Current through Register Vol. 28, No. 3, September 1, 2024
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.