The Kentucky Division of Cannabis Regulation (DCR) has issued a comprehensive Guidance Document on Thursday, shedding light on the frequently asked questions (FAQs) surrounding the packaging and labeling requirements for marijuana products. The document offers crucial insights for businesses operating within the cannabis industry, specifically addressing inquiries related to compliance with 19 CSR 100-1.120, the regulation governing packaging and labeling standards.
One of the primary questions addressed in the Guidance Document is whether all items listed in 19 CSR 100-1.120(1)(B)5 are mandatory.
The DCR clarifies that the language “may only utilize” implies that licensees have the discretion to include the listed information, unless explicitly required by the rule. For instance, while licensees are not mandated to use more than two logos or symbols, they are permitted to use up to two. Furthermore, text indicating side effects and behavioral effects need not be included, and the same applies to QR codes.
A pivotal aspect of the packaging requirements pertains to “text indicating side effects and behavioral effects of usage” outlined in 19 CSR 100-1.120(1)(B)5.C. The DCR emphasizes that such text must be clear and accurate, devoid of slogans or statements with vague meanings. The document provides illustrative examples, such as using terms like “sleepy,” “relaxed,” or “hungry” to depict the potential effects of the marijuana product. However, assigning the product as sativa, hybrid, or indica does not suffice for describing side effects and behavioral impacts, which should ideally find their place in promotional material.
A notable query that arises frequently pertains to the use of photographs of marijuana products on packaging. According to the DCR, such photographs are permissible if they are integrated into the logo and adhere to the specifications outlined in 19 CSR 100-1.120(1)(B)5.A.
The Guidance Document also clarifies that any variations in packaging, labeling, or product design must go through the Item Approval process, in line with 19 CSR 100-1.120. This includes each distinct final marijuana product SKU produced by individual licensees. To accommodate minor changes to previously approved products, the DCR is in the process of establishing a mechanism. This procedure would necessitate licensees to reference the approval number of the previously sanctioned package, highlight the deviations from the approved version, and confirm that no further changes are anticipated.
In an effort to streamline packaging practices, DCR issued a variance on August 18, 2023, allowing licensees to incorporate strain or flavor details on the label. This accommodation facilitates the utilization of identical packaging for different strains or flavors of products.
Addressing the use of stickers on packaging, the DCR provides clarity that stickers are acceptable if they have been approved through the Item Approval Process. The placement of stickers should be demarcated on the packaging itself, such as by indicating a dedicated area. For instance, if a licensee employs uniform packaging for multiple marijuana products, differentiation can be achieved through the addition of a QR code sticker directing customers to a relevant product website.
Regarding alternative placement of certain labels as specified by 19 CSR 100-1.120(1)(C), licensees can seek such alternatives through the Item Approval process in Metrc. However, other pertinent regulations, including federal packaging requirements, must be taken into account when proposing alternative placements.
Another significant query pertains to prerolls and the requirement for their packaging to be constructed from FDA-approved food contact substances. The DCR asserts that prerolls must indeed be packaged in materials approved by the FDA for food contact. This is due to the direct interaction between the preroll and its packaging, necessitating materials that are safe for human consumption, as mandated by 19 CSR 100-1.120(1)(B)4. Moreover, preroll wrap or paper should also be fashioned from food-grade material, given that users consume the final marijuana product.
Defining the term “wrapper,” the Guidance Document describes it as a covering for an individual serving or dose of a marijuana product, isolating it from other such servings or doses within the same packaging. An apt illustration of a wrapper is a single-serving pouch.
Licensees grappling with the question of updating testing labels on existing marijuana products are provided respite through a grace period. The DCR has extended this period until May 1, 2024, allowing licensees to continue using their existing products and packaging, including testing labels. During this grace period, licensees can use their current inventory of packaging and items in the market, as highlighted in the August 18, 2023 guidance titled “Packaging and Labeling Compliance Extension.”
While accommodating this grace period, the DCR encourages licensees to actively work towards achieving compliance. It expects that by the May 1, 2024 deadline, all existing final marijuana products will either have been sold or re-packaged in accordance with compliant packaging and labeling designs. This process necessitates obtaining an Item Approval number from the Department.
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