Are you a domestic importer of tobacco
products with questions about FDA's regulations?
Stay tuned for some answers and tips, on this
edition of FDA's tobacco compliance webinars.
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Welcome to FDA's Tobacco Compliance Webinars
Education and Information for Retailers and Small
Businesses sponsored by the U.S.
Food and Drug Administration and the
Center for Tobacco Products.
I'm David Racine - 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.
Joining me today is my colleague, CDR Kristina
Peters, from CTP's Office of Compliance and
Enforcement.
You will notice that some of the slides have links
to relevant guidance documents, letters, and
past webinars that can be found on FDA's websites.
We encourage you to review those materials in
addition to today's webinar.
Now, let's get started.
CDR Peters.
Thanks, CAPT Racine.
The purpose of this webinar is to answer some
questions we are frequently asked by
importers of tobacco products and to provide
some tips that we think may be helpful to
importers.
For importers who have not seen our 2016 imports
webinar, we strongly encourage you to watch
that webinar as well, although some of the
deadlines for meeting certain requirements have
changed since that video was made available.
The topics we will be discussing today include:
an update on the dates to meet certain requirements,
which have been revised, the automated commercial
environment (also known as ACE) and which data
elements are and are not required when importing a
regulated tobacco product, establishment
registration, importation of regulated tobacco
products for personal use, prior notice for the
importation of regulated tobacco products, product
codes, tariff classification and HTS
codes, and user fees.
As we previously mentioned, some compliance
dates provided in the 2016 imports webinar have
changed.
Compliance dates which were presented in the 2016
imports webinar and have since changed include the
compliance dates for ingredient listing
submissions for deemed products, the compliance
dates for Harmful and Potentially Harmful
Constituent, or HPHC submissions for deemed
products, the compliance dates for addictiveness
warning statements on packaging and advertising
for covered tobacco products (other than
cigars and those that do not contain nicotine), the
compliance date for required label statements
on deemed products in package form, and the
compliance dates for submission of applications
for premarket review for deemed products on the
market as of August 8, 2016.
You can see the new compliance dates for these
requirements across the next few slides.
The Automated Commercial Environment, or ACE, is
the primary system through which the trade community
reports imports and exports and the government
determines admissibility.
ACE is maintained by Customs and Border
Protection.
When an FDA regulated product is imported CBP
forwards the data to FDA.
The FDA published a final rule: "Submission of Food
and Drug Administration Import Data in the
Automated Commercial Environment" on November
29, 2016.
This rule explains what information is required to
be submitted by importers when entering an FDA
regulated product into the United States.
If a product you import has been detained by FDA,
please use the FDA's Office of Regulatory
Affairs Headquarters directory to identify the
appropriate individuals to contact to help you
understand why your product has been delayed
or detained.
For all FDA regulated products, including
tobacco products, importers are required to
submit the "FDA Country of Production", "The Complete
FDA Product Code", "The Full Intended Use Code",
and a telephone number and email address for the
importer of record.
Additionally, when importing a regulated
tobacco product importers must submit the brand or
commercial name of the article.
Brand name is not required for products solely
intended for either further manufacturing or
as investigational tobacco products.
We want to focus on two types of optional data
elements we frequently are asked about.
The first is the FDA Establishment
Identification number or FEI.
This is a unique number issued by FDA to track
inspections of the regulated establishment or
facility.
An FEI is not required to import tobacco products
into the United States, however FDA encourages
importers who have an FEI to enter it into ACE.
The second frequently asked about data element
is called an Affirmation of Compliance.
An Affirmation of Compliance is a data
element which can be included in an ACE entry
to indicate compliance with an FDA requirement.
At this time all affirmations of compliance
are optional for tobacco products.
However, we would like to encourage importers to use
the affirmations of compliance when
appropriate to expedite entry review of their
shipments.
Please also be aware that while the affirmation of
compliance is optional, imported products are
still required to meet the legal standards for
importation.
Another question we are frequently asked is
whether importers must register their
establishments and list their products with FDA.
Section 905(b) of the Food Drug and Cosmetic Act, or
FD&C Act, requires every person who owns or
operates any establishment in the U.S.
engaged in the manufacture, preparation,
compounding, or processing of a regulated tobacco
product to register with the FDA.
