WARNING LETTER
Breeze Smoke, LLC
MARCS-CMS 655821 —
May 25, 2023
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Mark Faraj and Steven Haddad
Breeze Smoke, LLC
4654 Lilly Ct.
West Bloomfield
,
MI
48323
United States
info@breezesmoke.com
(b)(6)
Issuing Office:
Center for Tobacco Products
United States
May 25, 2023
WARNING LETTER
Dear Mark Faraj and Steven Haddad:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.breezesmoke.com, and additional information, and determined that electronic nicotine delivery system (ENDS) products listed there are received 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)), 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. Certain tobacco products, including ENDS products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)), 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, Title I, 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. Tobacco products, including ENDS products containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. 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 and Misbranded
Our review of the website https://www.breezesmoke.com, and additional information, revealed that Breeze Smoke, LLC receives and delivers ENDS products without a marketing authorization order. Specifically, Breeze Smoke, LLC receives the products listed below from a foreign manufacturer and distributes those products in the United States to some or all of the retailers listed on https://www.breezesmoke.com. Breeze Smoke, LLC owns and operates the website https://www.breezesmoke.com, which lists the products below for sale, identifies retailers in the “Authorized Stores” tab of https://www.breezesmoke.com that sell those products, and directs consumers to those retailers. The following ENDS products offered for sale or distribution within the United States on https://www.smokersworldhw.com that lack a marketing authorization are Breeze Pro Disposable Vape – Candy Cane and Breeze Pro Disposable Vape - Candy Hearts.
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 an FDA marketing authorization order 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 (21 U.S.C. § 387b(6)(A)). In addition, these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting these products were not provided as required by section 905(j) of the FD&C Act.
Conclusion and Requested Actions
FDA has determined that your firm receives and delivers new tobacco products lacking premarket authorization in the United States. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, and promptly take any necessary actions to bring the tobacco products into compliance with the FD&C Act. It is your responsibility to ensure that these 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 implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory or legal 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 tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
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 these 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 these 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, RW2301912, 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.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA USPS, UPS, and Electronic Mail
cc:
Breeze Smoke, LLC
Attn: Mark Faraj and Steven Haddad
450 W. Fourth St.
Royal Oak, MI 48067
Breeze Smoke
Attn: Mark Faraj and Steven Haddad
26056 Van Dyke Ave.
Warren, MI 48015
Breeze Smoke LLC
Attn: Mark Faraj and Steven Haddad
1471 E Nine Mile Rd., Unit 200
Hazel Park, MI 48030
Breeze Smoke LLC
23999 West 10 Mile Road Ste 200
Southfield, MI 48033
Dongguan Shikai Technology Co., Ltd.
Attn: Ningle Zhong
(b)(6)
Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)
Attn: Marc C. Sanchez
1717 Pennsylvania Ave. NW, Suite 1025
Washington, DC 20006
msanchez@fdaatty.com
Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)
Attn: Marc C. Sanchez
53516 Bickett
Chapel Hill, NC 27517
Smokers World
2125 Stirling Road
Fort Lauderdale, FL 33312
INFO@smokersworldhw.com
GoDaddy.com, LLC
abuse@godaddy.com
Wix.com Inc
abuse@wix.com
Content current as of:
05/25/2023
Regulated Product(s)
Tobacco