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 OREGON ADMINISTRATIVE RULES  
OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION  
CHAPTER 333  
 
DIVISION 15  
 
IMPLEMENTATION OF REQUIREMENTS FOR OREGON'S INDOOR CLEAN AIR 
ACT,  NUTRITIONAL INFORMATION AT CHAIN RESTAURANTS , AND 
STANDARDS FOR REDUCING THE SALE OF TOBACCO AND INHALANT 
DELIVERY SYSTEMS TO MINORS  AND PACKAGING AND LABELING 
REQUIREMENTS FOR INHALANT DELIVERY SYSTEMS  
 
Packaging and Labeling  
 
333-015-0300  
Purpose, Scope and Effective Date  
(1) The purpose of OAR 333 -015-0305  to 333 -015-0375  is to set the minimum standards for the 
labeling and packaging of inhalant delivery systems that are sold to a consumer.   
(2) These minimum standards are applicable, on and after July 1, 2016.  
(3) These rules do not apply to an inhalant delivery system or prefilled inhalant delivery system 
that contains cannabinoids if that inhalant delivery system or prefilled inhalant deli very system 
complies with the packaging requirements in OAR 845 -025-7000 to 845 -025-7060 and the 
labeling requirements in OAR 333 -007-0010 to 333 -007-0100.  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0305  
Definitions  
For the purposes of OAR 333 -015-0300  to 333 -015-0375 : 
(1) "Authority " means the Oregon Health Authority.  
(2) "Cannabinoid " means any of the chemical compounds that are the active constituents of 
marijuana.  
(3) "Cartoon " means any drawing or other depiction of an object, person, animal or creature or 
any similar caricature that satisfies any of the following criteria:  
(a) The use of exaggerated features;  
(b) The attribution of human characteristics to animals, plants or  other objects, or the similar use 
of anthropomorphic technique; or  
(c) The attribution of unnatural or extra -human abilities, such as imperviousness to pain or 
injury, X -ray vision, tunneling at very high speeds or transformation.   
(4) "Child -resistant " means 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 .   Page 2 of 8 
  
(5) "Consumer product " means any article, or componen t 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 perma nent or temporary household or residence, a school, in recreation, 
or otherwise.  
(6) "Distributor " means  a person or company that supplies stores or businesses with goods.  
(7) "Fillable inhalant delivery system " means a product that is sold without nicot ine or non -
nicotine inhalants, not permanently sealed and can be opened and filled with any inhalant.  
(8) "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.  
(9)(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 s ection , whether the 
component or substance is sold separately or is not sold separately.  
(b) Inhalant delivery system does not include :  
(A) A ny product that has been approved by the Unit ed 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.  
(10) "Inner package " means the package 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.  
(11) "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.  
(12) "Manufacturer or distributor contact inf ormation " means the name, city, state and country of 
the manufacturer who made the inhalant delivery system.  
(13) "Minor " means an individual under 18 years of age.  
(14) "Nicotine " means any form of the chemical nicotine, including any salt or complex, 
regardless of whether the chemical is naturally or synthetically derived.  
(15) "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.   
 Page 3 of 8 
 (16) "Outer package " means the external package visible to a consumer in the retail setting such 
as, but not limited to, a box or container.  
(17) "Outlet " means any location in Oregon which sells at retail or otherwise distributes tobacco 
products or inhalant delivery systems to consumers including, but not limited to, locations that 
sell such products over the counter or through vending machines.  
(18) "Packaged in a manner attractive to minors " means an inhalant delivery system product 
where any package, including the outer package or label on the outer package, or the inner 
package or label on the inner package:  
(a) Depicts cartoons;  
(b) Depicts celebrities or fictitious characters played by people;  
(c) Depicts people using the product;  
(d) Depicts food or beverage;  
(e) Resembles any product of the type that is typically marketed to minors; or  
(f) Resembles the shape of any animal, commercially recogniz able toy or candy.  
(19) "Prefilled inhalant delivery system " means an inhalant delivery system that is permanently 
sealed, prefilled, disposable and not intended to be disassembled by the consumer.  
(20) "Retail setting " means a place of business in which merchandise is primarily sold directly to 
an ultimate consumer.  
(21) "Significant scientific agreement " means based on the totality of the publicly available 
evidence (including evidence from well -designed studies conducted in a manner which is 
consistent  with generally recognized scientific procedures and principles), there is significant 
scientific agreement among experts qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by evidence as defined by section  403(r)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(3)) and 21 CFR 101.14(c).  
(22) "These rules " means OAR 333 -015-0300 to 333 -015-0375 .  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0310  
Labeling Requirements for Liquid Nicotine Containers  
(1) A label on a liquid nicotine container must clearly display:  
(a) Ingredients in descending order of predominance;  
(b) Nicotine concentration expressed in milligrams per milliliter, which may be shor tened to read 
as mg/mL;  
(c) Milliliters of liquid contained in the liquid nicotine container;  
(d) Milligrams of nicotine contained in the liquid nicotine container;  
(e) Manufacturer or distributor contact information; and  
(f) Product warnings that read:  
(A) Keep out of reach of children;  
(B) Nicotine is highly addictive and can be toxic;  
(C) It is illegal to sell or distribute this product to minors; and  
(D) For accidental exposure , call t he Poison Center at 1 -800-222-1222 .  
(2) Labels and product warnings must:  
(a) Conform to the general label requirements in OAR 333 -015-0330 ; 
(b) Be displayed on the inner package; and  
(c) Be displayed on the outer package if the product has both an inner and outer package.  Page 4 of 8 
  
