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Updated Information on FDA Guidance Document with Enforcement Priorities for Certain Flavored E-Cigarettes

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their January 10th online bulletin. Reposted with permission.

As a follow up to the recent reports in the NATO News Bulletin regarding the FDA Final Guidance Document titled “Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization,” NATO members have asked whether they are able to have flavored cartridge-based and pod-based electronic nicotine products (except tobacco and menthol-flavored products) on their store premises or warehouse premises as of February 6, 2020, the date that these products are no longer permitted to be manufactured, distributed or sold.  NATO contacted the Food and Drug Administration and asked for clarification on this question.

Based on the reply that NATO has received from the FDA, retailers and wholesalers need to determine their own best practices for complying with the Final Guidance because flavored cartridge-based and pod-based electronic nicotine products (except tobacco and menthol-flavored products) are considered adulterated and illegal to market and sell as of February 6, 2020.  At the same time, the agency understands that retailers and wholesalers may need to store flavored cartridge-based and pod-based electronic nicotine products (except tobacco and menthol-flavored products) on and after February 6, 2020 until the products can be returned to the manufacturer.

This means that these products should be stored in a manner to prevent customers from thinking that the products are still available for purchase and in a place within a store or a warehouse that is not accessible to the public.  NATO would recommend that retailers consider packing the flavored cartridge-based and pod-based electronic nicotine products that are to be returned to a manufacturer in boxes and be sealed as a further precaution to prevent the products from being sold on and after February 6, 2020.  It is also important to remember that the FDA will be undertaking enforcement efforts beginning February 6, 2020 to ensure that flavored cartridge-based and pod-based electronic nicotine products (except tobacco and menthol-flavored products) are not being manufactured, distributed, or sold in the marketplace.

State Legislative Bill Introductions

State tobacco-related legislative bills that have been introduced in the past week are listed below alphabetically by state:

California:  Senate Bill 739 prohibits the sale of all flavored tobacco products.

Colorado:  House Bill 1001 increases the legal purchase age for tobacco and vapor products from 18 to 21 years of age; requires all retailers selling tobacco and nicotine products on or after July 21, 2021 to be licensed; prohibits any new retailers selling tobacco and nicotine products from being located within 500 feet of any school; and prohibits retailers selling electronic cigarette products from advertising those products in a manner that is visible from outside the establishment.

Illinois:  House Bill 4048 establishes a cap on the state cigar tax at $.50 per cigar. 

Indiana:  Senate Bill 193 prohibits the sale of flavored e-liquid.  House Bill 1124 prohibits the sale of flavored tobacco products (cigarettes, smokeless and e-cigarettes—includes menthol).  House Bill 1006 requires a person to be at least 21 to purchase tobacco products; requires age verification of a purchaser who appears to be under age 30; increases penalties for underage sales; prohibits a tobacco business from locating within 1,000 feet of a school (current locations grandfathered).  Senate Bill 1 prohibits a person under age 21 from buying or possessing tobacco products or electronic cigarettes.  House Bill 1128 prohibits a person under age 21 from buying or possessing tobacco products or electronic cigarettes.

Kentucky:  House Bill 32 modifies the tax structure for tobacco products—includes vapor products—new tax rate of 27.5% of wholesale—includes a floor tax.  House Bill 158 bans the sale of vapor products (includes mint and wintergreen).  Senate Bill 56 prohibits the sale of tobacco products and vapor products to persons under the age of 21.

Maryland:  House Bill 3 prohibits the sale of flavored tobacco products and electronic smoking devices (includes menthol, mint and wintergreen).  Senate Bill 3 increases the cigarette tax to $4.00 per pack and the OTP tax rate to 86% (includes electronic smoking devices).  Senate Bill 54 prohibits the sale of flavored electronic smoking devices (includes menthol).

Missouri: House Bill 1730 increases the purchase age for tobacco and vapor products from 18 to 21 years of age.  Senate Bill 829 increases the purchase age for tobacco and vapor products from 18 to 21 years of age and adds penalty provisions for illegal possession.

Nebraska: Legislative Bill 840 includes the use of electronic cigarettes in the Nebraska Clean Indoor Air Act. Legislative Bill 862 prohibits possession of tobacco and nicotine products by minors.

New Hampshire:  House Bill 1699 imposes a tax on electronic cigarettes at 40% of the wholesale price. House Bill 1628 establishes the “minimum age” at 19 for tobacco purchases and 21 for vapor products.

