AHPA presented the second annual Hemp-CBD Supplement Virtual Congress to on Aug. 27 to provide companies with an understanding of federal and state legal and regulatory obligations and current issues and opportunities in the hemp-CBD market. This event is now available on-demand.
If you are already registered you can access the on-demand event here: https://ahpahempcbdcongress.vfairs.com/
Keynote: Sen. Ron Wyden (D-OR)
Longtime hemp advocate and co-author of the hemp provisions included in the 2018 Farm Bill, U.S. Sen. Ron Wyden (D-OR) delivered the keynote at this year's congress.
Wyden continues to push for consumer access to hemp products by urging FDA and HHS to promptly create a regulatory pathway to use cannabidiol (CBD) as a food additive and as a dietary ingredient in dietary supplements.
NDI-GRAS for hemp-CBD
Recorded Aug. 18
This three-hour workshop covers U.S. regulatory considerations for hemp as a food additive and dietary ingredient. This interactive , virtual workshop was presented by AIBMR and provides attendees with an overview of new dietary ingredient (NDI) notifications and generally recognized as safe (GRAS) for hemp and hemp-derived cannabidiol (CBD). The workshop provides in-depth information on:
- GRAS Independent Conclusion or FDA NDI Notification? Pros and cons of each route for establishing proper regulatory status for CBD-containing ingredients.
- Understanding the presentation of manufacturing and identity
- Exposure estimation and how important this is for reasonable certainty (GRAS) or expectation of safety (dietary ingredients/dietary supplements)
- Toxicology as the basis for establishing proper margins of safety (MOS) and discussion of “Feasibility Study” concept regarding whether toxicology studies are needed.
cGMPs for hemp-CBD supplements
Recorded Aug. 20
This three-hour workshop provides an overview of current good manufacturing practice (cGMP) requirements for hemp-CBD dietary supplements. This interactive workshop was presented by EAS Consulting Group, LLC, and provided in-depth information on:
- Master Manufacturing and Batch Production Records
- Quality Unit Responsibilities and Material Reviews
- Product Complaints
- Specifications and Testing
- Material Control – Components, Packaging and Labels
- Holding and Distribution Operations
- Own Label Distribution Requirements
- Managing an FDA inspection
- Product Labeling
- Special Considerations for the Cannabis Industry
The Hemp-CBD Farm and Retail Financial Snapshot
Sponsored by: Informa Markets
Conservative forecasts by Nielsen indicate the U.S. hemp-based CBD market could be a $2.25-$2.75 billion industry this year alone. This session provides a financial overview from three different perspectives: retailer, farmer, and buyer. Speakers give a comprehensive review of which CBD retail brands, categories, and products are trending, They also project where the market is heading based on buyer perception and activity, and report on what is driving the growth of hemp cultivation and processing across the country.
Meeting Hemp Cultivation Challenges
Sponsored by: Lazarus Naturals
This session addresses farm operations and various challenges with the cultivation of hemp as an agricultural commodity. Topics include: acquiring germplasm as seeds or clones; certified seed programs; selecting varieties optimized for cannabinoid content or food/fiber types; pathogens and pest control; controlling and testing for THC content; weather considerations; and issues in harvest and processing such as availability of appropriate machinery; and processing facilities.
Progress on Interim Final Rule (IFR) Implementation
With the October 2019 promulgation of the USDA’s Interim Final Rule (IFR) for the U.S. domestic hemp production program, hemp growers must adapt to the new regulatory framework for the 2020 growing season. This session covers the USDA’s initial implementation of the IFR and insights into the important public comments received by the Agency that may shape its future regulatory direction. Presenters also address perspectives on the transition to hemp production plans, and the impact of other State specific initiatives.
Regulatory Update with FDA and States
Sponsored by: CFH, Ltd.
The Food and Drug Administration (FDA) has issued several public statements on its intention to create a lawful “pathway” for hemp and CBD as ingredients in foods and supplements. This session addresses challenges in understanding the evolving regulatory landscape for hemp and hemp-derived CBD products by outlining recent actions taken by FDA. In addition, regulatory issues at the State level, and emerging class action lawsuits are discussed.
Maximizing Sales by Minimizing Risks
This session focuses on how to maximize marketing by taking the necessary steps to ensure supplement claims are truthful, legal, and substantiated. The Federal Trade Commission (FTC) enforces against false, misleading, and deceptive advertising, and considers claims misleading if they are not substantiated. In addition, the Food and Drug Administration (FDA) has been sending warning letters to hemp-CBD companies making drug claims. Presenters cover problematic social media posts and customer testimonials, and discuss how to minimize risks presented by plaintiffs’ attorneys, state law enforcement, and competitors.
- Ron Wyden, U.S. Senator from Oregon
- Richard McKewen, Esq., Attorney, Northwest Regional Office, Federal Trade Commission
- Mai Dinh, Esq., Assistant General Counsel, Marketing, Regulatory, and Food Safety Programs, Division Office of the General Counsel, USDA
- John Grubb, Managing Partner, Summit Venture Management
- Roy Bingham, Co-founder & CEO, BDS Analytics
- Ian Laird, CFO & General Counsel, HempBenchmarks.com
- Rich Maturo, Vice President, Cannabis Product Measurement, Nielsen
- Mark Wheeler, Founder, Pacific Botanicals
- Kelly O’Connor, Client Services, Columbia Labs
- Jeff Higley, Owner, Oshala Farm
- Chris Bourne, Co-founder & Vice President Agriculture, Klersun LLC
- Evan Skandalis, Vice President of Farm Operations, Lazarus Naturals
- Adrienne Snow, Founder, Western States Hemp
- Andrea Golan, Esq., Associate Attorney, Vicente Sederberg, LLP
- Rick Fox, CEO, Meristem Farms, LLC
- Eric Steenstra, President, Vote Hemp
- Will Woodlee, Esq., Partner, Kleinfeld, Kaplan & Becker LLP and AHPA General Counsel
- Cynthia Meyer, Esq., Partner, Kleinfeld, Kaplan & Becker LLP
- Marc Ullman, Esq., Of Counsel, Rivkin Radler LLP
- Ashish Talati, Esq., Partner, Amin Talati Wasserman
- Timothy Murray, Ph.D., Director of Quality Assurance, Gaia Herbs
- Asa Waldstein, Senior Vice President Operations, Functional Remedies
- Michael McGuffin, President, AHPA
- AHPA Members: $449
- Non Members: $575
- AHPA Members: $275
- Non Members: $325