Altria Urges Changes in FDA E-Cigarette Regulations that Would Decrease Its Share of Vaping Market and Help Save Many Smaller Manufacturers

In a move that casts serious doubt on anti-tobacco groups' maligning of the motives of the tobacco companies in marketing vaping products, Altria Client Services, on behalf of Nu Mark (the maker of Mark Ten e-cigarettes), has submitted comments to the FDA that blast its pre-market tobacco application (PMTA) requirements for e-cigarettes, arguing that these requirements are unduly burdensome, unnecessary, and beyond the scope of the agency's jurisdiction under the Tobacco Control Act.In the comments, Altria Client Services expresses particular concern that the burdensome PMTA requirements will force many manufacturers out of business, undermining the Tobacco Control Act's public health goals.Altria writes: "The Draft Guidance is not aligned to the FSPTCA's goal of promoting public health because the complexity of information recommended for the application process and the short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 products being forced off the market."Altria also notes that FDA itself acknowledged that a large number of e-cigarette companies would go out of business, yet failed to account for this in its regulatory impact analysis.To remedy the situation, Altria suggests an approach similar to what I have been advocating: the agency 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 PM...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs