Earlier this month, a court case filed by anti-tobacco and health groups led to a ruling requiring e-cigarette manufacturers to submit their Premarket Tobacco Product Applications (PMTA) by May 2020, after the Food and Drug Administration announced the delay.
American District Judge Paul Grimm wrote in his order that based on the uncertainties in the effectiveness of e-cigarettes as a smoking cessation device, the exaggerated impact of e-cigarettes stated by manufacturers and their recognized attractiveness to young people, as well as clear public health emergencies considered, the deadline is necessary.
In response to the ruling, FDA agency Ned Sharpless issued a statement saying that the court’s order was welcomed by the agency in view of current concerns about the defamation on vapes from adolescents. Therefore, Sharpless said the FDA was happy to speed up the PMTA process.
“The FDA stands ready to expedite the review of electronic cigarettes and other new tobacco products. We remain committed to using all available regulatory tools at our disposal to deal with the epidemic among adolescents. We will continue to take stringent enforcement actions to ensure that electronic cigarettes and other tobacco products are not sold or resold to children. ”
“The judge’s decision is for the agency to receive and review applications quickly to assess the public health benefits and hazards of products and to ensure that any authorized marketing product is suitable for the protection of public health. Importantly, the judges recognized that the agency’s job was to provide a framework and clear guidance for companies seeking to promote e-cigarettes and ENDS products in the preparation of product applications, “Sharpless added.
New PMTA process
Meanwhile, FDA released final guidelines for manufacturers submitting new tobacco products for electronic nicotine delivery systems (ENDS) via PMTA last month.
Under the new PMTA approach, manufacturers and importers must prove to the agency that the marketing of new tobacco products will be suitable for protecting public health.
The agency’s assessment also includes reviewing the ingredients, additives, ingredients and health risks of tobacco products, as well as the production, packaging and labelling of products.
Following an extensive review of public to the previous draft guidelines, the recently issued guidelines further clarified the PMTA process for ENDS products and pointed out the information provided by the applicants in their submissions. Moreover, it also includes recommendations on how applicants can address public health issues in product design and manufacturing, such as accidental nicotine exposure and battery safety.