Medical cannabis businesses face many challenges in branding and marketing their products. The continuing illegality of medical cannabis products under federal law excludes medical cannabis businesses from many of the intellectual property protections afforded to other businesses. Further, many medical cannabis businesses entering new markets face challenges in educating potential clients on the differences between types of cannabis products and the particular attributes of their specific offerings.
Kentucky law establishes specific requirements for packaging and labeling cannabis products. See e.g., KRS 218B.140. The Kentucky Office of Medical Cannabis (“OMC”) developed additional regulations that identify permitted and prohibited practices for packaging and labeling medical cannabis products. 915 KAR 1:100. The regulation covers requirements for products intended for patients (915 KAR 1:100(2), (3)) and other cannabis businesses (915 KAR 1:100(4)).
Compliance with the statutory and regulatory requirements for labeling and packaging is essential for cannabis businesses operating in Kentucky. As with all such requirements, cannabis businesses could be subject to losing their licensed status for failure to comply. At a minimum, operators could face significant costs associated with having to recall distributed products and dispose of non-conforming packaging and products.
To assist licensees with compliance, OMC implemented a voluntary packaging and labeling compliance review process. 915 KAR 1:100(5). The nonrefundable fee for the review is $200.00, and requires the business to submit:
- Documentation from the packaging company confirming the packaging is child resistant and has at least a two (2) step process for initial opening;
- Clear digital photographs or proofs of the packaging and product labels; and
- The category of product being submitted (e.g., raw plant material, infused products, etc.).
Businesses utilizing this process will have the advantage of receiving confirmation of compliance prior to ordering or utilizing the proposed packaging, or identification of any non-conformity that will permit the company to remedy the issue and resubmit. Cannabis businesses should consider utilizing this process to avoid significant risks and costs later in the production cycle. Dentons has significant knowledge and experience with packaging and labeling compliance for cannabis businesses, and our attorneys can assist licensees with developing and submitting proposed packaging for approval.
