Current through Register Vol. 63, No. 12, December 1, 2024
(1) A label
required by these rules must:
(a) Be printed
on or affixed to the container holding the marijuana item or industrial hemp
commodity or product and printed on or affixed to any outer package or
container that is used to display the marijuana item or industrial hemp
commodity or product for sale or transfer to a consumer, patient or designated
primary caregiver;
(b) Comply with
the National Institute of Standards and Technology (NIST) Handbook 130 (2016),
Uniform Packaging and Labeling Regulation, incorporated by reference;
(c) Contain all required information in any
typed, legible font that is easy to read and contrasts sufficiently with the
background and is at least 1/16th of an inch in height based on the uppercase
"K";
(d) Be in English, though it
can also be in other languages; and
(e) Be unobstructed and
conspicuous.
(2) A label
may not:
(a) Contain any untruthful or
misleading statements including, but not limited to, a health claim that is not
supported by the totality of publicly available scientific evidence (including
evidence from well-designed studies conducted in a manner that is consistent
with generally recognized scientific procedures and principles), and for which
there is significant scientific agreement, among experts qualified by
scientific training and experience to evaluate such claims; or
(b) Be attractive to minors, as that is
defined in OAR 845-025-7000.
(3) Principal Display Panel.
(a) Every container that holds a marijuana
item or industrial hemp commodity or product for sale or transfer to a
consumer, patient or designated primary caregiver must have a principal display
panel, as that term is defined in OAR
845-025-7000.
(b) If a container holding the marijuana item
or industrial hemp commodity or product is placed within another container for
sale or transfer to a consumer, patient or designated primary caregiver, both
containers must have a principal display panel as that term is defined in OAR
845-025-7000 in addition to the
other labeling requirements provided in these rules.
(c) The principal display panel must contain
the product identity, net quantity of contents, and universal symbol or hemp
symbol, whichever is applicable.
(d) If the product is a medical grade
cannabinoid product, concentrate or extract processed by a licensee, or medical
marijuana processing site, the principal display panel must also include the
medical grade symbol.
(e) If the
product is an industrial hemp commodity or product processed by a licensee, the
principal display must include the hemp symbol in place of the universal
symbol.
(f) On or after July 1,
2022, if the package or container is 1.75 inches or less in height and has a
lid with a width of 2 inches or less, then the principal display panel must be
on the top of the lid.
(4) Product Identity
(a) The product identity be 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.
(b)
The product identity must clearly identify whether the item is derived from
marijuana or hemp. An item that contains both industrial hemp and marijuana
must identify the item as a marijuana item.
(c) The product identity for cannabinoid
extracts and concentrates must correctly identify whether the product is an
extract or a concentrate.
(5) Net Quantity Declaration
(a) The net quantity of contents provided on
the principal display panel must be the average net quantity of contents of all
of the packages in the batch.
(b)
The net quantity declaration 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.
(c) The net quantity
declaration shall be a distinct item separated from other printed label
information on all sides by at least a space equal to the height of the
lettering used in the declaration. The declaration shall be presented in bold
type in the bottom 30 percent of the principal display panel and in lines
generally parallel with the base of the container.
(6) Potency Labeling. The THC and CBD amounts
required to be on a label must be the value calculated by the laboratory that
did the testing in accordance with OAR
333-064-0100.
(a) The potency value shall be expressed as
an average of the samples taken and tested under OAR
333-007-0360. A label may not
have a THC value that exceeds the applicable maximum concentration limit by
over 10 percent as specified in OAR
845-026-0200 to
845-026-0220, as
applicable.
(b) For products tested
on or after February 1, 2020, if the potency value for THC or CBD is reported
by the laboratory as less than the limit of quantification, the value on the
label must be listed as "<LOQ".
(7) The universal symbol. The universal
symbol must be at least 0.48 inches wide by 0.35 inches high and can be
downloaded on the Commission's website.
(8) Medical grade symbol. The medical grade
symbol must be at least 0.35 inches in diameter and can be downloaded at
marijuana.oregon.gov.
(9) Hemp
symbol. The hemp symbol must be at least 0.48 inches wide by 0.35 high and can
be downloaded on the Commission's website.
(10) A marijuana item or industrial hemp
commodity or product may have one or more label panels printed on or affixed to
the container or packaging.
(11)
Small Container Label. A marijuana item or industrial hemp commodity or product
that is in a container that because of its size does not have sufficient space
for a label that contains all the information required for compliance with
these rules:
(a) May, in lieu of a label that
has all the information required in OAR
845-025-7030 to
845-025-7145, have a label
printed on or affixed to the container holding the marijuana item or industrial
hemp commodity or product that includes at least the following:
(A) A principal display panel containing the
net weight or volume, product identity, and universal symbol;
(B) Licensee business or trade name and
license number or registrant business or trade name and registrant
number;
(C) UID number;
(D) Concentration or amount of THC and CBD in
the container; and
(E) Required
warnings.
