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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:
   5
Category:
Administrative Law |  Cross Border Markets & Commerce |  Federal Law |  Hemp |  Hemp Law
Faculty:
Jessica Wasserman |  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


General

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 eligible for credit in the following states: AR, AL, AK, AZ, CA, CO, CT,DE, GA, HI, IL, IN, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, TN, TX, UT, VT, WV, and WI . 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.

INCBA on demand programs are eligible for credit in the following states: AR, AL, AK, AZ, CA, CO, CT,DE, GA, HI, IL, IN, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, TN, TX, UT, VT, WV, and WI . 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 current accreditation status, please select your jurisdiction below.



Handouts

Faculty

Jessica Wasserman's Profile

Jessica Wasserman Related seminars and products

WassermanRowe


Jessica Wasserman has practiced law in Washington DC for several decades, serving both In the federal government as an appointee at agencies including the Department of Commerce (NOAA climate change portfolio), the Department of Agriculture and the Congress and in the private sector at Hogan Lovells and Manatt Phelps. Jessica founded WassermanRowe in 2004 and the firm’s clients include major food, dietary supplement and medical device companies. Jessica is a graduate of the University of Michigan Law School and St. John’s College. 


Will Woodlee's Profile

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's Profile

Andrea Golan Related seminars and products

Associate Attorney

Vicente Sederberg


Andrea Golan is an associate attorney 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's Profile

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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