- Delivery Method:
- VIA Electronic Mail
- Issuing Office:
- Center for Tobacco Products
August 19, 2022
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.mixologyvape.co.nz and determined that electronic nicotine delivery systems (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 or contain nicotine from any source, and are intended for human consumption. 1 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, and are required to be in compliance with the requirements in the FD&C Act.
Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA’s jurisdiction to products “containing nicotine from any source,” not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Subtitle B. Specifically, this legislation expanded the definition of “tobacco product” under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) to include products containing nicotine from any source. As of April 14, 2022, it is illegal for a retailer2 to sell any tobacco product, containing nicotine from any source – including cigarettes, smokeless tobacco, cigars, and e-cigarettes – to anyone under 21.
FDA has determined that your Pacha Mama Disposable Vape Device – Pink Lemonade ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age.
Tobacco Product Sold to an Individual Under the Age of 21 is Misbranded
FDA’s investigation of the website https://www.mixologyvape.co.nz revealed that you sold an ENDS product to an individual under the age of 21.3 Specifically, during our investigation of https://www.mixologyvape.co.nz, a person younger than 21 years of age purchased Pacha Mama Disposable Vape Device – Pink Lemonade ENDS product from your website. No retailer may sell tobacco products to a person younger than 21 years of age under section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)).
Because this tobacco product is sold or distributed to persons younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Conclusion and Requested Actions
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 FD&C Act, 21 U.S.C. § 301 et seq., and FDA’s implementing regulations, including those 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. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that 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. See Section 910(a) of the FD&C Act. Retailers should discuss with their suppliers the current marketing status of any particular tobacco product’s application or any product’s marketing authorization.
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should address any violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and promptly 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 labeling, advertising, 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, RW2201820, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-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 Bryan Hills at (301) 796-9367 or via email at CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
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1 Effective April 14, 2022, an amendment to the FD&C Act extends FDA’s regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14
2The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 USC 387(14)).
3 Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21.