Stat. Auth.: ORS  431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0315  
Labeling Requirements for Non -nicotine Liquid Container  
(1) A label on a non -nicotine liquid container must clearly display:  
(a) Ingredients in descending order of predominance;  
(b) Milliliters of liquid contained in the non -nicotine liquid container;  
(c) Zero  milligrams of nicotine contained in the non -nicotine liquid container;  
(d) Manufacturer or distributor contact information; and  
(e) Product warnings that read:  
(A)  Keep out of reach of children; and  
(B) It is illegal to sell or distribute this product to minors.   
(2) Label and product warnings must:  
(a) Conform to general label requirements set forth in OAR 333 -015-0330 ; 
(b) Be displayed on the inner package; and  
(c) Be displayed on the outer package if the product has both an inner and outer package.  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
       
333-015-0320  
Labeling Requirements for Prefilled Inhalant Delivery Systems  
(1) A label on a prefilled inhalant delivery system must clearly display:  
(a) Ingredients in descending order of predominance;  
(b) Nicotine concentration expressed in milligrams per milliliter, which may be shortened to read 
as mg/mL;  
(c) Milliliters of liquid contained in the liquid nicotine container;  
(d) Milligrams of nicotine contained in the liquid nicotine container;  
(d) Manufacturer or distributor contact information; and  
(e) Product warnings that read:  
(A)  Keep out of reach of c hildren;  
(B)  Nicotine is highly addictive and can be toxic;  
(C) It is illegal to sell or distribute this product to minors; and  
(D) For accidental exposure, call the Poison Center  at 1-800-222-1222.  
(2) Label and product warnings must:  
(a) Conform to genera l label requirements set forth in OAR 333 -015-0330 ; 
(b) Be displayed on the inner package; and  
(c) Be displayed on the outer package if the product has both an inner and outer package.  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0325  
Labeling Requirements for Fillable Inhalant Delivery Systems  
 Page 5 of 8 
 (1) A label on a fillable inhalant delivery system that is not packaged with a liquid nicotine 
container must clearly display:  
(a) Manufacturer or distributor contact information; and 
(b) Product warnings that read:  
(A)  Keep out of reach of children; and  
(B) It is illegal to sell or distribute this product to minors.      
(2) Label and product warnings must:  
(a) Conform to general label requirements set forth in OAR 333 -015-0330 ; and  
(b) Be displayed on the outer package.  
(3) A fillable inhalant delivery system packaged with a liquid nicotine container must comply 
with OAR 333 -015-0340 . 
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0330  
General Label Requirements; Exceptions  
(1) A label required by these rules must:  
(a) Comply with the National Institute of Standards and Technology (NIST) Handbook 130 
(2015), Uniform Packaging and Labeling Regulation, incorporated by reference;  
(b) Use the Arial or Tim es New Roman font;  
(c) Comprise more than 30  percent  of the inner package and more than 30  percent  of the outer 
package;  
(d) Be printed using either black ink on a white background or white ink on a black background;  
(e) Be smear resistant ; 
(f) Be in no s maller than 6 point font;  
(g) Be in non -capitalized font, other than the first letter of a sentence;  
(h) Be in English, but it may be in other languages; and  
(i) Be unobstructed and conspicuous.  
(2) An inhalant delivery system may have one or more labels affixed to the outer package at the 
point of sale.  
(3) A label may not include health claims or descriptors that:  
(a) Imply a product is safer, healthier or less risky than other products;  
(b) Represent that a product has curative or therapeutic effects; or 
(c) Do not meet  the FDA Significant Scientific Agreement standard as defined in section 
403(r)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(3)) and 21 
CFR 101.14(c).  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.17 5 
 
333-015-0335   
Nicotine Content Requirements  
(1) In order for a label that is required to contain information about nicotine concentration to be 
compliant with these rules:  
(a) The nicotine content in the product may not exceed a 15  percent  variation in:  
(A) Mg/mL from the content level on the label; and  
(B) Mg from the content level on the label . Page 6 of 8 
 (2) A consumer product labeled as having 0 mg nicotine or 0 mg/mL of nicotine may not contain 
any nicotine.  
(3) The Authority may request from a manufacturer, retailer or distributor:   
(a) A mixing protocol report for solutions mixed at the point of sale in the retail outlet to verify 
nicotine content as labeled.  
(b) Laboratory testing protocols and dated testing results for quantities not mixed a t the time of 
sale, and not available for point of sale purchase, to verify nicotine content as labeled.  
(c) Laboratory testing protocols and dated results for manufacturers of liquid nicotine.  
(4) In accordance with ORS 433.870, a county that has assume d the responsibility of the duties 
and responsibilities under ORS 446.425 and 448.100, or contracted with the authority under ORS 
190.110, is responsible for enforcing the provisions of ORS 433.835 to 433.875 and has the same 
enforcement power as the autho rity.  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
Packaging  
 
