Or. Admin. R. 333-015-0305

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-015-0305 - Packaging and Labeling: Definitions

For the purposes of OAR 333-015-0300 to 333-015-0360:

(1) "Authority" means the Oregon Health Authority.

(2) "Cannabinoid" means any of the chemical compounds that are the active constituents of marijuana.

(3) "Child-resistant" means having inner or outer packaging that is:

(a) Intended to protect children from nicotine exposure in the household environment or other environment where the product is used;

(b) Designed or constructed to be significantly difficult for children under five years of age to open and not difficult for adults to use properly, as defined by 16 CFR 1700.20 (1995); and

(c) Re-sealable for any product intended for more than a single use, such as a fillable inhalant delivery system.

(4) "Consumer product" means any article, or component part thereof, produced or distributed for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.

(5) "Distributor" means a person or company that supplies stores or businesses with goods.

(6) "Fillable inhalant delivery system" means a product that is sold without nicotine or non-nicotine inhalants, not permanently sealed and can be opened and filled with any inhalant.

(7) "Inhalant" means nicotine, or any other substance that:

(a) Is in a form that allows the nicotine, cannabinoid or substance to be delivered into a person's respiratory system;

(b) Is inhaled for the purpose of delivering the nicotine, cannabinoid or other substance into a person's respiratory system; and

(c)

(A) Is not approved by, or emitted by a device approved by, the United States Food and Drug Administration (FDA) for a therapeutic purpose; or

(B) If approved by, or emitted by a device approved by, the United States Food and Drug Administration for a therapeutic purpose, is not marketed and sold solely for that purpose.

(8)

(a) "Inhalant delivery system" means:

(A) A device that can be used to deliver nicotine or cannabinoids in the form of a vapor or aerosol to a person inhaling from the device; or

(B) A component of a device described in this section or a substance in any form sold for the purpose of being vaporized or aerosolized by a device described in this section, whether the component or substance is sold separately or is not sold separately.

(b)

(A) Inhalant delivery system does not include any product that has been approved by the United States Food and Drug Administration for sale as a tobacco cessation product or for any other therapeutic purpose, if the product is marketed and sold solely for the approved purpose; and

(B) Tobacco products.

(9) "Inner package" or "inner packaging" means the materials used to wrap or protect a product that must be opened by a consumer in order to have access to the product and that may also be but is not required to be the outer package.

(10) "Liquid nicotine container" means a consumer product that consists of a container that:

(a) Has an opening from which nicotine in a solution or other form is accessible and can flow freely through normal and foreseeable use by a consumer; and

(b) Is used to hold soluble nicotine in any concentration.

(11) "Manufacturer or distributor contact information" means the name, city, state and country of the manufacturer who made the inhalant delivery system.

(12) "Minor" means an individual under 18 years of age.

(13) "Nicotine" means any form of the chemical nicotine, including any salt or complex, regardless of whether the chemical is naturally or synthetically derived.

(14) "Non-nicotine liquid container" means a container that:

(a) Has an opening from which liquid non-nicotine or liquid non-cannabinoid substances can flow freely through normal and foreseeable use by a consumer; and

(b) Is not used to hold liquid nicotine or cannabinoids.

(15) "Outer package" or "outer packaging" means the external material used to wrap or protect a product that is visible to a consumer in the retail setting such as, but not limited to, a box or container.

(16) "Packaging" means any of the materials used to wrap or protect an inhalant delivery system and includes but is not limited to the inner packaging and outer packaging.

(17) "Prefilled inhalant delivery system" means an inhalant delivery system that is permanently sealed, prefilled, disposable and not intended to be disassembled by the consumer.

(18) "Retail setting" means a place of business in which merchandise is primarily sold directly to an ultimate consumer.

(19) "Retailer" means a person or entity, as that term is defined in ORS 60.001, that sells for consideration, offers for retail sale, holds for sale, or exchanges or offers to exchange tobacco products or inhalant delivery systems or that distributes free or low-cost samples of tobacco products or inhalant delivery systems from a premises.

(20) "These rules" means OAR 333-015-0300 to 333-015-0360.

Or. Admin. R. 333-015-0305

PH 20-2016, f. & cert. ef. 6/24/2016; PH 249-2018, amend filed 08/30/2018, effective 9/1/2018; PH 16-2022, amend filed 02/10/2022, effective 2/10/2022; PH 48-2023, amend filed 10/09/2023, effective 10/9/2023

Statutory/Other Authority: ORS 431A.175 & ORS 431A.218

Statutes/Other Implemented: ORS 431A.175 & ORS 431A.190-431A.220