic bullets.” IFIC and the IFIC Foundation will present a body of comprehensive consumer research that provides a look at consumer interest in foods that can promote health, probiotics and label claims, which all point to communication implications for disussing probiotics with consumers.

Substantiating Structure /Function Claims Made for Dietary Supplements

Kenneth M. Taylor, PhD, Center for Food Safety and Applied Nutrition, United States Food and Drug Administration 

The Federal Food, Drug, and Cosmetic Act (the Act) provides that nutrition support statements may be made for dietary supplements. However, the Act also stipulates that such structure/function claims that are made in accordance with 21 U.S.C. 343(r)(6) must be substantiated to demonstrate that the statements are truthful and not misleading. To articulate its position toward adequate substantiation of structure/function claims, FDA has developed a guidance which describes the amount, type, and quality of supporting evidence that may be considered appropriate or acceptable. By applying a substantiation standard of “competent and reliable scientific evidence”, relevant matters such as the meaning of the claim(s), the relationship of evidence to the claim(s), the quality of the evidence, and the totality of the evidence should be considered when assessing if a structure/function claim is supported within the context of a surrounding body of evidence. This approach provides flexibility for the variety of evidence that may constitute adequate substantiation. In addition to addressing the statutory requirement, having a defined substantiation standard may also help to promote consumer confidence in products which make nutrition support statements.

Substantiation of Health Claims in Advertising

Richard L. Cleland, JD, Federal Trade Commission

Propelled by media attention, big budget advertising campaigns, and boomers’ never ending quest to stay healthy for as long as possible, probiotics are fast approaching star status. But, from an advertising perspective, are probiotics really ready for prime time. Federal law prohibits unsubstantiated health claims in advertising. Disease claims, as well as structure function claims, must be supported by competent are reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. To meet this standard, studies must meet the basic requirements of sound science. In general, this standard will require human clinical studies that are randomized, double-blind, placebo-controlled, and conducted by persons qualified by training and experience to conduct such studies. Studies must be strain specific and measure endpoints that support the advertising claims. Dosages used in the studies must be comparable to the dose users would receive under the minimum recommended use directions. Measurements must be valid and statistical analysis should be based on between group comparisons. Results must be both statistically and clinically significant. So far, probiotics have had difficulty meeting these standards, both in the E.U. and U.S.

FDA Ingredient Labeling Regulations

Geraldine June, MS, Food Labeling and Standards Staff

FDA food labeling regulations require several pieces of information on a food label. This information about a food is necessary to inform consumers about the attributes of the food product to assist them in making informed purchase decisions. The statement of identity, which is the name of the food and should be one of the principal pieces of information on a food product, can be a name prescribed by a regulation such as a standard of identity, a common or usual name, an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name. In addition to the statement of identity, food labels must include a list of ingredients by their common or usual names in descending order of predominance by weight. Thus, it is very important to have an appropriate truthful and non misleading name for a food and its ingredients to inform the consumer what the food product is and what it contains. This presentation will provide an overview of FDA labeling requirements for foods, including dietary supplements, with an emphasis on FDA requirements and policies on how common or usual names are established. The presentation will also provide some examples of how some common or usual names were established.

Probiotic Nomenclature for Product Labels: Recommendations from Lactobacillus and Bifidobacterium Nomenclature Committees

Charles Franz, PhD, Max Rubner-Institut, Federal Institute of Nutrition and Food

Probiotics are live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. The European Food Safety Authority (EFSA) recommends that microorganisms used in foods, including probiotics, should undergo a safety assessment; correct identification and taxonomy of the probiotic microorganism is a pre-requisite for this. Health Canada (2009) also demands that the correct identity of microorganisms should be declared on probiotic products. As is well known that the probiotic properties are strain, condition and dose dependent, the correct identification and labeling of probiotic strains is therefore essential. Lactobacilli and bifidobacteria are Gram-positive bacteria of which specific species are most often used as probiotics. While bifidobacteria belong to the Actinomycete subdivision of the Gram-positive bacteria, the lactobacilli can be grouped in the clostridial subdivision, the Firmicutes. The Lactobacillus species groups which containing probiotic species include the L. acidophilus group, the L. casei group, the L. reuteri group, the L. salivarius group and the L. plantarum group. Bacterial systematics embraces classification (taxonomy), identification and nomenclature, which are all essential for studying novel probiotic microorganisms or existing strains for which the taxonomy is under revision. Taxonomy is a dynamic science and for the lactobacilli it is far from satisfactory. The wide range of genome mol%GC content (32 to 54%) is twice as much as that normally accepted for a well-defined genus. This indicates that taxonomical changes are likely. This unsatisfactory taxonomy also applies to probiotic species such as in the case of L. casei and L. paracasei, for which the taxonomy is still quite controversial. Nevertheless, product labeling with the correct species identification and nomenclature are increasingly important issues. The recommendations to producers of probiotic microorganisms thus are to be cognisant of the unsatisfactory taxonomy of the lactobacilli and to continually update their knowledge on the current taxonomy of these bacteria from appropriate sources.

