In yet another sign of forward momentum for CBD, on Thursday, the Senate Appropriations Committee approved Majority Leader Mitch McConnell’s additions to the 2020 Senate Agriculture Appropriations Bill.
If implemented, the bill will require the Food and Drug Administration to pick up speed on developing more permissive guidance on hemp-derived CBD products, paving the way for increased business opportunities.
Currently, the FDA maintains that food additives and dietary supplements containing CBD are illegal, a stance that puts hemp producers in a regulatory gray zone and leaves customers prey to peddlers of CBD products making unapproved drug claims. Plus, as the National Association of State Departments of Agriculture (NASDA) said in comments to the FDA, “If no federal action is taken, states will be forced to develop regulatory structures for these products.” This could result in a patchwork regulatory landscape that would render producers and manufacturers permanently unable to sell across state lines.
McConnell’s additions to the 2020 Agricultural Appropriations Bill would require the FDA to issue an “enforcement discretion policy” on hemp CBD within 120 days, one that would remain in place until the agency finalizes a permanent legal pathway for the products.
In a statement issued ahead of the bill’s vote before the full Senate, McConnell signaled that he had secured: $16.5 million for the U.S. Department of Agriculture to implement the hemp provisions of the 2018 Farm Bill; $2.5 million for the research of hemp through Agriculture Research Service sites; a provision directing the Farm Credit Administration to offer services to hemp producers and businesses; and prohibited the federal government from banning the transfer, production, or sale of hemp in accordance with the 2014 Farm Bill.
Senator Jeff Merkley (D-OR) has partnered with McConnell on hemp policy, even before the passage of the 2018 Farm Bill. During the Appropriations Committee’s hearing on Thursday, Merkley said that the bill, which allocates $58 million more than last year, will “allow rural entrepreneurs an opportunity to start to grow their businesses [and] create much-needed jobs” across the agricultural sector. Merkley also said he is “pleased” the bill includes $2 million for the FDA to develop a regulatory framework for CBD.
With 31 members in favor and none in opposition, the 2020 Senate Agriculture Appropriations Bill will now be referred to the full Senate for a vote.
Richard Shelby (R – Alabama), who serves as Chairman of the Senate Appropriations committee, indicated that he expects “this move through the process quickly, before October 1.”
Context: Before leaving his post, former FDA Commissioner Scott Gottlieb indicated that it could take the agency a minimum of three to five years to clarify the legality of hemp-derived CBD products—a statement that raised alarm among stakeholders and prompted lawmakers, including Senator Ron Wyden (D-Oregon), to formally address the agency.
In June, Wyden wrote a letter to the Department of Health and Human Services and the FDA’s Acting Commissioner, Ned Sharpless, in which the Senator signaled that producers and manufacturers “are poised to make significant economic gains from hemp and its derivatives, but only if the federal regulatory system ensures the lawful and safe use of these recently liberated products.” In his missive, Wyden acknowledged the challenges the FDA faces in creating a pathway for hemp-derived CBD in foods and dietary supplements, chief among them: opposition from pharmaceutical companies.
Still, the Senator called upon the agency to take “prompt action to issue guidance announcing a formal enforcement discretion policy by August 1, 2019.” Wyden also requested that the FDA “issue an interim final rule that ensures a regulatory pathway for lawful use of CBD.” That did not occur. Instead, in August, the agency’s Principal Associate Commissioner for Policy, Lowell Schiller, delivered a speech saying that a progress update could expected by early fall. Meanwhile, industry stakeholders worry that it could still take the FDA several months to issue formal regulations.