URGENT -- UNPA / Hemp Extracts/CBD legislative update, December 16

​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:

1. We now better understand the strategy and tactics of those opposing a regulatory pathway for HEC and feel we have worked out a counter-strategy to respond to Congress and many other interested stakeholders. This entails a substantial ramp-up of activity, which we will lay out in a memo tomorrow (as it's getting kind of late tonight).
   
   
2. In essence, we have roughly six months (we hope) to conduct an activity plan parallel to that which FDA is now directed by Congress to undertake.
   
   

As a final note, as we have long said, and now repeat, the HEC issues being debated in Congress are, in fact, the first significant revisit of DSHEA-related issues in Congress. Hence, many members and staff on the Hill are being reintroduced to the dietary supplement regulation through the lens of CBD. So, it is our strongly held view that our strategy and tactics must include a mechanism to educate members on the history of DSHEA, the enormous popular support for public access to supplements, the legislative structure created by DSHEA, and that, in fact, DSHEA is a well-designed mechanism to resolve the regulatory pathway for HEC. Thus we have two critical tasks: (1) a high speed reeducation of Congress about DSHEA, and (2) laying the groundwork to establish a pathway for HEC, all within the next six months.

Please look for our follow-up memo tomorrow (December 17).

LDI
Trisha Knight
Peter Reinecke

-------------------

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:

• Includes $2 million for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and appropriate regulatory activities with respect to products under the jurisdiction of FDA that contain CBD and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 16390).
• Directs that within 60 days of enactment of this act [most likely Dec. 20, 2019], FDA will provide the House and Senate Appropriations Committees  with a report regarding 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.
• Within 180 days, FDA is directed to perform a sampling study of the current CBD marketplace to determine the extent to which products are mislabeled or adulterated.

 
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.

The report:

1. Authorizes additional funding for FDA to determine how it will handle CBD sales in the future. Often, the agency decries a lack of funding as the reason it cannot move more quickly on resolution of policy disputes or enforcement activities. The $2+ million helps address that concern.
2.  Directs FDA within two months to report on its progress in developing the data necessary, both to determine a policy of “enforcement discretion” and developing a pathway for legal sales. This shows that appropriators will be watching closely the progress FDA is making in resolving the issues that preclude legal CBD sales. That said, FDA had promised a report to Congress in “early fall,” which is still not forthcoming.
3.  Tells FDA that Congress wants a sampling study of the current CBD marketplace within 180 days to determine the extent to which products are mislabeled or adulterated.  This effort could boost our ongoing efforts to set a clear and effective legal and regulatory pathway and for more effective enforcement of good manufacturing, labeling and quality standards. But it should not minimize the urgency of acting.

 
Go-forward plan
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:

• Educating key members of Congress about the need for a quick resolution of this issue;
• Assessing the ability of UNPA members to develop and submit NDIs with safety information, should such submissions become possible;
• Meeting with lead congressional members/staff to assess their willingness to push this further;
• Working with other trade associations to meet with FDA to see if a mutual go-forward plan can be agreed to;
• Seeing whether adding other issues, such as mandatory product listings, could incentivize the ability of the agency to reach agreement on a pathway.