U.S. Hemp Roundtable reported that Wang and Quarles urged committee members to incorporate language into the 2023 Farm Bill that would regulate cannabidiol (CBD) and other hemp-derived compounds.
Others at the hearing, which was held by the House Agriculture Committee Subcommittee On Biotechnology, Horticulture, And Research, agreed.
Concerns Surround FDA InactionRanking Member Rep. Jim Baird (R-IN)stated, “we’ve heard a lot of great recommendations for the 2023 Farm Billhere, and one that I’d like to add is that theFDAhasn’t really had any kind of regulatory framework for hemp-derived CBD, so I would encourage us to include that in our discussions about the 2023 Farm Bill.” Chairwoman Stacey Plaskett (D-VI) responded, “Thank you, and I agree wholeheartedly with that assessment.”
Also in agreement: Full Committee Ranking Member Glenn Thompson (R-PA). He said, “FDA is missing in action” and that he hopes the committee can rectify that in the remaining months of Congress.
Another problem raised by Quarles and Wang:The 2018 Farm Bill legalized the growth and sale of hemp, and the U.S. Department of Agriculture (USDA) established rules for production. Yet, the inaction of the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabinoids continues to negatively impact the industry.
“The hemp industry has been severely hampered by the slowness of the federal Food and Drug Administration to create a regulatory pathway for hemp-derived cannabinoids, particularly cannabidiol,” said Commissioner Quarles. “Without clear direction from FDA regarding products containing hemp-derived CBD, large retailers will not carry the products and many business leaders are reluctant to move forward with the development and manufacture of CBD-related products. That reluctance, in turn, has dampened industry demand for harvested hemp material.”
Wang noted, “In passing the 2018 Farm Bill, Congress made clear its intent to support the production and sale of hemp and hemp derivatives such as CBD. Thousands of U.S. growers planted hemp in response, with farming for CBD representing most of all hemp acreage. However, public statements by FDA officials stating that it is unlawful to sell ingestible hemp-derived CBD products have taken their toll on the industry. CBD commerce and investment have been chilled due to continued inaction at the federal level, impairing economic opportunity for American farmers.”
Safety Issues RaisedUnregulated CBD products the risks to public health and safety caused, Wang warned. There also has been a proliferation of hemp products being sold and marketed as intoxicating.
“Farmers are not the only ones who are being crushed by this regulatory uncertainty," Wang explained. "Consumers are also impacted. Bad actors are selling products without appropriate safeguards and misleading consumers with false label claims."
Complicating matters, U.S. Hemp Roundtable noted, some struggling farmers and businesses have pivoted to market intoxicating products such as Delta-8 THC. This has prompted FDA and CDC warnings about significant consumer health and safety risks, particularly for minors. A clear regulatory pathway for CBD would relieve the economic pressure that is leading to this product shift while also helping to ensure products do not contain intoxicating hemp ingredients.
Actions NeededWang encouraged committee members to incorporate language into the 2023 Farm Bill found in H.R. 841 that would regulate CBD and other non-intoxicating hemp derivatives as dietary supplements. This would be in addition to the provisions within Rep. Chellie Pingree’s Hemp Advancement Act. Wang noted that the act would take necessary steps to limit the hemp product pathway to only non-intoxicating compounds.
Quarles suggested the consideration of several key provisions within the Hemp Advancement Act. This includes the removal of the requirement for testing labs to register with the DEA and an increase on total THC limits for unprocessed hemp material from 0.3% to 1.0%.
“Should Congress consider revising the federal definition of hemp plants, we urge it to raise the THC threshold from 0.3% to 1.0%,” Quarles said. "At the same time, it would be appropriate for the new 1.0% limit to include not only delta-9 THC, but every other THC isomer which could have an intoxicating effect on consumers, including without limitation synthetically createddelta-8, delta- 10, delta-7, HHC, and others. Embracing a “total THC” standard instead of a “delta-9 THC only” standard will establish a threshold which better reflects the material’s true intoxicating potential.”
Looking to the Future of CBDQuarles said: “In the coming years we will see modest increases in the number of acres planted, at least until FDA provides the regulatory pathways for products containing CBD and other non-intoxicating cannabinoids.”
Wang added his belief that “regulatory clarity for CBD will help create the positive momentum required to see the U.S. once again become the international leader in industrial hemp.”