Released by the US Food and Drug Administration FDAorders to refuse marketing of vaping products to 10 companies, which collectively manufacture and market nearly 6,500 vaping and flavored products, according to the website.FDA
The US Food and Drug Administration said that companies may not market or distribute these products in the United States, and retailers who sell these illegal products risk enforcement action from the US agency. FDA.
The authority added that pre-marketing tobacco product applications, which were intended for a variety of flavored e-cigarette products, did not provide sufficient evidence to show that allowing the marketing of these products would be appropriate to protect public health. Some of the flavors of the rejected products include citrus, strawberry, cheesecake, Cool mint, menthol.
She said: Today’s actions add to the US Food and Drug Administration’s continued progress in reviewing and issuing decisions on applications for more than 26 million new tobacco products that the US Food and Drug Administration has received since spring 2020, most of which were intended for electronic cigarette products. Actions on more than 99% of these applications.
--“Science is the cornerstone of the agency’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “Today’s decision to reject nearly 6,500 products was based on a lack of scientific evidence presented in the applications. We will continue to Ensure that all new tobacco products undergo robust pre-marketing scientific evaluation to determine whether they meet appropriate public health standards to be legally marketed.”
The US Food and Drug Administration is evaluating a public health standard that considers risks and benefits of a product to the population as a whole. As part of the review of these companies, the agency looked at whether products in the apps showed an additional benefit for adult smokers than tobacco-flavored e-liquids and products. e-cigarettes, as the evidence provided by the applicants was insufficient to demonstrate this benefit, which led to today’s denial orders, where “it is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that the marketing of a new tobacco product is appropriate to protect public health.”.
Brian King, director of the Center for Tobacco Products, said that the scientific sufficiency bar has not yet been met for any flavored e-cigarette product.
