The FDA has drafted new guidance for the regulation of e-cigarettes, particularly with regards to flavored nicotine products.
The first big change is that the FDA has bumped up the application due date by one year for FDA approval of flavored products. Manufacturers of all flavored ENDS (electronic nicotine delivery system) products will now have to submit premarket applications by August 8, 2021.
The second change is introducing a new compliance policy with regards to flavored ENDS products.
At the time that the current compliance policy was enforced, in 2017, e-cigarette use among youth was leveling off. But drastic growth in the popularity of e-cigs among minors over the past two years has led to various changes in the policy, including the restriction of sales of flavored ENDS products via certain retail channels from November 2018.
“The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018,” wrote Gottlieb in the announcement. “This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017.”
Identifying flavored pods as a culprit was the first step, but the FDA is now introducing a policy that looks at how accessible any flavored ENDS product is to minors to determine whether or not it can stay on the market.
For online sales, retailers must have an age-verification process that connects to third-party data sources in order to sell flavored nicotine products. For physical retailers, the policy says that flavored nicotine products must be behind some sort of age-gate, whether that’s at the front door of the shop or within a different age-gated section of the store itself. In other words, there must be some barrier to entry before POS between minors and flavored ENDS products.
From the announcement:
Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.
The main point to remember is that the FDA plans to prioritize enforcement of these products based on whether they’re sold in ways that pose a greater risk for minors to access them and become addicted to them.
While this proposal includes further regulation of the budding e-cigarette industry, it could be an important step forward for the space in the long term. The e-cigarette industry won’t reach its potential as an alternative to cigarettes until the issue of underage use is solved for good.
The FDA sees flavored ENDS products as a gateway for young people, and closing off access to those products as soon as possible gives the industry, from manufacturers to retailers to regulators, the opportunity to plan for how these products can be sold and distributed in the future, or if flavored products should exist at all.
The new plan does not propose enforcement of all ENDS products — tobacco, menthol and mint-flavored ENDS products can remain on the market and keep their original 2022 deadline for premarket FDA approval applications.
Juul Labs had this to say in response to the draft guidance:
We are committed to reducing youth usage while preserving our opportunity to eliminate combustible cigarettes, the number one cause of preventable death in the world. As part of our action plan deployed in November 2018 to keep JUUL products out of the hands of youth, we stopped the sale of flavored JUULpods to retail stores, strengthened our retail compliance and secret shopper program, enhanced our online age-verification, exited our Facebook and Instagram accounts and are continuously working to remove inappropriate third-party social media content. We support category-wide action including the responsible, restricted sale of flavored products and will review today’s draft guidance as we continue to work with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in combating underage use.
Gottlieb had taken measured steps to keep ENDS products away from minors while still allowing adult smokers to have an alternative on the market. Whether Sharpless will thread the needle quite as well remains to be seen, but Altria stocks fell on word of his appointment.
Today’s proposal is open for public comments for 30 days.