New Mexico Register / Volume XXXIII, Issue 1 / January 11,
2022
TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 8 COMMERICAL
AND MEDICAL CANNABIS
PART 3 PACKAGING, LABELING, ADVERTISING, MARKETING, AND COMMERCIAL DISPLAY
REQUIREMENTS FOR CANNABIS PRODUCTS
16.8.3.1 ISSUING AGENCY: New Mexico Regulation and Licensing Department, Cannabis
Control Division.
[16.8.3.1 NMAC – N, 04/01/2022]
16.8.3.2 SCOPE: This
rule applies to all licensees and applicant for licensure pursuant to the
Cannabis Regulation Act, the Lynn and Erin Compassionate Use Act, or division
rules.
[16.8.3.2 NMAC - N, 04/01/2022]
16.8.3.3 STATUTORY AUTHORITY: The requirements set forth herein are promulgated by the
cannabis control division pursuant to the authority granted under the Cannabis
Regulation Act and the licensing provisions of the Lynn and Erin Compassionate
Use Act.
[16.8.3.3 NMAC - N, 04/01/2022]
16.8.3.4 DURATION: Permanent.
[16.8.3.4 NMAC - N, 04/01/2022]
16.8.3.5 EFFECTIVE DATE: April 1, 2022, unless a later date is cited at the end of a
section.
[16.8.3.5 NMAC - N, 04/01/2022]
16.8.3.6 OBJECTIVE: The objective of Part 3 is to establish standards for
packaging, labeling, advertising, marketing, and commercial display requirements
for cannabis products. Part 3 is not applicable to personal use of cannabis
pursuant to the Cannabis Regulation Act or the Lynn and Erin Compassionate Use
Act.
[16.8.3.6 NMAC - N, 04/01/2022]
16.8.3.7 DEFINITIONS: [RESERVED]
16.8.3.8 ADVERTISING AND MARKETING:
A. Required Practices. The following practices are required in all advertising and marketing
activities:
(1) Responsible
persons. All advertisements and marketing for cannabis products shall
accurately and legibly identify all licensees or organizations who are
responsible for the proliferation of the advertisement or marketing activity.
(2) Reasonable expectation of audience
age. All advertisements in print and digital
communications shall only be placed in areas where at least seventy percent of
the audience is reasonably expected to be 21 years of age or older as
determined by reliable, current audience composition data. For the purposes of
this section, “reliable, current audience composition data” means data
regarding the age and location demographics of the audience viewing a
particular advertising or marketing medium. Immediately upon request, a
licensee shall provide to the division audience composition data as required in
this section for advertising or marketing placed by the licensee. If the
audience composition data for advertising or marketing provided by a licensee
does not comply with the requirements of this section, or the licensee fails to
provide audience composition data to the division upon request, the licensee
shall remove the advertising or marketing placement in question.
(3) Statements
and warnings: Any advertising or marketing materials created for viewing by
the public shall include the statement "Please Consume Responsibly"
in a conspicuous manner on the face of the advertisement and shall include the
following warnings that must be in type size at least ten percent of the
largest type used in the advertisement:
(1) for
use only by adults 21 and older;
(2) keep
out of reach of children;
(3) this
product is not approved by the FDA to treat, cure, or prevent any disease. FDA
has not evaluated this product for safety, effectiveness, and quality;
(4) do
not drive a motor vehicle or operate machinery while under the influence of
cannabis; and
(5) there
may be long term adverse health effects from consumption of cannabis, including
additional risks for women who are or may become pregnant or are breastfeeding.
B. Prohibited practices. Advertising and marketing activities of cannabis products shall not:
(1) occur
on radio, television or other broadcast media, internet pop-ups and mass
transit vehicles. The division shall not prohibit advertising and marketing
activities on these forums where:
(a) subscribers
of subscription-based radio, television or other broadcast media are twenty-one
years of age or older; or
(b) persons
21 years of age or older have solicited the advertising or marketing
activities.