333-015-0340  
Packaging Requirements for Liquid Nicotine Containers  
A liquid nicotine container for sale to a consumer:  
(1) Must be:  
(a) In child -resistant safety packaging; and  
(b) Labeled in accordance with these rules.  
(2) May not be placed in an inner or outer package that is attractive to minors.  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0345  
Packaging Requirements for Non -nicotine Liquid Containers  
A non -nicotine liquid container for sale to a consumer:  
(1) Must be:  
(a) In child -resistant safety packaging; and  
(b) Labeled in accordance with these rules.  
(2) May not be placed in an inner or outer package that is attractive to minors.  
Stat. Auth.: OR S 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0350  
Packaging Requirements for Prefilled Inhalant Delivery Systems  
A prefilled inhalant delivery system for sale to a consumer:  
(1) Must be labeled in accordance with these rules.  
(2) May not be placed  in an inner or outer package that is attractive to minors.  
Stat. Auth.:  ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0355  Page 7 of 8 
 Packaging Requirements for Fillable Inhalant Delivery Systems  
(1) A fillable inhalant delivery system that is not packaged  with a liquid nicotine container  for 
sale to a consumer:  
(a) Must be labeled in accordance with these rules.  
(b) May not be packaged in any packaging, including an inner or outer package, that is attractive 
to minors.  
(2) A fillable inhalant delivery system that is packaged with a liquid nicotine container for sale to 
a consumer must comply with OAR 333 -015-0340 . 
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
333-015-0360  
Verification of Child -Resistant Packaging  
Oregon -based outlets must provide verification of a manufacturer’s written laboratory testing 
report describing child -resistant packaging results based on using the protocol set forth in 16 
CFR 1700.20 (1995) to the Authority upon the Authority’s request.  
Stat. Auth.: ORS 431A.175  
Stats. Implemented: ORS 431A.175  
 
Enforcement  
 
333-015-0365  
Inspections  
The Authority shall coordinate random, unannounced inspections of Oregon -based outlets of 
inhalant delivery systems to ensure compliance with these rules.  
Stat. Auth.: ORS 431A.183  
Stats. Implemented: ORS 431A.183  
 
Violations  
 
333-015-0370  
Violations  
(1) It is a violation for a manufacturer, retailer or distributor  to:  
(a) Distribute, sell or allow to be sold an inhalant delivery device that does not comply  with a 
labeling requirement in OAR 333 -015-0310  to 333 -015-0030 . 
(b) Fail to respond to a request from the Authority for information or documentation.  
(c) Distribute, sell or allow to be sold an inhalant delivery device that does not comply with a 
packag ing requirement in OAR 333 -015-0340  to 333 -015-0360 . 
Stat. Auth.: ORS 431A.175, 431A.178  
Stats. Implemented: ORS 431A.175, 431A.178  
 
Penalties  
 
333-015-0375  
Civil Penalties  
 Page 8 of 8 
 (1) The Authority may impose a civil penalty for each violation of OAR 333-015-0310  to 333 -
015-0030  against a manufacturer, retailer or distributor  according to the following schedule:  
(a) $0 together with the issuance of a warning letter to the retailer; for the first violation  
(b) Minimum of $250 for the second violation within a  24-month period of the first violation.  
(c) Minimum of $500 for the third violation within a 24 -month period of the second violation.  
(d) Minimum of $2000 for the fourth violation within a 24 -month period of the third violation.  
(e) Minimum of $5000 for the fifth violation within a 36 -month period of the fourth violation.  
(f) Minimum of $11,000 for the sixth or subsequent violation within a 48 -month period of the 
fifth violation.  
(2) The Authority may impose a civil penalty for each violation of OAR 333-015-0340  to 333 -
015-0360  against a manufacturer, retailer or distributor according to the following schedule:  
(a) $0 together with the issuance of a warning letter to the retailer; for the first violation  
(a) Minimum of $500 for the second violation within a 24 -month period of the first violation.  
(b) Minimum of $800 for the third violation within a 24 -month period of the second violation.  
(c) Minimum of $2000 for the fourth violation within a 24 -month period of the third violation.  
(d) Minimum of $8 000 for the fifth violation within a 36 -month period of the fourth violation.  
(e) Minimum of $15,000 for the sixth or subsequent violation within a 48 -month period of the 
fifth violation.  
(3) A civil penalty may not to exceed $15,000 for each violation or  $1,050,000 for all violations 
found in a single inspection.  
(4) Each product that does not comply with these rules or that is distributed, sold, or allowed to 
be sold in violation of these rules is a separate violation.  For example, if 10 liquid nicotine  
containers are distributed, sold, or allowed to be sold without child -resistant packaging the civil 
penalty could be $5000 (10 x $500).  
Stat. Auth.: ORS 431A.178  
Stats. Implemented: ORS 431A.178