Thursday, June 1, 2023 - Today, the
Energy Marketers of America (EMA) submitted a
citizen petition to the Food and Drug
Administration (FDA) to implore them to publish
a clear and comprehensive list of electronic
nicotine delivery systems (ENDS) to eliminate
confusion and uncertainty in the marketplace.
Although the FDA has provided a list of products
with marketing granted orders (MDOs) and a list
of companies that received MDOs, those lists
have not proven useful to EMA’s members who need
to determine which products can and cannot be
legally sold.
Specifically, EMA
requested that the FDA “publish a list by brand
and category of (i) ENDS and other deemed
tobacco products with tobacco-derived nicotine
that were on the market as of August 8, 2016,
and (ii) ENDS and other deemed tobacco products
with nicotine not derived from tobacco that were
on the market as of April 14, 2022, that
indicates whether each of those products:
-
Has received a
marketing granted order;
-
Has received an MDO
that has been stayed by a court or FDA,
rescinded by FDA, or vacated by a court;
and/or
-
Has a timely filed
premarket tobacco product application
(“PMTA”) pending and is not subject to one
of FDA’s enforcement priorities identified
in FDA’s Enforcement Priorities for ENDS
and Other Deemed Products on the Market
Without Premarket Authorization.”
“The delays and
uncertainty have a very real impact on the daily
lives of American entrepreneurs including EMA’s
member companies who require predictability and
transparency to operate. EMA’s member companies
and other retailers are well positioned to aid
in the fight against illegal and dangerous
products by keeping them off their shelves, but
the ability to do so requires clear and rational
regulatory framework, with changes communicated
consistently and transparently,” said EMA
President Rob Underwood.
CLICK HERE to read EMA’s Citizen Petition.
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