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Hemp 201 - FDA and the marketing of CBD products: Will FDA provide a regulatory pathway for CBD in 2021?
- Average Rating:
- 1
- Bundle:
- The Comprehensive Hemp Bundle
- Categories:
- Administrative Law | Cross Border Markets & Commerce | Federal Law | Hemp | Hemp Law
- Faculty:
- Jessica Wasserman, JD | Will Woodlee | Andrea Golan | Wendi Young
- Duration:
- 1 Hour 07 Minutes
- Format:
- Audio and Video
- SKU:
- INCBA05122021FDAOD
- License:
- Access for 6 month(s) after purchase.
Description
Since the 2018 Farm Bill came into effect at the beginning of 2019, the US Food and Drug Administration has restricted the marketing of hemp-derived products including CBD products on the grounds that 1) CBD ingestible products can not legally be on the market because “CBD” is already approved as a drug article in Epidiolex; 2) there is not adequate safety data to support CBD as an ingredient in ingestible products. In the meantime, there is not pending in Congress legislation that would remove these impediments and allow a regulatory pathway. At the same time, FDA has not enforced against CBD products except through Warning Letters triggered by marketing that veers into clear medical curative claims. With a new Administration and Congress, changes in personnel at FDA and new safety data being published, is 2021 the year when CBD will come out from under the FDA shadows to be legally marketed in all 50state?
Whether of not FDA provides the regulatory pathway, there is ongoing legal and regulatory flux during 2021: FDA Warning Letters, FTC Warning Letters, state action against smokable products, Prop 65 warning requirements and more and the potential for class action litigation. Developments in science may support CBD safety and impact allowable claims; further clarification on the way FDA distinguishes drugs, supplements, foods and cosmetics containing CBD may emerge as the science of CBD further develops. And it is possible that a full spectrum CBD product could be distinguished from Epidiolex and shown to be safe through the FDA NDI process.
International developments as Mexico may follow Canada to fully legalizing cannabis and the EU and other countries built out CBD product regulations could influence US regulators.
Credits
This program is eligible for 1 hours of General CLE credit in 60-minute states, and 1.2 hours of General CLE credit in 50-minute states. Credit hours are estimated and are subject to each state’s approval and credit rounding rules.
INCBA webinars are generally eligible for credit in the following states: AR, AL, CA, CO, GA, HI, IL, NJ, NM, NY, ND, PA, TX, VT. Additional states may be available for credit upon self-application by attendees. States typically decide whether a program qualifies for MCLE credit in their jurisdiction 4-8 weeks after the program application is submitted. For many live events, credit approval is not received prior to the program.
The on-demand version of this webinar is eligible for credit in the following states: AR, AL, CA, CO, GA, HI, IL, NJ, NM, NY, ND, PA, TX, VT. Additional states may be available for credit upon self-application by attendees.
(Default credit disclaimer updated 02.08.2024)
For current accreditation status, please select your jurisdiction below.
Handouts
| HR 841/ Schrader Bill | Available after Purchase | ||
| FDA Resource and updates | Available after Purchase | ||
| FTC cases against CBD for unsubstantiated claims and deceptive advertising | Available after Purchase | ||
| PACT Act amendment, page 5136/ 2669 of Covid Relief Bill, Title VI, | Available after Purchase | ||
Faculty
Jessica Wasserman, JD Related Seminars and Products
Partner
WassermanRowe
Jessica Wasserman is the founder and CEO of WassermanRowe, a DC-based law and government relations firm providing services to Food and Drug Administration-regulated industries, including food, supplements, medical devices, botanical drugs and drugs. She has worked in Congress, federal agencies (at both career and political levels) and major law firms. She has worked on hemp and cannabinoid issues since the 2018 Farm Bill decriminalized and defined hemp. Having worked at the U.S. Department of Agriculture, she hit the ground running on the hemp harvest issues and then pivoted to the cannabis FDA issues (Warning Letters for drug label claims compliance; GMPs; Epidiolex drug preclusion issue; GRAS; NDI) as CBD manufacturers and retailers faced these issues. Currently, Jessica lobbies and advises on compliance on a wide range of cannabis issues, including reauthorization of the 2018 Farm Bill; the proliferation of state laws focused on “intoxicating” cannabinoid products; compliance for edible products sold in dispensaries; federal lobbying on the ongoing FDA cannabis scheduling review and more. Jessica is a graduate of the University of Michigan Law School.
Will Woodlee Related Seminars and Products
Partner
Kleinfeld, Kaplan & Becker LLP
Will Woodlee is a partner in the law firm of Kleinfeld, Kaplan & Becker, LLP. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco, cannabis/hemp, and consumer product companies on regulatory and advertising law matters. Will also serves as general counsel to the American Herbal Products Association, the national trade association of the herbal products industry. He was included in the 27th edition (2021) of Best Lawyers in America under the “FDA Law” category. For 2015-2021, Super Lawyers named Will a “Rising Star” of the Washington, DC, metro area’s “Food & Drugs” bar. Will earned a B.A. from Wake Forest University, graduating magna cum laude, with Honors in English, and as a member of Phi Beta Kappa, and a J.D. from Wake Forest University School of Law, where he served as an Executive Editor for the Wake Forest Law Review.
Andrea Golan Related Seminars and Products
Counsel
Vicente LLP
Andrea Golan is counsel in Vicente Sederberg’s Los Angeles office and a member of the firm’s regulatory compliance and hemp practice groups. Her practice focuses on advising businesses in ensuring compliance with regulatory requirements for cultivating, processing, testing, marketing, and selling cannabis and hemp products- including advising businesses with respect to the intersection of federal, state, and local laws.
Wendi Young Related Seminars and Products
Triverity Laboratories
Wendi Young is one of the founders of Triverity Laboratories where she is the President/CEO. Her passion is in solving problems and building systems. She loves it when there is a little bit of chemistry thrown into the mix. Prior to starting Triverity Wendi was the VP of Regulatory and Compliance at Mile High Labs where she developed the quality systems, lead laboratory operations and spearheaded global regulatory compliance. Wendi’s 17 years of experience in pharmaceutical product development gives her a unique perspective on the CBD industry.
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