WARNING LETTER
Big Ds Vape House
MARCS-CMS 580352 —
May 17, 2019
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Dennis Carman
Big Ds Vape House
13919 S. Plaza
Omaha
,
NE
68137
United States
owner@bigdsvapehouse.com
bigdsvapehouse@yahoo.com
Issuing Office:
Center for Tobacco Products
United States
MAY 17, 2019
WARNING LETTER
Dear Dennis Carman:
The Center for Tobacco Products of
the U.S.
Food and Drug Administration (FDA) recently reviewed the website https://bigdsvapehouse.com and determined that the e-liquid products listed there are manufactured and 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, these products are tobacco products because they are made or derived from tobacco and intended for human consumption.  Certain tobacco products, including e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that the Banana Nut Bread e-liquid 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. Additionally, FDA has determined that a statement or representation you made on the search engine description for your website
https://bigdsvapehouse.com regard
ing your e-liquids violates section 301(tt) of the FD&C Act (21 U.S.C. § 331(tt)) because it is directed to consumers and conveys, misleads, or would mislead consumers into believing that the tobacco products are approved by FDA.
Sales to Minors Violation
FDA’s investigation of the website https://bigdsvapehouse.com revealed
that you sold an e-liquid product
to a minor.
Specifically,
during our investigation of https://bigdsvapehouse.com, a pe
rson younger than 18 years of age purchased Banana Nut Bread e-liquid
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 electronic nicotine delivery system (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)).
Section 301(tt) Violation
FDA has determined that a statement or representation that you made on the search engine description for your website
https://bigdsvapehouse.com regarding the
e-liquid products violates section 301(tt) of the FD&C Act (21 U.S.C. § 331(tt)), which prohibits:
“[m]aking any express or implied statement or representation directed to consumers with respect to a
tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—
the product is approved by the Food and Drug Administration;
the Food and Drug Administration deems the product to be safe for use by consumers;
the product is endorsed by the Food and Drug Administration for use by consumers; or
the product is safe or less harmful by virtue of—
its regulation or inspection by the Food and Drug Administration; or
its compliance with regulatory requirements set by the Food and Drug Administration…”
Specifically, the e-liquid products are sold or distributed on the website to customers in the United States, including, for example: Capt. Berry Crunch, Andeez Mint, Overnight Orgasm, Hard Explosion, Got Off, Blueberry Twinkeez, Capt. Ohmerica, Big D’s Cinnamon Roll, Banana Cream Pie, and Banana Sweet Flakes, with the statement “Big D's Vape House Sells FDA approved handcrafted e-juice and vaping supplies since June 14, 2014” on the search engine description that you made for your website.  Because this statement or representation in the search engine description that you made for your website is directed to consumers and conveys, misleads, or would mislead consumers into believing that the tobacco products are approved by FDA, they are in violation of section 301(tt) of the FD&C Act.
Misbranded Tobacco Products
FDA has also determined that the e-liquid products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).  Section 903(a)(1) of the FD&C Act provides that a tobacco product is misbranded if its “labeling is false or misleading in any particular.”  Section 903(a)(7) of the FD&C Act provides that a tobacco product distributed or offered for sale in any State is misbranded if its “advertising is false or misleading in any particular.”  These e-liquid products are misbranded under section 903(a)(1) of the FD&C Act and/or section 903(a)(7)(A) of the FD&C Act as their labeling or advertising is false or misleading because it makes the statement or representation that the products are FDA approved.
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list.  You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those 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 any 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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  You can find the FD&C Act through links on FDA’s homepage at
http://www.fda.gov
.
Please note your reference number,
RW1901088
, 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:
Dennis Carman
Big D’s Vape House, LLC
15057 Atlas Plaza
Omaha, NE  68137
bigd@bigdsvapehouse.com
Big D’s Vape House, LLC
527 E 25
th
St Ste 1 # 2
Kearney, NE  68847
Big D’s Vape House, LLC
3140 Elk Ln Ste 100
Fremont, NE  68025
USCA, INC.
1603 Farnam Street
Omaha, NE  68102
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
06/11/2019
Regulated Product(s)
Tobacco