Takeaway: We will review major themes in FDA's pursuit of a cannabis regulatory framework as well as Congress' efforts, including impacts and timing

Call Now | Cannabis Regulation | Scientists v Farmers - 2019.08.15 Cannabis Regulatory Update2

Please join Emily Evans, Health Policy Sector Head, Shayne Laidlaw, Hedgeye Cannabis Analyst and JT Taylor, Macro Policy Sector Head as we review major regulatory themes that have emerged through public comments on the FDA's development of a regulatory framework for cannabis and cannabis-derived products. We will also discuss the status and future of federal legislative efforts including the SAFE Act and the STATES Act. Shayne and Emily will provide company-level insight on the impacts of  possible regulatory and legislative actions and timelines.

  

Health Policy Subscribers: CLICK HERE for event details (includes video link, materials link and dial-in).

(For uncooperate browser, cut and paste: https://app.hedgeye.com/feed_items/77045)

 

On May 31, 2019 the FDA held the first of what are sure to be a series of public meetings aimed at informing the FDA's efforts to develop a regulatory framework for Cannabis and Cannabis-derived products. Since then the public has submitted over 4,400 comments. These include input from the consumer products, food and beverage, and pharmaceutical industries.

On August 15 at 2pm we will explore the emerging themes, policy conflicts and areas of consensus including:

  • Pharma v Everyone Else. The FDA has expressed concern that widespread retail availability will reduce incentives for conducting research into effective medical uses of CBD. We will explore how that argument is standing up among stakeholders.
  • State of the Science. The science of the effects of cannabis and cannabis-derived products has suffered under restrictive access to plant material. How will the FDA accomodate the lack of scientific evidence in the face of consumer demand?
  • Regulatory Pathways. We will explore the drug preclusion debate that, at least initially, has led the FDA to believe the Generally Accepted as Safe and the New Dietary Ingredient pathways were not available. Industry stakeholders, however, have pointed out options that could be explored. We will discuss those and what they mean to the regulatory future of cannabis and cannabis-derived products.
  • Concentration Limits. If a regulatory pathway can be developed outside of the existing one for drugs, what likely limits will be placed on products?
  • Other Standards. Dosage limits, manufacturing standards, drug-to-drug interactions are other issues that have been raised. We will examine these and their implications.
  • Federal Legislation. The SAFE and STATES Acts are pending in Congress. We will also look at the neccessity of their passage in light of FDA action.
  • Scientists v. Farmers. How will the demands of scientific evidence on CBD match the market demands of US Farmers, particularly in tobacco-growing states?
  • State Actions. State level regulations to keep an eye on headed into 2020. 

We look forward to you joining us.

Emily Evans
Managing Director – Health Policy



Twitter
LinkedIn

Thomas Tobin
Managing Director


Twitter
LinkedIn

Shayne Laidlaw
Managing Director - Cannabis

James R.  (JT) Taylor
Managing Director, Macro Policy
Chief Political Strategist
Direct =