The Role Of International Biological Resource Centers in Identifying and Curating Bacterial Strains for Commercial Use

Brian J. Beck, PhD, American Type Culture Collection

As a Biological Resource Center (BRC), ATCC supports research discovery and application by academic, government and private sectors through a combination of products and services. ATCC’s mission is to acquire, authenticate, preserve, develop and distribute biological materials, information, technology, intellectual property and standards for the advancement and application of scientific knowledge. ATCC maintains four types of Collections (Contract, General, Patent, and Safe Deposit) that offer the depositor and users different levels of control and access. Biological materials held by these collections range from bacterial cultures and cell lines to derivatives such as proteins, genomic DNA and antibodies. Acquisition priorities include type strains, sequenced genomes, model research strains, reference strains used for quality control purposes and organisms with interesting functionality. Cultures are replicated with minimal passages and preserved to limit genetic drift and maintain the phenotype as close to the original as possible. Authentication/quality control is achieved by characterizing strains using genotypic and phenotypic testing to determine a contemporary phylogenetic assignment. Cryopreserved cultures are shipped world-wide through a network of distributors. Although new technologies such as phenotypic microarray and next-generation sequencing of genomes will likely revolutionize the identification and discrimination of strains, BRC’s must continue to balance time and cost-effective methodologies with maximum strain resolution.

Delimiting the Boundaries of the “Strain” in an Ever-Evolving Bacterial World

Eric W. Brown, PhD, US Food and Drug Administration

The ever-increasing introduction of live bacterial food and supplement ingredients into US markets has fostered an intense and renewed scientific interest among regulatory microbiologists for accurate strain identification and nomenclature. A precise taxonomic evaluation of a bacterium deployed in probiotic form can provide substantial insight into its overall safety for human consumption. Analyses of this nature also allow a delimiting of strain and species boundaries among closely related isolates along with a snapshot of the genetic and phylogenetic stability of a particular “strain”. This latter endeavor becomes even more important given the evolutionary implications for long-term application of specific bacterial isolates as probiotics in specific food or supplement commodities. The evolutionary landscape of bacterial strains often is dappled with numerous examples of vertical and horizontal change resulting in an isolate swarm. In certain instances, selection for specific clonal variants within the swarm can lead to the emergence of highly adapted individuals and ultimately new strains or subspecies. Such implications may confound stability among commercialized bacterial cultures over time. Facile genotypic and phenotypic approaches are now available that are capable of capturing and estimating this diversity. In addition, phylogenetic applications can provide further insight into the microevolution of strains. Here, we present several examples for this paradigm among pathogenic species known to associate with the food supply along with some of the widely applied genetic and genomic technologies now available that readily document this evolution. Finally, the implications of phylogenetic analysis of strains and species designated as live microbial ingredients will be discussed.

Naming and Marketing of Strains - An Industry Perspective

Duane Charbonneau, PhD, Procter & Gamble

Appropriate taxonomic identification of probiotics is an essential component of strain commercialization. It is necessary for regulatory submissions, patents placements and quality assurance. Establishment of strain-typing protocols is an important component and necessary for probiotic development. Taxonomic identification is valuable to assure appropriate lineages of newly discovered strains to those with a safe history of use in the host of choice. Several methods are available for determining taxonomic relationships: these include phenotypic determinations, structural lipid analysis, functional genomics and DNA sequencing of the 16S rRNA gene. Strain-typing methods such as bacterial barcode (rep-PCR) and Pulsed Field Gel Electrophoresis have also been utilized. Each method has limitations with respect to the precise taxonomic identification of any particular strain. Next generation sequencing of whole genome offers great promise for taxonomic elucidation in the future; however, current genome databases are limited in size. Thus bacterial nomenclature remains in a state of flux as new tools to assess taxonomic relationships are developed. Many commercial suppliers of probiotics utilize trade names in addition to scientific names to avoid the need to constantly modify product information and not confuse consumers as well as regulatory agencies. Trade names assure the consumer that the probiotic strain or strains in the product remain constant. Bacterial nomenclature name changes although sometimes necessary can become confusing to the scientist, regulator and consumer. Bacterial taxonomy is important but until definitive tools for taxonomic relationships are established more emphasis should be placed on strain typing, preclinical data, clinical safety and efficacy evaluations.

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