Herbal supplement manufacturers and marketers need to have a solid understanding of current Good Manufacturing Practices (cGMP). In this interactive presentation, you'll learn about the intricacies of cGMP, including all CFR 111 subparts. We'll give you examples about how to comply with each section, practical steps for implementing them in your facility, and common mistakes to avoid. We also provide real-world examples of how to prepare for and conduct oneself should you have to undergo an FDA inspection. We review common marketing mistakes made by herbal manufacturers and marketers.
Only $30 and supports this important organization
The Federal Trade Commission (FTC) enforces against false, misleading, and deceptive advertising, and considers claims misleading if they are not substantiated. In addition, the FDA has been sending warning letters to hemp-CBD companies making drug claims. Presenters address problematic social media posts and customer testimonials, and discuss how to minimize risks presented by plaintiffs’ attorneys, state law enforcement, and competitors.
Jane Wilson is Director or Program Development for the American Herbal Products Association (AHPA) and is the resident Prop 65 expert for this important trade organization.
Concierge For a Better Living
Cannabis, CBD, Regulations, & AHPA (6/4/20) Listen here
Cannabis, CBD, Regulations, and AHPA are what Asa Waldstein, a veteran of the dietary supplement industry, sit down and talk about in today’s episode of Concierge For Better Living with Doc Rob.
During these tough times, it gets harder and harder to find the light at the end of the tunnel. Asa helps do this by diving deep into the dietary faction of cannabis. He also explains how old practices such as canning, can and are making a comeback in today’s cannabis industry.
Ethical Product Marketing in the Coronavirus Era: Town Hall
Erica W. Stump is the owner and founder the Erica W. Stump, P.A. law firm.
FDA and Class Action Enforcement Trends & Updates: Fireside Chat (1/15/20) Pictures here
Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person)
In any rapidly emerging industry building a community to help support each other in education, compliance, and in developing best practices is always a good idea.
This is a fireside chat format to discuss FDA and class action enforcement and trends. We expect an update from the FDA soon and we can likely guess there will be more lawsuits and perhaps more warning letters as well.
Supplement cGMP Basics for Hemp-CBD Companies (12/10/19) Watch here
This webinar provides an overview of dietary supplement current good manufacturing (cGMP) requirements for hemp-CBD products. Legal and industry experts provide strategies and resources to comply and document compliance with these federal manufacturing requirements designed to ensure product quality and safety.
Overview of cGMP requirements
Strategies to comply and document compliance
cGMP resources for hemp-CBD companies
Preparing for and conducting an FDA cGMP inspection
Tara Lin Couch, Ph.D., Sr. Dir. of Dietary Supplement and Tobacco Services, EAS Consulting
Asa Waldstein reviews warning letters and gives examples of how to lower marketing risk for the cannabinoid and dietary supplement industries
Here are some other lower-risk ways to communicate how your product can help:
Balanced state of mind
Happy mood support
A good night’s sleep supports the body’s health
Slumber support for optimal health
Be kind to your body with hemp oil, your body systems will thank you!
Why Hemp-CBD Companies Need a Supplement Executive (6/20/20) Listen here
Maximizing sales by decreasing the time to get to operational efficiency is important. Learning on the job when it comes to best interpreting GMP's, knowing what machinery companies to purchase from, how to market products effectively and compliantly can slow the time to get to maximum peak performance. Focus on sales rather than being bogged down in the "learning curve"stages of growth by hiring an industry expert.
We discuss this and more during our fun discussion.
Regulatory Hurdles Associated with Cannabis & Its Concentrates (5/21/20) Watch here
Interesting topics for the CBD and hemp industries.
FDA/FTC enforcement trends
Truth in labeling
Tatiane Berdum: Host, Burdock Group
Elan Sudberg: CEO, Alkemist Labs
Dr. Marielle Weintraub: President, US Hemp Authority
Brett Goldman: Industry Regulatory Expert
Asa Waldstein: AHPA Cannabis Commitee Chair
Founder's Night: Iconic CEO's share their stories (2/11/20)
~90 people on a very snowy Tuesday night in Boulder!
hosted by Asa (In-person)
A special Founders Night, a Fireside Chat format with two CEOs sharing their personal journeys, visions of where the market is going, and the host of decisions they need to make--business and regulatory both-as their companies grow.
How do their companies deal with ever-changing regulations?
How much budget and staff do they allocate for Regulatory compliance?
Do venture capitalists take compliance into consideration when investing, both budget and company attitude?