ASTM D8449-23

Standard Specification for Label Content and Style, Format, Location, and Prominence of Elements for Consumer Products Containing Cannabinoids

SCOPE
1.1 This specification shall define the label content and style and format specifications for consumer products containing cannabinoids sold in an adult-use or medicinal-use marketplace.  
1.2 This specification shall define clear product categories for which these specifications apply.  
1.3 This specification shall apply to all consumer products containing cannabinoids packaged, distributed, and sold in an adult-use or medicinal-use marketplace regardless of the methods of obtention (source) of the cannabinoids.  
1.4 This specification shall not apply to inhalable or topical consumer products containing less than 10 000 PPM (1 %) total cannabinoids2, of which, no more than 3000 PPM (0.3 %) shall be total THC3.  
1.5 This specification shall not apply to ingestible consumer products containing less than 250 PPM (0.025 %) total cannabinoids, of which, no more than 10 PPM (0.001 %) shall be total THC4.  
1.6 This specification shall not define the label specifications for approved dietary supplements, over-the-counter drugs, or pharmaceuticals containing cannabinoids.  
1.7 This specification shall not define the label specifications for non-consumer products containing cannabinoids such as bulk or in-process products.  
1.8 This specification shall not define the design characteristics for label material, adhesives, ink, or other features unrelated to label content or style, format, location, and prominence of elements.  
1.9 Where aspects of this specification differ from jurisdictional regulatory requirements, the stricter of the two shall take precedence.  
1.10 Where aspects of this specification conflict with jurisdictional regulatory requirements, the authority having jurisdiction shall take precedence.  
1.11 Units—The values stated in either SI units or US Customary units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.12 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.13 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Mar-2023
• ICS: 01.080.10 - Public information symbols. Signs. Plates. Labels
• Technical Committee: D37 - Cannabis
• Drafting Committee: D37.04 - Processing and Handling

Relations

• Refers: ASTM D8233-19 - Standard Guide for Packaging and Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users, and Caregivers in a Business-to-Consumer Retail Environment (Retailers)
• Effective Date: 01-Feb-2019

Overview

ASTM D8449-23 is a comprehensive standard specification developed by ASTM International under Committee D37 on Cannabis. This standard provides clear guidelines for the label content and style, format, location, and prominence of elements for consumer products containing cannabinoids intended for adult-use and medicinal-use markets. It aims to enhance transparency, safety, and regulatory compliance through consistent and informative labeling that supports both public health and consumer rights while aligning with international trade and regulatory frameworks.

Key Topics

• Scope of Application

  • Applies to all consumer products containing cannabinoids sold in adult-use or medicinal-use marketplaces, regardless of cannabinoid source.
  • Excludes some products: inhalable/topical products with <10,000 ppm (1%) cannabinoids and <0.3% THC, ingestible products with <250 ppm (0.025%) cannabinoids and <0.001% THC, approved dietary supplements, over-the-counter drugs, pharmaceuticals, non-consumer (bulk/in-process) goods, and elements unrelated to content or style such as materials and adhesives.

• Label Content Specifications

  • Required Elements: Identity, responsibility (manufacturer details), quantity, cannabinoid content, universal symbols, warnings, usage, storage, batch numbers, and additional jurisdictionally mandated information.
  • Cannabinoid Declarations: Specifies total cannabinoids, total THC, and total CBD content in appropriate units (mg, %, etc.).
  • Style and Format: Labels must use legible fonts, distinguishable designs, and clearly placed required information; mandatory elements must not be on the bottom of the package.

• Prohibited Elements

  • No confusingly similar design to existing food, supplement, drug, or beverage labels.
  • No graphics appealing to children or suggesting consumption by minors.
  • No unauthorized use of official seals or insignia.
  • No misleading statements or unsupported health/structure-function claims.

• Jurisdictional Considerations

  • Where local regulations differ, the stricter requirement prevails; in case of conflict, local authorities have precedence.
  • Accommodations for language, measurement systems (SI and US Customary), and ecological labeling practices.

Applications

ASTM D8449-23 serves multiple stakeholders in the cannabinoid product industry:

• Product Manufacturers and Distributors

  • Ensures each cannabinoid-containing consumer product is labeled with accurate, complete, and non-misleading information, increasing compliance and consumer trust.
  • Reduces liability risk by providing clear declarations of content, responsibility, and warning information.

• Retailers and Dispensaries

  • Facilitates legal sale in adult-use and medicinal-use channels by providing a standard for evaluating product labels prior to sale.
  • Allows easier verification and acceptance of products sourced from multiple manufacturers.

• Regulators and Inspectors

  • Provides a clear benchmark for regulatory compliance, helping to monitor and enforce consistent labeling practices.
  • Enables authorities to take action on misleading, inadequate, or non-compliant labels based on standardized criteria.

• Consumers and Patients

  • Empowers users to make informed purchasing decisions based on transparent, easy-to-understand labeling.
  • Supports public health and safety through warnings, batch tracing, and dosage/serving information.

Related Standards

Several references and related ASTM and regulatory standards complement ASTM D8449-23 for comprehensive cannabinoid product management:

• ASTM D8233: Guide for packaging and labeling of resin cannabis products for sale.
• ASTM D8270: Terminology relating to cannabis.
• ASTM D8441/D8441M: Specification for international symbols identifying consumer products containing intoxicating cannabinoids.
• USP Chapter 17: Prescription container labeling (United States Pharmacopeia).
• NIST Handbook 130 and 133: Uniform packaging, labeling, and net content checking.

Using ASTM D8449-23 as a foundation for product labeling in the cannabinoid sector promotes regulatory alignment, supports safe commerce, and advances public health outcomes in this rapidly evolving market segment.

