Internet and Publication Surveillance


Welcome to this edition
of FDA Tobacco Compliance Webinars – Education and
Information for Retailers and Small Businesses,
sponsored by the U.S. Food and Drug
Administration and its Center for
Tobacco Products. I’m David Racine. Thanks for joining us. In this series of
webinars, we help you — retailers, and small
businesses — better understand our work
regulating tobacco. In today’s edition, we’ll
discuss Internet and Publication Surveillance
of Tobacco Products. Joining me is Anthony
Villa with FDA’s Office of Compliance and
Enforcement’s Division of Promotion, Advertising,
and Labeling. We won’t be taking any
live questions during today’s presentation, but
you can still send your questions to the Center
by emailing us at: [email protected] hhs.gov or by calling
us at 877-CTP-1373. Now, here’s Anthony with
today’s presentation. Thanks, David. On May 10, 2016, FDA
issued a final rule deeming certain additional
tobacco products subject to its tobacco product
authorities – otherwise known as the “Deeming
Rule.” This webinar is designed to assist
regulated tobacco industry to understand selected
requirements under the deeming regulation. Today, I will also
be discussing FDA’s surveillance and
monitoring of tobacco products that are
generally found on the Internet and in printed
publications, and other media. This presentation consists
of three parts: o An overview of Internet and
publication surveillance; o Warning letters and
compliance actions which FDA initiates that result
from surveillance; and o A list of common
violations and related examples of what we
have encountered. Let’s start with an
Overview of Internet and Publication Surveillance. The Federal, Food, Drug,
and Cosmetic Act (or the FD&C Act), as amended
by the Family Smoking Prevention and Tobacco
Control Act (also known as the Tobacco Control Act)
gives FDA authority to regulate the manufacture,
sale, distribution, and marketing of
tobacco products. The Tobacco Control
Act gave FDA immediate authority to regulate
cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco under Chapter
IX of the FD&C Act. The FD&C Act also allows
FDA, through regulation, to deem other tobacco
products subject to its tobacco product
authorities. The FD&C Act defines
tobacco products, in part, as any product made or
derived from tobacco that is intended for human
consumption as well as any component, part, or
accessory of a tobacco product. Now that the Final Deeming
rule has published and is currently in effect,
FDA’s regulatory authority covers all products that
meet the definition of a tobacco product, including
its components and parts, except accessories, of
those newly regulated tobacco products. The Deeming rule
extends tobacco product authorities under Chapter
IX of the FD&C Act, as well as its implementing
regulations, referred to as the “automatic
provisions” in the rule, to all newly deemed
tobacco products. The automatic provisions
are those provisions in the FD&C Act and
implementing regulations that generally apply to
“tobacco products” and now extend to and
automatically apply to newly deemed
tobacco products. However, FDA intends to
limit enforcement of most automatic provisions
to “finished tobacco products,” which means a
tobacco product, including all components and parts,
sealed in final packaging intended for consumer use. And what are components,
parts and accessories? The deeming rule defines
“component or part” and “accessory.” The term
“component or part,” is defined as, “any software
or assembly of materials intended or reasonably
expected to: 1) alter or affect the tobacco
product’s performance, composition, constituents
or characteristics; or 2) be used with or for the
human consumption of a tobacco product. This term excludes
anything that is an accessory of a tobacco
product.” Some examples of components or parts of the
newly regulated products could include cigar
tobacco filler, filters, batteries for electronic
nicotine delivery systems, or ENDS, and cigar tips. The Deeming rule defines
“accessory” to mean any product that is intended
or reasonably expected to be used with or for the
human consumption of a tobacco product; does not
contain tobacco and is not made or derived from
tobacco; and meets either of the following: (1) Is
not intended or reasonably expected to affect or
alter the performance, composition, constituents,
or characteristics of a tobacco product or (2)
is intended or reasonably expected to affect or
maintain the performance, composition, constituents,
or characteristics of a tobacco product but (i)
solely controls moisture and/or temperature of a
stored product (like a humidor) or (ii) solely
provides an external heat source to initiate but not
