- Delivery Method:
- VIA UPS and Electronic Mail
- Reference #:
- ER2300836 and 23WV072125
Recipient NameDustin Boggess
- Team Full Steam LLC d/b/a Full Steam Vapor
3999 Teays Valley Road, Suite D
Hurricane, WV 25526
- Issuing Office:
- Center for Tobacco Products
July 6, 2023
Dear Mr. Boggess:
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 Team Full Steam LLC d/b/a Full Steam Vapor manufactures and distributes electronic nicotine delivery system (ENDS) products (including e-liquid products) for commercial distribution in the United States, and that the ENDS products are manufactured and offered for sale or distribution to customers in the United States. The FDA also completed a compliance check inspection of your retail establishment on May 17, 2023. This Warning Letter is a notification from FDA advising you that Full Steam Vapor was observed to be in violation of federal tobacco laws and regulations.
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, these 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, electronic nicotine delivery systems (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.
The FD&C Act requires “new tobacco products” to have a premarket authorization 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)).
A New Tobacco Product Without Required Marketing Authorization Is Adulterated and Misbranded
FDA has determined that you manufacture, sell, and/or distribute to customers in the United States e-liquid products without a marketing authorization order, including: RY4 Caramel Vanilla Tobacco 3MG 60 ML.
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 FDA marketing authorization orders 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 (21 U.S.C. § 387b(6)(A)). In addition, it is misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) 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 adulterated or 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)).
In addition, on May 17, 2023, an inspector representing the FDA completed an inspection of Full Steam Vapor located at 3999 Teays Valley Road, Suite D, Hurricane, WV 25526. During this inspection, the establishment was in violation because the establishment offered for sale an ENDS product that lacks the required marketing authorization.
This inspection revealed that the establishment sells and/or distributes tobacco products, including ENDS products, which requires that the establishment and its owners comply with federal laws and regulations governing the sale, distribution, and/or advertising of such products.
During this inspection, an inspector observed that the establishment offered for sale tobacco products that are required to have, but lack, premarket authorization. Specifically, on May 17, 2023, the establishment offered for sale an Esco Bars Blue Razzleberry Pomegranate ENDS product.
The Esco Bars Blue Razzleberry Pomegranate ENDS product 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 (21 U.S.C. § 387b(6)(A)). In addition, it is misbranded under Section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) 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)).
Conclusion and Requested Actions
All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion. Products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. 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 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, 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 and/or misbranded may be detained or refused 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.
Your establishment may have previously received a Warning Letter, Civil Monetary Penalty, or No-Tobacco-Sale Order from FDA. Although this Warning Letter includes violations of Sections 902 and 903 of the FD&C Act, please remember your ongoing obligation to comply with the regulations in 21 C.F.R. Part 1140.
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 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. Please note that this warning letter does not constitute final agency action, but if you have evidence or information that you believe demonstrates that this notice was issued in error, you should also preserve any evidence or information relevant to this warning letter in the event FDA initiates regulatory action at a later date. 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 numbers, ER2300836 and 23WV072125, in your response and direct your response via email at CTPCOmpliance@fda.hhs.gov and 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 CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products