Asa's Regulatory Education Series & Guest Appearances

Regulatory Happiness Awaits!

Update on Cannabinoid Product Regulation
Hemp Leaders Summit

June 25, 2021
Learn more here

Asa Waldstein moderates this FDA and FDA panel.

  •  Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission

  • Dr. Matthew Curran, Food Safety Director, Florida Department of Agriculture and Consumer Services 
     

U.S. Dietary Supplement Market Entry Regulatory Considerations
June 2021
Watch here

In this video, host Jeff Crowther and special guest Asa Waldstein discuss market entry considerations such as manufacturing, labeling, marketing, advertising, and some specific U.S. regulations that might be looked over by global players entering the market for the first time.

Asa's Regulatory Education Series Presents
Distributor Pitfalls to Avoid
June 3rd, 2021
Watch recording here

Nathalie Bougenies and Steven Yeager join me for our next Regulatory Education Series event.

 

What companies need to consider when distributing products?

Here are some of the topics we will cover.

What contracts do distributors need to have in place?
What CFR 111 requirements do distributors need to comply with?
What Prop 65 liabilities do distributors carry?
What is the liability of the distributor?
What liabilities do platforms which sell lots of products and making claims have?
How do distributors handle product returns? Do they need to be tested before going back into inventory?
And more!

 

Asa's Regulatory Education Series Presents

Preparing for Cannabinoid Regulations

May 4th, 2021

Video here

Michael McGuffin and Johnel Lagabon join me for our next Regulatory Education Series event which will be primarily NDI focused.

We discuss what hemp cannabinoid companies should be doing to prepare for FDA regulations. This will be reviewed from a legislative, scientific, and practical point of view.

• What if H.R. 841 passes? What would this require? What can companies do now to prepare?
• Overview of NDI regulations.
• Difference between NDI and GRAS?
• If a company starts with self GRAS, how close to NDI
requirements does this get them?
• Specifics of NDI for raw material suppliers or finished
products? Discuss strategy.
• Other thoughts on what companies can be doing to prepare?

 

The Hoban Minute

The Rigorous Road to Compliance

May 6th, 2021

Learn more here

Asa sits down with The Hoban Minute to talk about his roots in herbalism, his career in the herbal products and supplement industry, the importance of regulatory compliance, and why creativity is the best tool for marketing cannabinoid products, and more!

The Natural Nurse

Herbalism, Compliance, & GMP's

(3/25/21)

Listen here

I speak with The Natural Nurse about herbalism, GMP's, and marketing compliance

Hemp Startup Journey 

The Surprising Risks of Marketing CBD Products (2/26/21)

Watch or Listen here   

In this engaging conversation with FDA compliance expert Asa Waldstein, we discuss how to avoid an FDA warning letter which surprisingly goes way beyond what businesses state on a product label.

We cover best practices for CBD company social media managers, effective marketing messages with lower risk language, dos and don'ts of reposting and hashtags, mitigating compliance risk, avoiding making CBD health claims, and how to market your products instead. You will find out what it means for Asa to Create Authentic Excitement in your differentiation strategy and the peace of mind you may get from it. We also discuss cGMP compliance and Asa's recommendations for Spectrum Labs' GMP accreditation journey.

Learn about (AHPA) American Herbal Products Association and its mission.

 

Importance for CBD brands to understand the supplement industry and its relationship to the FDA?

 

High-risk marketing mistakes made by supplement and hemp product marketers.

 

How we can market proucts without making claims.

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

AHPA Hemp-CBD Supplement Congress 

(8/27/20) Watch available sessions here 

Our session focuses on how to maximize marketing reach 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 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.

Moderator: Asa Waldstein

Presenters:

Hemp-CBD and Prop 65 Pitfalls to Avoid: Town Hall

(6/29/20) Watch here

We discuss California Prop 65 regulation changes and pitfalls to avoid.


I will be joined by two very special guests which cover the expert legal, regulatory, and trade organization sides of the industry.

  • 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.

Asa's Regulatory Education Series Presents

Ethical Product Marketing in the Coronavirus Era: Town Hall 

(4/23/20) Watch here

Discussing the do's and don'ts of marketing products during the Coronavirus era.

I will be joined by two special guests which cover the expert legal, regulatory, and marketing sides of the industry.

  • Linda Nielander is VP of Sales and Marketing for Quicksilver Scientific.

  • Erica W. Stump is the owner and founder the Erica W. Stump, P.A. law firm.

Asa's Regulatory Education Series Presents

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.

I am joined by special guests:

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.

