Applying to legally market a tobacco product in compliance with FDA regulations may feel complicated 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Prior to finalizing this guidance, FDA had issued a draft guidance for ENDS manufacturers in May 2016.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; and
- Other recommended design considerations for some ENDS and their parts.
Many of these changes were based on input from the public. For instance, the list of HPHCs recommended for testing were revised from the draft guidance based on comments from the public to only include chemicals that are present in ENDS products. HPHCs that are not formed from the use of the ENDS products have been removed from the list. Other HPHCs that may form during use of ENDS products were added to the list.
When FDA issues any draft guidance or proposed regulatory action, it takes all comments from the public into consideration. Public comments help FDA implement comprehensive and well-researched regulations for the protection of public health.
Because protecting the health of all Americans is important when considering whether it is appropriate to allow a new tobacco product on the market, the final guidance also includes clear recommendations for how manufacturers should address potential safety concerns of ENDS and liquid nicotine.
Liquid nicotine poses a very real threat when it is swallowed or when even a very small amount contacts skin. Accidental exposure to nicotine-containing e-liquids may be toxic, and even deadly, especially to young children. To reduce the risks of this exposure, the 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.
Some ENDS designs may be more prone to other hazards, including but not limited to, battery overheating, fires or explosions. To mitigate these potential harms in ENDS devices, the guidance has information about battery specifications, examples of battery testing certificates, and potential safety features.
FDA understands that many ENDS manufacturers are small business owners who may have concerns 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 theoretical 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 themselves or another party;
- Using published literature reviews, including meta-analyses, or independent analyses of publicly available data to help support a PMTA rather than paying for new analyses; and
- 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.