WARNING LETTER
Smokers Outlet Online
MARCS-CMS 556344 —
May 31, 2018
Product:
Tobacco
Recipient:
Recipient Name
Frederick Fogelman
Smokers Outlet Online
4585 W Market St
York
,
PA
17408-6111
United States
Issuing Office:
Center for Tobacco Products
United States
MAY 31, 2018
VIA UPS and Electronic Mail
Smoker’s Outlet Online
Attn:
Frederick Fogelman
4585 W Market St
York, PA 17408-6111
customerservice@smokersoutletonline.com
WARNING LETTER
Dear Frederick Fogelman:
The Center for Tobacco Products of
the U.S.
Food and Drug Administration (FDA) recently reviewed the website
https://www.smokersoutletonline.com
and determined that
the electronic nicotine delivery system (ENDS) products
listed there are offered for sale or distribution to customers in the United States.  Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention
and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.  Certain tobacco products, including ENDS, are subject
to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that
your
Blu Disposable E-cigarettes Magnificent Menthol
ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product
to a person younger than 18 years of age.
Sales to Minors Violation
FDA’s investigation of the website
https://www.smokersoutletonline.com
reve
aled that you sold an
ENDS product
to a minor
.
Specifically,
during our investigation of
https://www.smokersoutletonline.com
, a person younger than 18 years of age purchased Blu Disposable E-cigarettes Magnificent Menthol
ENDS product from
your website
.
No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as ENDS products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b).  Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco.  Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act.  21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations.  The product cited in this violation is a “covered tobacco product.”  Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded
if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R
. Part 1140.
Because this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is
misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Conclusion and Requested Actions
The violation discussed in this letter does not necessarily constitute an exhaustive list.  You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is
your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website
, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.
Failure to ensure 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.  Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.  You can find the FD&C Act through links on FDA’s homepage at
http://www.fda.gov
.
Please note your reference number, RW1400158, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235
or via email at
CTPCompliance@fda.hhs.gov
.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Smoker’s Outlet Online
Attn: John Peeler
75 Acco Drive
Suite A-12
York, PA 17349
it-vendors@smokersoutletonline.com
Smoker’s Outlet
Attn: Frederick Fogelman
1100 Mt Rose Ave
York, PA 17403
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Content current as of:
11/27/2018
Regulated Product(s)
Tobacco