Topics

  • Overview of cGMP requirements

  • Strategies to comply and document compliance

  • cGMP resources for hemp-CBD companies

  • Preparing for and conducting an FDA cGMP inspection

Presenters

Compliance Pitfalls to Avoid
June 2021
Watch here

Have a cannabinoid company and worried about falling victim to easily avoidable compliance pitfalls? If so, watch the CBD Association's vlog and learn from dietary supplement expert Asa Waldstein about the best business practices your company should be following.  We also discuss the cannabinoid regulatory, marketing, and enforcement trend landscape.

International Herb Symposium

Online Event

June 1oth, 2021

Learn more here

cGMP's and Marketing Compliance for herbal product manufactures, In depth 3-hour workshop with Steven Yeager.

USA CBD Expo

In-Person Chicago,

October 30th, 2021

Learn more here

Regulatory discussion with topics to be determined.

 

Lucky Leaf Expo

What Can Marketers Learn From FDA/FTC Action 

(In-Person Austin, TX May 14-15, 2021)

Learn more here

 In this session, we review recent enforcement trends and discuss ways companies operating in the hemp-CBD marketplace can limit their risk, while still be truthful and not misleading. This includes identifying high-risk verbiage and providing examples of lower-risk ways to get the same message across. This discussion reviews the dos and don'ts of digital marketing such as best practices for blog posts.

NoCo Hemp Expo

Regulatory Reality on the Horizon (3/26/21)

Learn more here

Read my post here

 I am honored to share the stage with industry icons Robert Hoban and Tim Gordon. They are some of my industry favorites, and I am so excited about our regulatory panel!

The industrial hemp business community is encouraged to stay vigilant, involved and up to date as a number of federal and state bills, USDA, FDA and DEA proposed regulations, and other policy activities impact the hemp market – and your business – on state, national and international levels.

Herbally Yours

Know Your Legal GMP's (2/21)

Listen here

I talk about my herbalism journey, the American Herbalist Guild, dietary supplement safety, AHPA, GMP's, and more!

Asa's Regulatory Education Series Presents

Preparing For FDA Inspections: Fireside Chat

(2/12/21) Watch here

Asa and Steven Yeager discuss tools on how to prepare for and execute a successful FDA inspection. This includes an "Ask Me Anything" session where you can ask anything from us.

How To Prepare: (Examples include):

  • No Claims on Web & Social Media

  • Outside of Building Clean

  • Back Doors locked (GMP prerequisite)

  • SOP Ready: What to do during an FDA inspection

  • -And more!


Company Conduct:

  • Quickly Turn Around Requests

  • Make Copies of Everything

  • Correct Observations Immediately

  • Work with the investigator

  • And more!

 

Steven Yeager is Director of Quality and Regulatory Affairs for Mountain Rose Herbs and has overseen several FDA GMP inspections. Learn more here.

  • Patrick C. McCarthy ValidCare: Answering FDA’s

  • Call for CBD Safety Data

  • Jinpeng Li: Introduction to cannabinoids and the new wonder drug/consumer product: CBD

  • Barbara Kaplan: Inhibition of Peripheral Immune Function and Neuroinflammation by CBD in EAE

  • Brad Lampe: Derivation of an acceptable daily intake of orally-consumed cannabidiol (CBD) in adult consumers: challenges and limitations​

  • and more..

Reviewing the intersection of the dietary supplement and hemp-CBD industries from a legal, regulatory, ethical, marketing, operational, and brand perspective.

A discussion about considerations supplement companies face when adding hemp/CBD into products or when opening up new hemp product

lines.


We also explore this from the perspective of hemp companies adding supplements into their products and open ing up new non-hemp product lines.

I am joined by two wonderful guests:

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

  • Support resilience

  • Slumber support for optimal health

  • Mental equilibrium

  • 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

  • cGMP Compliance

  • Animal products

  • Epidiolex desceduling

  • And more...

  • 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)

Our last in-person event. See pictures here

~90 people on a very snowy Tuesday night in Boulder!

Boulder Hemp-CBD

Group Meet-Up

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?


I am joined by special guests:

Asa's Regulatory Education Series Presents

Ethical CBD Marketing: How to avoid FDA, FTC, and class action trouble (12/17/19) Pictures here

The first Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person)

Read Blog Post here

What can we learn from recent "Big 15" Warning Letters, revised Consumer Update, and recent class action news?

Have you ever wondered why some companies receive FDA Warning Letters and are unsure about how to ethically market your product without getting into trouble?

Are you looking for clarification about what the FDA is enforcing and how to read Warning Letter trends?

What is a claim and what are the risks when making them on your website or social media? Can I get in trouble for "Liking" a post?

If I link to a clinical study is this allowable? Do I need to be careful with blogs?

What is the Farm Bill IFR and how do I submit comments?

What is an attorney's opinion on recent class-action lawsuits?

This event will focus on a discussion about the dos and don'ts of labeling, marketing, and selling Hemp-CBD and much more!
I am honored to be joined by very special guests:

.