Are you an importer of tobacco products
with questions about FDA’s new compliance policy?
Stay tuned for new compliance policy information,
on this edition of FDA’s tobacco compliance webinars.
Welcome to FDA’s Tobacco Compliance Webinar
– Tobacco Product Compliance Policy - Updates for Importers,
sponsored by the U.S. Food and Drug Administration
and the Center for Tobacco Products.
Thanks for joining us today!
We receive many questions from domestic importers of tobacco products
about FDA regulations.
As we’ve done in the past, we’ll be answering some of those questions today,
and give importers some additional tips on how to comply with the regulations.
You will notice that some of the slides have links to relevant information
that can be found on FDA’s website.
We encourage you to review those materials in addition to today’s webinar.
The purpose of this webinar is to explain FDA’s enforcement priorities,
highlight some changes that may affect imported products and importers,
and to provide some tips that we think may be helpful to importers.
For importers who have not seen our 2018 imports webinar,
we strongly encourage you to watch that webinar as well,
but please note some of the deadlines for meeting certain requirements
have changed since that video was made available.
The topics we will be discussing today include:
the enforcement priorities for ENDS and other deemed tobacco products Final Guidance,
the September 9, 2020 application deadline for deemed new tobacco products,
the new subclass code that has been created for use in building product codes,
the impact of the compliance policy on imported tobacco products,
and two new import alerts.
Before we jump in to today’s content, let’s review some basics.
Section 900(20) of the Federal Food, Drug and Cosmetic Act
(also referred to as the FD&C Act)
defines a “tobacco product manufacturer” as:
“any person, including any repacker or relabeler, who –
A. manufactures, fabricates, assembles, processes, or labels a tobacco product;
or B. imports a finished tobacco product for sale or distribution in the United States.”
As such, importers of tobacco products are considered manufacturers of tobacco products
and must abide by all applicable requirements set forth in the FD&C Act,
including obtaining marketing authorization for new tobacco products.
Section 910 of the FD&C Act requires any new tobacco product to have premarket authorization.
A new tobacco product is any tobacco product that was not commercially marketed
in the United States as of February 15, 2007,
or any modification of a tobacco product where the modified product
was commercially marketed in the United States after February 15, 2007.
Generally, a marketing authorization order is required for a new tobacco product unless
(1) FDA issues an order finding the product substantially equivalent to a
predicate tobacco product (under section 910 of the FD&C Act) or (2)
FDA issues an order finding the product to be exempt from the requirements of substantial equivalence
and you make the required submission under section 905 of the FD&C Act.
All deemed products that meet the definition of a “new tobacco product”
are subject to the premarket requirements in sections 910 and 905 of the FD&C Act.
An example of such a deemed product is an electronic nicotine delivery system
(or ENDS product), which includes devices, components,
and/or parts that deliver aerosolized e-liquid when inhaled.
Another example is an e-liquid, which is a type of ENDS product and generally refers
to liquid nicotine and nicotine-containing e-liquids (i.e., liquid nicotine combined
with colorings, flavorings, and/or other ingredients).
Liquids that do not contain nicotine or other material made or derived from tobacco,
but that are intended or reasonably expected to be used with
or for the human consumption of a tobacco product,
may be components or parts and, therefore,
subject to FDA’s tobacco control authorities.
Now we are ready to discuss FDA’s enforcement priorities regarding certain
deemed tobacco products that do not have premarket authorization.
In April, FDA updated its guidance for industry entitled
"Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS)
and Other Deemed Products on the Market
Without Premarket Authorization (Revised).”
This is a revision to the January 2020 guidance which describes, among other things,
how FDA intends to prioritize its enforcement resources with regard to ENDS products
that do not have premarket authorization.
FDA revised this guidance to change the date required to submit premarket
authorization applications to the agency from May 12, 2020, to Sept. 9, 2020.
But please note that this guidance does not in any way change the fact that
it is illegal to market any new tobacco product without premarket authorization,
or to sell any tobacco product to minors.
The Agency may pursue enforcement action at any time against
any deemed new tobacco product marketed without premarket authorization,
regardless of whether the tobacco product falls within one of the ENDS categories
that we will discuss in the next slide.
Beginning on February 6, 2020, FDA began prioritizing enforcement of
premarket review requirements for certain ENDS products without FDA marketing authorization:
(1) Any flavored, cartridge-based ENDS product
(other than a tobacco- or menthol-flavored ENDS product);
A cartridge-based ENDS product is a type of ENDS product that consists of,
includes, or involves a cartridge or pod
that holds liquid that is to be aerosolized through product use.
