Regulatory Considerations for Probiotic Path-to-Market

The global probiotic market stands at just over $41 billion USD with a projected growth reaching an all-time high of $76 billion USD by the year 2024. In order to tap into this anticipated growth, probiotic stakeholders should understand the unique regulatory landscape and requirements for introducing new products into the market and maintaining compliance of products already positioned in the marketplace. The complex nature of probiotics, or live microbial ingredients (LMIs), requires an in-depth understanding of the science in order to effectively navigate the regulatory landscape for probiotics in the US and Canada.

The level by which informed consumers are looking for safety information from competent authorities, such as New Dietary Ingredient (NDI) acknowledgement letters from the US Food and Drug Administration (FDA), as a measure of consumer confidence has created an undervalued marketing potential in finished probiotic products for going through the pre-market NDI safety gate in the US. Consequently, anticipated enforcement of NDIs by the FDA should be a major consideration for companies in 2020. Understanding the intersection of the science and regulation of probiotics is crucial to developing a successful path-to-market and reducing regulatory risk.

In this webinar, regulatory experts from KGK Science will outline:

• The regulatory pathways that can be taken by manufacturers of products containing new probiotic strains to introduce them to the US and Canadian markets
• The major differences in applicable US and Canadian regulations that govern the introduction of new probiotic strains into the respective jurisdiction
• How to position a new or existing probiotic organism to fit the regulatory requirements of different jurisdictions and reduce regulatory risk;
• The benefits of hiring a consultant when considering bringing probiotic products into the market

Speaker

James Akingbasote, PhD, Regulatory Toxicologist, KGK Science Inc.

Dr. James Akingbasote provides scientific support in the area of regulatory compliance. With more than a decade of academic, industrial and clinical experience, James works alongside in-house research and clinical teams in conjunction with clients in the preparation of GRAS dossiers and submission of applications for new dietary ingredients, Masterfile and claims substantiation for natural health products, including probiotics that meet the regulatory requirements of Health Canada and the FDA. He earned a Bachelor of Pharmacy degree from the Obafemi Awolowo University, Nigeria, a Master of Research in Mechanistic Molecular Toxicology from the University of Birmingham, UK and a Doctor of Philosophy in Clinical and Molecular Pharmacology from the University of Liverpool, UK. He has co-authored several peer-reviewed journal articles in the areas of pharmacology and toxicology of natural health products and pharmaceuticals, including a book chapter in Comprehensive Toxicology.

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