New Mexico: Senate Bill 91 (pre-filed) prohibits the sale of all flavored electronic cigarette products.

New York:  Senate Bill 7068 prohibits the sale flavored smokeless products (including menthol, mint and wintergreen) within 500 feet of schools.  Assembly Bill 8911 prohibits the sale of flavored smokeless products (including menthol, mint and wintergreen) within 1,000 feet of schools.  Senate Bill 7050 prohibits the sale of electronic cigarettes that contain certain toxic metals (list to be established by the department of public health).

Utah:  House Bill 23 was pre-filed on December 23, 2019 and amends the regulation of retail tobacco specialty businesses by including in that regulation businesses with names suggesting they are tobacco specialty businesses, increasing the number of annual random inspections of such businesses for tobacco sale violations from a maximum of two to a minimum of two, and allowing for suspension or revocation of a retail tobacco specialty business license on the first sale of a tobacco product to an underage person.  House Bill 1118 (pre-filed) amends the regulation of retail tobacco specialty businesses by including in that regulation businesses that sell flavored tobacco products, defined to include any tobacco product other than those either having the flavor of tobacco or non-vapor menthol-flavored products; requires tobacco retailers, for each sale of tobacco products, to provide to the customer, and keep a record of, the name of the product sold, the amount charged, and the time and date of the sale; and prohibits free distribution of smokeless and chewing tobacco and vapor products or sales of such products at a price below 90% of cost or through the use of coupons.

Virginia:  House Bill 93 bans the sale of flavored tobacco products. House Bill 785 and Senate Bill 484 allow any county, city, or town the authority to tax cigarettes.  House Bill 1119 bans the sale of flavored tobacco products, with any characterizing flavor that is not tobacco flavor.  House Bill 1120 increases the tax on cigarettes to $.09 per cigarette. House Bill 1185 limits flavored vaping product sales including menthol to age-restricted stores only.  House Bill 1283 prohibits the sale of tobacco products through self-service vending machines and prohibits tobacco sales within a certain number of feet of a youth-oriented facility.

Washington:  House Bill 2321 (pre-filed) prohibits new vapor licenses from being issued to any retail establishment located within 1,000 feet of the perimeter of a school, public park, recreation center, child care facility, playground, or gaming arcade, unless the established is age restricted to only allow access to anyone 21 years of age or older.  Contains an exemption for retailers who are currently licensed.

West Virginia: House Bills 2323, 2988, and 4066 increase the purchase age for tobacco and vapor products from 18 to 21 years of age.  House Bill 3071 increases the tax on e-cigarettes to $.15 per milliliter.

State Legislative Bill Actions

State tobacco-related legislative bills that have been acted on by a state legislative committee or state legislature are listed below alphabetically by state:

New Hampshire:  House Bill 680 (carried over from 2019), which includes vapor products and components in the definition of tobacco products for purposes of taxation (65.03% of wholesale), failed to pass the House on January 8, 2020.  House Bill 1410, which prohibits the use of flavors and certain chemicals in vaping products (excludes menthol), will be heard in the House Commerce and Consumer Affairs Committee on January 15, 2020.  House Bill 1624, which establishes a moratorium on the sale of e-cigarettes, will be heard in the House Commerce and Consumer Affairs Committee on January 15, 2020.  House Bill 1662, which increases the age to 21 for sales and possession of tobacco products and e-cigarettes, will be heard in the House Commerce and Consumer Affairs Committee on January 14, 2020.  Senate Bill 248, which increases the age for sales and possession of tobacco products to twenty-one, passed the Senate on January 8, 2020.

New Jersey:  The following bills were heard in the Assembly Appropriations Committee on January 9, 2020: Assembly Bill 3178, which prohibits the sale of flavored electronic smoking devices; Assembly Bill 3181, which prohibits coupons and price reduction promotions in the sale of tobacco and vapor products; Assembly Bill 5922, which revises the requirements for the sale of tobacco and vapor products; Assembly Bill 5923, which revises licensure and operational requirements for vapor businesses and increases taxes imposed on vapor products (20% of retail on open systems and $.20 per fluid milliliter for closed systems).

New York:  Senate Bill 6697, which prohibits the sale of refillable electronic liquids, liquid nicotine or e-liquids, was amended and recommitted to the Senate Rules Committee on January 2, 2020.