Keywords: cannabinoid labeling standard, ASTM D8449-23, cannabis product labeling, safety, compliance, consumer protection, medicinal-use, adult-use, regulatory requirements.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8449 − 23
Standard Specification for
Label Content and Style, Format, Location, and Prominence
of Elements for Consumer Products Containing
Cannabinoids
This standard is issued under the fixed designation D8449; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.8 This specification shall not define the design character-
istics for label material, adhesives, ink, or other features
1.1 This specification shall define the label content and style
unrelated to label content or style, format, location, and
and format specifications for consumer products containing
prominence of elements.
cannabinoids sold in an adult-use or medicinal-use market-
1.9 Where aspects of this specification differ from jurisdic-
place.
tional regulatory requirements, the stricter of the two shall take
1.2 This specification shall define clear product categories
precedence.
for which these specifications apply.
1.10 Where aspects of this specification conflict with juris-
1.3 This specification shall apply to all consumer products
dictional regulatory requirements, the authority having juris-
containing cannabinoids packaged, distributed, and sold in an
diction shall take precedence.
adult-use or medicinal-use marketplace regardless of the meth-
1.11 Units—The values stated in either SI units or US
ods of obtention (source) of the cannabinoids.
Customary units are to be regarded separately as standard. The
1.4 This specification shall not apply to inhalable or topical
values stated in each system are not necessarily exact equiva-
consumer products containing less than 10 000 PPM (1 %)
lents; therefore, to ensure conformance with the standard, each
total cannabinoids , of which, no more than 3000 PPM (0.3 %)
system shall be used independently of the other, and values
shall be total THC .
from the two systems shall not be combined.
1.5 This specification shall not apply to ingestible consumer
1.12 This standard does not purport to address all of the
products containing less than 250 PPM (0.025 %) total
safety concerns, if any, associated with its use. It is the
cannabinoids, of which, no more than 10 PPM (0.001 %) shall
responsibility of the user of this standard to establish appro-
be total THC .
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.6 This specification shall not define the label specifica-
1.13 This international standard was developed in accor-
tions for approved dietary supplements, over-the-counter
dance with internationally recognized principles on standard-
drugs, or pharmaceuticals containing cannabinoids.
ization established in the Decision on Principles for the
1.7 This specification shall not define the label specifica-
Development of International Standards, Guides and Recom-
tions for non-consumer products containing cannabinoids such
mendations issued by the World Trade Organization Technical
as bulk or in-process products.
Barriers to Trade (TBT) Committee.
2. Referenced Documents
This specification is under the jurisdiction of ASTM Committee D37 on
2.1 ASTM Standards:
Cannabis and is the direct responsibility of Subcommittee D37.04 on Processing and
D8233 Guide for Packaging and Labeling of Consumer
Handling.
Resin Cannabis Products for Sale to Adult Consumers,
Current edition approved April 1, 2023. Published April 2023. DOI: 10.1520/
D8449-23. Legally Authorized Medical Users, and Caregivers in a
10 000 ppm is the limit that the US Pharmacopeia Cannabis Expert Panel has
Business-to-Consumer Retail Environment (Retailers)
recommended as the threshold for labeling cannabinoids. A reference is provided in
D8270 Terminology Relating to Cannabis
the Related Materials section of this specification.
3000 ppm for total THC (delta-9-THC) is based on the harmonized specifica-
tion for classifying Cannabis sativa L. plants as “hemp” in Europe and North and
South America. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10 ppm is the Health Canada limit for total THC (delta-9-THC) above which all contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
consumer products containing cannabinoids most be labeled with a Universal Standards volume information, refer to the standard’s Document Summary page on
Symbol. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D8449 − 23
D8441/D8441M Specification for International Symbol for 3.2.6.1 Discussion—Depending on the packaging layer, the
Identifying Consumer Products Containing Intoxicating display panel in use and the principal display panel may be the
Cannabinoids same.
2.2 United States Pharmacopeia (USP):
3.2.7 exogenous, adj—descriptive term used to define some-
USP Chapter 17 Prescription Container Labeling
thing as relating to or developing from external factors/sources/
2.3 NIST Standards:
influences.
NIST Handbook 130 Uniform Laws and Regulations in the
3.2.7.1 Discussion—When used to describe cannabinoids
Areas of Legal Metrology and Fuel Quality, Section IV,
derived from sources other than a cannabis plant or any part
Part A – Uniform Packaging and Labeling Regulation
thereof, refer to the cannabinoids as “exogenous cannabi-
NIST Handbook 133 Checking the Net Contents of Pack-
noids.”
aged Goods
3.2.8 extract, n—cannabis resin preparation resulting from
an extraction process; or substance that results from the
3. Terminology
extraction of the flowers and/or glandular trichomes of a
3.1 Definitions:
cannabis plant.
3.1.1 General—Definitions are in accordance with Termi-
3.2.9 finished, adj—refers to any product that is in the final
nology D8270, unless otherwise indicated.
form in which it will be sold/provided to an authorized
3.2 Definitions of Terms Specific to This Standard:
consumer/purchaser.
3.2.1 adult-use, n—any non-therapeutic application associ-
3.2.9.1 Discussion—In other words, a packaged and labeled
ated with the production/manufacture of products containing
product intended for sale.
cannabinoids intended to be incorporated through any route of
administration by adult consumers.
3.2.10 label, n—any written, printed, or graphic matter
3.2.1.1 Discussion—When referring to adult-use
