NEWS
APPLICATIONS DENIED
The US Food and Drug Administration has rejected applications for 55,000 flavoured vaping products , citing the ‘ public health threat ’ to young people for doing so
Words : Patrick Griffin
US regulators have effectively banned 55,000 flavoured vaping products on the grounds that the risks posed to young people outweigh the benefits to adult smokers . The Food and Drug Administration issued its first ‘ marketing denial orders ’ under the controversial PMTA approvals process . The denials apply to three companies - JD Nova Group , Great American Vapes , and Vapor Salon - and include flavours such as Apple Crumble , Dr . Cola and Cinnamon Toast Cereal . Acting FDA Commissioner Janet Woodcock said : “ Flavoured tobacco products are very appealing to young people , therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed .” The FDA said the companies had failed to show that the benefits to adult smokers were “ sufficient to overcome the public health threat posed by the well-documented , alarming levels of youth use of such products .” Mitch Zeller , director of the FDA ’ s Center for Tobacco Products , said flavoured e-liquids were ‘ extremely popular ’ among youth . He added : “ Companies who want to continue to market their flavoured ENDS products must have robust and reliable evidence showing that their products ’ potential benefit for adult smokers outweighs the significant known risk to youth . “ The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘ appropriate for the protection of the public health ’. “ If this evidence is lacking or not sufficient , the FDA intends to issue a marketing denial order , which requires the product to be taken off or not introduced to market .”
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“ Assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed .
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