Md. Code Regs. 10.62.37.12

Current through Register Vol. 51, No. 7, April 5, 2024

Section 10.62.37.12 - Edible Cannabis Product Requirements

A. General Requirements.

(1) A permittee shall obtain approval from the Commission for all edible cannabis products prior to offering the products for distribution or sale to a licensed dispensary by submitting a request in the perpetual inventory control system.

(2) A permittee seeking approval to offer an edible cannabis product shall submit:

(a) A photograph, digital image, or digital rendering of the product, labeling, and packaging;

(b) The varying levels of potency and dosing of the edible cannabis product;

(c) The recipe, including the production process, for manufacturing the edible cannabis product; and

(d) Any scientific studies or laboratory testing results supporting the stability and approximate expiration date of the edible cannabis product.

(3) The Commission shall review and approve each edible cannabis product before the product may be commercially manufactured or sold by a permittee, to ensure the:

(a) Product complies with the requirements of this chapter; and

(b) Safety of minors.

B. Dosage Requirements.

(1) Unless expressly authorized by the Commission, an edible cannabis product may not contain more than:

(a) 10 milligrams of THC per serving; and

(b) 100 milligrams of THC per package.

(2) A permittee is encouraged to manufacture varying levels of potency for each edible cannabis product the permittee distributes, including products containing:

(a) 2.5 milligrams of THC per serving; and

(b) 5 milligrams of THC per serving.

(3) Each single serving contained in a package of a multipleserving solid edible cannabis product shall be physically separated in a way that enables a patient to determine how much of the edible cannabis product constitutes a single serving.

(4) A package containing more than one serving of non-solid edible cannabis product shall:

(a) Have a resealing cap or closure; and

(b) Include within the package a measuring device that is appropriate for the product form, such as a measuring cap or dropper for liquids or a measuring spoon for powders.

(5) A package containing more than one serving of a liquid edible cannabis product may have a non-opaque strip or measuring marks on the bottle or package, but the strip or marks do not suffice as a measuring device.

(6) A permittee seeking to manufacture an edible cannabis product containing more than 10 milligrams of THC per serving or 100 milligrams of THC per package shall submit a request, in a form prescribed by the Commission, that provides scientific or medical evidence or research that supports the use of higher doses of THC to treat a qualifying medical disease or condition.

(7) The Commission may deny a request under §B(6) of this regulation if:

(a) The request is facially insubstantial; or

(b) The Commission determines that:

(i) The scientific or medical evidence or research is inadequate; or

(ii) The potential risks to patients and to the safety of minors outweighs the potential benefits.

(8) An edible cannabis product consisting of multiple servings shall be homogenized so that each serving contains the same concentration of THC.

C. Appearance of Edible Cannabis Products.

(1) A solid edible cannabis product may only be manufactured or distributed in geometric shapes.

(2) A permittee may not manufacture an edible cannabis product that due to its shape, design, or flavor is likely to appeal to minors.

(3) The manufacture or sale of edibles in the following shapes is prohibited:

(a) Human, animal, or fruit;

(b) A shape that bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings; and

(c) A commercially available food or beverage product that targets, or is primarily marketed to, minors.

D. Prohibited Products.

(1) Edible cannabis products may not contain:

(a) Meat;

(b) Seafood;

(c) Unpasteurized eggs; or

(d) Unpasteurized dairy of any type.

(2) The following types of products may not be sold:

(a) Alcoholic beverages, as defined in Alcoholic Beverage Article, § 1-101, Annotated Code of Maryland; and

(b) Any product containing any non-cannabis additive that would increase potency or toxicity, or that would create an unsafe combination with other psychoactive substances, including nicotine and caffeine.

(3) The prohibition in §D(2)(b) of this regulation does not apply to products containing naturally occurring caffeine, such as coffee, tea, or chocolate.

Md. Code Regs. 10.62.37.12

Regulation .12 adopted effective 48:8 Md. R. 309, eff. 4/19/2021