Recent Changes that Impact the Sale of Tobacco Products in Retail Establishments

Recent Changes that Impact the Sale of Tobacco Products in Retail Establishments


Recent changes in the
law and FDA guidance will impact retailer
responsibilities under FDA’s regulation of
tobacco products. Find out what you need to
know in this episode of FDA’s Tobacco
Compliance Webinars. Welcome to this edition of
FDA’s Tobacco Compliance Webinars – Information
and Education for Manufacturers, Retailers
and Small Businesses, brought to you by the Food
and Drug Administration’s Center for
Tobacco Products. I’m Carolyn Lockeed. Thank you for joining us. In this webinar, we’ll
review recent changes that impact the sale of
tobacco products in retail establishments. The FDA has created this
webinar to assist you with understanding recent
changes made in the law and the issuance of a
final guidance outlining enforcement policies that
will impact retailers and small businesses. In this webinar
we will give: An overview of the changes
made to the Federal Food, Drug, and Cosmetic Act,
known as the FD&C Act, to increase the federal
minimum age of sale of tobacco products to 21
years of age; An overview of the Final Guidance:
Enforcement Priorities for Electronic Nicotine
Delivery Systems, known as ENDS, and Other Deemed
Products on the Market Without Premarket
Authorization. Note that throughout this
webinar we will refer to this as the “Enforcement
Priorities Guidance” or just “Guidance.” An
overview of FDA’s enforcement tools;
and Additional helpful resources. Let’s first discuss the
changes made to the FD&C Act to increase the
federal minimum age of sale of tobacco products. On December 20, 2019, the
FD&C Act was amended by law to raise the minimum
age for tobacco product sales to 21. This means that as of
December 20, 2019, it became illegal to sell
tobacco products to anyone under 21. There are no exceptions
to this requirement. This law applies to sales
of all tobacco products – including cigarettes,
smokeless tobacco, hookah tobacco, cigars, pipe
tobacco, electronic nicotine delivery systems
including e-cigarettes and e-liquids – to anyone
under 21 years of age It is important that
retailers understand that it is now their
obligation, under this law, to ensure that they
only sell tobacco products to individuals 21
years of age or older. A good way for retailers
to do this is to check IDs of individuals attempting
to purchase tobacco products in their stores. As a reminder, FDA’s
current regulations on the sale and distribution of
tobacco products require retailers to verify
a tobacco product purchaser’s age by means
of photo ID that contains their date of birth if
that individual is under the age of 27. In addition to increasing
the federal minimum age of sale for tobacco products
to 21, this law also directs FDA to update its
current regulations for retailers. FDA fully intends to make
appropriate changes to its regulations, and we will
provide additional details as they become available. While retailers must
ensure they do not sell tobacco products to
individuals under the age of 21 under the new
law, they are also still responsible for the
current requirements under FDA’s regulations,
including, for example, those pertaining to the
use of vending machines, free samples, and the sale
of individual cigarettes. FDA will continue to
conduct compliance check inspections of tobacco
product retailers to determine a retailer’s
compliance with federal laws and regulations. At the end of the webinar,
we will provide additional resources. These resources include
web links to important information for
retailers, including their requirements under the
FD&C Act and tobacco product regulations, and
how to sign up to get our email updates on
these subjects. Now let’s move on to
our second topic, the Enforcement
Priorities Guidance. On January 2, 2020, FDA
published a final guidance for industry entitled
“Enforcement Priorities for Electronic Nicotine
Delivery Systems (ENDS) and Other Deemed Products
on the Market Without Premarket Authorization.”
This guidance document describes how FDA
intends to prioritize our enforcement resources with
regards to the marketing of ENDS products that
do not have premarket authorization. Under the FD&C Act, “new”
tobacco products, meaning those tobacco products
that were not commercially marketed as of February
15, 2007 with limited exceptions, are required
to have premarket authorization from the FDA
before they may be legally marketed. Deemed tobacco products,
including ENDS, became subject to this
requirement in August 2016. FDA previously provided
extended compliance dates for these premarket
requirements for most ENDS products. FDA has changed
this policy. Accordingly, retailers
should pay careful attention to the
enforcement priorities outlined in the guidance
and discussed in the next several slides. This information is
important for retailers because retailers are
prohibited by law from selling and distributing
tobacco products that are required to and do
not have premarket authorization. On February 6, 2020,
thirty days after the issuance of this final
guidance, FDA intends to begin prioritizing
enforcement of the premarket authorization
requirements for certain ENDS products. As a reminder, retailers
are not permitted to sell tobacco products that
do not have the required premarket authorization. Specifically, FDA
intends to prioritize the enforcement of the
premarket requirements for: (1) Any flavored,
cartridge-based ENDS product (other
than a tobacco- or menthol-flavored
ENDS product). (2) All other ENDS
products for which the manufacturer has failed
to take (or is failing to take) adequate measures
to prevent minors’ access. (3) Any ENDS product that
is targeted to minors or whose marketing is likely
