- Delivery Method:
- VIA UPS and Electronic Mail
Recipient NameStacey Hamilton
- Kaleidoscope Custom Vapor Lounge, LLC
2992 South Church Street, Suite B
Murfreesboro, TN 37127
- Issuing Office:
- Center for Tobacco Products
August 31, 2021
Dear Ms. Hamilton:
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 Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Custom Vapor Lounge manufactures and distributes e-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. Therefore, e-liquids 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)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you manufacture, sell, and/or distribute to customers in the United States the following e-liquid products without a marketing authorization order: KALEIDOSCOPE Vapor 6mg nicotine and KALEIDOSCOPE Vapor C008 60ML e-liquid product.
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 (21 U.S.C. § 387b(6)(A)). In addition, it 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)).
Conclusion and Requested Actions
Your firm is a registered manufacturer with over 5,300 products listed with FDA. FDA received your Premarket Tobacco Product Application (PMTA), assigned STN No. PM0003302, on September 30, 2020. However, FDA issued a negative action for STN No. PM0003302 in the form of a refusal to accept determination on May 6, 2021, which covers 5,122 products. 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 PM0003302 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 comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately address this matter 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.
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. 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, ER2100212, 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products