affixed to, applied to, attached to, blown into, formed, molded
marketplaces, the preferred term is “adult-use,” because ASTM
into, embossed on, debossed, or appearing upon or adjacent to
Committee D37 does not want to associate consumer products
a product/package, for the purposes of branding, identifying, or
containing cannabinoids intended for adult consumers, espe-
giving any information with respect to the commodity or to the
cially those with significant concentrations of delta-9-
contents of the package.
tetrahydrocannabinol, with those intended for general con-
3.2.10.1 Discussion—An inspector’s tag or other non-
sumer populations.
promotional matter, affixed to or appearing upon a product/
package, shall not be considered a label requiring the repetition
3.2.2 cannabis inflorescence (flower), n—flowering tops of a
cannabis plant. of label information required by this specification.
3.2.2.1 Discussion—Cannabis flowers may occur singularly
3.2.11 medicinal use, n—any therapeutic application asso-
or in clusters (cola), possessing glandular trichomes, bracts,
ciated with the production/manufacture of products containing
calyxes/sepals, and stigmas, and bear the reproductive struc-
cannabinoids intended to be incorporated through any route of
tures (for example, stamens or pistils) involved in the devel-
administration.
opment of seeds.
3.2.12 operator, n—refers to any entity or individual
3.2.3 cannabis resin, n—terpenophenolic secondary me-
licensed/permitted by an authority having jurisdiction to
tabolites produced within the secretory cells (glandular
cultivate, process, handle, package, distribute, or sell, or
trichomes) of a cannabis plant, including the cannabinoids,
combinations thereof, a cannabis plant, its parts, or products, or
terpenes, and other phytochemicals, whether refined or unre-
combinations thereof.
fined.
3.2.13 package, n—the term “package,” whether standard
3.2.4 concentrate, n—cannabis resin preparations resulting
(fixed), or random in quantity, means any product enclosed in
from a separation process; or substance that results from the
a container or wrapped in any manner in advance of being
separation of the glandular trichomes of a cannabis plant.
offered or exposed for retail sale; or whose weight, measure, or
3.2.5 confusingly similar, adj—in the case of goods and
count has been determined in advance of being offered or
services, the likelihood that a reasonable person, exercising the
exposed for retail sale. See also finished.
degree of care typically afforded when purchasing similar
3.2.13.1 Discussion—An individual item or lot of any adult-
goods or services, would be confused as to the origin,
use or medicinal-use consumer product containing cannabi-
sponsorship, or approval of the goods or services.
noids on which there is marked a declaration of quantity per
3.2.6 display panel, n—that part, or those parts, of a
unit of weight or of fluid measure or of count, or combinations
package/container that is, or are, most likely to be used to affix
thereof, shall be considered a package or packages.
a label or display required information.
3.2.14 phytochemical, n—any chemical that is derived from
a botanical source.
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook 3.2.15 primary, adj—descriptive term used to define the
Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
hierarchy of the term to follow, typically indicating the first in
Available from National Institute of Standards and Technology (NIST), 100
a series.
Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http://www.nist.gov.
The term “adult” shall be defined by the authority having jurisdiction. 3.2.15.1 Discussion—When used to describe the container
D8449 − 23
that immediately touches the product, refer to the container/ THC-A,9 THC A, d9-THCA, d9 THCA,9-THCA,9 THCA
package as the “primary package.” (or any combination thereof).
3.2.15.2 Discussion—In the context of packaging and
3.3.9 LPG—liquefied petroleum gas.
labeling, “immediate” is synonymous with “primary.”
3.3.10 PPM or ppm—parts per million.
3.2.16 principal display panel, n—that part, or those parts,
3.3.11 THC—tetrahydrocannabinol.
of a label that is, or are, so designed as to most likely be
3.3.12 THC-A—THCA—tetrahydrocannabinolic acid.
displayed, presented, shown, or examined under normal and
customary conditions of display and purchase. 3.3.13 w/o—without.
3.2.17 resin cannabis product, n—any product, whether
4. Significance and Use
finished or work in progress, containing or comprised of
cannabis flowers or resins or both and includes, but is not 4.1 This specification shall provide label content specifica-
limited to, the cannabis flowers and resins themselves, extracts/ tions that can be used as acceptance criteria for verifying/
concentrates/derivatives thereof, and preparations therefrom. certifying:
4.1.1 An adult-use consumer product containing cannabi-
3.2.18 topical use, n—any application associated with the
noids’ label possesses the minimum information required to
production of non-edible health and beauty products from a
maintain public and environmental health and safety; and
cannabis plant.
4.1.2 A medicinal-use consumer product containing can-
3.2.18.1 Discussion—Topical-use products containing can-
nabinoids’ label possesses the necessary additional information
nabinoids shall be subcategorized into adult use or medicinal
for a patient to know exactly what they are consuming and how
use.
to consume it.
3.2.19 total cannabinoids, n—means the sum of the most
4.2 This specification shall provide label style and format
prominent cannabinoids found in nature with certified refer-
specifications to ensure label content is distinguishable and
ence materials (such as those provided by the US Pharmaco-
prominent features appear in a consistent location, style, and
peia: d8-THC, d9-THC, d9-THCA, CBD, CBDA, CBDV,
format across product form and type.
CBN, CBG, CBGA, and CBC), taking into consideration
conversion from acidic form to neutral form.
4.3 The user of this specification shall be responsible for
3.2.19.1 Discussion—The list of cannabinoids included in
evaluating a product’s label to conformance with these speci-
the definition of “total cannabinoids” is intended to be updated fications and those of the authority having jurisdiction in which
