16 Del. Admin. Code § 4470-11.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4470-11.0 - Limitations

11.1 Registration

11.1.1 Marijuana Infused Food Establishments are only permitted to engage in direct sales with consumers in the State of Delaware.

11.1.2 Online sales are not permitted. Online advertising and marketing are permitted subject to the limitations listed in 16 Del.C. Ch. 49A.

11.1.3 Wholesale or other sales to resellers or food establishments are not permitted by a Marijuana Infused Food Establishment.

11.1.4 A Marijuana Infused Food Establishment shall only produce those specific food products listed on their registration.

11.1.5 Approved sources of non-marijuana ingredients:

11.1.5.1 Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that it obtains non-marijuana ingredients for edible marijuana products or marijuana-infused products from sources that comply with the requirements of federal and state law and regulations and are approved by the Division, including, without limitation, commercial and retail businesses.

11.1.6 The production of edible marijuana products or marijuana-infused products for sale shall not use non-marijuana ingredients prepared or stored in a private home.

11.2 Allowable Products

11.2.1 Products produced in a Marijuana Infused Food Establishment are limited to non-TCS baked goods and candy.

11.2.2 The manufacturing of baked goods shall be allowed in a Marijuana Infused Food Establishment to include cookies, muffins and brownies.

11.2.3 Bakery items which as a finished product contain components such as fruit filling, cream filling or meat are prohibited.

11.2.4 Candy products including, but not limited to chewables, fudge, lollipops, chocolates, and hard candy, are allowed to be manufactured in a Marijuana Infused Food Establishment provided the final products are non-TCS.

11.2.5 All labeling requirements set forth in subsection 16.2 must be met before the product is sold.

11.2.6 Products may not exceed 10mg of THC-Delta 9 or 25mg of CBD per serving.

11.2.7 Marijuana infused products are limited to five servings per package.

11.2.8 Products infused with THC, must have the letters "THC" molded into the product.

11.3 Application

11.3.1 Compassion Centers seeking registration as a Marijuana Infused Food Establishment must submit to the Division an application demonstrating that they meet the requirements set forth in these regulations. The application shall include:

11.3.1.1 The name, mailing address, e-mail address, telephone, and signature of the person applying for the registration and the name, mailing address, and physical address of the Marijuana Infused Food Establishment;

11.3.1.2 Information about products and processes including but not limited to products to be made, ingredients, example labels, processes and products;

11.3.1.3 Floor plan of the processing area identifying appliances to be used, food contact surfaces (types of materials used for contact surfaces must be described,) areas for refrigeration and dry good storage, and restroom facilities;

11.3.1.4 Proof of completion of training that satisfies Section 13.0; and

11.3.1.5 A statement signed by the applicant that:

11.3.1.5.1 Attests to the accuracy of the information provided in the application;

11.3.1.5.2 Affirms that the applicant will comply with these regulations; and

11.3.1.5.3 Allow the Division access to the establishment as specified under subsection 10.6 and to the records specified under subsection 7.5.

11.3.2 Compassion Centers may first apply to the Division for an endorsement as a Marijuana Infused Food Establishment on or after July 1, 2020.

11.3.3 Following the submission of an application demonstrating that all requirements of these regulations have been met, up to and including the on-site inspection, the producer may begin sales to consumers in accordance with these regulations.

11.3.4 Upon registration by the Division, a Marijuana Infused Food Establishment and associated activities shall comply with the standards established by these regulations.

11.3.5 It shall be a violation of these regulations to operate in Delaware as a Marijuana Infused Food Establishment, as defined by these regulations, if not registered with the Division.

11.3.6 Registration with the Division does not exempt the Marijuana Infused Food Establishment from other state, county or local codes unless specifically listed in subsection 10.5.

11.3.7 If the proposed Marijuana Infused Food Establishment uses a private well as a source of potable water, the well must be in compliance with State of Delaware Regulations Governing Public Drinking Water, 16 DE Admin. Code 4462.

11.3.7.1 Private wells shall comply with chemical and bacteriological standards; a satisfactory analysis is required before a registration may be issued. Completion of any required sampling is the responsibility of the Compassion Centers.

11.3.7.2 Tests conducted within 60 days of the date of the initial or renewal application will be accepted to demonstrate compliance.

11.3.8 Establishments served by a public water supply and sewage systems do not require further evaluation.

11.4 Renewal

11.4.1 Registration must be renewed bi-annually.

11.4.1.1 Marijuana Infused Food Establishments must maintain a Medical Marijuana Compassion Center License through the Division.

16 Del. Admin. Code § 4470-11.0

19 DE Reg. 409(11/1/2015)
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)