INSUBCONTINENT EXCLUSIVE:
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
“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
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.Commissioner Gottlieb announced his resignation a week ago
National Cancer Institute Director Dr
Ned Sharpless will take over as acting FDA Commissioner in April.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.
