WARNING LETTER
https://www.vapevandal.com
MARCS-CMS 575722 —
March 29, 2019
Product:
Tobacco
Recipient:
Recipient Name
Benedict Tan
https://www.vapevandal.com
United States
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
VIA Electronic Mail
MAR 29, 2019
Benedict Tan
V Star Enterprises
vapevandal@gmail.com
WARNING LETTER
Dear Benedict Tan:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your website
https://www.vapevandal.com
and determined that V Star Enterprises offers for sale or distribution cigarette products 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 cigarette products, 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 Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS) cigarette product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) for not having a required FDA marketing authorization order in effect, and/or misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a required notice or other information respecting the product was not provided.  FDA has also determined that your Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS) cigarette 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.  Additionally, FDA has determined that your Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS) cigarette product is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because it purports to contain a natural or artificial characterizing flavor.
New Tobacco Products Without Required Marketing Authorization are Adulterated and Misbranded
FDA’s review of the website
https://www.vapevandal.com
revealed that you sell and/or distribute to customers in the United States the following cigarette product that does not have a marketing authorization order:
Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS).
The FD&C Act requires premarket review for any “new tobacco product,” which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)).  This means that, without a marketing authorization order, it is a prohibited act to sell or distribute the product in interstate commerce, to import such products into the United States, or to receive from interstate commerce and sell or offer to sell or otherwise deliver the product.
FDA has determined that the following cigarette product was not commercially marketed in the United States as of February 15, 2007: Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS).  Because this product is required to have premarket review and does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act, this product is adulterated under section 902(6)(A) of the FD&C Act. In addition, because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)), this product is misbranded under section 903(a)(6) of the FD&C Act.  The introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)).
Tobacco Products Sold to Minors Are Misbranded
FDA’s investigation of the website
https://www.vapevandal.com
revealed that you sold a cigarette product to a minor. Specifically, during our investigation of
https://www.vapevandal.com
, a person younger than 18 years of age purchased Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS) from your website. No retailer may sell cigarettes, cigarette tobacco and/or roll-your-own tobacco, or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a). 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(a), this product is misbranded under section 903(a)(7)(B) of the FD&C Act.
Cigarettes with a Characterizing Flavor Are Adulterated
Additionally, our review of the website
https://www.vapevandal.com
revealed that you offer for sale or distribute the following cigarette product:
Marlboro - Mint 200 Heat Sticks (Designed for use with IQOS).
This product is purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
Cigarettes that are distributed or offered for sale in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).  Thus, your flavored cigarette product is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, the cigarette product does not contain a characterizing flavor, it is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as its labeling or advertising is false or misleading because it makes the representation that the product contains, for example, mint as a characterizing flavor of the tobacco product.
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), and in any other media in which you advertise 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, RW1901050, 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 Electronic Mail
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Content current as of:
04/09/2019
Regulated Product(s)
Tobacco