as other cannabinoids with certified reference materials be-
the product is to be sold.
come available for use in testing.
4.4 The standard shall define types of display panels and the
3.2.20 total CBD, n—is defined as CBD + 87.7 % × CBDA.
required information thereon.
3.2.21 total THC, n—is defined as delta-9-
4.5 Prior to label manufacture/printing, the user of this
THC + 87.7 % × delta-9-THCA.
specification shall consider the ecological impact of the label
production/manufacturing process to satisfy the goals of the
3.2.22 universal symbol, n—a graphic representation, as
UN Sustainability Criteria.
defined by the authority having jurisdiction, indicating a
warning of potentially harmful substances and/or effects of
5. Applicable Adult-Use and Medicinal-Use Consumer
improper use.
Product Categories Containing Cannabinoids
3.2.23 work in progress, adj—refers to any product or good
5.1 This specification shall apply to the following forms of
that is in any stage of manufacture before being classified as a
adult-use and medicinal-use consumer products containing
“finished” product.
cannabinoids.
3.2.23.1 Discussion—“In process” is synonymous with
“work in progress.”
5.2 It is the responsibility of the user of this specification to
define the product form and intended use to determine the
3.3 Abbreviations:
appropriate label specifications.
3.3.1 CBC—cannabichromene.
5.3 Inhalation:
3.3.2 CBD—cannabidiol.
5.3.1 Forms—Flower, Extract/Concentrate, Pre-Rolls, and
3.3.3 CBD-A = CBDA—cannabidiolic acid.
Vape Cartridges.
3.3.4 CBG—cannabigerol.
5.3.2 Uses—Single (discrete) and Multiple (non-discrete).
3.3.5 CBN—cannabinol.
5.4 Ingestion:
3.3.6 CO2—CO —carbon dioxide.
5.4.1 Forms—Solid and Liquid.
5.4.2 Uses—Single (discrete) and Multiple (non-discrete).
3.3.7 delta-9-THC—delta-9-tetrahydrocannabinol or delta 9
tetrahydrocannabinol; also delta 9 THC, d9-THC, d9 THC,
NOTE 1—Concentrates/Extracts intended for ingestion shall follow
9-THC,9 THC (or any combination thereof). solid ingestible label specifications.
NOTE 2—Ingestible products include edibles.
3.3.8 delta-9-THC-A—delta-9 tetrahydrocannabinolic acid
NOTE 3—Ingestible products include oral-mucosal and sublingual
or delta 9 tetrahydrocannabinolic acid; also delta 9 THC A,
products intended for systemic effects. For example, a product intended to
delta-9-THCA, delta 9 THCA, d9-THC-A, d9 THC A,9- be held in the mouth and absorbed into the blood stream is an example of
D8449 − 23
an oral-mucosal or sublingual product intended for systemic effects.
7. Label Specifications
5.5 Topical: 7.1 General Label Specifications—Adult-use and
medicinal-use labels for consumer products containing can-
5.5.1 Forms—Dermal and Mucosal.
nabinoids shall meet the following characteristics and features:
5.5.2 Uses—Single (discrete) and Multiple (non-discrete).
7.1.1 For all display panels, text shall be displayed using an
NOTE 4—Concentrates/Extracts intended for topical use shall follow
easily decipherable type face.
topical label specifications.
7.1.2 For all display panels, except the principal display
NOTE 5—Topical products include oral-mucosal products intended for
panel, font size shall be no less than six points.
localized topical effects. For example, a product applied to a canker sore
that forms a protective film and affects only the canker sore itself is an
NOTE 9—When using a font size of six points, uppercase letters shall be
example of an oral-mucosal product intended for localized topical effects.
required to ensure the label content is legible and easily readable.
7.1.3 Non-alterable.
5.6 Immature Plants and Seeds.
NOTE 10—Meaning the label cannot be written on or otherwise altered
6. Prohibited Content and Design Elements
by any means.
6.1 Adult-use and medicinal-use labels for consumer prod- 7.1.4 Unobstructed and conspicuously placed.
ucts containing cannabinoids are prohibited from displaying
NOTE 11—Labels shall not be placed on top of other labels or the
the following content and design elements as well as those
universal symbol unless otherwise approved by the authority having
prohibited by the authority having jurisdiction: jurisdiction.
NOTE 12—In marketplaces requiring a point-of-sale label or dispensary
6.1.1 The label shall not be confusingly similar to the
label, a space/area shall be left vacant to accommodate the application of
trademarked, characteristic, or product-specialized label of any
a dispensing entity’s label at the point of sale of the product to prevent
commercially available food or beverage, over-the-counter
information displayed on the package by the manufacturer from being
drug, or prescription product. obstructed.
6.1.2 The label shall not bear any statement, artwork, or
7.1.5 Language requirements of the authority having juris-
design that could reasonably lead an individual to believe that
diction.
the package contains anything other than an adult-use or
NOTE 13—For brevity, examples shown in this specification are in
medicinal-use consumer product containing cannabinoids.
English only and do not represent a jurisdiction where multiple languages
6.1.3 The label shall not bear any seal, flag, crest, coat of are required to be on the label. However, the principles outlined in these
examples are applicable in other languages.
arms, or other insignia that could reasonably mislead an
individual to believe that the product has been endorsed,
7.1.6 Serving and Dosage information represented in SI
manufactured, or approved for use by an authority having
units only.
jurisdiction, unless explicitly approved by the authority having
NOTE 14—The term “serving” shall only appear on adult-use consumer
jurisdiction to include such iconography/symbology.
products containing cannabinoids and shall identify the maximum amount
6.1.3.1 This requirement shall not prohibit design elements
of THC in a single unit/piece allowed by the authority having jurisdiction.
Nothing precludes multiple pieces/units from making up a “serving” so
such as iconography/symbology indicating a product as com-
long as the total THC does not exceed the maximum amount of THC
pliant with dietary or religious, quality management, sustain-
allowed by the authority having jurisdiction.
ability considerations, etc.
