4 Del. Admin. Code § 5001-8.0

Current through Reigster Vol. 28, No. 6, December 1, 2024
Section 5001-8.0 - Marijuana and Marijuana Product Health Standards
8.1 Allowable and prohibited products
8.1.1 Allowable marijuana and marijuana products include:
8.1.1.1 Smokable marijuana, including shake, trim, pre-rolled marijuana, and infused pre-rolled marijuana;
8.1.1.2 Marijuana concentrates, including any type of hash (water hash, pressed hash), dry sieve (kief), and hash oils (extract oil, shatter, wax, resin, and rosin);
8.1.1.3 Non-smokable marijuana products intended for oral consumption, including edible marijuana products, multi-serving marijuana beverages, single-serving marijuana beverages, and tinctures;
8.1.1.4 Topical marijuana products, including balms, lotions, ointments, and rubbing alcohol solutions; and
8.1.1.5 Transdermal marijuana products, including patches.
8.1.2 Marijuana products not listed under subsection 8.1.1 of this regulation must be approved by the Commissioner.
8.1.3 Marijuana and marijuana products may not:
8.1.3.1 Contain nicotine;
8.1.3.2 Contain alcohol if the sale of the alcohol would require a license under 4 Del.C. Ch. 5;
8.1.3.3 Contain any non-cannabinoid additive that would increase potency, toxicity, or addictive potential;
8.1.3.4 Require refrigeration to prevent spoilage;
8.1.3.5 Contain compounds such as fruit filling, cream filling, or meat;
8.1.3.6 Take a shape, color, or character that is identical or substantially similar to commercially available candy or ice cream or a real or fictional person, animal, or fruit, including a caricature, cartoon, or artistic rendering; or
8.1.3.7 Be designed or packaged in a way that is likely to appeal to children, such as using bright, cartoon-like colors, shapes associated with children's products, or characters from children's media.
8.1.4 Equipment or accessories used for vaporizing marijuana concentrates must be coilless ceramic atomizers or similar products where the oil or concentrate does not touch metal coils.
8.1.5 Products developed for inhalation or vaping may not contain: medium-chain triglycerides (MCT), Polyethylene glycol (PEG), Propylene glycol (PG), Vegetable glycerin (VG), Vitamin E acetate, Diacetyl, or Squalene. Any diluent must be 100% naturally occurring plant-derived terpene oil.
8.2 Marijuana product serving size
8.2.1 For edible marijuana products, a standardized single serving of a marijuana product must contain no greater than 10 milligrams of THC.
8.2.2 For multi-serving marijuana beverages, contain no greater than 10 milligrams of THC.
8.2.3 For marijuana tinctures using a calibrated dropper or similar measuring device, contain no greater than 10 milligrams of THC per individual serving, as indicated on the calibrated dropper or similar measuring device.
8.2.4 A marijuana product manufacturer must:
8.2.4.1 Determine the total number of standardized servings for each marijuana product, which must not exceed 10 milligrams of THC per serving.
8.2.4.2 Ensure that each standardized serving of an edible marijuana product be physically demarcated or packaged in a manner that a person could reasonably and clearly determine how much of the product constitutes a single serving.
8.2.4.3 Ensure that each standardized serving is easily separable with minimal effort.
8.2.4.4 Comply with the requirements in Section 9.0 for multi-serving liquid edible marijuana products, which must not exceed 10 milligrams of THC per serving; and
8.2.4.5 For products containing multiple servings, ensure that each serving contains the same amount of THC.
8.3 Marijuana product package size
8.3.1 A standardized package of a marijuana product must:
8.3.1.1 For edible marijuana products, contain no greater than 5 standardized servings per package;
8.3.1.2 For multi-serving marijuana beverages, contain no greater than 50 milligrams of THC per package; and
8.3.1.3 For marijuana tinctures, contain no greater than 300 milligrams of THC per package.
8.3.2 Edible marijuana products formulated with less than 5 standardized servings may package multiple products together to reach the 5 serving maximum per package. Small individual products must comply with appearance standards in accordance with Section 9.0 of this regulation.
8.3.3 In accordance with Section 9.0 of this regulation, if a marijuana product package contains multiple servings, the package must be a child-resistant container that is resealable.

4 Del. Admin. Code § 5001-8.0

28 DE Reg. 226 (9/1/2024) (Final)