Retailer’s Guide to “Covered” Tobacco Products: Webinar


Welcome to this edition of
FDA’s Tobacco Compliance Webinars – Information and
Education for Retailers and Small Businesses,
brought to you by the Food and Drug Administration
and the Center for Tobacco Products. I’m David Racine,
thanks for joining us. Today we will be talking
about “covered” tobacco products and joining me
to discuss why tobacco retailers should be
familiar with the term “covered” tobacco
products is Paul Gouge, a regulatory counsel in the
Office of Compliance and Enforcement. Now, let me go ahead and
turn the program over to Paul. Thanks David. The term “covered tobacco
product” comes from FDA’s final rule titled:
“Deeming Tobacco Products To Be Subject to the
Federal Food, Drug, and Cosmetic Act (or the FD&C
Act), as Amended by the Family Smoking Prevention
and Tobacco Control Act; Restrictions on the
Sale and Distribution of Tobacco Products
and Required Warning Statements for Tobacco
Products” – In short, we refer to this simply
as the “deeming rule”. During this webinar I’ll
talk about some of the regulations or
“restrictions” that apply to “covered” tobacco
products and I will provide you with
some examples. If you’re a retailer,
and you sell a “covered” tobacco product, you
should become familiar with these restrictions so
that you can comply with the law. Before we go into what
products are “covered” products, let’s briefly
look at the restrictions in place. First – “covered” tobacco
products cannot be sold to anyone under 18
years of age. There are no exceptions. Second – Retailers MUST
verify the date of birth of purchasers of these
products by photo ID if they are under age 27. And Third – It is not
permitted to sell these products using electronic
or mechanical devices, such as a vending machine,
unless it is in a facility where no person under 18
is present or allowed to enter at any time. And finally – I want to
mention that free samples of all tobacco products
are prohibited, except for smokeless tobacco
distributed in a qualified adult-only facility. There are other
requirements for covered tobacco products that will
become effective in the future. Once these other
requirements become effective, “covered”
tobacco products will be required to display health
warnings on their package labels and advertisements. Cigar products will need
to display one of six warnings on product
packaging and advertisements. These warnings must be
rotated quarterly in accordance with an
approved warning plan. These requirements are not
yet in effect so we are not going to discuss them
further for this webinar. If you’d like to find
out more about upcoming requirements, their
effective dates, and the safe harbor provision for
certain retailers, please visit our website. In order for you to comply
with the restrictions that we previously mentioned,
we’ll need to first describe what a “covered”
tobacco product is. The term “covered tobacco
product” under the deeming rule means: Any tobacco
product deemed by the final rule to be subject
to the FD&C Act, but it excludes any component or
part that is not made or derived from tobacco. Let’s take a closer look
at this definition of a “covered tobacco product”. The first part says: Any
tobacco product deemed by the final rule to be
subject to the Food, Drug, and Cosmetic Act. Congress gave the FDA
the authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless
tobacco, including components, parts and
accessories, and other tobacco products that
the agency, through regulation, deems to be
subject to its tobacco product authorities. On May 10th 2016, FDA
published the Final Deeming rule. This rule deemed all
products that met the definition of a tobacco
product subject to FDA’s tobacco product
authorities. This includes components
and parts of newly deemed tobacco products, however,
specifically excludes the accessories of
these products. The deeming rule became
effective on August 8, 2016. Specifically, some
examples of newly regulated tobacco products
under the deeming rule include: Electronic
Nicotine Delivery Systems such as e-cigarettes and
vape pens; Pipe Tobacco, Cigars and Hookah or
Waterpipe tobacco. If you sell ANY of these
products, you need to be aware of the regulations
that we’ll discuss throughout this webinar. Before we get into those
regulations, we’ll need to take a quick look at what
we mean by both “component or part” and “accessory”
of the newly deemed products. “Component or part” means
any software or assembly of materials that is
intended or reasonably expected to: Alter
or affect the tobacco product’s performance,
composition, constituents or characteristics; or be
used with or for the human consumption of a tobacco
product, AND is not an accessory of a
tobacco product. This is important to
understand because components or parts
of deemed products are regulated by FDA but are
not necessarily “covered” tobacco products. Here are some examples of
components or parts of the newly deemed products. As you see on the slide, a
coil would be a component or part of an ENDS product
because it would alter or affect the tobacco
product’s performance, composition, constituents,
or characteristics. Likewise, heating charcoal
would be a component or part of hookah tobacco. Therefore, these products
are regulated by FDA as components or parts
of tobacco products. In contrast, accessories
of newly deemed products are NOT regulated under
FDA’s tobacco authorities because they are not
deemed by the new regulation. You can see the definition
of an accessory on this slide and we’ll see some
examples of accessories on the next slide. Now, keep in mind that
accessories of tobacco products other than the
newly deemed tobacco products ARE still
regulated under FDA’s tobacco authorities. This slide shows some
examples of ACCESSORIES of NEWLY Regulated
Tobacco PRODUCTS. Hookah tongs, pipe
pouches, and humidors are all examples
of accessories. Because they are
accessories, they are not subject to the new
requirements of the deeming rule. Now that we know what the
terms components or parts and accessories mean,
let’s take another look at the definition for
a “covered” product. The term “covered tobacco
product” under the deeming rule means: Any tobacco
product deemed by the final rule to be subject
to the FD&C Act, BUT specifically excludes any
component or part that is not made or derived
from tobacco. So, looking at the
definition, heating charcoal, which we just
heard was a component or part of hookah tobacco,
is not a covered tobacco product. Although it is a component
or part of a deemed tobacco product, it is
not made or derived from tobacco. Because of this, it would
be excluded from the definition of a “covered”
