Applying to legally market a tobacco product in compliance with FDA regulations may feel complicat- ed and confusing, especially for first time applicants. While there are three main ways to bring a new tobacco product to market, a premarket tobacco application (PMTA) is the most likely pathway by which manufacturers of e-cigarettes and other electronic nicotine delivery systems (ENDS) will apply to market their products. To help manufacturers navigate the PMTA process, FDA has finalized a guidance on how to complete it as correctly, efficiently, and cost-effectively as possible.
Prior to finalizing this guidance, FDA had issued a draft guidance for ENDS manufacturers in May 2016. While the final version is very similar to the draft, there are a few significant changes that are important to know before submitting a PMTA. These changes have been primarily made to further explain the types of information that may help FDA determine if marketing a proposed new tobacco product would be appropriate for the protection of public health.
Some of the changes in the updated guidance include:
A revised list of the harmful or potentially harmful constituents (HPHC) that are recommended for analysis of an ENDS product;
The types of short-term testing that may be conducted to support an ENDS PMTA;
Other recommended design considerations for some ENDS and their parts.
PMTA for ENDS guidance asks that manufacturers consider including instructions to consumers for responding to accidental nicotine exposure, as well as a prominently displaying a nicotine exposure warning on product packaging. In addition to these instructions, FDA recommends applicants provide a plan for tamper-resistant packaging, including how to tell if the packaging has been tampered with or damaged.
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.
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