maintain combustion of a tobacco product
(like a lighter). Some other examples of
accessories of the newly regulated products are
pipe pouches, ash trays, cigar cutters, and
carrying cases. Remember that FDA has not
extended its regulatory authority to accessories
of the newly regulated products at this time. What does internet and
publication surveillance entail? In fulfilling FDA’s
mandate to regulate the sale, distribution,
marketing, and advertising of tobacco products,
FDA’s Center for Tobacco Products conducts routine
surveillance of the Internet and publications,
including online retailers, e-commerce
websites, and social media. FDA’s surveillance will
now include newly deemed tobacco products and
provisions that are currently in effect. In instances where our
surveillance efforts reveal violations of
the FD&C Act, CTP will promptly take appropriate
enforcement action. We will be reviewing some
examples of violations under the FD&C Act and
warning letters that have recently been issued. The Tobacco Control
Act gave FDA immediate authority to regulate
cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco under its tobacco
product authorities. FDA still regulates
those products. For more information about
those requirements for the tobacco products I just
mentioned, we encourage you to visit our website
– www.fda.gov/ Tobacco products. What additional tobacco
products does FDA regulate? As we can see on this
slide, as of August 8, 2016, FDA regulates other
tobacco products that meet the definition of “tobacco
product” under the FD&C Act, including the
components and parts of those tobacco products,
but excluding accessories of newly regulated
tobacco products. Some examples of newly
deemed tobacco products include: o Electronic
Nicotine Delivery Systems otherwise referred to
as ENDS o Pipe Tobacco o Cigars o Waterpipe Tobacco
(hookah), and o E-liquid Some examples of
components or parts of the newly regulated tobacco
products include: a cartomizer of an
e-cigarette, a mouth piece used to smoke pipe
tobacco, and flavorings that are added to a cigar. And remember – this is
not an exhaustive list. Are there warning
requirements for these newly regulated
tobacco products? There is a new
addictiveness warning requirement for covered
tobacco products, cigarette tobacco, and
roll-your-own tobacco. Covered Tobacco Products
are defined as any tobacco product deemed to be
subject to the FD&C Act under 21 C.F.R. ♪ 1100.2, but excludes any
component or part that is not made or derived
from tobacco. (21 C.F.R. ♪ 1140.3) The final rule
establishes a specific warning that must appear
on all covered tobacco product packages and
advertisements, and cigarette tobacco and
roll-your-own tobacco product packages
and advertisements. This addictiveness warning
is “Warning: This product contains nicotine. Nicotine is an addictive
chemical.” This warning must appear on packages
for these products that are manufactured as
of May 10, 2018, and manufacturers must not
introduce these products into domestic commerce
without the warning statement, as of June 11,
2018, regardless of when the products were
manufactured. For cigars, this warning
is only one of the six required warning
statements under the final rule, which we will
discuss later in this presentation. The addictiveness warning
statement must also be included in all
advertisements for covered tobacco products, and
cigarette tobacco and roll-your-own tobacco. This requirement takes
effect May 10, 2018. For covered tobacco
products that are made or derived from tobacco but
do not contain nicotine, the product packages and
advertisements may bear this alternative warning
statement, “This product is made from tobacco,”
instead of the addictiveness warning, if
the manufacturer of that product submits a
confirmation statement to the FDA certifying its
product’s nicotine-free status and that the
manufacturer has data to support that statement. Please see the small
entity compliance guide for more information on
this alternative warning statement. Please note that
components or parts that are not made or derived
from tobacco are not “covered tobacco products”
and therefore are not required to display any
of the required warning statements and do not
need to self-certify the product does not
contain nicotine. Let’s talk about the
warning requirements for cigars. Anthony – Slide 14
Cigar manufacturers and importers are required to
display additional warning statements on their
product packages and advertisements,
in addition to the addictiveness warning. Cigar packages and
advertisements must bear one of the six warning
statements, and be displayed, distributed,
and rotated, according to an FDA-approved
warning plan. For cigars that are sold
