WARNING LETTER
Blackhawx
MARCS-CMS 606491 —
March 27, 2020
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Blackhawx
2355 Westwood Blvd., Suite 1401
Los Angeles
,
CA
90064
United States
blackhawx@harpermediainc.com
customerservice@blackhawx.com
support@BLACKHAWX.com
customerservice@BLACKHAWX.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
MAR 27, 2020
WARNING LETTER
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.blackhawx.com and determined that the electronic nicotine delivery systems (ENDS) products listed there are manufactured, 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 ENDS, 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 ENDS products manufactured, advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your website advertising ENDS products fails to include the required nicotine warning statement.
ENDS Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded
Our review of the website https://www.blackhawx.com revealed that the advertising for several ENDS products that you manufacture, package, import, distribute, or retail in the United States does not include the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3(b), for example: Tobacco Flavored Disposable - 10 Pack, 'Presidente' - Disposable Electronic Cigar, and Menthol E-Cigarette Cartridges. 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 ENDS products, must bear the following warning statement:
WARNING: This product contains nicotine. Nicotine is an addictive chemical.
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 under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website regarding ENDS products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your ENDS products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
In addition, a tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Because your website regarding ENDS products does not include the required nicotine warning statement for these products, your ENDS products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the 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.
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 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, RW2001290, in your response and direct your response 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 Ele Ibarra-Pratt at
(301) 796-9235
or via email at CTPCompliance@fda.hhs.gov.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
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Content current as of:
04/07/2020
Regulated Product(s)
Tobacco