Our Senior Political Advisors, Peter Reinecke and Patricia Knight, forward the following report from Washington, outlining a plethora of recent regulatory and legislative activity around the hemp/cannabinoids issue, as well as the likely tie-in to any potential modifications to the Dietary Supplement Health and Education Act.
Please note that this report is not for distribution or re-publication outside of UNPA or for use by media without prior request. Thank you for your understanding and consideration.
WASHINGTON CBD UPDATE
Nov. 1, 2019
Much has happened in the past week in Washington, and we wanted to blast the following out to you, even though many of the below items are not the final chapters in the CBD story.
On Thursday, the Senate passed the “minibus” appropriations (spending) bill for 2020, which provides funding for a number of agencies, including FDA. The bill was passed by a solid, bipartisan vote of 84-9.
The House has passed all its appropriations bills, including the FDA bill. But the House and Senate have yet to agree on the overall 2020 spending limits for each of the 13 spending bills, which has slowed action on all the bills and could slow down final approval of the FDA spending bill.
As you may recall, the House bill contains an increase of $3 million for the FDA Office of Dietary Supplement Programs (ODSP), with the new funding being directed toward enforcement of DSHEA, including inspection and enforcement activities. The Senate bill contains this same funding increase. So, we should expect that increase to remain in any final spending bill. The only threat to this would be if Congress can’t agree to any spending plan and ends up continuing all federal programs at last year’s levels.
UNPA has made it a priority to grow the ODSP budget, and we’ve met with numerous congressional offices, as well as FDA, to offer our support. ODSP was funded at only $4.6 million in FY 2016, while the increase would take that to over $10 million in 2020.
A CBD PATHWAY AS PART OF THE FDA APPROPRIATIONS BILL?
UNPA and others have been working with the Senate Majority Leader’s office (Sen. Mitch McConnell, R-Ky.) to unlock the promise of his language in last year’s farm bill. As UNPA members are well too aware, the farm bill made hemp legal but did not establish a legal pathway for CBD products.
Most efforts to date have focused on including a “CBD fix” by including language in the committee report accompanying the FDA/Agriculture Appropriations bill, since that bill was seen as having a high likelihood of enactment this year. And the Senate did include language in its report. For CBD, this gave us the first glimpse of the committee’s thinking. One significant shortcoming with this approach, however, which we’ll discuss in a minute, is that a committee report cannot become law—so it is not binding on federal agencies. We’ve copied the pertinent part of the Senate report below:
Cannabidiol [CBD].--The Committee provides the FDA with $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the FDA which 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. 1639o). Within 90 days of enactment of this act, the FDA shall provide the Committee 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 120 days of enactment of this act, the FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp as defined by section 297A of the Agricultural Marketing Act of 1964 (7 U.S.C. 1639). Such enforcement discretion shall be in effect until the FDA establishes a process for stakeholders to notify the FDA for use of CBD in products that include safety studies for intended use per product and makes a determination about such product. The FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug [IND] application in the development of a regulatory pathway for CBD in products under the jurisdiction of the FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.
UNPA, working with the Council for Responsible Nutrition, the American Herbal Products Association and the Consumer Healthcare Products Association, met recently with Sen. McConnell’s staff, expressing appreciation for their work to forge a pathway for CBD products. The groups shared concerns that the above appropriations report language was not binding on FDA and that CBD products would still not be lawful per the FDA. It was pointed that out that a statutory change to make CBD a legal dietary ingredient is needed.
The four trade associations worked together effectively to propose such legislative language as an alternative to report language and were pleased that this type of approach is garnering serious interest by the Senate Majority Leader and others in Congress. The next opportunity for this proposal to be adopted by Congress would be the conference between the House and Senate on the FDA/Agriculture Appropriations bill. That will be the focus of our appropriations-related efforts moving forward.
WHAT ABOUT THE OTHER CANNABINOIDS?
UNPA has actively been raising an important legacy issue: How to treat cannabinoids other than CBD? This concern is now also being raised by congressional staff. As one influential Capitol Hill office said, “Are we going to have to repeat this exercise for every cannabinoid?” As a result, the four trade associations have worked to craft legislative language would make other non-THC derivatives of the hemp plant legal dietary ingredients, if they are in full compliance with NDI requirements and other consumer protections of DSHEA, such as adhering to GMPs and appropriate labeling.
AND WHAT ABOUT THE HOUSE OF REPRESENTATIVES?
On the House side, the Appropriations Committee has taken a different tack—its report language focused more on enforcement against illegal CBD products than on finding a solution to bring CBD products to market. This will have to be discussed when the House and Senate meet to try to negotiate a final bill. This process could begin as early as next week.
Long-time supplement champion Frank Pallone. D-N.J., who is now chair of the Energy and Commerce Committee, is also looking closely at how to resolve this impasse. We are continuing to meet with his staff to work toward a solution.
PRODUCT LISTING COULD BE PART OF THE MIX
Both the House Energy and Commerce and Senate HELP committees, the committees with jurisdiction over FDA, have told us they are aware of proposals to tie passage of legislation to forge a CBD pathway to legislation requiring dietary supplement product listings, so that FDA knows what products are being sold. UNPA has been supportive of a carefully drafted product- listing requirement, which could fit nicely with our objective of making certain the supplement industry is seen as responsible and regulated.
PROGRESS IS BEING MADE ON THE USDA FRONT
Yesterday, the Department of Agriculture published an immediately effective interim final rule (https://www.ams.usda.gov/rules-regulations/establishment-domestic-hemp-production-program) that codifies the U.S. Domestic Hemp Production Program pursuant to the 2018 farm bill. In brief. the rule both outlines how the Agriculture Department will approve state and Indian Tribal plans for hemp production, and it sets up the federal plan for approval of production in states or Indian Tribal territories without their own USDA-approved plan.
Publication of that rule today is seen as putting even more pressure on FDA, given that there is now a framework for legally produced hemp to be grown. Use for CBD-related products is expected to be the majority of hemp sales under the new farm bill provisions.
WHAT WE’RE WATCHING:
- There’s increasing publicity about vitamin-based vaping products and their proliferation online. Although consumers may perceive these products as harmless, in fact, they are not legal uses of DS under DSHEA, which made clear that dietary supplements must be consumed (eaten) to be sold legally.
- On October 22, FDA and FTC sent a joint warning letter to a Florida company illegally selling online unapproved products containing CBD with unsubstantiated claims. Is this the first of many to come under the united FDA/FTC front?
- The week before, on October 16, FDA sent out a Consumer Update (https://www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding) cautioning pregnant and breast-feeding women against CBD use. Is this a clue to what the agency is finding as it works to address the safety of CBD products?
- Today, the White House announced that it will nominate a new permanent FDA commissioner: Steven Hahn, a radiation oncologist at MD Anderson in Houston. We are unaware of any specific positions or statements he has made relevant to supplements. His nomination will likely be considered by the Senate before the end of 2019.
© Copyright 2019, the United Natural Products Alliance. All rights reserved