Dear Colleagues --
Please see the update below provided by Peter and Trish. Always a lot going on in Washington.
We appreciate all they are doing to keep us up to speed on this fast-moving issue.
CONFIDENTIAL -- UNPA MEMBERS ONLY
PLEASE DO NOT RE-DISTRIBUTE / NOT FOR MEDIA USE
UNPA / UPDATE FROM SENIOR POLITICAL CONSULTANTS TRISH KNIGHT AND PETER REINECKE
February 19, 2020
Although Congress is in recess this week, we wanted to give you a short update on the latest CBD scuttlebutt here in the Nation’s Capital.
The final FY 2020 appropriations bill was accompanied by report language asking the FDA to provide a report in 60 days on the agency's progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and the process in which CBD meeting the definition of hemp will be evaluated for use in products.
Although this language is not binding, that is, it does not have the force of law and thus can be ignored by the agency, our congressional sources indicate they expect to see the report any day now. The appropriations bill was signed into law on December 20, 2019, exactly 60 days ago today.
Many on Capitol Hill are hoping this report will yield valuable information about the agency’s plans and timeline. Even so, most also appreciate that the FDA’s actions on CBD and their transparency in revealing that information to the public are not exactly synonymous. Therefore, if the appropriations report is less than helpful, several key members of Congress are poised to follow up with the agency to ask probing questions aimed at yielding better information. UNPA has been working with those members and has suggested several lines of questioning which we think will help provide a foundation for moving the discussion forward.
Our read of the Hill right now is that many members of Congress are willing to give FDA this one chance to improve transparency. So, in our judgment, letting that play out is a prerequisite to any next steps. Indeed, this was reinforced at a meeting we had on Friday with the staff of a leading Senate Democrat who indicated that they will press the FDA through the regulatory environment first.
We have been working with several coalitions, and also the Hemp Roundtable and the four dietary supplement trade associations, to try to forge a united strategy on legislative language that we can all pursue on the Hill. We see the need for unity, and for moving rapidly as paramount – given the increasing number of CBD products on the market, the FDA’s lack of enforcement on all but the egregious health claims, and an unsettled hemp farming market.
One version is the language that the DSTAs sent to Congress at the end of last year, that would bypass the so-called “exclusionary rule” in sec. 321(f)(f) of the Food, Drug and Cosmetic Act, so that hemp-derived CBD would be considered a dietary supplement, and safety would be determined through the NDI process. Another version being discussed would defer more to the FDA, by compelling the agency to issue a final regulation by a date certain, effective on a date certain. These strategy discussions are underway.