(i) For a retail marijuana item or
industrial hemp commodity or product, the following warning is required on the
label: "For use only by adults 21 and older. Keep out of reach of
children."
(ii) For a medical
marijuana item, the following warning is required on the label: "For use by
OMMP patients only. Keep out of reach of children."
(b) Must include all required
label information on an outer container or other required label information not
listed in subsection (11)(a) of this rule on a hangtag attached to the
marijuana item or industrial hemp commodity or product.
(c) May use a peel-back or accordion label
with the information required in subsection (11)(b) of this rule on the inside
of the peel-back or accordion label, if the peel-back or accordion label can be
easily identified by a patient or consumer as containing important
information.
(12) Tiny
Container Label. A marijuana item or industrial hemp commodity or product that
is in a container that has a complete surface area available for applying a
label that is less than 2 inches squared:
(a)
May have a label printed on or affixed to the container that holds the
marijuana item or industrial hemp commodity or product that includes at least
the following:
(A) A principal display panel
with the universal symbol and product identity;
(B) UID number;
(C) Concentration or amount of THC and CBD in
the container;
(D) Licensee or
registrant business or trade name and license or registrant number;
and
(E) A warning that reads: "Keep
out of reach of children."
(b) Must include all required label
information on an outer container or other required label information not
listed in subsection (12)(a) of this rule on a hangtag attached to the
marijuana item or industrial hemp commodity or product.
(c) May use a peel-back or accordion label
with the information required in subsection (12)(c) of this rule on the inside
of the peel-back or accordion label, if the peel-back or accordion label can be
easily identified by a patient or consumer as containing important
information.
(13) The
outer container used to display the marijuana item or industrial hemp commodity
or product for sale or transfer to a consumer, patient, or designated primary
caregiver must comply with the labeling requirements in these rules, even if an
inner container qualifies for the exception under section (11) or (12) of this
rule.
(14) A marijuana item or
industrial hemp commodity or product that simultaneously falls within more than
one category, for example a cannabinoid concentrate that is intended for human
consumption, must comply with the labeling requirements that apply to both
cannabinoid concentrates and cannabinoid edibles, with the exception of the "DO
NOT EAT" warning if the product is intended for human consumption or the "BE
CAUTIOUS" warning if the effects of the product are customarily felt
immediately.
(15) If a marijuana
item or industrial hemp commodity or product is placed in a package that is
being re-used, the old label must be removed and it must have a new
label.
(16) A licensee or
registrant must have documentation that demonstrates the validity of the
calculation of the amount of sodium, cholesterol, protein, sugar, carbohydrates
and total fat in a cannabinoid edible and must make that documentation
available to the Commission or the Authority upon request.
(17)
(a) A
marijuana item or industrial hemp commodity or product that contains an
ingredient consisting of two or more sub ingredients must either:
(A) Use the common name of the ingredient
followed by a parenthetical listing of all ingredients in a descending order of
predominance; or
(B) List all sub
ingredients as individual ingredients in descending order of
predominance.
(b) The
list of ingredients must include any substance used in processing, preparing,
manufacturing, packaging, or holding the cannabinoid product that is present in
the final product, including any cooking or release spray.
(c) The list of ingredients must correctly
identify the type of marijuana item or industrial hemp ingredient used to make
the product.
(18) A
cannabinoid edible that contains only a single serving may omit the servings
per container declaration as long as the label clearly states that the package
contains a single serving.
(19) A
cannabinoid edible shall use one of the nutrition information formats provided
by the Commission to display on the label the amount of calories, sodium,
protein, added sugars, cholesterol, total carbohydrates, and total fat per
serving, the serving size and number of servings per container, and the list of
ingredients and potential allergens.
(20) If the container holding the marijuana
item or industrial hemp commodity or product does not meet the child resistant
standards set out in these rules, the outermost label must contain the
following statement: "This package is not child resistant."
(21) Exit packaging must contain a label that
reads: "Keep out of the reach of children."
(22) A cartridge or vaporizing device
containing a cannabinoid or hemp concentrate, extract or product intended for
use with an inhalant delivery system as that is defined in ORS
431A.175 is not required to be
labeled in accordance with these rules except that the cartridge or device must
have a label with the universal symbol or hemp symbol, as appropriate. All the
remaining label requirements must be included on the packaging as required by
these rules.
(23) The Commission
may require that marijuana items and industrial hemp commodities and products
sold at retail by Commission licensees be labeled with a Universal Product
Code.
(24) Once a label is approved
by the Commission, the label identification number provided by the Commission
must be prominently displayed on the label of the outermost
container.
(25) If a cannabinoid
concentrate or extract contains any added substances, the item shall be
considered a cannabinoid product and labeled under OAR
845-025-7120.
Statutory/Other Authority: ORS
475C.604
Statutes/Other Implemented: ORS
475C.604