to promote use of ENDS by minors. Additionally, FDA intends
to prioritize enforcement for any ENDS product that
is offered for sale after May 12, 2020, and for
which the manufacturer has not submitted a premarket
application or after a negative action by FDA
on a timely submitted application. Under the first
enforcement priority, FDA intends to prioritize
enforcement of the premarket authorization
requirements for flavored, cartridge-based ENDS
beginning February 6, 2020. Cartridge-based ENDS,
for the purposes of this guidance, mean ENDS
products that consist of, include, or involve a
cartridge or pod that holds liquid that is to
be aerosolized through product use. Some examples of ENDS
products include vapes or vape pens, personal
vaporizers, and e-cigarettes. The guidance describes a
cartridge or pod as any small, enclosed unit
(sealed or unsealed) designed to fit within
or operate as part of an ENDS. Under the first
enforcement priority, FDA does not intend to
prioritize enforcement of the premarket
authorization requirements for flavored
cartridge-based ENDS that are tobacco or
menthol flavored. Examples of flavored
cartridge-based ENDS products covered by this
enforcement priority include products
containing flavors such as bubble gum, mango,
strawberry, and mint. It also applies to those
products that contain a flavor in addition to
tobacco or menthol, such as mango menthol or
iced strawberry menthol. Beginning February 6,
2020, FDA intends to prioritize enforcement
of the premarket review requirements for flavored,
cartridge-based ENDS products (other
than tobacco- or menthol-flavored ENDS
products), including against retailers
selling such products. Retailers should not
sell any flavored cartridge-based ENDS
products (other than a tobacco-or
menthol-flavored ENDS products) to anyone. This enforcement priority
applies where the product is sold to anyone,
regardless of their age. This is true for the
sale of such products to individuals over
the age of 21. Retailers should also not
offer for sale affected flavored cartridge-based
ENDS products in their stores or on
store shelves. FDA encourages retailers
to reach out to their suppliers and product
manufacturers for possible ways to manage their
current inventory of flavored
cartridge-based ENDS. However, it is important
to point out that the enforcement priorities
outlined in the guidance only apply to ENDS
products that lack premarket authorization. If an affected product
receives premarket authorization from the
FDA, retailers may sell that product. When any tobacco product
receives premarket authorization, FDA will
list the product on the premarket tobacco product
marketing orders page. We have provided the web
address for this page on this slide. Please remember, it
is illegal to sell any tobacco products to
individuals under the age of 21, including all ENDS. This is true even for
products that are legally marketed. During this webinar, I
have explained that as of December 20, 2019, it
became illegal to sell tobacco products to anyone
under the age of 21. Retailers must not sell
tobacco products to anyone that is not 21 years
of age or older. A good way for retailers
to do this is to check IDs of individuals attempting
to purchase tobacco products in their stores. This is also a requirement
under FDA’s tobacco product regulations. While FDA will be updating
its current regulations, retailers are required
to comply with all requirements in these
regulations, such as those relating to the use of
vending machines, free samples, and the sale of
individual cigarettes. I have also provided
an overview of the Enforcement
Priorities Guidance. This guidance states
that FDA intends to begin prioritizing enforcement
of the premarket authorization
requirements for flavored cartridge-based ENDS
products beginning on February 6, 2020. As a reminder, retailers
should not sell or display for sale these products
until they are authorized for marketing, even to
individuals that are 21 years of age or older. Generally, if FDA observes
violations of the law during a tobacco retailer
inspection, including those described in this
webinar, FDA intends to issue a Warning Letter. A Warning Letter is the
FDA’s advisory action used to try to achieve prompt
voluntary compliance with the law and establish
prior notice. FDA requests that a
retailer respond to a Warning Letter within 15
working days in writing, by mail or email. Responses should include
steps the retailer will take to correct the
violation or violations and prevent
future violations. For example, this could
include stopping sales and offers to sell the items. The response should
include the retailer’s current contact
information, including your telephone number
and email address. A retailer should promptly
correct any violations listed and comply with
all applicable laws and regulations. Failure to comply may
result in FDA initiating further actions including,
but not limited to, civil money penalties,
no-tobacco-sale orders, criminal prosecution,
and/or injunctions. For more information
about the requirements for tobacco product retailers
under the law, and for a copy of the Enforcement
Priorities Guidance, we encourage you to visit
our website at the links provided on this slide. You may also sign-up for
email updates from CTP at the website on the screen. Please direct any
additional questions to us via email at
[email protected] or via phone at 1-877-287-1373
For small business assistance, please contact
CTP’s Office of Small Business Assistance,
OSBA, at: [email protected]
or at 1-877-287-1373 Thank you for watching
this program, brought to you by the FDA’s Center
for Tobacco Products, whose mission is to
protect our kids and the nation’s health from
the dangers of tobacco.


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