individually without packaging, the six warning
statements must be posted on a sign at the
retailer’s point of sale. The specific format and
content requirements can be found in the new rule. The 6 cigar warning
statements are, as follows: o WARNING: Cigar
smoking can cause cancers of the mouth and throat,
even if you do not inhale o WARNING: Cigar smoking
can cause lung cancer and heart disease o WARNING:
Cigars are not a safe alternative to cigarettes
o WARNING: Tobacco smoke increases the risk of lung
cancer and heart disease, even in nonsmokers o
either: – WARNING: Cigar use while pregnant can
harm you and your baby, or – SURGEON GENERAL WARNING:
Tobacco Use Increases the Risk of Infertility,
Stillbirth and Low Birth Weight o WARNING: This
product contains nicotine. Nicotine is an
addictive chemical. You may choose to display
either one of the warning statements regarding
reproductive health. FDA is allowing the use
of the reproductive health warning statement as
required by the Federal Trade Commission (FTC)
consent decrees as an optional alternative to
the FDA warning, “WARNING: Cigar use while pregnant
can harm you and your baby.” FDA expects that
providing this optional alternative will benefit
entities bound by the FTC consent decrees. Similar to smokeless
tobacco products, a warning plan must ensure
that the 6 required warning statements for
cigars are randomly displayed on product
packages, randomly distributed to
areas in the U.S. where the product is
marketed, and rotated quarterly, in an
alternating sequence, for advertisements, for
each brand of cigar. Cigar warning plans must
be submitted to FDA, for our review and approval
and should be submitted by the responsible
manufacturer, importer, distributor, or retailer
of the cigar product. Responsible manufacturers,
importers, distributors, and retailers must submit
the warning plan by May 10, 2017. Submitters may voluntarily
submit their warning plans sooner than May 10,
2017, for FDA review and approval. Based on our experience
with the review of Smokeless Tobacco Warning
Plans, the amount of time it took to review and
approve the submitted warning plans was
variable depending on the completeness, quality, and
quantity of submissions. FDA expects that many will
submit their warning plans near the due date
of May 10, 2017. You should keep these
factors in mind in deciding when to submit
your warning plan. Again, submitters are
welcome to voluntarily submit their warning
plans as soon as possible. If you have any questions,
please do not hesitate to contact us at:
[email protected] As mentioned previously,
there are specific font, text, size and formatting
requirements for the warning statements. Here are some examples of
the requirements under the new rule. For product packages, the
warning statement must be on 2 principal
display panels. The area of the warning
statement must cover at least 30% of each of the
principal display panels. For tobacco product
advertisements, the warning statement must
occupy at least 20% of the upper portion of
the advertisement. And, keep in mind that
there are other specific formatting requirements
contained in the new rule, which are similar to those
currently required for smokeless
tobacco products. With respect to packages,
the retailer will not be in violation of cigar
packaging requirements if: o The packaging of the
cigars sold contains a health warning statement,
o The package is supplied to the retailer by a
license or permit holding manufacturer, importer,
or distributor who has the required state, local, or
Alcohol and Tobacco Tax and Trade Bureau (TTB)
issued license or permit, if applicable, and o The
warning on the package is not altered or covered
up in a manner that is material to the warning
statement requirements (example – placing a
sticker over the warning statement). With respect to
advertisements, the new warning requirements apply
to a retailer only if that retailer is responsible
for or directs the warning statements required
under the rule. However, this does not
relieve a retailer of liability for cigar
advertisement requirements if the retailer displays
an advertisement in a location open to the
public (1) that does not contain a health warning,
or (2) the retailer has altered a health
warning statement on the advertisement in
a material way. And when do these
requirements go into effect. Manufacturers,
distributors, and importers must display
the new warnings on all advertisements and
packages of newly manufactured covered
tobacco products, cigarette tobacco and
roll-your-own tobacco. This requirement takes
effect May 10, 2018 (24 months after final
publication of the rule). In addition, manufacturers
must include the new warnings on packages
