4 Del. Admin. Code § 5001-9.0

Current through Reigster Vol. 28, No. 6, December 1, 2024

Section 5001-9.0 - Packaging and Labeling Requirements for Marijuana and Marijuana Products

9.1 General packaging requirements. All marijuana and marijuana products for retail sale must be packaged as follows:

9.1.1 If the packaging is soft sided, the opening must be sealed in a manner which would indicate if the container has been tampered with or opened. The tamper-evident feature shall not be resealable and shall remain clear that the package has been previously opened.

9.1.2 If the packaging is rigid, the opening shall contain a tamper-evident seal that, once opened, shall remain clear that the package has been previously opened.

9.1.3 The packaging must be child-resistant in accordance with 16 CFR 1700.15.

9.1.4 If the packaging is soft-sided, it must be 4 millimeters or greater in thickness.

9.1.5 If the packaging is rigid, it must have a lid or closure that can be placed tightly and securely.

9.1.6 If the marijuana product contains multiple servings, the packaging must be a child-resistant container that is resealable and must comply with subsection 9.3 if an edible marijuana product or beverage.

9.1.7 The marijuana product must be food-grade in quality and meet the food safety requirements in 16 Del.C. Ch. 33.

9.2 General labeling requirements

9.2.1 All marijuana and marijuana products for retail sale must be labeled in accordance with this regulation. All information on the label may not mislead consumers. All marijuana and marijuana product labels must:

9.2.1.1 Be printed directly on, or on a label or sticker affixed directly to, the marketing layer;

9.2.1.2 Include text no smaller than size 6 font or 1/2 inch;

9.2.1.3 Be legible, unobstructed, conspicuous, and contrast sufficiently with the background;

9.2.1.4 Be printed in the English language, but may also include translations in additional languages; and

9.2.1.5 Contain required information on a peel-back accordion-style, expandable, extendable, or layered label.

9.2.2 All marijuana and marijuana product labels must include the following product information:

9.2.2.1 The net weight of the marijuana or marijuana product in accordance with subsections 9.3, 9.4, and 9.5 of this regulation;

9.2.2.2 The finished product batch number;

9.2.2.3 If marijuana flower, the name of the marijuana establishment that cultivated, harvested, and packaged the marijuana flower;

9.2.2.4 If a marijuana product, the name of the marijuana establishment that manufactured and packaged the marijuana product;

9.2.2.5 The name of the marijuana establishment that sold the product;

9.2.2.6 An itemization, including weight, of the major cannabinoids and terpenes contained in the marijuana or marijuana product. Cannabinoids existing in concentrations of less than 1% shall be printed with a leading zero before the decimal point;

9.2.2.7 If a marijuana product, a list of all major allergens contained in and used in the manufacturing process in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343, specifically including milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans;

9.2.2.8 A list of any solvents used in the manufacturing process;

9.2.2.9 The production date, which for flowers will be the date the marijuana was harvested and for product will be the date the product was produced; and

9.2.2.10 The Delaware Poison Control Center telephone number.

9.2.3 All marijuana and marijuana product labels must include the following warning statements:

9.2.3.1 "For use by adults 21+. KEEP OUT OF REACH OF CHILDREN!"

9.2.3.2 "Marijuana ingestion by children can cause severe illness and hospitalization. KEEP IN LOCKED STORAGE CONTAINERS."

9.2.3.3 "There may be health risks associated with the use of this product, and additional risks for women who are pregnant or breastfeeding or individuals 25 years of age and younger. Do not operate a motor vehicle or heavy machinery while using this product. The use of this product may result in adverse reactions with prescription medication, consult with your doctor or pharmacist."

9.2.4 All marijuana and marijuana product labels must include a universal symbol made available by the Commissioner. The universal symbol must:

9.2.4.1 Appear on the front of or the most prominently displayed area of the marketing layer;

9.2.4.2 Be printed in an area no smaller than 1/2 inch by 1/2 inch;

9.2.4.3 Contrast sufficiently with the background to be easily identified; and

9.2.4.4 Remain in the form provided by the Commissioner and shall not be modified, recreated, stylized, distorted, or otherwise altered in a manner that changes the appearance or size of the universal symbol.

9.2.5 Retail marijuana stores must retain copies of marijuana and marijuana product Certificate of Analyses and provide a copy to customers upon request.

9.3 Edible marijuana product and marijuana beverage packaging and labeling requirements

9.3.1 Edible marijuana product packaging must:

9.3.1.1 Contain no greater than 10 milligrams of THC per serving.

9.3.1.2 Contain no greater than 50 milligrams of THC per package; and

9.3.1.3 Clearly indicate the size of a serving.

9.3.1.4 If impracticable to clearly demark each serving of marijuana or to make each serving easily separable, contain not more than 10 milligrams of THC per package or be sold in a package that contains more than 1 individually wrapped single-serving edible marijuana product.

9.3.2 Marijuana beverage packaging must:

9.3.2.1 Contain no greater than 10 milligrams of THC per serving.

9.3.1.2 Contain no greater than 50 milligrams of THC per package; and

9.3.2.3 Clearly indicate the size of a serving.

9.3.3 In addition to requirements in subsection 9.2 of this regulation, edible marijuana product and marijuana beverage labels must include:

9.3.3.1 Total contents of THC and CBD, and any other advertised or marketed cannabinoid, stated in milligrams, as provided by the Certificate of Analysis. The total contents of THC and CBD must be provided for both individual servings and total servings within a package;

9.3.3.1.1 For edible marijuana products and marijuana beverages containing at least 5 milligrams of THC or CBD, there may not be a variance of more than 10% from the actual THC and CBD content.

9.3.3.1.2 For edible marijuana products and marijuana beverages containing less than 5 milligrams of THC or CBD, there may not be a variance of more than 20% from the actual THC and CBD content.

