Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nyx-e-cigarettes-incorporated-605739-03272020
Timestamp: 2020-08-08 12:38:47
Document Index: 80433515

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

NYX E Cigarettes Incorporated - 605739 - 03/27/2020 | FDA
NYX E Cigarettes Incorporated - 605739 - 03/27/2020
NYX E Cigarettes Incorporated MARCS-CMS 605739 — March 27, 2020
NYX E Cigarettes Incorporated
support@nyxecigs.com
sales@nyxecigs.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.nyxecigs.com and 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.
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)).
Our review of the website https://www.nyxecigs.com revealed that you offer for sale or distribution to customers in the United States the following ENDS products without a marketing authorization order: STLTH Pod Pack (3 Pack) - Strawberry and STL TH Pod Pack (3 Pack) - Blue Raspberry.
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 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 promptly correct any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco·products into compliance with the FD&C Act.
Please note your reference number, RW2001278, in your response and direct your response to the following address:
NYXECIGS.COM@domainsbyproxy.com