Arizona e-cigarette（Vape） sales regulations
Requires manufacturers of vapor products sold in Arizona to be certified by the Attorney General (AG) for approval or review by the U.S. Food and Drug Administration (FDA). Requires the AG to establish a directory of vapor products approved for sale. Establishes penalties for violations of vapor product certification and sale requirements.
Background
The manufacture, import, packaging, labeling, promotion, sale and distribution of vapor products in the United States are regulated by the FDA. These products may be referred to or include vapes, vaporizers, vape pens, hookah pens, electronic cigarettes, e-cigars and e-pipes, all of which are electronic nicotine delivery systems. These products use an e-liquid that usually contains nicotine, as well as flavorings, propylene glycol, vegetable glycerin and other ingredients that are heated to create an aerosol that is inhaled (FDA). These products are subject to most of the same federal requirements as cigarettes, cigarette tobacco, roll-your own tobacco and smokeless tobacco, including premarket review requirements and the adulteration and misbranding regulations.
Under the Federal Food, Drug and Cosmetic Act, persons who seek to market a new tobacco product must first obtain an order to do so unless deemed by the FDA to be substantially equivalent to a tobacco product currently commercially marketed on or before February 15, 2007, or the new tobacco product is exempt from substantial equivalence requirements. When a new product is found to not be substantially equivalent to an appropriate predicate product, a new premarket tobacco product application is required and the applicant must receive a marketing order prior to marketing the product (FDA).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
Vapor Product Certification
1. Requires, by August 1, 2024, manufacturers of vapor products sold in Arizona, whether directly or indirectly through a distributor, retailer or similar intermediary, to certify under penalty of perjury to the AG that either:
a) the manufacturer has received a marketing authorization or similar order for the vapor product from the FDA; or
b) the vapor product was marketed in the United States on or before August 8, 2016, the manufacturer submitted a premarket tobacco product application to the FDA on or before September 9, 2020, and the application remains under review or a final decision has not yet taken effect.
2. Requires manufacturers to recertify with the AG each year.
3. Requires the certification form prescribed by the AG to require a manufacturer to separately list each vapor product the manufacturer sells in Arizona.
4. Requires submitted certification forms to be accompanied by:
a) a copy of the marketing authorization or the premarket tobacco product application acceptance letter issued by the FDA; and
b) a fee for each vapor product prescribed by the AG.
5. Allows the AG to revise the certification form fee periodically.
6. Requires manufacturers to notify the AG within 30 days of any material change to a certification form, including the issuance or denial of a marketing authorization or other order or action of the FDA that affects the ability of the vapor product to be introduced or delivered into interstate commerce for commercial distribution.
Vapor Product Directory
7. Requires, beginning October 1, 2024, the AG to maintain and make available on its website a directory listing all manufacturers and vapor products that have been certified and to update the directory at least monthly.
8. Directs the AG to provide manufacturers notice and an opportunity to cure deficiencies before removing manufacturers or vapor products from the directory.
9. Prohibits the AG from removing a manufacturer or vapor product from the directory for at least 15 days after the manufacturer is noticed.
10. Deems notice sufficient and immediately received by a manufacturer if sent electronically or by fax.
11. Grants a manufacturer 15 days after being noticed by the AG to establish that the manufacturer or its vapor products should be included in the directory.
12. Allows for appeal of the AG's decision to remove or not include a manufacturer or vapor product in the directory.
13. Stipulates that, if a vapor product is removed from the directory, each retailer and distributor have 20 days to remove the product from its inventory and return the product to the manufacturer for disposal.
Violations
14. Declares vapor products, beginning 21 days after removal from the directory, contraband that is subject to seizure, forfeiture, destruction and may not be purchased or sold.
15. Requires a person whose vapor products are confiscated to pay for the cost of seizure, forfeiture and destruction.
16. Prohibits a person or manufacturer from selling or offering for sale a vapor product in Arizona that is not included in the directory, beginning on the later of:
a) October 1, 2024; or
b) The date the AG first makes the directory available for inspection on its website.
17. Subjects distributors, retailers or any other person that sells or offers for sale a vapor product that is not included in the directory to a daily civil penalty for each vapor product in violation, in the following amounts:
a) up to $500 for a first violation;
b) between $750 and $1,000 for a second violation within 36 months;
c) between $1,000 and $1,500 for a third violation within 36 months; and
d) between $1,500 and $3,000 for a fourth or subsequent violation within 36 months.