(2) be
done in such a manner that is deemed to be is deceptive, misleading, false or
fraudulent, or that tends to deceive or create a misleading impression, whether
directly or by omission or ambiguity;
(3) shall
not make unproven health benefit claims and any health benefit claims must be
supported by substantial evidence or substantial clinical data;
(4) be
on billboards, posters, handbills or other visual media that are located or can
be viewed within three hundred feet of a school, daycare center or church;
(5) contain
symbols or images, including a celebrity or celebrity likeness, that are
commonly used to market products to minors;
(6) use
predatory marketing or advertising practices targeting minors; and
(7) be
designed to mimic any other product brand;
(8) promote the over consumption of cannabis or cannabis products; or
(9) depict the actual consumption of cannabis or cannabis products.
C. Branding. “Branding”
means promotion of a cannabis establishment’s brand through publicizing the
cannabis establishment’s name, logo, or distinct design feature of the brand.
(1) Branding shall not be designed to be appealing to a
child and shall not contain:
(a) cartoons;
(b) a design, brand or name that resembles
a non-cannabis consumer product of the type that is typically marketed to
minors;
(c) contain symbols or images, including
a celebrity or celebrity likeness, that are commonly used to market products to
minors.
(2) Branding
is not considered a marketing or advertising activity.
(3) Branding
is allowed without the required warnings and statements for advertising and
marketing of cannabis establishments.
[16.8.3.8 NMAC – N, 04/01/2022]
16.8.3.9 CANNABIS FINISHED PRODUCT LABELING:
A. Unless
otherwise provided, cannabis finished products shall meet the minimum
labeling requirements of this section.
B. The label shall be printed on or
affixed to the container and printed on or affixed to any outer package or
container that is used to display the edible or topical cannabis finished
product for retail sale.
C. Font size used on a label shall be
no smaller than 1/16 of an inch by measuring the height of a lower-case letter
“o”.
D. Labels shall identify the intended
use and directions for use. Products having more than one intended use shall
identify every intended use on the label and shall comply with all labeling
requirements for each intended use. If there is any conflict between the
labeling requirements for multiple intended uses, the most restrictive labeling
requirements shall be followed.
E. Labels shall be in English, though
it can be in other languages.
F. Labels shall be unobstructed and conspicuous.
G. If the cannabis finished product’s
target potency or potency value of the Total THC or CBD is less than one
milligram per serving, the potency may be expressed as “<1 mg.” If “<1
mg” was used to display the Total THC or CBD per serving, then a corresponding
statement regarding the Total THC or CBD content for the entire container shall
be included on the container. For example, if there are five servings in the
container, “<5 mg” should be displayed for the Total THC or CBD statement
that was represented as “<1 mg” per serving.
H. The potency statement stated on an
edible or topical cannabis finished product label shall not deviate by more
than fifteen percent of what is stated on the label.
I. A label
shall not:
(1) contain any untruthful or misleading
statements including, but not limited to, health or benefit claims, and
(2) contain advertising or marketing; and
(3) contain words that refer to products
that are commonly associated with minors or marketed by minors; including use
of the word(s) “candy” or “candies” on the label of any container, unless the
words identify the strain of cannabis in the cannabis finished product.
J. Cannabis finished product labels
shall have a principal display panel.
K. The principal display panel shall
include:
(1) the product identity or common name
in bold type, in a size reasonably related to the most prominent printed matter
on the principal display panel and shall be parallel to the base on which the
package rests as it is designed and displayed.
(2) Net quantity, net weight, or volume
in U.S. customary and metric units of contents displayed in bold type in the
bottom thirty percent of the principal display panel in lines generally
parallel with the base of the container; and shall be in terms of fluid measure
if the item is liquid, or in terms of weight if the item is solid, semi-solid,
or viscous.
(3) Potency, as confirmed by a cannabis
testing laboratory, in bold font and including:
(a) for
edible products, Total THC and CBD in milligrams per serving;
(b) percent
of Total THC per container; and
(c) if
detected, percent of CBD per container.
(4) A logo designed and provided by the
division that notifies a reasonable person that the product contains cannabis
that is no smaller than 1/2 inch by 1/2 inch.