For purposes of this definition, 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.
(2) All other ENDS products for which the manufacturer has failed to take
(or is failing to take) adequate measures to prevent minors’ access;
and (3) Any ENDS product that is targeted to minors
or whose marketing is likely to promote use of ENDS by minors.
FDA will make enforcement decisions on a case-by-case basis.
In addition to the new compliance policy as outlined in the Guidance,
a recent court case has resulted in a new deadline to submit applications
for deemed new products, including ENDS.
On July 12, 2019, the U.S. District Court for the District of Maryland
issued an order directing FDA to require that premarket authorization applications
for all new deemed tobacco products be submitted to the Agency by May 12, 2020.
On March 30, FDA requested a 120-day extension of the premarket application deadline
solely as a result of the coronavirus pandemic
and exceptional and unforeseen circumstances.
On April 22, 2020, the court granted the 120-day extension,
which now sets the premarket application deadline to September 9, 2020.
FDA is providing a one-year period during which deemed products on the market
as of the August 8, 2016 deeming date
who submit applications by the September 9 deadline
might remain on the market pending FDA review.
As a result, deemed new tobacco products on the market as of August 8, 2016,
for which premarket authorization applications are not filed by September 9, 2020,
are subject to FDA enforcement action in the agency’s discretion.
The order does not restrict FDA’s authority to enforce the premarket review provisions
against deemed products, or categories of deemed products,
prior to September 9, 2020, or during the one-year review period.
FDA intends to prioritize enforcement of any ENDS product that is offered for sale
in the United States after September 9, 2020
and for which the manufacturer has not submitted a premarket application
(or after a negative action by FDA on an application).
Now, let’s discuss a new relevant subclass code
that has been created for use in building FDA import product codes.
The product code consists of seven characters,
and is described in detail in the 2018 imports webinar.
FDA has created a new subclass code for tobacco-flavored products
to differentiate these products from other flavors.
The next slide will include an example of how to use this new subclass code
when using the Product Code Builder.
On the left side you will see how to build the product code for a finished,
flavored e-cigarette other than a tobacco or menthol-flavored e-cigarette.
The product code would include the industry code 98 for tobacco products,
class code “L” for an ENDS product,
subclass “C” for other flavor,
PIC code “A” for consumer Use,
and group code 01 for e-cigarette.
The full product code would then be 98LCA01.
On the right side there is a similar example for how to build a product code
for a tobacco flavored ENDS cartridge.
The product code would be industry code 98, class code “M”
for an ENDS Component or Part,
subclass “D” for tobacco flavor,
PIC code “A” for consumer Use,
and group code 07 for ENDS cartridge.
The full product code would be 98MDA07.
CTP has created two new import alerts to prevent entry into the United States
of tobacco products that are adulterated or misbranded.
The first import alert is titled Detention Without Physical Examination
of New Tobacco Products Without Required Marketing Authorization.
The products under this import alert are new tobacco products lacking
the required FDA marketing authorization.
Such products may be placed on a Red List.
Products meeting the criteria of the import alert
will be detained and refused entry into the United States.
Of note, products imported for personal use, and products entering the US
through international mail facilities or through commercial carriers
are not exempt from this new compliance policy.
The second import alert is titled
“Detention Without Physical Examination
of Electronic Nicotine Delivery Systems (ENDS)
Lacking Premarket Authorization.”
The products under this import alert are ENDS products
lacking the required FDA marketing authorization.
Such products may be placed on a Red List.
Divisions may detain without physical examination
ENDS products that are identified on the Red List of this alert.
As with the other new import alert, products being imported for personal use
or entering the US through international mail facilities or through commercial carriers,
are not exempt from the new compliance policy.
We have some great resources for you on our website,
and we encourage you to review these materials.
Please also check our website often for updates and sign up for the Center’s
“CTP News” and “CTP Connect” emails.
If you have any questions regarding the topics discussed in this webinar,
please contact AskCTP@fda.hhs.gov
or 1-877-287-1373.
In addition, the Office of Small Business Assistance provides
technical and other non-financial assistance
to support small tobacco businesses
to assist them in complying with the FD&C Act.
The Office of Small Business Assistance can be contacted by email at
SmallBiz.Tobacco@fda.hhs.gov.
You can also access ORA’s Contact Us page, and FDA’s Imported Tobacco homepage
for additional imports information.
Lastly, we’ve provided a link to the
ENDS Enforcement Priorities Final Guidance that we discussed today.
Thank you for your participation in this webinar
brought to you by the Center for Tobacco Products
– protecting our kids, and the nation’s health from tobacco.