tobacco product. This means that it is
regulated by the FDA, but that it doesn’t fall under
the same restrictions that a “covered” tobacco
product would. Here’s another way that
you can easily determine whether or not a tobacco
product is a “covered” tobacco product. To do so, simply ask
these three key questions. Does the product meet the
statutory definition of a “tobacco product”? In other words, is it made
or derived from tobacco and intended for human
consumption, including any component, part, or
accessory of a tobacco product? Is the tobacco product
deemed by the final rule to be subject
to the FD&C Act? If the “deemed” tobacco
product IS a part or component, is it made
or derived from tobacco? If the answer toanyof
these questions is NO, then the product is NOT a
“covered” tobacco product. Now, let’s take a look at
some examples to better understand this concept. In this example, we are
looking at a cigar that is sold directly
to consumers. Let’s go through the
questions to determine if this is a “covered”
tobacco product or not. First, does the product
meet the statutory definition of a
“tobacco product”? For this product, it
is made or derived from tobacco and intended
for human consumption. Therefore, the
answer is YES. Next, Is the tobacco
product deemed by the final rule to be
subject to the FD&C Act? As noted earlier, the
Deeming Rule deemed all products meeting the
statutory definition of tobacco product, other
than cigarettes, cigarette tobacco, roll-your-own
tobacco, smokeless tobacco, and accessories
of newly deemed tobacco products. Is this one of those
deemed products? Yes – as previously
discussed, cigars meet the statutory definition of
a tobacco product and are not one of the four
originally regulated categories (cigarettes,
cigarette tobacco, roll-your-own tobacco, and
smokeless tobacco), and they are NOT an accessory. Therefore, they
are deemed. If the “deemed” tobacco
product is a part or component, is it made
or derived from tobacco? A cigar is not a part or a
component, therefore this third question is
not applicable. We didn’t answer NO to any
of these three questions. Therefore this cigar
meets the definition of a “covered” tobacco product
and will be subject to retailer restrictions. Let’s go to
another example. Here, you see pipe tobacco
sold to a consumer. Once again, let’s
go through the three questions and if any of
the answers is NO, then the product would NOT
be a “covered” product. First, does the product
meet the statutory definition of a
“tobacco product”? For this product, it
is made or derived from tobacco and intended
for human consumption. Therefore, the
answer is YES. Next, is the tobacco
product deemed by the final rule to be
subject to the FD&C Act? Yes – as discussed
previously, pipe tobacco is deemed by the final
rule and this is NOT an accessory. Finally, If the “deemed”
tobacco product is a part or component, is it made
or derived from tobacco? Again, this is not
applicable – Pipe tobacco is NOT a part
or a component. We didn’t answer NO to any
of the three questions. Therefore pipe tobacco
meets the definition of a “covered” tobacco product
and will be subject to the applicable restrictions. In our next example,
we are looking at an E-cigarette replacement
battery that is sold separately to consumers. First, Does the product
meet the statutory definition of a
“tobacco product”? For this product,
the answer is YES. A replacement battery IS a
part or a component of an electronic nicotine
delivery system or ENDS. Second, is the tobacco
product deemed by the final rule to be
subject to the FD&C Act? Yes – parts or components
of an ENDS product are deemed by the final rule. As we showed earlier,
this is NOT an accessory. Finally, the
third question: If the “deemed” tobacco
product is a part or component, is it made
or derived from tobacco? In this case the
answer is NO. The replacement battery,
which IS a part or component of an ENDS
product, is NOT made or derived from tobacco. Since we answered NO to
one of our 3 questions, this e-cigarette
replacement battery that is sold separately
to consumers is NOT a “covered” tobacco product
and is therefore NOT subject to the
restrictions for covered tobacco products. In our last example, we
have Hookah tongs sold separately to consumers. Again, we go through
these three questions… First, does the product
meet the statutory definition of a
“tobacco product”? For this product, the
answer is yes because the hookah tong is an
accessory of the hookah tobacco which makes it a
tobacco product under the definition. Second, is the tobacco
product deemed by the final rule to be
subject to the FD&C Act? No – As we mentioned
previously, accessories of the newly deemed tobacco
products are NOT covered under the deeming rule. The third question is not
applicable since hookah tongs are not deemed
and are NOT a part or component. Since we answered NO to
one of our 3 questions, we now know that hookah
tongs sold separately to consumers are not a
“covered” tobacco product and are therefore
NOT subject to the restrictions for covered
tobacco products. Remember, it’s important
to know if a tobacco product is a “covered”
tobacco product under the deeming rule. If it is, the restrictions
that I mentioned at the top of this webinar apply. Here’s a quick reminder
of those restrictions that are in effect for
covered tobacco products. Remember that for covered
tobacco products: A retailer may not sell to
individuals under the age of 18 years and must
be sure to check the customer’s age using photo
identification if they are under 27 years old. Secondly, a retailer may
not sell using electronic or mechanical devices. For instance, retailers
may not use vending machines to sell covered
products unless the machine is in a facility
where no person under 18 is allowed to
enter at any time. Finally, keep in mind that
retailers may not give away free samples of
any tobacco product. There are other
requirements for covered tobacco products that will
become effective in the future. You will be able to find
out more information about those dates and
restrictions on our website. That brings me to
the conclusion of my presentation. Hopefully you now
understand what a covered tobacco product is, and
remember the restrictions regarding the sale
of these products. David… Thanks Paul – If you
still have questions about “covered” tobacco
products, please contact us at [email protected]
or call us at 1-877-CTP-1373. Thanks again to Paul and
thanks to all of you for watching this program,
brought to you by the Center for Tobacco
Products, protecting our kids and the nation’s
health from tobacco.

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