(5) A
logo designed and provided by the division that demonstrates a cannabis product
is produced or manufactured by an integrated cannabis microbusinesses or
cannabis producer microbusinesses or owned by representatives of communities
that have been disproportionately harmed by rates of arrest through the
enforcement of cannabis prohibitions in law and policy and underserved
communities that include tribal, acequia, land grant-merced and other rural
historic communities;
(6) for an edible or topical cannabis finished
product that is perishable or meets the definition of a time/temperature
control for safety food, the label shall bear a statement that the product must
be refrigerated; and
(7) the following warning statement in
bold font “For use only by adults 21 and older. Keep out of reach of children.
Do not drive a motor vehicle or operate machinery while under the influence of
cannabis.
BE CAUTIOUS. Cannabinoid edibles can
take up to two hours or more to take effect.”
L. Except as provided in Subsections M
and N of this section, cannabis finished product labels shall have an
information panel or static quick response (QR) code that links the consumer to
the required information that contains the following without intervening
material:
(1) cannabis manufacturer business or
trade name;
(2) unless the business or trade name
placed on the package is the actual manufacturer, it must be accompanied by a
qualifying phrase which states the firm's relation to the product (e.g.,
“manufactured for” or “distributed by”);
(3) cannabis manufacturer license number;
(4) pesticide used in the product by the
cannabis producer;
(5) date product was manufactured;
(6) ingredient list:
(a) using the common or usual name;
(b) sub-ingredients, as follows: any ingredient
containing two or more sub-ingredients shall parenthetically list the component
ingredients in descending order of predominance after the multi-component
ingredient;
(c) identifying the cannabis
extract/concentrate and each isolated cannabinoid as an ingredient; and
(d) in descending order of predominance
by weight or volume.
(7) if
utilized, pharmacologically active ingredients;
(8) a
"contains" statement identifying allergens at the end of or
immediately adjacent to the ingredient list; or listing the allergen in
parenthesis within the ingredient list after the common or usual name of the
ingredient derived from that major food allergen;
(9) nutritional information meeting the
requirements of 21 CFR 101.9;
(10) the following statement: “This product
is not approved by the FDA to treat, cure, or prevent any disease. FDA has not
evaluated this product for safety, effectiveness, and quality. There may be
long term adverse health effects from consumption of cannabis, including
additional risks for women who are or may become pregnant or are
breastfeeding.”
(11) the New Mexico poison and drug
information center phone number;
(12) the product expiration date. Persons
shall not alter that expiration date or affix a new label with a later expiration
date;
(13) the
state track and trace system number or identifier associated with the product;
and
(14) a list of any solvent(s), processing
aids, and chemicals used to manufacture cannabis product, cannabis concentrate or
extract, or isolated cannabinoid identified.
M. When, because of its container size,
an edible cannabis finished product label does not have sufficient space for a
label meeting the requirements of Subsections K-L of this section, labels
shall, at a minimum, contain:
(1) a principal display panel containing
the net weight or volume, product identity, and logos designed and provided by
the division;
(2) cannabis manufacturer business or
trade name;
(3) cannabis manufacturer license;
(4) potency, as specified in Paragraph
(3) of Subsection K of this section;
(5) the warning statements, as specified
in Paragraph (7) of Subsection K of this section;
(6) the
state track and trace system number or identifier associated with the product;
and
(7) all other required labeling as
specified in Subsections K-L of this section through the use of a static quick
response (QR) code that links the consumer to the required information or a
peel-back or accordion label that can be easily identified by a consumer as
containing important information.
N. When the surface area being labeled
is less than two inches squared and does not have sufficient space for a label
meeting the requirements of Subsections K-L of this section, labels shall, at a
minimum, contain:
(1) a principal display panel containing
the product identity and logo designed and provided by the division that
notifies a reasonable person that the product contains cannabis that is no
smaller than 1/2 inch by 1/2 inch;
(2) cannabis manufacturer business or
trade name;
(3) cannabis manufacturer license number;
(4) potency, as specified in Paragraph
(3) of Subsection K of this section;
(5) the warning statement “For use only
by adults 21 and older. Keep out of reach of children.”
(6) the
state track and trace system number or identifier associated with the product;
and
(7) all other required labeling as
specified in Subsections K-L of this through the use of a static quick response
(QR) code that links the consumer to the required information or use a
peel-back or accordion label that can be easily identified by a consumer as
containing important information.