18. Subjects a manufacturer whose vapor products are not listed in the directory and sold in Arizona, whether directly or through a distributor, retailer or similar intermediary, to a daily civil penalty of $500 for each vapor product in violation.
19. Declares a manufacturer that falsely represents any of information required for certification guilty of a class 3 misdemeanor for each false representation.
20. Declares a violation of laws governing vapor product certification an unlawful practice, subject to investigation and appropriate action by the AG.
Investigations
21. Authorizes the AG to enforce and designate agents to enforce vapor product certification requirements, including local law enforcement, the Department of Liquor Licenses and Control or the Department of Revenue.
22. Allows the AG or the AG's designee to examine the stock of vapor products on the premises and the books, papers, invoices and other records of a person that possesses, controls or occupies a premises where vapor products are placed, stored, sold or offered for sale.
23. Requires individuals possessing, controlling or occupying a premises where vapor products are available to allow the AG and the AG's designees the means, facilities and opportunity for examination.
24. Declares a vapor product sold in violation of state law contraband that may be seized without a warrant by the AG, designees or employees of the AG or a law enforcement officer under direction by the AG.
25. Requires the AG to investigate each complaint that is receives relating to the certification and sale of vapor products.
26. Authorizes the AG, if action is brought, to recover fees and reasonable expenses incurred in investigating and preparing the case.
27. Subjects each distributor and retailer to unannounced compliance checks for the purposes of enforcing vapor product certification requirements.
28. Specifies that compliance checks:
a) May be conducted during normal business hours; and
b) Must include the review of records retained within 30 days of a violation.
29. Requires the AG to publish the results of all compliance checks at least annually and to make the results available to the public on request.
Nonresident or Foreign Manufacturers
30. Requires a nonresident or foreign manufacturer that has not registered as a foreign corporation, foreign limited partnership, foreign limited liability company or foreign series to appoint and continually engage the services of a U.S. agent to act as an agent for the service of process.
31. Specifies that service under vapor product certification laws constitutes legal and valid service of process on the nonresident or foreign manufacturer.
32. Prohibits a nonresident or foreign manufacturer that does not comply with appointing an agent from having its vapor products listed or retained in the directory.
33. States that the appointment of the Secretary of State (SOS) as an agent does not allow the nonresident or foreign manufacturer to have its vapor products included or retained in the directory.
34. Requires a nonresident or foreign manufacturer to:
a) provide notice to the AG at least 30 calendar days before the termination of the agent's authority;
b) provide proof to the AG of the appointment of a new agent at least five calendar days before the termination of an existing agent appointment; and
c) notify the AG of the termination of an agency appointment within five calendar days, including proof of the appointment of a new agent.
35. Declares a nonresident or foreign manufacturer selling vapor products in Arizona, that has not appointed and engaged an agent, to have appointed the SOS as the agent and subject to being processed against in court by service of process on the SOS.
Vapor Product Fund
36. Establishes the Vapor Product Fund (Fund), consisting of monies deposited through vapor product certification.
37. Directs the AG to administer and deposit all collected fees in the Fund.
38. Specifies that monies in the Fund are continuously appropriated and are exempt from lapsing.
39. Requires the AG to use Fund monies exclusively for administering and enforcing vapor product certification requirements.
Miscellaneous
40. Requires the AG, beginning January 31, 2025, to annually provide a report to the President of the Senate and Speaker of the House of Representatives regarding:
a) the status of the directory;
b) revenue and expenditures related to administration;
c) enforcement activities; and
d) allows the AG to adopt rules necessary to administer vapor product certification laws.
41. Defines vapor product as a noncombustible product containing nicotine from any source that employs a mechanical heating element, battery or circuit, regardless of shape or size, that can be used to heat a liquid nicotine solution to produce an aerosol or vapor, including a consumable nicotine solution suitable for use in a vapor product whether sold with the vapor product or separately.
42. Excludes, from the definition of vapor product, any product that is regulated by the FDA under subchapter V of the Federal Food, Drug and Cosmetic Act.
43. Becomes effective on the general effective date.