The US Food and Drug Administration (FDA) has published final guidance regarding Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS), detailing how they intend to prioritize enforcement resources in relation to the marketing of certain deemed tobacco products which don’t have premarketing authorization.
This guide outlines the implications for manufacturers of ENDS products and applicable enforcement timeframes in relation to different product types.
What does the new enforcement policy say?
To date, no ENDS products have been authorized by FDA – meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement at any time, at FDA’s discretion.
Beginning 30 days from the publication of the recent notice (dated January 02, 2020), FDA intends to prioritize enforcement against the following products that do not have premarket authorization:
- Flavored, cartridge-based ENDS products (other than tobacco or menthol flavored)
- ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minor’s access
- ENDS products targeted to minors or likely to promote the use of ENDS by minors
Companies in these categories which do not cease manufacture, distribution and sale of products within the 30 days risk FDA enforcement action.
Why the focus on flavored, cartridge-based products?
In 2019, two of the largest US surveys of tobacco use among youth indicated that e-cigarette use has hit the highest levels ever recorded – so it’s no surprise that enforcement priorities are being centred on products targeted at minors or failing to prevent their access.
In terms of the focus on flavored products (which includes fruit and mint products), research has long shown that flavors increase youth appeal to tobacco products, including ENDS, and evidence continues to accumulate. The fact that adult smokers also use flavors to convert from combustibles to ENDS is undisputed but with FDA focus on curbing youth use, a clampdown was inevitable.
With reference to cartridge-based products, the FDA define these as products that consist of, include, or involve a cartridge or pod that holds liquid that is to be aerosolized through product use. A cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.
The National Youth Tobacco Survey (NYTS) indicates that youth overwhelmingly prefer cartridge-based ENDS products. It’s been found that these products are easy to conceal, can be used discretely, may have a high nicotine content and are manufactured on a large scale.
In response to concerns that alternative products may become more popular if flavored, cartridge-based products become less available, the FDA have stated that they will closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.
The FDA believe that this policy balances the urgency of the public health threat of youth use of e-cigarettes, with the potential role that they can play in helping adult smokers transition away from combustible cigarettes to a potentially less risky form of nicotine delivery.
Is this a ban on flavored, cartridge-based products?
No. The FDA has already begun the review of several premarket applications for flavored ENDS products. If any of these applications demonstrate that a product meets the applicable standard in the law and is appropriate for the protection of public health, the FDA could authorize that product for sale.
Furthermore, manufacturers of flavored cartridge-based products are welcome to continue to submit premarket applications and can resume the manufacture, distribution and sale of products when they receive a successful premarket authorization.
What about other types of ENDS products?
The guidance states that after May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS product that continues to be sold and for which the manufacturers have not submitted a premarket application. However, for ENDS products other than those described above, where applications have been submitted by the May 2020 deadline, the FDA will hold back on enforcement for up to one year pending FDA review of the application.
A point to note is that flavored e-liquid products marketed for open systems and cigalike products are not subject to the latest enforcement priorities, but do still need to submit a premarket application by May 12, 2020.
ENDS manufacturers committed to compliance
This enforcement policy will come as no surprise to most within the ENDS industry and FDA expect that responsible members of the industry will comply with premarket requirements. In-fact many have already begun preparing applications with urgency.
Broughton offer a team of scientific and regulatory experts to manage the full Premarket Tobacco Product Application PMTA process on your behalf. To discuss how to seek a premarket authorization for your products contact us to arrange a meeting.