The 2018 Farm Bill defined hemp as the Cannabis sativa L. plant that contains less than 0.3% delta-9-tetrahydrocannabinol (THC) on a dry weight basis. Therefore, whether a product is defined as hemp is based on how much delta-9-THC is present. This narrow definition has created a regulatory gap where other psychoactive THC isomers are not considered in federal or State law when determining product regulation. Under existing State law, products derived from hemp containing highly intoxicating THC isomers and derivatives are not subject to any health or safety standards governing their manufacture or sale – unlike nearly identical products containing delta-9-THC.
The Maryland Medical Cannabis Commission (“MMCC”) Legislative Report on Hemp-derived Non-delta-9-THC Products
In accordance with Chapters 511 and 512 of the Acts of 2022, the MMCC submitted a legislative report to the General Assembly outlining its findings and recommendations on the classification and regulation of THC, other than delta-9-THC, that are artificially, synthetically, or naturally derived and manufactured products containing delta-8- and delta-10-THC. The MMCC’s recommendations reflect best practices from other states and the existing medical cannabis program. The MMCC made the following recommendations to ensure that potentially intoxicating compounds and products are subject to manufacturing, testing, health, and safety standards, regardless of the source of the initial biomass.
- Align product regulations with the health and safety risks of the product
- Synthetically Derived v. Naturally Derived – Establishing testing criteria to evaluate the safety of synthetically or artificially hemp-derived products.
- Intoxicating v. Non-Intoxicating – Those products determined to be intoxicating should not be considered hemp or, at the very least, have a regulatory framework that achieves parity with cannabis regulations, given their potential for intoxication and impairment.
- Consumable v. Non-Consumable – Products sold to end users should be regulated more stringently than those used for an industrial purpose. Further, regulations could differentiate between products for inhalation and ingestion rather than topical applications in humans or the end-users. Some products act differently in the body when ingested rather than inhaled, making the method of administration an important regulatory consideration.
- Require certain hemp-derived products to be subject to laboratory testing, packaging and labeling, therapeutic claims standards and other product safety measures
- Laboratory Testing – The General Assembly should adopt the Hemp Industry Association’s position on testing of hemp-derived products for safety to include testing for the presence of certain contaminates, including (i) microbials; (ii) heavy metals; (iii) pesticides; (iv) solvents; (v) reagent residuals; and (vi) bleaches. The specific contaminates to be tested for should be established in regulations and consistent with other states’ testing protocols.
- Packaging and Labeling – Establishing minimum packaging and labeling requirements for certain hemp products (e.g., intoxicating product, consumable/inhalable product). Packaging labels should include: (i) warning statements governing safe use and secure storage of products; (ii) a list of THC and other cannabinoid ingredients or additives; and (iii) a COA displaying the laboratory testing results of the product.
- Therapeutic Claims – Hemp-derived products should meet the federal and state standard for therapeutic or medicinal claims.
- Federal Manufacturing Standards – Federal good manufacturing practices standards should be applied to the manufacture of hemp-derived products sold in Maryland, when possible. Absent the explicit use of federal cGMP standards, the State should establish other product safety standards to govern the manufacture, storage, and distribution of hemp-derived products would ensure product quality and consumer safety.
- Only allow for sales of certain products in licensed, regulated establishments.
- Requiring manufacturers and retailers of certain hemp-derived products to be licensed and conducting compliance inspections on these businesses will improve product quality and safety, reduce youth access, and assist with any applicable tax collections.
- Expand public health messaging and resources established under Chapter 26 of the Acts of 2022 to include any THC Product.
- Messaging around health and safety of cannabis products should be expanded to include and consider any products containing THC, regardless of the initial plant source.
The MMCC does not take a position on whether one State agency should be solely responsible for regulating finished hemp-derived products, including those products that highly intoxicating or if so, which State agency should take primacy.
To access a copy of the MMCC’s legislative report, visit the Maryland Legislative Library & Information Services website (https://mlsd.ent.sirsi.net). If you would like to schedule a call to discuss how these changes may affect you or your business, please contact Jonathan Wachs at 301-575-0302 and firstname.lastname@example.org.
ABOUT JONATHAN WACHS
If you would like to subscribe to receive Friday Factoids® in your inbox click here.
Jonathan Wachs provides strategic counseling and operational advice to clients in the areas of intellectual property, commercial transactions, and outsourced legal departments. As head of the firm’s Intellectual Property Group, Mr. Wachs works closely with clients to develop, register, analyze, enforce, and transfer intellectual property assets in a customized, cost-efficient, and highly effective manner. Additionally, he conducts intellectual property audits through which clients learn the nature and value of their intellectual property assets and the steps needed to protect such assets from misappropriation or dilution. As a business lawyer, he has successfully negotiated and completed several multimillion-dollar business transactions and has served as general counsel to several small and midsize businesses and organizations in various industries and professions.
ABOUT OFFIT KURMAN
Offit Kurman, one of the fastest-growing, full-service law firms in the United States, serves dynamic businesses, individuals and families. With 19 offices and more than 280 lawyers who counsel clients across more than 30 areas of practice, Offit Kurman helps maximize and protect business value and personal wealth by providing innovative and entrepreneurial counsel that focuses on clients’ business objectives, interests and goals. The firm is distinguished by the quality, breadth and global reach of its legal services and a unique operational structure that encourages a culture of collaboration. For more information, visit www.offitkurman.com.
CALIFORNIA | DELAWARE | MARYLAND | NEW JERSEY | NEW YORK | NORTH CAROLINA | PENNSYLVANIA |SOUTH CAROLINA | VIRGINIA | WASHINGTON, D