9.3.3.2 The number of servings per package;

9.3.3.3 If applicable, the recommended size of a serving;

9.3.3.4 A nutritional fact panel;

9.3.3.5 A list of all the active and inactive ingredients in descending order of predominance by weight in the edible marijuana product or marijuana beverage;

9.3.3.6 The net weight of the edible marijuana product or marijuana beverage in grams; and

9.3.3.7 The following warning statements:

9.3.3.7.1 A statement to read "Caution: When eaten or swallowed, the intoxicating effects of this product may be delayed by 2 or more hours."; and

9.3.3.7.2 For any product intended for topical application, a statement identifying that the product is "not intended for human consumption, ingestion, or inhalation."

9.4 In addition to requirements in subsection 9.2 of this regulation, inhalable marijuana product labels must include:

9.4.1 The product potency, which must be described by 1 of the following:

9.4.1.1 The actual potency results for total THC and total CBD reported by a testing facility on the Certificate of Analysis.

9.4.1.2 The percentage of total THC and total CBD based on the results of the analysis reported by a testing facility, and as the average percentage of total THC and total CBD found in the inhalable marijuana product, so long as the actual percentage totals of the THC and CBD content do not have a variance greater than 15% from the potency statement on the product label; or

9.4.1.3 If the Certificate of Analysis reports that the total THC or total CBD is "not detected" or "zero", the label may state "0" for these cannabinoids.

9.4.2 The net weight, which must be stated in grams, except that inhalable marijuana products containing less than 1 gram of net content may state the net contents in milligrams. In determining the weight of marijuana concentrate in a marijuana product, the weight of any other ingredients may not be included. Variance in net weight is allowed as follows:

9.4.2.1 For marijuana flower or trim, the actual net contents by weight may be as much as 0.1 grams less, or 0.5 grams greater than the net content on the label.

9.4.2.2 For pre-rolled marijuana, the actual net contents by weight may be as much as 5% less than or 10% more than the net content on the label.

9.4.2.3 For marijuana products composed primarily of marijuana concentrates or extract, the actual net contents by weight may be as much as 5% less or 10% more than the statement of net content.

9.5 Topical marijuana product and transdermal marijuana product packaging and labeling requirements

9.5.1 In addition to requirements in subsection 9.1 of this regulation, topical marijuana product and transdermal marijuana product packaging must:

9.5.1.1 Be packaged in a child-resistant container that has a resealable cap or closure compliant with 16 CFR 1700.15;

9.5.1.2 Transdermal marijuana products shall be packaged in a plastic container 4 millimeters or greater in thickness.

9.5.2 In addition to requirements in subsection 9.2 of this regulation, topical marijuana product and transdermal marijuana product labels must include:

9.5.2.1 A potency statement stating the total content of THC and CBD in milligrams in the container, and for transdermal marijuana products, the total content of THC and CBD in milligrams contained in each transdermal marijuana product;

9.5.2.2 The amount of the topical marijuana product or transdermal marijuana product recommended for use at any 1 time; and

9.5.2.3 A warning statement to read "For Topical Application Only-Do Not Eat or Smoke."

9.6 Marijuana establishments collecting samples for purposes of mandatory compliance testing must follow the following mandatory compliance procedures:

9.6.1 Deposit the sample into containers required by the marijuana testing facility analyzing the samples;

9.6.2 Affix a tamper evident seal to each sample container. The seal must be initialed by the Marijuana establishment staff which took the sample;

9.6.3 Ensure that the universal symbol is present every sample collection container, in accordance with the requirements in subsection 9.2.4 of this regulation;

9.6.4 Label each sample collection container with the following notice: "FOR TESTING PURPOSES ONLY"; and

9.6.5 Each sample collection container must be accompanied by a label generated by the seed-to-sale tracking system.

9.7 Marijuana and marijuana product packaging and labels may not contain the following:

9.7.1 Neon colors;

9.7.2 Imitation or resemblance of any existing branded consumer products;

9.7.3 Cartoons, cartoon-like fonts, caricatures, fruit, human or animal shapes, balloons or toys;

9.7.4 Depictions of a celebrity or celebrity likeness; or

9.7.5 Images of minors or words or images that refer to products that are commonly associated with minors or marketed to minors, including the word "candy."

9.8 Child Safety Measures

9.8.1 A retail marijuana store must provide with all marijuana and marijuana products sold at retail a written notification in at least 12-point font which contains the following warnings:

9.8.1.1 Marijuana ingestion by children can cause severe illness and hospitalization.

9.8.1.2 Marijuana products should be kept out of reach of children and in locked storage containers.

9.8.1.3 Allowing, through negligence or otherwise, children to ingest marijuana and marijuana products or storing marijuana and marijuana products in a location which is accessible to children may result in an investigation by an agency which provides child welfare services or criminal prosecution for child abuse or neglect.

9.8.1.4 Common signs and symptoms of marijuana ingestion in children are:

9.8.1.4.1 Dizziness;

9.8.1.4.2 Confusion;

9.8.1.4.3 Abnormal heart rate;

9.8.1.4.4 Sleepiness/Drowsiness;

9.8.1.4.5 Upset stomach;

9.8.1.4.6 Vomiting;

9.8.1.4.7 Diarrhea; and

9.8.1.4.8 Changes in breathing.

9.8.1.5 If your child collapses, appears to be having a seizure, or has difficulty breathing, contact 911 immediately.

9.8.2 A retail marijuana store must provide with all marijuana and marijuana products sold at retail safe drug storage educational information.

9.8.3 Each retail marijuana store shall offer for sale containers for the storage of marijuana and marijuana products which lock and are designed to prohibit children from unlocking and opening the container.

4 Del. Admin. Code § 5001-9.0

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