January 2025 Attorney General Letters to Retailers and Distributors re Unauthorized Vape Products
1/16/2025: ATTORNEY GENERAL LOPEZ IS SOUNDING THE ALARM OVER ILLEGAL VAPES BEING SOLD IN HAWAIʻI
In January 2025, the Department of the Attorney General’s (the Department) Tobacco Enforcement Unit sent letters to over 800 Hawaii tobacco retailers and licensees as part of a multistate effort to curb the importation and sale of vape products not authorized by the United States Food and Drug Administration (FDA). The letters provided information on the requirements by the FDA that such products be authorized before being shipped, sold or marketed in the United States.
On January 16, 2025, the FDA announced new additional authorization for the marketing of twenty (20) nicotine pouches. The Tobacco Enforcement Unit immediately sent out additional letters to update the tobacco retailers and licensees of the FDA’s announcement.
As of January 16, 2025, the FDA has only authorized 34 ENDS products and 24 oral nicotine products. Please visit the FDA’s Searchable Tobacco Products Database for the latest information. This page will be updated as more information becomes available from the FDA.
FDA NEWS RELEASE – FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products dated 1/16/25
January 17 Updated Retailer letter
January 17 Updated Licensee letter
FDA’s “Searchable Tobacco Products Database”
List of E-Cigarettes Authorized by FDA (as of Jan. 2025) Note: this list doesn’t have the authorized oral nicotine products.
Frequently Asked Questions:
Why was this letter mailed?
The purpose of the letter was to put businesses on notice of the legal status of many e-cigarette and nicotine products under federal law so that they could ensure their practices comply with law. The Department’s goal is to secure voluntary compliance from tobacco retailers and distributors.
Are my products allowed to be sold?
As of January 16, 2025, the FDA has authorized 34 tobacco- and menthol-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S.
As of January 16, 2025, the FDA has authorized 24 oral nicotine products. These include specific nicotine pouches and chewable discs. These are the only oral nicotine products that may be lawfully sold in the U.S.
We encourage you to follow the FDA’s direction to “discuss with [product] suppliers… the current status of any particular tobacco product’s application or any product’s marketing authorization.”1 Please note that a pending application does not create a safe harbor to sell that product.2
You may also reach out to the FDA’s Office of Small Business Assistance, which provides technical and other non-financial assistance to small tobacco product businesses. They can be contacted as follows:
FDA/CTP Office of Compliance and Enforcement
Email: [email protected]
Phone: 1-877-287-1373 (Monday-Friday, 9:00 a.m. – 4:00 p.m. EST)
What are the penalties for violations under federal and state law?
Please visit the FDA’s website for information about enforcement actions and penalties for unauthorized tobacco products here.
As stated in the letter dated January 16, 2025, electronic smoking devices (ESDs) and e-liquids are now included in the Cigarette Tax and Tobacco Tax Law, found in chapter 245 of the Hawaii Revised Statutes (HRS). Wholesalers and dealers of ESDs and e-liquids in the State of Hawaii are required to have a tobacco license issued by Hawaii’s Department of Taxation (DOTAX). DOTAX may suspend, revoke, or decline to renew any tobacco license for good cause, which may include instances where a licensee has failed to comply with federal law pertaining to the sale, importation, acquisition, possession, distribution, or transportation of tobacco products. (See HRS §245-2). Recent changes in the law also include new criminal offenses relating to the shipment of tobacco products, including ESDs and e-liquids, to a person or entity in Hawaii that does not hold a tobacco license issued by DOTAX.
Is there a deadline to remove unauthorized tobacco products from the shelves?
Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may risk FDA enforcement actions.
The FDA has authority and regularly inspects and investigates domestic establishments, including vape shops, that manufacture, process, sell or distribute tobacco products to determine compliance with applicable provisions of the law, including premarket authorization requirements.
The Department also regularly inspects and investigates Hawaii retail establishments to determine compliance with all applicable federal and state laws and regulations.
Footnotes:
- Food and Drug Administration, Deemed New Tobacco Product Application Lists, https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists
- Food and Drug Administration, Searchable Tobacco Products Database Additional Information, https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/searchable-tobacco-products-database-additional-information
Any questions may be directed to [email protected]