of products that are introduced into domestic
commerce, as of June 11, 2018 (which is 24 months
plus 30 days after the publication date of the
rule), regardless of the date of manufacture. Again, a covered tobacco
product is defined as any product deemed subject
to the FD&C Act by the deeming rule, but excludes
any component or part that is not made or
derived from tobacco. Examples of covered
tobacco products include: e-cigarettes, e-liquid,
cigars, hookah (waterpipe) tobacco, pipe tobacco,
and dissolvables. Examples of components or
parts that are not covered tobacco products include:
a pipe or an ENDS atomizer sold without
liquid nicotine. FDA now regulates
vape shops. Please speak to that. Vape shops are
establishments that often sell a variety of products
but it generally sells to individuals for personal
consumption ENDS products, including their
components or parts. When a vape shop
participates in these activities, it would be
considered a “retailer” under the FD&C Act and
would be subject to the same provisions of
the FD&C Act and its implementing regulations,
as other tobacco product retailers. Vape shops often also
mix, prepare, or combine e-liquids or create
or modify aerosolizing apparatuses for direct
sale to consumers for use in ENDS. When a vape shop
participates in these activities, it would be
considered a ‘tobacco product manufacturer’
under the FD&C Act and would be subject to the
same provisions of the FD&C Act and its
implementing regulations, as other tobacco
product manufacturers. A vape shop could be a
tobacco product retailer and a tobacco product
manufacturer under the FD&C Act and in those
cases the vape shop would be subject to applicable
requirements of both tobacco product
manufacturers and retailers under the FD&C
Act and its implementing regulations, and subject
to inspection by the FDA. A webinar with additional
information for vape shops is available on
the FDA website. With deeming comes
other requirements. Can you please tell
us more about them? Under the Deeming
rule, manufacturers, distributors and retailers
cannot distribute free samples of tobacco
products, including their components and parts. This free sample
prohibition is already in effect for cigarettes and
smokeless tobacco, with an exception for smokeless
tobacco products that are distributed in a qualified
adult only facility. In addition, all newly
deemed tobacco products will be subject to the
modified risk provisions in section 911
of the FD&C Act. For example, section 911
prohibits introducing into interstate commerce
products that are labeled or advertised as having a
“lower risk” or as “less harmful” than other
marketed products, unless they have an FDA
order in effect. This provision took
effect on August 8, 2016. In addition, there is a
different compliance date for newly deemed tobacco
products that are labeled or advertised using
the descriptors “low”, “light”, or “mild” or
similar descriptors, without an FDA
order in effect. Products that are labeled
or advertised with these types of modified risk
descriptors cannot be manufactured beginning
August 8, 2017, and cannot be distributed beginning
September 8, 2017, without a marketing
order from FDA. These modified risk
tobacco product restrictions are already
in effect for cigarettes, cigarette tobacco,
roll-your-own-tobacco, and smokeless tobacco. It is important to note
that there are marketing requirements for certain
newly deemed products. For products that were on
the market as of August 8, 2016 but after February
15, 2007- FDA expects that manufacturers will submit
a marketing application for these newly regulated
products within the specified compliance
period, but no later than 24 months from the
effective date (or by August 8, 2018). FDA expects that
manufacturers will continue selling their
products for up to three years while they submit
and FDA reviews their applications. For products that are
first marketed after August 8, 2016, a
premarket authorization from FDA is required prior
to marketing that product. Now, IF your product is
eligible for grandfather status, which means it
was on the market as of February 15, 2007 and was
not modified after that date, such products are
not subject to premarket review requirements. As discussed earlier,
there are additional restrictions for “covered
tobacco products” – covered tobacco products
are the newly deemed products, except for
components or parts that are not made or
derived from tobacco. As of August 8th, 2016,
the following provisions took effect for covered
tobacco products. Retailers, including
online retailers: o Are not allowed to sell
(covered) tobacco products to persons under
the age of 18. This requirement applies
to traditional “brick and mortar” retail
