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  5. South Texas Vapor - 607361 - 06/11/2020
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WARNING LETTER

South Texas Vapor MARCS-CMS 607361 —

Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Jesus Torres
Recipient Title
Owner
South Texas Vapor

5300 San Dario Avenue, Suite 138
Laredo, TX 78041
United States

jesustorresldo@gmail.com
Issuing Office:
Center for Tobacco Products

United States

WARNING LETTER

Dear Mr. Torres:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that South Texas Vapor manufactures and distributese-liquid products for commercial distribution in the United States, and that the e-liquid products 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 e-liquid 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.

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 Act. These products include, but are not limited to, electronic nicotine delivery systems (including ecigarettes), 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.

A New Tobacco Product Without Required Marketing Authorization Is Adulterated and Misbranded

The FD&C Act requires “new tobacco products” to have premarket authorization. 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)).

FDA has determined that you manufacture, sell, and/or distribute to customers in the United States Cherry Jo e-liquid product without a marketing authorization order.

The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act. In addition, it is misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act. The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).

A Tobacco ProductWithout Required Ingredient Listing Submissions Is Misbranded

FDA has determined that you have not provided an ingredient listing to FDA as required by section 904(a)(1) of the FD&C Act (21 U.S.C. § 387d(a)(1)). Section 904(a)(1) requires each tobacco product manufacturer or importer, or agents thereof to provide “a listing of all ingredients, including tobacco, substances, compounds, and additives that are…added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and sub brand.”

Because you have not provided FDA with an ingredient listing, FDA has determined that your Cherry Jo eliquid product, which South Texas Vapor manufactures and offers for sale to customers in the United States, is misbranded under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. § 387c(a)(10(A)) because you failed to comply with requirements prescribed under section 904 of the FD&C Act (21 U.S.C. § 387d). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). In addition, the failure to provide any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. § 331(q)(1)(B)).

Tobacco Products Manufactured in an Establishment Not Duly Registered Are Misbranded

FDA has determined that all e-liquid products manufactured by South Texas Vapor are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because they have been manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 905(b) of the FD&C Act (21 U.S.C. § 387e(b)). Specifically, you are required to register your establishment engaged in these activities on or before December 31 of each year pursuant to section 905(b). You registered your manufacturing establishment located at 5300 San Dario Avenue, Suite 138, Laredo, TX 78041-3043 with the FDA on October 12, 2017, but have failed to submit your annual establishment registration since that date. The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). In addition, the failure to register your establishment in accordance with section 905 is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).

Conclusion and Requested Actions

It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the types described above may result in FDA’s taking regulatory action, including, but not limited to, civil money penalties, 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 any adulterated and/or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any 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.

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 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, ER2000052, in your response and direct your response to the following address:

DEM-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 Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.

Sincerely,
/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

 
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