NOTE 15—Serving information should reflect the weight or volume of
the suggested serving size and weight of the active ingredient(s) in each
NOTE 6—See the Claims and Other Label Specifications section of this
serving of an adult-use consumer product containing cannabinoids.
specification for more information.
NOTE 16—The term “dosage” or “dose” shall only appear on medicinal-
use consumer products containing cannabinoids. Dosage information
6.1.4 The label shall not bear any caricature, cartoon, image,
should reflect the weight of the active ingredient(s) in each dose of a
graphic, or feature that might make the package attractive to
medicinal-use consumer product containing cannabinoids.
children (or minors).
7.2 Label Content Specifications:
NOTE 7—The term “children” (or “minors”) shall be defined by the
7.2.1 All adult-use and medicinal-use consumer products
authority having jurisdiction.
containing cannabinoids shall be labeled with the following
content:
6.1.5 The label shall not make any false or misleading
7.2.1.1 Declaration of Identity;
statements, including but not limited to structure/function or
7.2.1.2 Declaration of Responsibility;
cannabinoid dominance/ratio or other unsubstantiated claims.
7.2.1.3 Declaration of Quantity;
NOTE 8—See the Claims and Other Label Specifications section of this
7.2.1.4 Declaration of Cannabinoids;
specification for more information.
7.2.1.5 Declaration of Terpenes (optional for adult-use);
6.1.6 The label shall not bear any color combinations that
7.2.1.6 Universal Symbol;
result in poor contrast making the label content illegible.
7.2.1.7 Batch Number;
6.1.7 Required label content, excluding branding elements, 7.2.1.8 Beyond Use/Use By/Best Before Date or an Expi-
ration Date (requires shelf-life testing);
shall NOT be located on the bottom of a package - that part of
a package upon which the package is most likely to be placed 7.2.1.9 Intended Use;
7.2.1.10 Storage Instructions;
when displayed, presented, shown, or examined under normal
and customary conditions of display and purchase. 7.2.1.11 Warning Statements; and
D8449 − 23
7.2.1.12 Any other information mandated by the authority 8.6 The declaration of identity shall stand out from other
having jurisdiction. text using prominent bold print or type of a size that is
reasonably related to the most prominent printed feature and
7.2.2 Required content may appear on one or more display
should be one of the most important features on the label.
panels of the package/container and on one or more package
layers.
NOTE 20—Generally, the declaration of identity should be at least half
7.2.3 At least one package layer shall possess all required
the size of the largest print on the label.
content.
8.7 The declaration of identity may appear on one or more
lines of print or type.
NOTE 17—Typically this is the outer most package layer and is the layer
of packaging most likely to be used to display the product.
9. Declaration of Responsibility
8. Declaration of Identity
9.1 Consumer products containing cannabinoids shall be
labeled with a declaration of responsibility clearly defining
8.1 Consumer products containing cannabinoids shall be
with whom liability falls if a product complaint or recall
labeled with a declaration of identity clearly distinguishing the
occurs.
product as containing cannabinoids.
9.2 The declaration of responsibility shall appear on the
8.2 The declaration of identity for adult-use consumer
package including:
products containing cannabinoids shall be in terms of:
9.2.1 The name;
8.2.1 The name specified in or required by the authority
9.2.2 Address;
having jurisdiction;
9.2.3 Telephone number;
8.2.2 The common or usual name of the product; or
9.2.4 Email address or website; and
8.2.3 The brand name, or other appropriate description, and
9.2.5 Permit/license number of the manufacturer, packer, or
a statement of function (such as “flavored seltzer with added
distributor of the product.
cannabinoids”).
9.3 The declaration of responsibility shall appear in the
8.2.3.1 Example—Cannablasters (flavored gummies with
form of:
cannabinoids).
9.3.1 “[Cultivated, Manufactured, Distributed, etc.] by [In-
NOTE 18—At a minimum, the word “cannabis,” “cannabis-based,”
sert Name Here], [Insert Permit Number Here], [Insert Address
“cannabis-derived,” or other common name acknowledged by an authority
Here], [Insert Telephone Number Here], [Insert Email Address
having jurisdiction, shall appear on the product label.
Here]”; or
NOTE 19—Adult-use consumer products containing cannabinoids with
9.3.2 Any other wording of similar import that expresses the
defined cannabinoid dominance and/or ratio claims shall declare the
cannabinoid dominance and/or ratio in the declaration of identity. See the
facts.
Cannabinoid Dominance and Ratio Claims section of this specification for
9.4 The “name” shall be the actual legal name, or, when not
more information.
incorporated, the name under which the business is conducted,
8.3 The declaration of identity for medicinal-use consumer
of the entity that is responsible for the consumer product
products containing cannabinoids shall be in terms of:
containing cannabinoids.
8.3.1 The name specified by the producer, including a
9.5 The “permit/license number” shall be the actual permit/
statement of active ingredients;
license number of the entity that is responsible for the
8.3.2 The cannabinoid dominance and/or ratio and the
consumer product containing cannabinoids.
scientific name of the product; or
9.6 The “address” shall be in the format customary to the
8.3.3 The naming convention defined by an internationally
country of the entity that is responsible for the consumer
recognized pharmacopeia, such as the United States
product containing cannabinoids and shall include (a) street
Pharmacopeia, for the form of consumer product containing
information, (b) city, (c) state/province/territory, (d) ZIP code
cannabinoids.
or other form of mailing code used, if any, and (e) country.
8.3.3.1 For the inflorescence (flowers) of a cannabis plant
9.6.1 The street information may be omitted only if it is
use an herbal material naming convention.
listed in a readily accessible, well-known, widely published,
8.3.3.2 For the concentrates and extracts of a cannabis plant
