Hemp Leaders Comment on the “Cannabis Administration and Opportunity Act”
A group of leading hemp organizations, companies, and advocates sent a letter to Senators Schumer, Booker, and Wyden today requesting important changes to provisions of the “Cannabis Administration and Opportunity Act“ (CAOA) regarding hemp and cannabidiol (CBD). A copy of the letter is included below.
As most of our readers are aware, the CAOA is currently in a “discussion draft” format. Senators Schumer, Booker, and Wyden have requested comments from stakeholders in the cannabis and hemp industries in advance of filing it as a legislative bill. You can read a memo on the discussion draft by clicking here and a one-pager by clicking here.
In their comments about the CAOA to the Senators regarding hemp and CBD, the signatories to the letter recommend the following:
– that the food and beverage categories, in addition to dietary supplement products, be included in any clarifying hemp-derived cannabidiol and other hemp legislation.
– the removal of the requirement that all CBD and hemp-containing dietary supplement products submit a new dietary ingredient (NDI) notification to the FDA.
(i) Certain dietary supplement brands will have to submit NDI notifications, as required under DSHEA; however, to require all CBD and hemp-containing products to submit NDI notifications is a costly exercise – certainly for small operations – and to what end. Statistics show that the NDI process has not been overly successful, nor do we believe the agency is equipped to timely review NDI notifications. Furthermore, the current NDI process is subject to a draft guidance document, which carries no legal weight, has yet to be finalized, and has arguably reached beyond the statutory standard of ‘reasonably expected to be safe.’ This adds to the uncertainty on the exact type of data and information that is needed to satisfy the NDI notification (not approval) measure. If CBD and hemp-containing dietary supplement products were truly new to the market, then perhaps a blanket NDI requirement would be appropriate; however, these products have been on the market for several years.
– the inclusion of further instruction to the Secretary that if the option to set a recommended daily serving of CBD is exercised, that any such threshold to be established is limited to the level of CBD as found in the drug product Epidiolex®.
– the inclusion of language that, moving forward, FDA must proceed with formal rulemaking before applying the drug exclusion rule to any substance. This language would serve to avoid future regulatory paralysis for CBD, hemp, and other ingredients.
Thanks to all of the signors for their pioneering leadership and insight. Special thanks to my colleague Tami Wahl for spearheading these comments and drafting the letter. The signors include: Eric Steenstra, Vote Hemp; Mike Lewis, Hemp Industries Association; William Kleidon, California Hemp Council; Blake Butler, Southeast Hemp Association; Janel Ralph, RE Botanicals and Palmetto Harmony; Garrett Perdue, Root Bioscience; Jeremy Johnson, Traditional Medicinals; Ross Sloan, West Town Bank; Dan Hentschke, Charlotte CBD; Mike Sims, Crowntown Cannabis; Dr. Shawn Seitz, Alpha Tech Pet; Ander Schreiner, Ssiirrii, Inc. dba Earthy Now; Daniel Young, Grasslands Botanicals; Tyler Stone, Sycamore BioPharma, and Rod Kight, Kight Law.
Here is the letter:
September 2, 2021
Rod Kight is an international hemp lawyer. He represents businesses throughout the hemp industry. Additionally, Rod speaks at hemp and cannabis conferences, drafts and presents legislation to foreign governments, is regularly quoted on hemp and cannabis matters in the media, and is the editor of the Kight on Cannabis legal blog, which discusses legal issues affecting the hemp and cannabis industry. You can contact him by clicking here.