16 Del. Admin. Code § 4470-10.0
Current through Register Vol. 28, No. 7, January 1, 2025
Section 4470-10.0 - General Provisions for the Production of Edible Marijuana Products10.1 Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. § 122. These regulations establish registration procedures and standards of practice for conducting marijuana infused food processing operations in Compassion Center kitchens that safeguard public health and provide to consumers food that is tested for safety, potency and consistency. A marijuana infused food establishment that prepares, sells or dispenses edible marijuana products must: 10.1.1 Before preparing, selling or dispensing an edible marijuana product, obtain written authorization from the Division to prepare, sell or dispense edible marijuana products; and10.1.2 If the marijuana business prepares edible marijuana products, ensure that the edible marijuana products are prepared according to the applicable requirements set forth in these regulations.10.2 Each compassion center and facility for the production of edible marijuana products or marijuana-infused products shall, in consultation with the Division, cooperate to ensure that all edible marijuana products and marijuana-infused products offered for sale: 10.2.1 Are labeled clearly and unambiguously as medical marijuana;10.2.2 Are not presented in packaging that is appealing to children. These requirements include: 10.2.2.1 Tamper or child-resistant packaging;10.2.2.2 Opaque or plain in design;10.2.2.3 Resealable for any product intended for more than a single use;10.2.2.4 Prohibited from using bright colors, defined as colors that are "neon" in appearance;10.2.2.5 Prohibited from imitating or having a semblance to any existing branded consumer products, including foods, beverages and toys;10.2.2.6 Prohibited from using cartoons, cartoon-like font, caricatures, fruit, human or animal shapes, pictures/photographs images, or picture/photographs of product;10.2.2.7 Prohibited from featuring a design, symbol, or celebrity brand or name that resembles a non-cannabis consumer product;10.2.2.8 Prohibited from featuring images of minors or words that refer to products that are commonly associated with minors or marketed to minors; and10.2.2.9 Each single serving of an edible contained in multiple serving package small be marked, stamped or otherwise imprinted with the following symbol: Click here to view Image
10.2.3 Are regulated and sold on the basis of the concentration of THC and/or CBD in the products and not by weight; and10.2.4 Are packaged and labeled in such a manner as to allow tracking by DEC3S.10.3 Labeling 10.3.1 Products shall be properly labeled with the following: Name of Compassion Center, phone and website of compassion center that produced the edible, name of product, net weight, date of production / lot number, barcode, refrigeration of the product if required and cannabinoid profile.10.3.2 Labels shall include a list of ingredients in decreasing order by weight, serving size and how many servings per package, batch, serial number and barcodes.10.3.3 Labels shall include the following statement: "This food is made in a Marijuana Infused Food Establishment and is NOT subject to routine Government Food Safety Inspections" with a seal stating "tested for contaminants".10.3.4 Labels shall be printed in at least 6-point type, as long as the information can be easily read using standard reading glasses, in a color that provides a clear contrast to the background label.10.3.5 Additional information as required by the Division must be made available for review upon request from the consumer, including the following: 10.3.5.1 The date on which the product was manufactured;10.3.5.2 If the product is perishable, a suggested use-by date;10.3.5.3 The total milligrams of active cannabinoids and terpenoids in the product, as provided by the independent testing laboratory that tested the product;10.3.5.4 A list of all ingredients including amount in grams of sodium, sugar, carbohydrates and total fat per serving and all major food allergens as identified in 21 U.S.C. §§ 343;10.3.5.5 A warning that states: "Caution: When eaten or swallowed, the intoxicating effects of this drug may be delayed by 2 or more hours."10.3.5.6 If a marijuana extract was added to the product, a disclosure of the type of extraction process and any solvent, gas or other chemical used in the extraction process, or any other compound added to the extract;10.3.5.7 A warning that states: "This product may have intoxicating effects and may be habit forming."10.3.5.8 The statement: "This product is unlawful outside of the State of Delaware."10.3.5.9 A medical marijuana dispensary must provide with all edible marijuana products and marijuana-infused products sold at retail accompanying material that discloses any products applied to the marijuana plants and growing medium during production of the marijuana used to create the extract added to the edible marijuana products or marijuana-infused products and the type of extraction method used, including, without limitation, any solvents, gases or other chemicals or compounds used to produce or that are added to the extract, and contains the following warnings: 10.3.5.9.1 "The impairment effects of edible products may be delayed by two hours or more. This product has not been analyzed or approved by the FDA to treat, cure, or prevent any disease. There is limited information on the side effects of using this product, and there may be associated health risks.10.3.5.9.2 "This product contains or is infused with marijuana or active compounds of marijuana.";10.3.5.9.3 "This product should not be used by women who are pregnant or breast feeding."10.3.5.9.4 "For use only by the person named on the label of the dispensed product. Keep out of the reach of children."10.3.5.9.5 "Products containing marijuana can impair concentration, coordination and judgment. It is against the law drive or operate a vehicle or machinery under the influence of this product."10.3.5.9.6 "FOR USE BY ADULTS 18 and OLDER, KEEP THIS PRODUCT AWAY FROM CHILDREN."10.4 Packaging 10.4.1 The immediate food contact surface of any product packaging material shall be food grade in quality, and therefore meet the food safety requirements of 16 Del.C. Ch. 33.10.4.2 Any product containing marijuana must be packaged in child-resistant packaging in accordance with 16 C.F.R. § 1700.10.4.3 Marijuana-infused products must be packaged in plastic which is 4 millimeters or more in thickness and must be heat-sealed without an easy-open tab, dimple, and corner or flap so that it is difficult for a child to open and as a tamperproof measure.10.4.4 Any container or packaging containing usable marijuana, edible marijuana products or marijuana-infused products must protect the contents from contamination and must not impart any toxic or deleterious substance to the usable marijuana or marijuana product.10.5 Exemptions 10.5.1 Establishments registered as marijuana infused food establishments in Delaware shall be exempt from the Cottage Food Regulations.10.5.2 Establishments registered under these regulations shall be exempt from the State of Delaware Food Code, 16 DE Admin. Code 4458.10.6 Inspections 10.6.1 The Division may conduct one or more preoperational inspections to verify that the marijuana infused food establishment is: 10.6.1.1 Constructed and equipped in accordance with the registration application;10.6.1.2 Has established standard operating procedures as specified; and10.6.1.3 Is otherwise in substantial compliance with these regulations.10.6.2 Additional inspections both scheduled and no-notice will be conducted at the discretion of the Division and as deemed necessary by the Division.16 Del. Admin. Code § 4470-10.0
15 DE Reg. 1728 (06/01/12)
17 DE Reg. 738(1/1/2014)
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)