Recently, the Food and Drug Administration (FDA) has been facing enormous pressurization against smoking cessation products such as vapes and e-cigarettes. On Wednesday, the federal judge miniaturized the FDA on carrying out the regulation of these vaping products and speed up their reviewing process of all the currently available in the marketplace for consumers.
Various public health groups, the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids filed a case in the Maryland court regarding the FDA’s delayed process of reviewal of vaping products and its unchecked sale in the market which according to them, promoted as well as led to a hike in the number of underage vapers.
According to the judge, “The FDA’s decision to delay reviewing electronic cigarette products for several years amounted to a serious dereliction of duty.”
United States District Judge Paul W. Grimm of the District of Maryland arrived at the decision of the particular case which involved “an abdication of its statutory responsibilities”
Grimm’s decision makes it mandatory for the FDA to release a 2017 guidance delaying premarket tobacco applications (PMTA) for e-cigarette and vape products to a postponed date. The agency made the use of its discretionary rights, enforcing the agency to implement the deadline for PMTA applications and similarly allowed products that would be technically deemed as non-compliant to remain on the market during the given time period. However, public health organizations were able to challenge several legal precedences in this case.
According to the 2017 compliance policy that was released in August, the FDA postponed the deadlines for filing PMTA submissions for Vaping Products and accessories to 8th of August 2021 for combustible products, and August 8, 2022, for non-combustible products.
An FDA spokesperson on this occasion has mentioned that the decision is being reviewed and considered by the agency. “FDA has and will continue to tackle the troubling epidemic of e-cigarette use among kids. This includes preventing youth access to, and appeal of, flavored tobacco products like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market or sell these products to minors, and educating youth about the dangers of e-cigarettes and other tobacco products,” he said.
Previously ruling FDA Commissioner, Scott Gottlieb extended the deadline for a year to 2021 before the closure of his tenure, but Grimm’s verdict will bound the agency to execute their moves as soon as possible. Although, FDA could appeal against the verdict stating that the agency has strangled the manufacturers and staff to review the products and therefore need more time to prepare for regulatory actions.