[16.8.3.9 NMAC - N, 04/01/2022]
16.8.3.10 CANNABIS SEED AND IMMATURE CANNABIS PLANT LABELING:
A. Unless
otherwise provided, cannabis seeds and immature cannabis plants sold to
consumers, qualified patients, or reciprocal patients shall meet the minimum
labeling requirements of this section.
B. The label shall be printed on or
affixed to the container or receptacle and printed on or affixed to any outer
package or container that is used to display the cannabis seed or immature
cannabis plant for retail sale.
C. Font size used on a label shall be
no smaller than 1/16 of an inch by measuring the height of a lower-case letter
“o”.
D. The label shall be in English,
though it can be in other languages.
E. The label shall be unobstructed
and conspicuous.
F. The label shall not contain any
untruthful or misleading statements including, but not limited to, health or
benefit claims.
G. The principal display panel shall
include:
(1) the product identity or common name
in bold type, in a size reasonably related to the most prominent printed matter
on the principal display panel;
(2) potential potency, as confirmed by a
cannabis testing laboratory of the parent cannabis plant; and
(3) a logo designed and provided by the
division that is no smaller than 1/2 inch by 1/2 inch.
H. For cannabis seeds the display panel
shall also include net quantity of seeds.
I. Cannabis
seed and immature cannabis plant labels shall have an information panel or
static quick response (QR) code that links to or contains the following without
intervening material:
(1) if applicable, the cannabis
manufacturer business or trade name;
(2) if applicable, unless the business or
trade name placed on the package is the actual manufacturer, a qualifying
phrase which states the firm's relation to the product (e.g., “manufactured
for” or “distributed by”);
(3) if applicable, cannabis manufacturer license
number;
(4) pesticide used in the product by the
cannabis producer;
(5) if applicable, date product was
manufactured;
(6) the
following warning statement in bold font “For use only by adults 21 and older.
Keep out of reach of children.”
[16.8.3.10 NMAC - N, 04/01/2022]
16.8.3.11 CANNABIS
FINISHED PRODUCT LABELING IN CANNABIS CONSUMPTION AREAS: Packaging
and labeling exemptions and minimum requirements. A licensed cannabis
consumption area may sell cannabis products to a consumer, qualified patient,
or reciprocal patient without packaging and labeling under the following
conditions:
A. the consumer, qualified patient, or
reciprocal patient intends to consume cannabis product on the licensed premises
of the cannabis consumption area and will store unused product on the premises
as required by cannabis consumption area licensing requirements in 16.8.2 NMAC;
B. at the time of transfer of the cannabis finished product to
a consumer, the licensed cannabis consumption area provides the consumer with a
written statement of the potency of the cannabis product’s THC or Total THC,
and CBD, which shall be expressed as a percentage for inhaled cannabis finished
products, and expressed in milligrams for edible cannabis finished products and
topical cannabis finished products. If CBD is not detected in the inhaled
cannabis finished product, then CBD potency is not required;
C. the licensed cannabis consumption area maintains and makes
available to the consumer, qualified patient, or reciprocal patient upon request
written or electronic documentation reflecting all relevant information
required in cannabis consumption area licensing requirements 16.8.2 NMAC; and
D. for multiple-serving edible cannabis finished product, the
licensed cannabis consumption area at the time of transfer to the consumer,
qualified patient, or reciprocal patient shall provide a measurement device
necessary for the purchaser to achieve accurate measurements of each serving in
increments equal to or less than 10 milligrams of Total THC per serving.