and publicly available resource, including but not limited to a
use a concentrate or extract naming convention, respectively.
printed directory, electronic database, or website.
8.3.3.3 For ingestible and topical forms of consumer prod-
9.6.2 The “address” shall be a physical location. P.O. Boxes,
ucts containing cannabinoids use a dietary supplement naming
or similar, should be avoided and are not recommended.
convention.
9.7 The “telephone number” shall be an actual phone
8.3.3.4 Example—THC-Dominant Cannabis Inflorescence.
number of the entity that is responsible for the consumer
8.4 The declaration of identity shall appear, at a minimum,
product containing cannabinoids and shall be in the format
on the immediate container and each principal display panel
customary to the country in which the product was manufac-
and shall not be misleading or deceptive.
tured and/or distributed.
8.5 The declaration of identity shall appear generally paral- 9.7.1 The “telephone number” shall include the country
lel to the base of the display panel in use and shall not exceed code for consumer product containing cannabinoids distributed
an angle of 22°. and/or sold internationally.
D8449 − 23
tion is not “lost” among other information.
9.8 The “email address” or “website” shall be an actual
email address or website URL of the entity that is responsible
10.7 The declaration of quantity shall appear on the lower
for the consumer product containing cannabinoids.
30 % of the principal display panel in use. (See Fig. 3.)
9.9 The declaration of responsibility shall appear, at a
10.7.1 Immediate containers meeting small container ex-
minimum, on the immediate container and each packaging
emptions are exempt from this requirement.
layer, and may be located on any display panel.
NOTE 25—See Section 11.16 Small Packages of NIST Handbook 130
9.10 The declaration of responsibility may appear on one or
(latest version), Uniform Laws and Regulations in the Areas of Legal
more lines of print or type. Metrology and Fuel Quality, Section IV, Part A ˗ Uniform Packaging and
Labeling Regulation.
9.11 Elements of the declaration of responsibility that are
10.8 The declaration of quantity shall be of a text size no
not required by the authority having jurisdiction where the
product is to be distributed or sold, or both, may be omitted. smaller than the minimum size requirements proportionate to
the dimensions of the principal display panel in use but shall be
9.12 It is the responsibility of the user of this specification to
no less than 1.6 mm ( ⁄16 in.) in height and no more than three
know which elements of the declaration of responsibility are
(3) times as high as they are wide.
applicable in the jurisdiction where the product is to be
distributed or sold, or both, and to comply with those require-
NOTE 26—The process for how to determine the minimum text size for
ments.
the principal display panel in use is provided in Section 8.2 Calculation of
Area of Principal Display Panel for Purposes of Type Size of NIST
10. Declaration of Quantity
Handbook 130 (latest version), Uniform Laws and Regulations in the
Areas of Legal Metrology and Fuel Quality, Section IV, Part A ˗ Uniform
10.1 Consumer products containing cannabinoids shall be
Packaging and Labeling Regulation.
labeled with a declaration of quantity clearly defining the net
10.9 The declaration of quantity may appear on one or more
quantity of contents contained within the package.
lines of print or type.
10.2 The declaration of quantity shall be exclusive of
wrappers and any other material packed with the product.
10.10 The declaration of quantity shall appear in the format
customary to the country or geographical region in which the
10.3 The declaration of quantity shall be in terms of the
product is to be distributed or sold, or both. In authorities
largest whole unit.
having jurisdiction where a dual unit customary format is used,
NOTE 21—The declaration of quantity of a product shall always declare
SI units shall precede the alternate unit declaration.
the net quantity of contents even when such terms are not used.
10.10.1 Example:
NOTE 22—Only declarations of quantity in terms of fluid measure may
omit the term “net.”
Customary Style Reference
NOTE 23—The term “net” shall not be abbreviated.
Format
SI Units (U.S. Customary)
10.4 The declaration of quantity shall appear, at a minimum,
kg (lb)
on the primary packaging (immediate container) and each
Dual Unit g (oz)
mL (fl oz)
principal display panel.
L (gal)
10.5 The declaration of quantity shall appear generally mL or L
SI Only
g or kg
parallel to the base of the display panel in use and shall not
exceed an angle of 22°. (See Fig. 1.)
10.11 The declaration of quantity shall be either by Weight,
Volume, or Count and Weight or Volume as defined by the form
10.6 The area around the quantity declaration shall be clear
of consumer product containing cannabinoids.
of other text and graphics by the height of the letter N (in the
font used) on the top and bottom of the quantity declaration and
10.12 A declaration of quantity in terms of weight or
width of two letter N’s (in the font used) on either side of the
volume shall be combined with appropriate declarations of the
quantity declaration. (See Fig. 2.)
count of the individual units unless a declaration of weight or
NOTE 24—The free area requirement ensures that the quantity declara- volume alone is fully informative.
FIG. 1 Generally Parallel Requirement Visualization
D8449 − 23
FIG. 2 Free Area Requirement Visualization
10.15.1.1 Example:
Customary Style Reference
Format
30 mL (1 fl oz)
Dual Unit Net Contents 30 mL (1 fl oz) or 30 mL (1 fl oz) Net Contents
Net 30 mL (1 fl oz) or 30 mL (1 fl oz) Net
30 mL
SI Only Net Contents 30 mL or 30 mL Net Contents
Net 30 mL or 30 mL Net
10.16 Count Declarations:
10.16.1 When stating the net quantity of contents in terms of
count, a quantity declaration must include the count and the
term “total net weight” or “total net mass,” in the case of
weight, or the term “total net contents” or “total net” or “total
FIG. 3 Upper 70 % Lower 30 % Requirement Visualization
contents,” in the case of fluid measure.
10.16.2 For improved clarity, the weight or volume of each
10.13 A declaration of quantity in terms of count shall be
