Altria’s Nu Mark has told the US Food and Drug Administration that its pre-market tobacco application (PMTA) requirements for electronic cigarettes are unduly burdensome, unnecessary, and beyond the scope of the agency’s jurisdiction under the Tobacco Control Act (TCA), according to Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health.
Siegel said that in the comments made by Altria Client Services on behalf of Nu Mark, the maker of Mark Ten electronic cigarettes, particular concern was expressed that the burdensome PMTA requirements would force many manufacturers out of business, undermining the TCA’s public health goals.
‘The Draft Guidance is not aligned to the FSPTCA’s [Family Smoking Prevention and Tobacco Control Act – TCA] goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS [electronic nicotine delivery systems] products being forced off the market,’ Altria was quoted as saying.
Altria noted also that the FDA had acknowledged that a large number of electronic cigarette companies would go out of business, yet had failed to account for this in its regulatory impact analysis.
Siegel said that in order to remedy the situation, Altria had suggested an approach similar to one that he had been advocating. He quoted Altria as saying that the FDA should ‘establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements’.
Two of Altria’s main goals, as stated in the comments, were to:
1) ‘support manufacturers’ efforts to develop and bring to market innovative products that may advance the public health’.
2) ‘allow industry participants to engage and compete in a dynamic market’.
Siegel opened his piece by saying that Altria’s intervention had cast ‘serious doubt on anti-tobacco groups’ maligning of the motives of the tobacco companies in marketing vaping products’.
Siegel’s full blog, The Rest of the Story is at: http://tobaccoanalysis.blogspot.co.uk/2016/07/altria-urges-changes-in-fda-e-cigarette.html