Dear Colleagues --
I have just received from Peter and Trish the attached update from Capitol Hill.
Please read this memo carefully. First, our intense efforts to establish a lawful pathway for hemp extracts/CBD (HEC) has NOT been included in this must-pass funding bill. That was the key goal, and hence a key disappointment.
Rather, Congress has funded FDA to undertake specific activities over the next 180 days and report back to Congress. The memo provides details.
What does this mean, and where are we? What this means is we DO NOT have resolution toward a regulatory pathway, and we believe that aggressive efforts on the part of FDA and those arguing against a consumer market for HEC have been both effective and convincing in sowing doubt in the minds of Congressional staff and members, thus leading to specific activities to better understand key metrics around the HEC consumer market.
This is what needs to happen now:
Please look for our follow-up memo tomorrow (December 17).
December 16, 2019
Update from Peter Reinecke and Trisha Knight, Senior Political Advisors
THIS JUST IN….
Conferees working on a House-Senate compromise for the end-of-year, government-wide funding bill have completed their negotiations and locked in legislative language that will be considered this week in Congress prior to the Dec. 20 appropriations expiration.
The bill is likely to be voted on by the House tomorrow, Tuesday, Dec. 17, with the Senate to follow on Thursday, Dec. 19. President Trump will need to sign the legislation by midnight on Friday, Dec. 20, to avoid a government shutdown.
With respect to hemp extracts/CBD, the 1,773-page bill does not include any legislative language, beyond a long-standing provision prohibiting federal funding to stop the transportation, processing, sale or use of hemp/seeds grown in accordance with federal law within or outside the state in which the hemp is grown or cultivated. This has been included to address the interstate transportation issue only.
It appears that despite the efforts of Sen. McConnell, Sen. Merkley and others, language was not included in the bill due to FDA pushback on legislating in this area, and particularly on legislating without the agency feeling assured of CBD’s safety in terms a safe serving size, overall population exposure and possible restrictions or warning labels for certain populations (e.g. pregnant women).
Clearly, the recent ramp-up in warning letters, the speech by Principal Associate Commissioner for Policy Lowell Schiller at the recent CRN conference and the agency’s revised, Nov. 25 Consumer Update, warning women about using CBD when pregnant or lactating, are all pieces of that puzzle. We also believe that the recent confirmation of Stephen Hahn, M.D., as FDA commissioner, may have factored into this decision—in terms of congressional deference in allowing the new agency head the time to get up to speed and help direct a solution.
For the future regulation of CBD, there is non-binding but directive report language that does the following:
In addition, the bill earmarks an additional $3 million in funding for the Office of Dietary Supplement Programs, a significant increase, which the industry has long sought.
Implications of the language
The bill did not include the legislative change we sought to make CBD a legal dietary ingredient in dietary supplements. In the interim, the language does move the ball forward in terms of metrics that can quantify the need for action.
We are continuing to assess this situation and how it evolved. Preliminary reports we have received from the Hill indicate that FDA was not supportive of the industry’s language recommending an NDI pathway for CBD dietary supplements. In particular, the agency insists on evidence that would support a dosage level as safe.
In terms of a go forward plan, after determining what we can about what led to this state of play, we are planning at least the following and will formulate a more detailed plan after consulting with UNPA HE/C members: