WARNING LETTER
VallHund Vapes Inc.
MARCS-CMS 553031 —
May 10, 2018
Recipient:
VallHund Vapes Inc.
United States
Issuing Office:
Center for Tobacco Products
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
May 10, 2018
VIA Electronic Mail
Michael Mario De Pinto
VallHund Vapes Inc.
vallhundvapes@gmail.com
WARNING LETTER
Dear Michael Mario De Pinto:
This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.vallhundvapes.com and determined that the e-liquid 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, 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)).
False or Misleading Violation
FDA has determined that your Chill Purple Grape e-liquid is 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)) because its labeling and/or advertising is false or misleading.
FDA’s investigation of the website http://www.vallhundvapes.com revealed that it sells or distributes Chill Purple Grape e-liquid with labeling and/or advertising that causes it to imitate a food or beverage, particularly one that is marketed toward, and/or appealing to, children (see Exhibit A). Specifically, the labeling and/or advertising of the product looks very similar to the labeling and/or advertising for grape soda products that are marketed toward, and/or appealing to, children (see Exhibit B). For example, the labeling and/or advertising for Chill Purple Grape e-liquid includes statements and representations, such as “Purple Grape,” “Refreshing Soda Flavor,” an illustration depicting a bunch of purple grapes, as well as a label on the back that is substantially similar to a food Nutrition Facts label. In addition, the labeling and/or advertising of Chill Purple Grape e-liquid includes a cylindrical shape and design that is substantially similar to a soda can; a foil covering on the top of the can that is substantially similar to soda cans in Exhibit B; the appearance of a soda-can tab when the foil covering is removed; and a color scheme that is substantially similar to soda cans in Exhibit B. Further, Chill Purple Grape e-liquid has a strong scent like grape soda. This labeling and/or advertising causes the product to imitate a food or beverage, particularly one that is marketed toward, and/or appealing to, children and is therefore misleading.
Children are at particular risk for ingesting e-liquid products with labeling and/or advertising that causes the product to imitate a food or beverage, particularly a food or beverage that is typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to the nicotine in the e-liquid product, even in relatively small amounts, could result in acute toxicity.  Child poisonings due to the ingestion of liquid nicotine have recently increased substantially.  Severe harms can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory arrest.
Given that the labeling and/or advertising for Chill Purple Grape e-liquid describes its nicotine content as 6mg/mL, with a total volume of 60mL, an accidental ingestion of approximately half a teaspoon would reach the lower end of the fatal dose range for an average two-year-old.  Additionally, an accidental ingestion of approximately 2% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old.
The FD&C Act provides, in part, that a tobacco product shall be deemed to be misbranded (1) if its labeling is false or misleading in any particular (section 903(a)(1)), or (2) if the tobacco product is distributed or offered for sale in any State and its advertising is false or misleading in any particular (section 903(a)(7)(A)). The labeling and/or advertising for Chill Purple Grape e-liquid is misleading because it causes the product to imitate soda, particularly one that is marketed toward, and/or appealing to, children.  Therefore, the product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act.
Sales to Minors Violation
Additionally, FDA has determined that your Chill Purple Grape 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’s investigation of the website http://www.vallhundvapes.com revealed that you sold an e-liquid
product to a minor.
Specifically,
during our investigation of http://www.vallhundvapes.com, a person younger than 18 years of age purchased Chill Purple Grape 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)).
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 the ones 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 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 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, RW1800854, 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, 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 Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Close Out Letter
VallHund Vapes Inc. - Close Out Letter 7/13/18
Content current as of:
05/10/2018