[16.8.3.10 NMAC - N, 04/01/2022]
16.8.3.12 CANNABIS FINISHED PRODUCT PACKAGING:
A. Unless
otherwise specified, edible or topical cannabis finished products shall meet
the following minimum packaging requirements:
(1) containers used for edible
cannabis products or edible cannabis finished products shall be food-grade or
GRAS and must not impart any toxic or deleterious substance to the packaged
product;
(2) containers used for topical cannabis
products and topical cannabis finished products must be suitable for the
intended purpose and must not impart any toxic or deleterious substance to the
packaged product;
(3) unless otherwise provided,
containers shall be child-resistant. If the product is multiple use, or
contains multiple servings, it shall also be packaged in a container that is
resealable and continually child-resistant;
(4) cannabis finished products that
contain only cannabis flower must be packaged in resealable containers and are
not subject to the child resistant container requirement;
(5) containers shall be compostable and
recyclable, or made from recycled materials;
(6) edible cannabis finished products
shall not exceed 10 milligrams of Total THC per serving, or 100 milligrams of
Total THC per container;
(7) single-serving edible cannabis
finished products that are placed into a child-resistant container may be
bundled into an exit package;
(8) edible cannabis finished products
containing multiple servings in a single container shall:
(a) when in in solid form, be:
(i) easily separable in order to allow
an average person 21 years of age or older to physically separate, with minimal
effort, individual servings of the product; and
(ii) easily and permanently scored to
identify individual servings;
(b) be packaged in a single serving
size; and
(c) be marked, stamped, or otherwise
imprinted with a logo designed and provided by the division that notifies a
reasonable person that the product contains cannabis that is no smaller than 1/2
inch by 1/2 inch for each single serving contained in a multi-serving package.
(9) Unless as
otherwise specified in Paragraph (10) of this subsection, liquid cannabis
finished products shall be single-serving only.
(10) Each liquid cannabis finished product
that is a multiple-serving edible cannabis finished product shall be:
(a) packaged in a structure that uses a
single mechanism to achieve both child-resistant properties and accurate
pouring measurement of each liquid serving in increments; and
(b) the measurement component is within
the child-resistant cap or closure of the bottle and is not a separate
component.
(11) A cannabis manufacturer shall
maintain a copy of the certificate showing that each child-resistant container
into which edible or topical cannabis finished product is placed is
child-resistant and complies with the requirements of 16 C.F.R. 1700.15 and 16
C.F.R. 1700.20;
(12) Packaging containers shall not be
designed to be appealing to a child and shall not use words that refer to
products that are commonly associated with minors or marketed by minors,
including use of the word(s) “candy” or “candies” on the label of any
container.
(13) Once any remaining cannabis has been
removed and destroyed pursuant to these rules, a cannabis establishment may
reuse containers subject to the following requirements and restrictions:
(a) the
containers have been sanitized and disinfected either by a cannabis
establishment or by a third-party to ensure that they do not contain any
harmful residue or contaminants, and
(b) if
child resistant, the containers can be reused with new child resistant
packaging that complies with 16 C.F.R. 1700.15 and 16 C.F.R. 1700.20; or if new
child resistant packaging is not being used, based on a visual inspection, the
existing child-resistant packaging appears to be in good working order and does
not appear to pose a risk of unintended exposure or ingestion of cannabis. The
visual inspection must ensure such containers are not brittle or have chips,
cracks, or other imperfections that could compromise the child-resistant
properties of the container or otherwise pose a threat of harm to a patient or
consumer.
[16.8.3.12 NMAC - N, 04/01/2022]
16.8.3.13 EXIT PACKAGING: All finished cannabis products purchased by a customer,
qualified patient, or reciprocal patient shall not leave the licensed
retailer’s premises unless the cannabis products are placed in an opaque exit
package.
[16.8.3.13 NMAC - N, 04/01/2022]
16.8.3.14 CANNABIS SEED AND IMMATURE PLANT
PACKAGING: Unless otherwise specified, cannabis
seeds sold shall meet the following minimum packaging requirements:
A. cannabis seeds and immature cannabis plants
shall be placed into a container;
B. containers
must be suitable for the intended purpose and must not impart any toxic or
deleterious substance to the packaged product; and
C. containers shall be compostable and
recyclable, or made from recycled materials.
[16.8.3.14 NMAC - N, 04/01/2022]
16.8.3.15 SEVERABILITY: If any part or application of this rule is held to be
invalid, the remainder or its application to other situations or persons shall
not be affected. Any section of this rule legally severed shall not interfere
with the remaining protections and duties provided by this rule.
[16.8.3.15 NMAC – N, 04/01/2022]
History
of 16.8.3 NMAC: [RESERVED]