The guidance has information about battery specifications, examples of battery testing certifi- cates, and potential safety features.
FDA understands that many ENDS manufacturers are small business owners who may have con-cerns about the costs of submitting PMTA. In August 2016, when all ENDS products were brought under FDA’s regulatory jurisdiction, some rumored estimated costs would have been prohibitive for many small businesses. FDA’s estimates, however, are significantly lower than these theoret- ical numbers; total costs for meeting all PMTA requirements will vary from product to product.
Although there is no set cost for preparing a complete PMTA, FDA recognizes manufacturers’ concerns about affordability and has provided some measures in the guidance that could potentially reduce cost. These steps include:
“Bridging”,which allows a PMTA applicant to forego costly research studies if they can refer to existing data or studies previously conducted by themseleves or another party
Using published iterature reviews,including meta-analyses, or independent analyses of publicly avilable data to help support a PMTA rather than paying for new analyses.
Referencing tobacco product master files (TPMFs),which may increase efficiency and reduce costs for complying with premarket requirements
FDA understands the labor, time, and financial commitment involved in applying to market an ENDS product, and has taken manufacturers into consideration when writing this guidance. Because FDA’s new comprehensive tobacco regulatory plan places nicotine at the heart of tobacco control efforts, the agency aims to authorize new tobacco products that will provide adults, who are addicted to nicotine, with less harmful alternatives to smoking cigarettes, while keeping any form of nicotine out of the hands of children. ENDS manufacturers are encouraged to create innovative, potentially less harmful tobacco products that can efficiently deliver satisfying levels of nicotine to addicted adult smokers, with less of the known toxicity than combustible products.