Last week, the Food and Drug Administration issued final guidance for vape manufacturers to submit premarket tobacco product applications (PMTA), which are required to obtain official authorization to market their products. These guidelines will invariably affect manufacturers of vape products that can be used with both tobacco and cannabis.
In order for any new tobacco product to be legally marketed, the FDA must issue an order permitting the marketing of that product. To issue a PMTA marketing order, the FDA must first evaluate the product “based on a public health standard that considers the risks and benefits of the product to the population as a whole, including tobacco product users as well as non-users.”
The guidance, which is non-binding and can be found here, and can assist anyone submitting PMTAs for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA). In addition to this guidance, the FDA will designate a single Regulatory Health Project Manager so that applicants have a single point of contact in Center for Tobacco Products (CTP) office to answer questions regarding PMTAs, and applicants will have access to an appeals process in the event that the FDA denies their application.
For a bit of quick background, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which was enacted in 2009, amended the FDCA to give the FDA authority to regulate tobacco products. In 2016, the FDA issued a final rule, “Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (81 FR 28973). In the final deeming rule, the FDA clarified that all ENDS (including, but not limited to, e-cigarettes, e-pens, e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes) are subject to the FDA’s authority. These products are subject to most of the same FDCA provisions to which cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco are subject, including premarket review requirements and adulteration and misbranding regulations.
The FDA lays out a number of important definitions in its guidance, including that of an “e-cigarette,” which may be either open (i.e. a refillable e-cigarette that includes a reservoir that a user can refill with an e-liquid of their choosing), or closed (i.e. an e-cigarette that includes an e-liquid reservoir that is not refillable, or that uses e-liquid contained in replaceable cartridges or pods that are not intended to be refillable).
Acting FDA Commissioner Dr. Ned Sharpless noted in his statement regarding the guidance that:
[t]here are no authorized e-cigarettes currently on the market and [FDA oversight] is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death.”
The guidance outlines how the agency will review ingredients and additives to ENDS, how they are packaged, labeled and marketed, and how the devices themselves are designed and made.
The FDCA requires that the FDA deny any PMTA where it finds “there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.” This determination will be made with respect to the risks and benefits to the population as a whole, taking into account the following:
- the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
- the increased or decreased likelihood that those who do not use tobacco products will start using such products.
It will be important for manufacturers of all vaporizer products to review and understand this guidance, particularly those that are engaged in the manufacture and distribution of products intended or used for both cannabis and tobacco.