unit included in the package may also appear in the declaration
combined with appropriate declarations of the weight or
of quantity.
volume of the individual units.
10.16.2.1 Example:
10.14 Weight Declarations:
Customary Style Reference
10.14.1 When stating the net quantity of contents in terms of
Format
weight, the quantity declaration must include the term “net
28 pre-rolls, total net wt 28 g (1 oz)
Dual Unit Or
mass” or “net weight” either preceding or following the
28 pre-rolls, 1 g (.035 oz) each, total net wt 28 g (1 oz)
declaration.
28 pre-rolls, total net wt 28 g
10.14.1.1 Example:
SI Only Or
28 pre-rolls, 1 g each, total net wt 28 g
Customary Style Reference
Format
10.17 Product Form Considerations:
Net Weight 196 g (7 oz)
Dual Unit 10.17.1 Aerosols and Other Pre-pressurized Containers
454 g (1 lb) Net Mass
Dispensing Product Under Pressure—The declaration of quan-
Net Weight 196 g
SI Only
454 g Net Mass
tity on an aerosol, and on other pre-pressurized containers
dispensing products under pressure, shall disclose the net
NOTE 27—The term “weight” may be abbreviated as “wt,” “Wt,” or
quantity of the commodity (including propellant) in terms of
“WT.”
weight and the minimum number of usable sprays if required
10.14.1.2 Example—“Net Wt 3.5 g ( ⁄8 oz)” (U.S. Custom-
by the authority having jurisdiction.
ary Style Reference Shown)
NOTE 28—Aerosols and other pre-pressurized containers dispensing
10.15 Fluid Measure (Volume) Declarations:
product under pressure utilizing propellants shall declare the type of
10.15.1 When stating the net quantity of contents in terms of
propellant in the ingredients list.
fluid measure (that is, volume), the quantity declaration may
10.18 Character of Declaration (Restrictions on Declara-
stand alone or may include the term “net” or “net contents”
tions of Quantity):
either preceding or following the declaration.
10.18.1 Average—The average quantity of contents in the
packages of a particular lot, shipment, or delivery shall at least
equal the declared quantity, and no unreasonable shortage in
any package shall be permitted even though overages in other
packages in the same shipment, delivery, or lot compensate for
such shortage.
10.18.1.1 The user of this specification shall be responsible
for utilizing guides/resources, such as NIST HB 133, to
determine what is an unreasonable shortage.
10.18.2 Rounding—In all conversions for the purpose of
showing an equivalent SI or U.S. customary quantity to a
rounded U.S. customary or SI quantity, or in calculated values
to be declared in the net quantity statement, the number of
D8449 − 23
significant digits retained must be such that accuracy is neither 11.4 Cannabinoid content declarations shall be no less than
sacrificed nor exaggerated. (NLT) 85 % and no more than (NMT) 115 % of the labeled
amount (that is, 615 %), or NLT and NMT three times the
10.18.2.1 Conversions, the proper use of significant digits,
and rounding must be based on the operator’s knowledge of the limit of quantitation (LOQ) of the labeled amount (that is, 63
× LOQ), whichever is least restrictive.
accuracy of the original measurement that is being converted.
10.18.2.2 In no case shall rounded net content declarations
11.5 Cannabinoid content declarations shall appear in the
overstate a quantity; the operator may round the converted
form of:
values down to avoid overstating the net contents.
11.5.1 A percentage of the net quantity, or weight measure-
10.18.2.3 The user of this specification shall be responsible
ment in milligrams per gram, for inhalable product forms and
for utilizing guides/resources, such as NIST HB 130, to
immature plants and seeds; or
determine the rounding rules that are applicable.
11.5.2 A weight measurement in milligrams per container
and per serving/dose for ingestible and topical product forms.
NOTE 29—For packages labeled with a dual unit declaration of quantity,
the larger of the two values shown on the label is what is used during an
NOTE 31—For immature plants and seeds, cannabinoid content decla-
inspection to validate the label claim.
rations reflect projected values of cannabinoids that could result if the
NOTE 30—Appendix B: Converting U.S. Customary Units to SI Units
seeds were propagated, or the plants were allowed to mature, and DO
for Quantity Declarations on Packages of NIST Handbook 130 (latest
NOT reflect cannabinoid content of the immature plants and seeds
version), Uniform Laws and Regulations in the Areas of Legal Metrology
themselves.
and Fuel Quality, Section IV, Part A ˗ Uniform Packaging and Labeling
11.6 Cannabinoid content declaration shall be displayed in a
Regulation has guidelines on rounding SI conversions of U.S. customary
values.
box with a border no less than 1.5 mm (.059 in.) thick.
10.18.3 Approximations—The label shall not approximate
11.7 Cannabinoid content declarations may appear on one
declarations of quantity.
or more lines of print or type.
10.18.3.1 In no case shall any declaration of quantity of
11.8 Cannabinoid content declarations shall be located, at a
contents be qualified by the addition of the words “when
minimum, on the immediate container and each layer of
packed,” “minimum,” “not less than,” or any words of similar
product packaging.
import (for example, “estimated,” “approximate,” etc.), nor
11.9 The declaration of cannabinoids for ingestible and
shall any unit of weight, fluid measure, or count be qualified by
topical product forms shall appear on the principal display
any term or symbol (such as “jumbo,” “giant,” “full,” “6 ,” “≈
panel and in a cannabinoid information label. Specifications for
,” or the like) that tends to exaggerate the amount of product in
the Cannabinoid Information Label are outlined in the Form
a package.
Specific Label Requirements, Ingestible and Topical sections
10.18.4 Point of Sale Declaration of Quantity Stipulations
of this specification.
(Bulk Bin):
10.18.4.1 Product sold at the point of sale by weight shall
12. Declaration of Terpenes (Optional for Adult-Use)
have a label affixed to the package prior to transfer to the
consumer with the label requirements defined in this specifi-
12.1 Medicinal-use consumer products containing cannabi-
cation.
noids shall be labeled with a declaration of terpenes clearly
