Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sublime-liquids-604369-02282020
Timestamp: 2020-04-09 16:39:23
Document Index: 457684436

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 1143', '§ 1143', '§ 1143', '§ 1143', '§ 1100', '§ 1100', '§ 1100', '§ 387', '§ 1143', '§ 387']

Sublime Liquids - 604369 - 02/28/2020 | FDA
Sublime Liquids - 604369 - 02/28/2020
Sublime Liquids MARCS-CMS 604369 — February 28, 2020
Sublime Liquids
10647 Wixom Street
sublimeliguids@gmail.com
stevenburben@gmail.com
Dear Saad Mansour:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.sublimeliquids.com and determined that thee-liquid products listed there are advertised 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)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including a-liquids, are subject to FDA jurisdiction under section 901 (b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several e-liquid products advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(8) of the FD&C Act (21 U.S.C. § 387c(a)(7)(8)) because your website advertising e-liquid products fails to include the required nicotine warning statement.
Our review of the website https://www.sublimeliquids.com revealed that the advertising for several a-liquid products that you manufacture, package, import, distribute, or retail does not include the required nicotine warning statement, for example: Sublime Liquids Apple Jack, Sublime Liquids Cowboy, and Sublime Liquids FOB. Under 21 C.F.R. § 1143.3(b), advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for a tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1 )). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2). Under 21 C.F.R. § 1143.1, a "covered tobacco product" is defined as any tobacco product deemed to be subject to the FD&C Act under 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll.,.your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The products cited in this violation are "covered tobacco products." 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 regulations prescribed regarding e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S;C. § 387c(a)(7)(B)).
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), and in any other media in which you advertise comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that any adulterated and/or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, 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 do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Please note your reference number, RW2001247, in your response and direct your response to the following address:
Sublimeliquids.com@domainsbyproxy.com