The hemp industry may be off to a bumpy start under the Biden administration. The day after the inauguration, the Food and Drug Administration (FDA) withdrew a proposal to regulate over-the-counter-CBD.
Although media reports indicate that the action was anticipated, it caused yet another frustrating setback to the hemp industry. At a time when consumer interest in hemp products is growing, the industry still lacks clarity on several key legal components that can affect the potential success and liabilities of hemp businesses.
The FDA’s Cannabidiol Enforcement Policy Draft Guidance for Industry was sent to the White House Office of Management and Budget in July 2020. The proposal was submitted over a year after the FDA renewed its efforts to review cannabinoids like CBD, but the details of the proposal were reportedly never made public.
It only needed approval by the White House Office of Management and Budget before it could be made public. However, that never happened under the Trump administration.
The proposal was reportedly withdrawn January 21, after the Biden administration issued a memo instructing all federal agencies to withdraw pending rules.
Regulation of over-the-counter CBD products is widely considered to be overdue. The hemp industry relies on FDA regulations for guidance regarding the types of hemp products they can legally sell, the quality that those products legally must meet, the details that must legally be on the product labels, and the way those products can legally be marketed.
So far, the FDA has only approved one CBD product, Epidiolex, which is a prescription drug used to treat two severe forms of epilepsy.
The FDA does not have a deadline to meet when setting regulations for over-the-counter CBD products, and there has been no mention of an FDA timeline for resubmitting a new CBD proposal. However, an FDA spokesperson reportedly told HEMP Industry Daily that the FDA “will work closely with the new administration to advance appropriate regulations and policies that are in line with the agency’s public health mission.”
Despite the initial setback of this withdrawn proposal, the hemp industry may still be likely to expand under the Biden administration.
“The hemp industry and the farmers who grow the plant have enjoyed strong bipartisan support amongst policymakers in Washington D.C. for the past several years,” according to a Forbes article from last November. “Hemp is one of those policy issues that unites leaders across party and ideological lines.”
The article also predicted that the hemp industry will likely have opportunities to expand under the Biden administration because hemp industry growth compliments other goals that this administration is expected to prioritize.
“[W]e're … likely to see a variety of policies that come out of a Biden Administration that support the increased growth of industrial hemp because the plant fits under the tenets of [Biden’s] vision for economic and global agronomic policy surrounding carbon capture, sustainability, and plant based economies,” the article stated.
Some sources claim that Biden’s nomination for the Assistant Health and Human Services Secretary position is an encouraging start. Dr. Rachel Levine, who Biden chose to fill the position, has reportedly written about medical marijuana throughout her career. The American Trade Association of Cannabis and Hemp even reportedly referred to her as a “trailblazer” in Pennsylvania where she has served as the state’s physician general, assistant health secretary, and state secretary.
Biden’s picks for the Secretary of Health and Human Services position and for the Vice President position could also indicate positive changes for the industry are ahead. Xavier Becerra, who is currently serving as California’s Attorney General, pledged in 2017 to protect the state’s legal cannabis market from actions that could have been taken by the Trump administration. Vice President Kamala Harris was the lead Senate sponsor of the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act.
Although the hemp industry may be off to a bumpy start under the Biden administration, there is still hope for positive change. Ultimately, there is no telling what possibilities lay ahead.
Sources
[1] https://hempindustrydaily.com/fda-withdraws-pending-cbd-enforcement-proposal/
[2] https://hempindustrydaily.com/fda-submits-cbd-enforcement-policy-draft-guidance-to-white-house/
[3] https://www.supermarketnews.com/cbd/fda-clarifies-regulatory-stance-cbd-products
[4] https://www.forbes.com/sites/roberthoban/2020/11/23/dea-bullies-legal-hemp-industry-again/?sh=6bcb77cb6586
[5] https://foodinstitute.com/focus/cbd-market-likely-to-expand-under-biden-administration/
[6] https://www.cnn.com/2021/01/19/politics/rachel-levine-health-and-human-services/index.html
