Or. Admin. Code § 845-025-7030

Current through Register Vol. 63, No. 10, October 1, 2024

Section 845-025-7030 - Labeling for Sale to Consumer

(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.

Or. Admin. Code § 845-025-7030

OLCC 6-2016, f. 6-28-16, cert. ef. 6/29/2016; OLCC 17-2016(Temp), f. & cert. ef. 9-30-16 thru 12-26-16; OLCC 22-2016, f. 12-22-16, cert. ef. 12/27/2016; OLCC 6-2018, amend filed 05/23/2018, effective 6/1/2018; OLCC 14-2018, amend filed 12/27/2018, effective 12/28/2018; OLCC 3-2020, amend filed 01/28/2020, effective 2/1/2020; OLCC 21-2021, amend filed 12/30/2021, effective 1/1/2022; OLCC 146-2022, minor correction filed 03/25/2022, effective 3/25/2022; OLCC 202-2022, amend filed 11/21/2022, effective 1/1/2023

Statutory/Other Authority: ORS 475C.604

Statutes/Other Implemented: ORS 475C.604