State marijuana regulators are telling congressional lawmakers that their investigation into the lack of federal rules for hemp-derived CBD products must take into account other cannabinoids like delta-8 THC that are emerging on the market—and they also need to provide an agency like the Food and Drug Administration (FDA) with enhanced regulatory authority.
In response to a request for expert input on CBD regulations from key House and Senate committees last month, the Cannabis Regulators Association (CANNRA) sent lawmakers a letter on Friday that offered recommendations on creating a framework for all hemp-based cannabinoids. The submission is informed by group members’ collective experiences overseeing state cannabis programs.
One of the regulators’ main points to the House Energy & Commerce Committee and Senate Health, Education, Labor, and Pensions (HELP) Committee concerns the scope of the inquiry.
While there’s been significant focus on CBD, the federal legalization of hemp under the 2018 Farm Bill also broadly decontrolled all derivatives besides delta-9 THC, including intoxicating compounds like delta-8 THC and THC-O-acetate. CANNRA said Congress “effectively legalized marijuana federally, without product regulation, and called it ‘hemp.'”
The Drug Enforcement Administration (DEA) has said that it considers those cannabinoids illegal if they’re synthetically produced—as is common practice for delta-8 THC—but the market for such products has flourished nonetheless with limited enforcement. Several states have independently taken steps to ban or restrict such substances.
“Hemp-derived products on the market today can be ingested, applied topically, aerosolized, inhaled or combusted, applied transdermally or transmucosally, or used in other ways,” the letter says. “Many of these products and forms extend beyond anything that would be allowed in state-regulated ‘marijuana’ marketplaces.”
“A comprehensive regulatory approach that accounts for all cannabinoid hemp products is urgently needed. A federal regulatory approach must have a broad focus with regulatory authority to address the products that are available on the market today and the products that may be available in the future,” the regulators said. “A focus on CBD alone is insufficient, in part because many CBD products contain other cannabinoids which also need to be regulated for consumer safety and public health.”
Many lawmakers and hemp industry stakeholders have criticized FDA for refusing to enact regulations for CBD, but CANNRA said it agrees with the agency that it currently lacks the necessary authority to develop a comprehensive framework that would be necessary for such a complex market.
“Existing pathways do not address aerosolized, inhaled, or combusted products,” the letter says. “They also do not include sufficient authorities for testing, regulation of packaging and labeling across modes of use and products, regulation of additives and ingredients that could pose risk, and authority to limit the potential appeal and consumption of products by youth. Current state regulatory frameworks for cannabinoids derived from marijuana extend well beyond any of the current FDA pathways.”
The regulators said that “FDA needs specific authorities and defined, short timelines under which to issue regulations.”
Also, they advised that the agency should coordinate with states, territories and tribes so that rules aren’t developed in a silo. And while federal rules are critical, states “should be able to enact regulations that extend beyond federal minimums to further protect their communities and consumers.”
The organization, which recently expanded its membership to include international regulators, additionally emphasized that regulation “does not mean recriminalization.”
“Part of a regulatory agency’s job is to determine whether a product can be manufactured safely or consumed safely and what regulatory policies are needed to safeguard against potential adverse effects. A determination that a product is unsafe for a commercial marketplace is not synonymous with recriminalizing or criminalizing use of that product,” they said. “Enforcement actions across states often focus on progressive civil penalties or impacts on licenses as a way to deter production of unapproved products.”
The 43-page letter then provides detailed responses to about two dozen specific questions that the committees listed in their request for information about the issue, touching on everything from the current CBD market landscape to challenges association with the absence of marketing regulations to packaging and labeling requirements.
CANNRA isn’t the only organization that responded to the congressional call for input.
The U.S. Hemp Roundtable, whose general counsel recently testified at a House subcommittee hearing concerning FDA inaction on CBD, also answered the panel’s questions in a recent letter.
Unlike CANNRA, however, the hemp association argued that FDA’s position that it does not have proper authority to develop a regulatory framework for the cannabinoid is “flawed,” and Congress should direct it to take action. It also said that there should be regulated access to semi-synthetic cannabinoids like delta-8 THC for adults.
The American Trade Association for Cannabis and Hemp (ATACH) also sent a responsive letter to the committees, saying that while FDA should be responsible for regulating CBD, “the real elephant in the room is unregulated intoxicating hemp synthesized intoxicants.”
“Make no mistake, the broad definition of hemp in the 2018 Farm Bill resulted in an explosion of unregulated hemp-derived products that are intoxicating,” ATACH President Michael Bronstein said. “CBD is sometimes used to create hemp synthesized intoxicants and often these hemp products meet or exceed the levels of THC content contained in state level legal markets. The safety profile of these products are not known, are marketed to consumers outside of a regulated system, and can appeal to and be accessed by youth.”
The association said that such products should be regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), rather than FDA.
The Kentucky-based CBD company Cornbread Hemp similarly shared their perspective on the issue in a letter to the committees on Thursday. The company’s executives said that the “vacuum caused by a lack of FDA regulations has created a patchwork of state laws that are bad for business and confusing to consumers.”
They also said that if Congress does move to implement regulations for cannabinoids, they should reserve more strict rules for intoxicating compounds while treating CBD containing up to 0.3 percent THC by dry weight as dietary supplements under the Dietary Supplement Health and Education Act.
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Meanwhile, House Oversight Committee Chairman James Comer (R-KY) said in April that his panel would be launching an investigation into the matter, and he requested that FDA turn over documents related to its decision not to regulated the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.
The hemp industry took a major plunge in 2022, according to a report from the U.S. Department of Agriculture (USDA) that was released in April—and stakeholders say the FDA’s refusal to issue regulations for CBD products is largely to blame.
Bipartisan congressional lawmakers refiled a separate pair of bills in March that are also meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Sens. Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer (D-OR), separately filed legislation last month that would remove regulatory barriers that FDA claims prevents it from allowing CBD sales.
The Hemp Access and Consumer Safety Act, which was also introduced last Congress but did not advance, would exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from certain federal restrictions, while permitting officials to enact labeling and packaging rules.
FDA’s announcement that it wouldn’t be regulating CBD came days after the agency released finalized guidance that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.
The agency did separately received some bipartisan praise for releasing first-ever guidance on developing psychedelic medicines. At the same time, it is actively working to review the federal scheduling of marijuana under a directive from President Joe Biden last year.
Photo courtesy of Kimzy Nanney.