establishments as well as online retailers o Are
required to verify the purchaser’s age by photo
ID for persons less than 27 years of age – it is
a violation to sell newly deemed tobacco products
to anyone under the age of 18. It is the responsibility
of the online retailer to take appropriate steps to
ensure that they do not sell tobacco products to
anyone under the age of 18. Retailers are not allowed
to sell covered tobacco products in vending
machines (or other forms of electronic or
mechanical devices) except in a facility where no
one under the age of 18 is permitted to enter at
any time (or adult-only facility). When FDA sees violations
of these requirements and restrictions, what
action does it take? CTP has issued Warning
Letters for violations of the FD&C Act in the past
and will continue to issue Warning Letters to the
tobacco industry for violations under the
Deeming Rule to address the sale, distribution and
marketing of misbranded and adulterated tobacco
products to U.S. consumers. Future Warning Letters
might include violations for selling covered
tobacco products to minors online, selling or
distributing deemed products in interstate
commerce as modified risk tobacco products without
an FDA order, distributing free samples of tobacco
products, or advertising or labeling that does
not contain the requisite health warnings, among
other violations that may be found through our
surveillance program. Tell us more about
warning letters. In general, FDA issues
warning letters for violations of
regulatory significance. Warning Letters are an
agency advisory action which is meant to notify
regulated industry of violations, achieve prompt
voluntary compliance with the FD&C Act and
establish prior notice. A Warning Letter contains
a description of each documented violation and
requests a response from a firm within 15 working
days of the Warning Letter’s receipt. The response should
describe corrective actions and a plan for
maintaining compliance with the FD&C Act. It is FDA’s practice
to provide a firm the opportunity to voluntarily
and promptly take corrective action
before FDA initiates an enforcement action. It is the regulated
industry’s responsibility to ensure tobacco products
and all related labeling and advertising comply
with the FD&C Act and its implementing regulations. Failure to correct the
violations and come into full compliance with the
FD&C Act may result in FDA initiating further action
without notice, including, but not limited to,
civil money penalties, no-tobacco-sale orders,
criminal prosecution, seizure, and/or
injunction. Warning Letters are
posted on the FDA website. You can search for them
in either of the top two links listed
in this slide. Now let’s switch gears
and discuss some common violations that may be
found in Warning Letters. A Warning Letter may
contain a number of violations for tobacco
products, for example: making FDA-approved
claims; selling to minors online; introducing
modified risk tobacco products into interstate
commerce without an order from FDA; flavored
cigarette, cigarette tobacco, or roll-your-own
tobacco products; advertising smokeless
tobacco products without any accompanying health
warning statements; or selling “Not Substantially
Equivalent” or NSE products in
interstate commerce. Is it a violation for
a firm to claim that a product is
approved by FDA? Section 301(tt) of the
FD&C Act prohibits making statements or
representations to consumers on a product
label or in product labeling, advertising, or
in the media in such a way that would convey or
mislead a consumer into believing that: o A
product is approved by FDA, o FDA deems the
product to be safe for consumer use, o The
product is endorsed by FDA for consumer use, or o The
product is safe or less harmful because it is
regulated or inspected by FDA or is in compliance
with FDA regulations. This example Warning
Letter cites a firm for violation of
section 301(tt). Specifically, the firm
stated on its website that its products were
made with “F.D.A. approved liquid.” This
example Warning Letter also cites a firm for
violation of Section 301(tt). The firm included an image
of the FDA logo with the word “Approved”
directly underneath. And what about
sales to minors? A minor is a person
younger than 18 years of age. Prior to the deeming rule,
FDA regulations stated that retailers may not
sell cigarettes, smokeless tobacco, cigarette
tobacco, or roll your own tobacco to minors either
in-store or online. With Deeming, this
prohibition has been extended to covered
tobacco products, including but not limited
to ENDS, cigars, pipe tobacco, hookah,
and dissolvables. This restriction is
currently in effect. Covered tobacco products
means any tobacco product deemed to be subject to
