WASHINGTON — The U.S. Food and Drug Administration (FDA) is barring most flavors, including fruit and mint, from unauthorized cartridge-based e-cigarettes until companies go through the premarket tobacco application (PMTA) process.
Companies that do not cease to manufacture, distribute and sell the flavored cartridge-based e-cigarettes—excluding tobacco and menthol—in 30 days following the publication of the guidance risk enforcement actions from the FDA.
The move aims to balance public health concerns with the needs for addicted adult cigarette smokers trying to cut back, according to the FDA.
A 53-page guidance on the ruling was released Jan. 2, two days after President Donald Trump teased the announcement on New Year’s Eve saying, “Vaping is coming out. … We have to protect our families. At the same time, it’s a big industry. We want to protect the industry.”
NACS has been a vocal advocate for the even treatment of retailers selling tobacco products, and it opposed initial efforts by the FDA to permit sales of flavored e-cigarettes in retail stores that are considered “adult only,” while prohibiting them in convenience stores, according to a statement from the organization.
"It would appear that FDA heeded our concerns regarding a level playing field among retailers and adjusted their final guidance policy accordingly,” Lyle Beckwith, senior vice president of government relations for Alexandria, Va.-based NACS, said in the statement.
Cartridge-based electronic nicotine-delivery systems (ENDS) products involve a cartridge or pod that holds liquid that is to be aerosolized when the product is used, according to the FDA. A cartridge or pod is any small, enclosed unit designed to fit within or operate as part of an ENDS product. The products that fall under the guidance include:
- Any flavored cartridge-based ENDS product, aside from a tobacco- or menthol-flavored ENDS product.
- ENDS products for which the manufacturer has failed to take adequate measures to prevent minors’ access.
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
“By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products,” the FDA ruling stated.
The release from the FDA said the 2019 National Youth Tobacco Survey showed that more than 5 million U.S. middle and high school students have used e-cigarettes in the past 30 days, with a majority reporting cartridge-based products as their usual brand.
Menthol- and tobacco-flavored cartridge-based ENDS products were not included in the guidance because of the relatively low numbers of youth using them, according to the FDA; however, this is subject to change. The guidance also said manufacturers must take steps to prevent minors from purchasing their products.
The FDA’s action applies until these products have received authorization from the FDA through the PMTA process, for which applications are due by May 12.
“Hopefully, if everything is safe, they’re going to be going very quickly back onto the market,” Trump said in his Dec. 31 statement.
Trump on Dec. 20 signed a federal spending bill that raised the minimum age to purchase tobacco products from 18 to 21. The legislation amended the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products, including cigarettes, electronic cigarettes, cigars and hookah tobacco.