Preparing for Cannabinoid Regulations: An NDI Focused Conversation (Full Webinar) скачать в хорошем качестве

Preparing for Cannabinoid Regulations: An NDI Focused Conversation (Full Webinar)

Asa Waldstein, Michael McGuffin, and Johnel Lagabon discuss what hemp cannabinoid companies should be doing to prepare for FDA regulations. This is reviewed from a legislative, scientific, and practical point of view. 2:11 Michael McGuffin’s thoughts on HR 841, and what does this mean for hemp companies if it passes? 5:03 What is the difference between NDIN’s and GRAS? 9:09 Why choose self-GRAS or FDA-GRAS? 22:51 What can companies be doing now to prepare for the future? 31:01 What NDI responsibilities do extract suppliers have versus manufacturers of a finished product? 35:20 If a company does self-GRAS do they need to submit an NDIN? 36:45 What is the risk or penalties associated with introducing an NDI into commerce without going through the NDIN process? 40:44 What role does Real World Data being collected by companies like ValidCare play a role in the NDIN or GRAS process? 42:31 What practical steps will small-scale producers of CBD oils and salves need to do? 43:46 Will naturally occurring cannabinoid profiles in a full or CO2 extract require an NDIN? Resource links here: https://www.asawaldstein.com/resources Michael McGuffin has served as the President of the American Herbal Products Association (AHPA) since 1999. A leading expert on dietary supplement regulation, Mr. McGuffin has been published in scholarly and scientific journals, including the Food and Drug Law Journal and Clinical Pharmacology & Therapeutics, and also wrote the highly-lauded publication AHPA’s Annotated Final Rule on Dietary Supplement cGMP (2007). Johnel Lagabon has been the Engagement Manager at Burdock Group since 2017 and has helped ingredient innovators in across multiple industries, including the hemp & CBD space, overcome the regulatory hurdles to bringing their novel ingredients to market. His firm, Burdock Group, has over 30 years of success serving the food, animal feed, and dietary supplement industry, and is a trusted ingredient safety and regulatory advisor to many fortune 500 companies. Thank you! Asa Waldstein www.AsaWaldstein.com -The comments by myself and any presenters are considered educational only, and are not intended as legal or regulatory advice.