And every registrant must file a list of its
regulated tobacco products in accordance with section
905(i).
Establishment registration and product listing
requirements currently apply only to those
persons who own or operate domestic establishments
engaged in manufacturing tobacco products; an
importer who does not own or operate such an
establishment is not subject to the
requirements of section 905(b) or section 905(i)
of the FD&C Act.
Foreign establishments are not required to register
and list until FDA issues regulations stablishing
such requirements in accordance with section
905(h) of the FD&C Act.
Additional requirements including but not limited
to ingredient reporting, health warnings, and
premarket authorization apply equally to foreign
and domestic manufacturers.
Another question we frequently receive from
importers is whether there are any exceptions to FDA
regulations for the importation of tobacco
products for personal use.
The FD&C Act does not exempt tobacco products
imported for personal use from applicable
requirements for tobacco product imports.
Therefore, under section 801 of the FD&C Act,
imported tobacco products are subject to refusal of
admission if, among other things, they are, or
appear to be, adulterated or misbranded.
CTP follows the FDA policy on Coverage of Personal
Importations in Chapter 9 of the RPM regarding
personal use quantities of FDA-regulated imported
products in baggage and mail.
The Center for Tobacco Products also frequently
receives questions regarding whether
importers must submit prior notice of imported
shipments of regulated tobacco products.
The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 -- the
Bioterrorism Act -- requires that FDA receive
prior notification of food, including animal
feed that is imported or offered for import into
the United States.
However, prior notice is not required for the
importation of regulated tobacco products.
FDA frequently receives questions about how to
determine the correct product code for an
imported product.
The FDA Product Code is seven characters long and
is broken into the following fields: Industry
- The first two characters of the FDA Product Code
represent the various industries regulated by
the FDA.
The industry code is always numeric.
The industry code for tobacco products is 98.
Class - The third character of the FDA
Product Code, this is always a letter.
For tobacco products, Class means the general
type of product, such as smokeless tobacco or
cigarettes.
Subclass - The fourth character of the FDA
product code, this is always a letter.
For tobacco products, the subclass code is used to
categorize the flavor of the product.
Process Indicator Code - The fifth character of the
FDA product code, for tobacco products this is
always a letter.
For tobacco products, the PIC code describes the
intended use of the product.
The intended use can either be for consumer
use, for further manufacturing, or for
investigational use.
Product - The final two characters of the FDA
Product Code.
For tobacco products, the Product Code helps further
identify the specific product.
The product code builder is an online tool which
can assist in locating and building a product code.
On this slide, you can see two example product codes.
The term tariff classification is a system
that enables uniform identification of imported
and exported goods for purposes of duty and tax
collection, enforcement of national laws and
international treaties, analysis for economic and
business planning, and international trade
negotiations.
FDA is frequently asked how the tariff
classification or HTS code of a product affects
whether a product is or is not a regulated tobacco
product.
Your tariff classification does not determine whether
your product is a regulated tobacco product.
The FD&C act gives FDA authority to collect user
fees from domestic manufacturers and
importers of certain tobacco products.
At this time domestic manufacturers and
importers of cigarettes, snuff, chewing tobacco,
roll-your-own tobacco, cigars, and pipe tobacco
are subject to user fees.
More information about user fees may be found in
the link in the slide.
You must submit information required for
FDA to calculate assessments and you must
pay these user fees.
Failure to pay a user fee renders your tobacco
products adulterated under ♪ 902(4) of the FD&C Act
and subject to possible enforcement action.
It is a prohibited act to introduce or deliver for
introduction into interstate commerce any
tobacco product that is adulterated.
The Guidance contains detailed information on
what you must submit and how FDA uses this
information to assess user fees.
FDA will notify you of the amount of the quarterly
assessment no later than 30 calendar days before
the end of each quarter of the fiscal year with the
following information: Amount of the assessment;
Due date; Class assessment information; Domestic
manufacturer or importer assessment information;
Any adjustments made by FDA; How to pay the fees;
Interest information; and Dispute contact
information.
That's all I have today.
Thanks for listening.
CAPT Racine.
Thanks CDR Peters.
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" email services.
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
in complying with the FD&C Act.
The Office of Small Business Assistance can be
contacted by email at: SmallBiz.Tobacco@fda.hhs.gov
And let me thank all of 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.
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