Following the FDA’s approval of PMTA (marketing authorization) for four menthol e-cigarette products from NJOY on June 21, seven e-cigarette products from British American Tobacco’s (BAT) brand VUSE were also granted PMTA on July 18.
This is a rapid increase in the number of e-cigarette products with FDA marketing authorization since the deadline for e-cigarette products to submit premarket tobacco product applications (PMTA) to the FDA in 2020, from 23 before June 2024 to 34, an increase of 47.8% in one month.
In recent months, the FDA has not only significantly increased the number of products that pass PMTA, but has also taken a number of other steps. At the same time, US customs and state governments are also cracking down on illegal e-cigarettes. Two Supremacists combed through these actions in order to gain insight into the development trend of compliance in the US e-cigarette market.
FDA: Accelerated approval for channel optimization
In late June, the FDA Center for Tobacco Products updated the Tobacco compliance inspection results information on its website, and the newly launched “Tobacco Compliance Inspection Results Database” integrates all tobacco retail inspection results to provide easier access to information for the public, public health organizations, and the tobacco industry.
Then, on July 15, the FDA reissued its agreement with Swedish Match USA, Inc. The General Snus Products existing Modified Risk Tobacco Products (MRTP) order renewal related application documents and announced the deadline for public comment.
Also on July 15, the FDA’s Center for Tobacco Products (CTP) published two notices in the Federal Register that it plans to launch a new generation of CTP portals next year for filing applications for certain new tobacco products.
In terms of product authorization, the FDA issued marketing authorization orders for four menthol e-cigarette products from NJOY LLC and seven e-cigarette products from VUSE on June 21 and July 19, respectively, through the Premarket Tobacco Product Application (PMTA).
So far, the FDA has approved 34 e-cigarette products, all of which are flavored with tobacco or mint.
Regulators: Crack down on illegal disposable products
In addition to the FDA, the US government, customs and other regulatory agencies are also constantly strengthening the supervision of retail stores and imported e-cigarettes, and severely cracking down on illegal sales and imports.
On July 16, police in Georgetown, Massachusetts, raided a store illegally selling THC electronic cigarettes, arrested two men involved in the case, and seized hundreds of illegal electronic cigarette products, involving RAMA, RAZ, JUUL and other well-known e-cigarette brands.
The next day, the United States International Trade Commission (USITC) voted to open an investigation (Section 337 investigation) into certain disposable atomizers (e-cigarette) devices, both based on complaints filed by a subsidiary of Renault American Corporation on June 11, 2024, supplemented on June 12, 2024 and July 1, 2024. Targeted dozens of Chinese e-cigarette companies.
The supplementary complaint alleges that the United States violated Section 337 of the Customs Act of 1930 with the import and sale of certain disposable atomizer equipment that infringes one of the patents asserted by the petitioner, and requests the United States International Trade Commission to issue a general or limited exclusion order and a cease and desist order.
Then, on the 18th of the same month, New York City Mayor Eric Adams (Eric Adams) announced that during the “Padlock protection operation”, more than 600 illegal electronic cigarette shops in New York City were closed and illegal products worth about $1 million were seized.
In addition, there are industry insiders engaged in the United States e-cigarette logistics told the two supremacy, recently, the United States Customs and FDA are joint law enforcement at customs clearance ports, and the law enforcement team has implemented strict inspections of imported e-cigarette products.
From NJOY to VUSE, the pace of FDA approval has accelerated to allow more e-cigarette products to get the green light, and consumers have more diverse choices; From raids in Massachusetts to massive seizures in New York City, government and law enforcement agencies are stepping up their efforts to crack down on illegal e-cigarettes.
This series of changes highlights the accelerated development of the e-cigarette market compliance process in the United States.
The two will continue to pay attention to and interpret the latest developments in the US e-cigarette market, please pay attention.