WARNING LETTER
Mountain Vaporz LLC
MARCS-CMS 584670 —
August 22, 2019
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Kim Predmore
Mountain Vaporz LLC
2756 Route 611, Suite 101
Tannersville
,
PA
18372
United States
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
AUG 22, 2019
VIA UPS and Electronic Mail
Mountain Vaporz, LLC
Attn: Kim Predmore
2756 Route 611, Suite 101
Tannersville, PA 18372
mountainvaporz@msn.com
WARNING LETTER
Dear Kim Predmore:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website
https://mountainvaporz.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 your Caramel Frappe 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. FDA has also determined that the e-liquid products advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website regarding e-liquid products fails to include the required nicotine warning statement for these e-liquid products. Additionally, FDA has determined that your Caramel Frappe e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because the labeling for this product that you manufacture, advertise, and offer for sale or distribution in the United States does not display the required nicotine warning statement, in the manner required by 21 C.F.R. §1143.3.
Sales to Minors Violation
FDA’s investigation of
the website
https://mountainvaporz.com
revealed that you sold an e-liquid product
to a minor.
Specifically,
during our investigation of
https://mountainvaporz.com
,
a person younger than 18 years of age purchased Caramel Frappe 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)).
E-Liquid Products with Labeling and/or Advertising that Fail to Include the Required Nicotine Warning Statement are Misbranded
Additionally, our review of the website
https://mountainvaporz.com
revealed that the labeling and/or advertising for several e-liquid products that you manufacture, advertise and offer for sale or distribution in the United States does not include the required nicotine warning statement, for example: Alien Blood, Apple, Banana Cream Pie, Bombies, Caramel Frappe, and Johnny Rancher.
In addition, our review of the labeling for the Caramel Frappe e-liquid product revealed that the labeling for this product that you manufacture, advertise, and offer for sale or distribution in the United States does not display the required nicotine warning statement, in the manner required by 21 C.F.R. §1143.3. For example, the labeling for Caramel Frappe e-liquid does not display the required nicotine warning statement. Instead, it states: “
WARNING! This product
may
contain Nicotine. Nicotine is an addictive chemical.” (21 C.F.R.
§ 1143.3(a)(1)) (emphasis added).
Under 21 C.F.R § 1143.3, labeling and/or advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products must bear the following warning statement:
WARNING: This product contains nicotine. Nicotine is an addictive chemical.
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the following required warning statement on the package label: “WARNING:  This product contains nicotine.  Nicotine is an addictive chemical” (21 C.F.R. § 1143.3(a)).
It also is unlawful for such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)). Under 21 C.F.R.              § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 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 products cited in this violation are “covered tobacco products.” 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 1143.
Because your website regarding e-liquid products does not include the required nicotine warning statement for these products, and because the labeling for the Caramel Frappe e-liquid product does not display the required nicotine warning statement for this product, in the manner required by 21 C.F.R. § 1143.3, in violation of 21 C.F.R. § 1143.3(a) and 21 C.F.R. § 1143.3(b), these e-liquid products are 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 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 that any adulterated or 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 do not believe that your products are 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, RW1901110, 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:
Mountain Vaporz North
Attn: Kim M. Predmore
2668 Route 940 Unit 102
Pocono Summit, PA 18346
Mountain Vaporz
Attn: Kim Predmore
296 Wilke Road
Tannersville, PA 18372
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abuse@godaddy.com
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Content current as of:
09/03/2019
Regulated Product(s)
Tobacco