the FD&C Act, but excludes any component or part of
a tobacco product that is not made or derived
from tobacco. And just to reiterate –
The prohibition on sales to minors includes
online sales. This example Warning
Letter cites a firm for violation of section 1140
for selling a regulated tobacco product to a
minor over the Internet. Here is another example. This Warning Letter cites
a firm for violation of section 1140 for selling a
regulated tobacco product to a minor on its website. Now I’m going to discuss
Modified Risk Tobacco Products. As previously discussed,
a Modified Risk Tobacco Product (or MRTP) is
defined under section 911(b)(1) as “any tobacco
product that is sold or distributed for use to
reduce harm or the risk of tobacco-related
disease associated with commercially marketed
tobacco products.” Under section 911(a), no person
may introduce or deliver for introduction into
interstate commerce any modified risk tobacco
product without an order in effect issued by
FDA pursuant to section 911(g). So what are MRTPs? First, any regulated
tobacco product with a label, labeling, or
advertising that uses “light,” “mild,” “low,” or
similar descriptors is an MRTP. A regulated tobacco
product may also be an MRTP if its label,
labeling, or advertising represents explicitly or
implicitly that: o The tobacco product
presents a lower risk of tobacco-related disease or
is less harmful than other commercially marketed
tobacco products; o The tobacco product or its
smoke contains a reduced level or reduced exposure
to a substance; or o The tobacco product or its
smoke does not contain a substance or is
free of a substance. Examples include: “low
tar” or “low nicotine” or “less harmful” claims. Lastly, an MRTP is
a product where the manufacturer “has taken
any action that would be reasonably expected
to result in consumers believing that the tobacco
product or its smoke may present a lower risk of
disease or is less harmful than one or more
commercially marketed tobacco products, or
presents a reduced exposure to, or does not
contain or is free of a substance.” When are these
provisions in effect? These provisions for
Low, Light, and Mild are currently in effect for
cigarettes, smokeless tobacco, cigarette tobacco
and roll-your-own tobacco. The effective dates with
regard to newly deemed tobacco products and
“Light,” “Mild,” or “Low” will be: o The Stop Date
For Manufacturing – As of August 8, 2017,
manufacturers are prohibited from
manufacturing these products. o The Stop Date For
Distribution – As of September 8, 2017,
manufacturers and importers of finished
tobacco products are prohibited from
introducing these products into domestic commerce. Importers of finished
tobacco products are also considered to be tobacco
product manufacturers. The effective dates with
regard to MRTPs other than “Light,” “Mild,” or “Low”
are: o For cigarettes, smokeless tobacco,
cigarette tobacco and roll-your-own tobacco,
these provisions are currently in effect and
all regulated entities are prohibited from
introducing these products into domestic commerce
without having an FDA order in effect. o This prohibition
extended to newly deemed tobacco products on August
8, 2016 which is the effective date of
the deeming rule. o More information can be
found in the Guidance for Industry and FDA Staff
located on the FDA website. This example Warning
Letter cites a firm for an MRTP violation. The firm’s website
advertises smokeless tobacco products as being
less harmful with claims such as “snuff is
healthier than smoking” and “snuff allows you
to experience nicotine without the potentially
lethal effects of … tar contained in cigarettes.”
MRTP claims such as these are currently prohibited
for newly deemed products without an FDA
order in effect. Product packaging and
advertising for smokeless tobacco products must
carry one of four required warning label statements. The use of these warning
label statements must be in accordance with
an FDA-approved plan. Failure to have these
required warning label statements on smokeless
tobacco products is a violation of sections
903(a)(1) and/or 903(a)(7)(A) of
the FD&C Act. This example Warning
Letter cites a firm for advertising smokeless
tobacco products without the required health
warnings on its website. Where can our audience
find more information? For more information on
these topics, please note the link, email and phone
number appearing on the slide. Thank you Anthony. This concludes
today’s webinar. I’d like to close by
thanking all of you for your participation in
today’s broadcast, which was brought to you by
the Center for Tobacco Products – protecting our
kids, and the nation’s health from tobacco.

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