Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fullest-closet-606980-05112020
Timestamp: 2020-08-03 23:25:53
Document Index: 169645514

Matched Legal Cases: ['§ 321', '§ 387', '§ 1100', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

Fullest Closet - 606980 - 05/11/2020 | FDA
Fullest Closet - 606980 - 05/11/2020
Fullest Closet MARCS-CMS 606980 — May 11, 2020
Fullest Closet
3975 Morgan Street
support@fullestcloset.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.fullestcloset.comand determined that the electronic nicotine delivery system (ENDS) products listed there are 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, 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 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 Act. These products include, but are not limited to, ENDS (including e-cigarettes), 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 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)).
New Tobacco Products Without Required Marketing Authorization are Adulterated
Our review of the website https://www.fullestcloset.com revealed that you offer for sale or distribution to customers in the United States the following ENDS products without a marketing authorization order: UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Apple, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Blueberry, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Grape, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Mango, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Mint, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Mixed Fruit, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Pink Apple, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Pink Lemonade, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods – Strawberry, UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods –Watermelon.
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 FDA marketing authorization orders 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.
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), 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 type described above may result in FDA’s initiating 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 adulterated and/or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please note your reference number, RW2001302, in your response and direct your response to the following address: