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  5. Vapor Boss - 617451 - 09/01/2021
  1. Warning Letters

WARNING LETTER

Vapor Boss MARCS-CMS 617451 —

Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Robert Garcia
Vapor Boss

17218 Foothill Blvd., Unit 101
Fontana, CA 92335
United States

support@vaporboss.com
vaporboss.us@gmail.com
vaporbossllc@gmail.com
Issuing Office:
Center for Tobacco Products

United States

September 1, 2021

WARNING LETTER

Dear Robert Garcia:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://vaporboss.com and determined that the electronic nicotine delivery system (ENDS) 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)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including ENDS products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1. Therefore, ENDS products are required to be in compliance with the requirements in the FD&C Act.

Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the FD&C Act. These products include, but are not limited to, ENDS (including e-cigarettes and e-liquids), cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.

Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, 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) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and 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) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).

New Tobacco Products Without Required Marketing Authorization are Adulterated and Misbranded

Our review of the website https://vaporboss.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS products, under Vapor Boss brand, without a marketing authorization order including: Boss Bar I Love Licorice and Boss Bar Mango.

The ENDS products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act. In addition, these products are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act.

Conclusion and Requested Actions

Your firm is a registered manufacturer with over 200 products listed with FDA. FDA received your Premarket Tobacco Product Application (PMTA) assigned STN PM0001802 on September 9, 2020, which covers 20 products. However, FDA issued a negative action for PMTA STN PM0001802 in the form of a refuse to accept determination on January 8, 2021. As discussed above, new tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001802 that resulted in a refuse to accept determination, are adulterated and misbranded. For information on how FDA intends to prioritize enforcement resources with regard to the marketing of certain adulterated and misbranded ENDS and other deemed new tobacco products, please refer to the FDA’s guidance titled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market.

It is your responsibility to ensure that all of 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 address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, no-tobacco-sale orders, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.

The violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C Act.

Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, 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. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

Please note your reference number, RW2101615, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and 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:

Vapor Boss LLC,
Attn: Robert Garcia
5145 Congemi Ct
Rancho Cucamonga, CA 91739

Vapor Boss
Attn: Robert Garcia
8550 Nuevo Ave
Fontana, CA 92335

Vapor Boss
Attn: Robert Garcia
12125 Day St Ste J303
Moreno Valley, CA 92557

Vapor Boss
Attn: Robert Garcia
959 W Foothill Blvd
Upland, CA 91786

Vapor Boss
Attn: Robert Garcia
225 S Riverside Ave
Rialto, CA 92376

Vapor Boss
Attn: Robert Garcia
105 W Arrow Hwy
San Dimas, CA 91773

Contact Privacy Inc. Customer 0153798779
vaporboss.com@contactprivacy.com

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