The federal Agricultural Improvement Act (AIA) of 2018 legalized the manufacturing of industrial hemp and its derivatives, including cannabidiol (CBD), a nonpsychoactive compound that research has shown can be used to treat certain health conditions, including epileptic seizures, anxiety and insomnia.
A technical assistance requester recently asked the Network for information on states’ role in regulating CBD products.
Under the AIA, states have primary regulatory authority over hemp manufacturing so long as they devise a regulatory plan approved by the federal Department of Agriculture (USDA). (AIA § 297B(a)(1)) Prior to the AIA, Hawaii, Washington State, and Colorado maintained a regulatory scheme for the use of CBD in products within their respective states.
AIA’s Regulatory Approval Process
The AIA allows states to produce hemp “with a delta9 tetrahydrocannabinol concentration [THC] of not more than 0.3 percent on a dry weight basis.”(AIA § 297A(1)) To maintain primary regulatory authority over hemp manufacturing, state departments of agriculture must submit a regulatory plan to USDA’s Secretary for approval. (AIA § 297B(a)(1)) Hemp regulatory plans must include a record of relevant information related to the land in which the hemp will be grown as well as procedures for:
States may include additional procedures in their regulatory programs consistent with the AIA. (AIA § 297B(a)(2)(B))
After submission, the Secretary has 60 days to approve a state’s regulatory plan. Unapproved plans may be amended and resubmitted by the state. (AIA § 297B(b)) If a state chooses not to submit a regulatory plan or its plan remains unapproved, by default the state must follow the Secretary’s regulatory plan for hemp production. (AIA § 297C(a)(1))
Following the passage of the AIA, the FDA Commissioner released a statement explaining that the FDA still has the authority to regulate cannabis and cannabis-derived compounds, including CBD products, under the Food, Drug, & Cosmetic Act. It is illegal to introduce food products containing CBD into interstate commerce because CBD is an active ingredient in several FDA-approved drugs. As a result, the FDA does not currently regulate CBD in food products. However, the Commissioner’s statement suggests that the FDA is investigating a potential regulatory framework for the use of CBD in food products.
In 2017, Hawaii passed an Industrial Hemp Pilot Program to regulate the cultivation of industrial hemp and distribution of hemp seeds for agricultural or academic research. (HAW. REV. STAT. § 141-32(a) (2017)) The Hemp Pilot Program requires licensure for the growth of CBD products and submission of a pre-planting report to the Hawaii Department of Agriculture. (HAW. REV. STAT. § 141-33 (2017)) Further, the Hemp Pilot Program requires inspection and sampling of industrial hemp crops to ensure that THC levels do not exceed 0.3%. (HAW. REV. STAT. § 141-37 (2017))
Washington State Regulations
In 2018, Washington passed a regulatory program to monitor the production and use of CBD in a number of products. (WASH. REV. CODE. § 69.50.326 (2018)) CBD use is limited to edibles, oils, tinctures, and other products derived from marijuana. THC levels in all CBD products cannot exceed 0.3% on a dry weight basis.
Washington requires licensure for the growth, production, and retail of CBD products. CBD products must be entered into the traceability system and their records must be kept up-to-date. (WASH. REV. CODE. § 69.50.325 (2018)) CBD products are required to undergo the same laboratory testing as other marijuana products, CBD products are subject to additional laboratory testing for contaminants and toxins. (WASH. REV. CODE. § 69.50.326 (2018))
Colorado’s Industrial Hemp Regulatory Program, established in 2014, provides the state’s regulatory plan for hemp cultivation. Colorado law establishes an industrial hemp committee to develop and implement a hemp registration program and a seed certification program. (COLO. REV. STAT. § 35-61-103 (2015)) The Industrial Hemp Regulatory Program requires individuals to register with the state department of agriculture to grow industrial hemp for commercial or research purposes. (COLO. REV. STAT. § 35-61-102 (2015)) Similar to Washington State, THC levels cannot exceed 0.3%. Inspection programs operated by the state ensure compliance with such limits. (COLO. REV. STAT. § 35-61-105 (2015))
Network attorneys are available to answer questions on this and other public health topics at no cost to you, and can assist you in using law to advance your public health initiatives. Contact a Network Attorney in your area for more information. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.