defining the net quantity of terpenes contained within the
11. Declaration of Cannabinoids
package.
11.1 Adult-use and medicinal-use consumer products con- 12.2 Medicinal-use consumer products containing cannabi-
taining cannabinoids shall be labeled with a declaration of
noids shall be labeled with a declaration identifying, at a
cannabinoids clearly defining the net quantity of cannabinoids minimum, the total terpenes.
contained within the package. 12.2.1 For further clarity, the top five terpenes in descending
order should be included with the declaration of terpenes but
11.2 Adult-use consumer products containing cannabinoids
shall not need to be quantified.
shall be labeled with a declaration quantifying, at a minimum,
total cannabinoids, total THC, and total CBD by weight or 12.3 Terpene content declarations shall be no less than
(NLT) 85 % and no more than (NMT) 115 % of the labeled
volume contained within the product.
amount (that is, 615 %), or NLT and NMT three times the
11.3 Medicinal-use consumer products containing cannabi-
limit of quantitation (LOQ) of the labeled amount (that is, 63
noids shall be labeled with a declaration identifying, at a
× LOQ), whichever is least restrictive.
minimum, the total cannabinoids and the main cannabinoids
12.4 The declaration of terpenes shall be in the form of:
that have certified reference materials (delta-8-THC, delta-9-
THC, delta-9-THCA, CBD, CBDA, CBDV, CBN, CBG, 12.4.1 A weight measurement in milligrams per gram, for
inhalable product forms and immature plants and seeds; or
CBGA, and CBC) by weight or volume contained within the
product. 12.4.2 A weight measurement in milligrams per package/
container and per serving/dose for ingestible and topical
11.3.1 At a minimum, inhalable medicinal-use consumer
product forms.
products containing cannabinoids shall be labeled with a
declaration identifying the cannabinoids listed above and all
NOTE 32—For immature plants and seeds, terpene content declarations
quantifiable cannabinoids contained within the product exceed-
reflect projected values of terpenes that could result if the seeds were
ing 1 % by weight or volume. propagated, or the plants were allowed to mature, and DO NOT reflect
D8449 − 23
terpene content of the immature plants and seeds themselves.
15. Beyond Use/Best Before/Use By/Durable Life Dates
and Expiration Dates
12.5 The declaration of terpenes shall be displayed in a box
with a border no less than 1.5 mm (.059 in.) thick.
15.1 A “Beyond Use Date,” “Best Before Date,” “Use By
12.6 The declaration of terpenes shall be located, at a Date,” “Durable Life Date,” or “Expiration Date” shall desig-
minimum, on the immediate container and each layer of nate the time during which the product is expected to remain
product packaging.
within established shelf-life specifications if stored under
defined conditions, and after which it should not be used.
12.7 The declaration of terpenes may appear on one or more
lines of print or type.
15.2 Operators should perform a shelf-life determination for
all consumer products containing cannabinoids prior to distri-
12.8 Adult-use consumer products containing cannabinoids
bution and/or sale to establish shelf-life specifications using an
may be labeled with a declaration of terpenes.
internationally recognized pharmacopoeia guideline, such as
12.8.1 The declaration of terpenes for adult-use consumer
the US Pharmacopeia.
products containing cannabinoids may be in the form of a
percentage of the net weight or volume.
15.3 A “Beyond Use Date,” “Best Before Date,” “Use By
Date,” “Durable Life Date,” “Expiration Date,” or “Packaging
13. Universal Symbol
Date” shall be prominently displayed on the package and shall
13.1 All consumer products containing cannabinoids for be in the format customary to the country or geographical
which these specifications apply shall be labeled with a
region in which the product is to be sold.
universal symbol.
15.4 A “Beyond Use Date,” “Best Before Date,” “Use By
13.2 The universal symbol shall have dimensions no less
Date,” “Durable Life Date,” “Expiration Date,” or “Packaging
1 1
than 12.7 mm by 12.7 mm ( ⁄2 in. by ⁄2 in.) and be prominently
Date” shall be located, at a minimum, on the immediate
displayed on the immediate container and each principal
container and each packaging layer.
display panel. See 23.4.1 for specifications related to the
15.5 Packaging Date:
universal symbol and vaporizer cartridges.
15.5.1 Consumer products containing cannabinoids without
13.3 Universal symbol specifications shall be defined by the
a defined “Beyond Use Date,” “Best Before Date,” “Use By
authority having jurisdiction.
Date,” “Durable Life Date,” or “Expiration Date” shall be
13.4 For consumer products containing intoxicating
labeled with the “Packaging Date” and a statement informing
cannabinoids, the standardized symbol as per Specification
the consumer that no shelf life determination has been per-
D8441/D8441M should be used to identify these consumer
formed.
products.
15.5.2 Example—The statement: “The shelf life of this
product has not been determined.” may suffice.
14. Batch Number
15.6 Beyond Use Date:
14.1 Adult-use and medicinal-use consumer products con-
15.6.1 A “Beyond Use Date” shall be used ONLY when a
taining cannabinoids shall be labeled with a batch number that
product is taken out of its original packaging or manipulated.
corresponds to the entire life cycle of the product from start to
finish, that is, from seed to sale.
15.6.2 Appropriate “Beyond Use Date” declarations shall
be made using an internationally recognized pharmacopoeia
14.2 Only one batch number associated with the product
guideline, such as the US Pharmacopeia.
shall appear on the package.
15.7 Best Before Date:
NOTE 33—If a label is to be applied to the package by the dispensing
entity at the point of sale, the batch number associated with the product on
15.7.1 A “Best Before Date” shall be used when a product
the dispensing entity’s label shall be the same as the batch number that
can reasonably be assured to have a shelf-life more than ninety
appears on the package.
(90) days.
NOTE 34—This is to avoid confusion, increase accountability, and
eliminate multiple batch numbers from being associated with the same
15.8 Use By Date or Durab
...