WARNING LETTER
James Audi d/b/a The Broke Smoker
MARCS-CMS 590284 —
September 27, 2019
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
James Audi
James Audi d/b/a The Broke Smoker
16025 Kamana Rd, Ste 101
Apple Valley
,
CA
92307
United States
info@thebrokesmoker.com
jim@thebrokesmoker.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
SEP 27, 2019
WARNING LETTER
Dear James Audi:
The Center for Tobacco Products of
the U.S.
Food and Drug Administration (FDA) recently reviewed the website
https://www.thebrokesmoker.com
and determined that the e-liquid products listed there are manufactured 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 e-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 your BrokeSmoker Hawaiian Juice e-liquid, BrokeSmoker Doublemint e-liquid, and BrokeSmoker Sweet Tart e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age.
Additionally,
FDA has determined that several e-liquid products that are manufactured 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/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your (1) product package and (2) website advertising the e-liquid products fail to include the required nicotine warning statement.
Sales to Minors Violation
FDA’s investigation of the website
https://www.thebrokesmoker.com
revealed that you sold an e-liquid product to a minor.
Specifically,
during our investigation of
https://www.thebrokesmoker.com
,
a person younger than 18 years of age purchased
BrokeSmoker Hawaiian Juice, BrokeSmoker Doublemint, and BrokeSmoker Sweet Tart e-liquid products from your website.
No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 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 1140.
Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
E-Liquid Products with Packages that Fail to Include the Required Nicotine Warning Statement are Misbranded
FDA’s investigation of the website
https://www.thebrokesmoker.com
revealed that the packages for several e-liquid products,
specifically
BrokeSmoker Hawaiian Juice, BrokeSmoker Doublemint, and BrokeSmoker Sweet Tart e-liquid products, that you manufacture,
package, sell, offer to sell, distribute, and/or import for sale or distribution into the United States does not include the required nicotine warning statement
in the manner required by 21 C.F.R. § 1143.3(a).
Under
21 C.F.R. § 1143.3(a),
packages 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:
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 any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the required warning statement on the package label (21 C.F.R. § 1143.3(a)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(a)(2). As described above, 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 e-liquid products do not include the required nicotine warning statement on the packages, in violation of 21 C.F.R. § 1143.3(a), 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)).
E-Liquid Products with Labeling and/or Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded
Additionally, our review of the website
https://www.thebrokesmoker.com
revealed that the labeling and/or advertising for several e-liquid products that you
manufacture, package, import, distribute, or retail does not include the required nicotine warning statement in the manner required by 21 CFR 1143.3(b), for example
: BrokeSmoker Lemon Sparkle Cupcake, BrokeSmoker Watermelon, Custard by National Donut, and Go Nanas by Naked 100. 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:
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). As described above, 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 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)).
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 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 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 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, RW1901158, 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
VIA UPS and Electronic Mail
cc:
James Audi d/b/a The Broke Smoker
Attn: Joseph Robertson
18835 Chapae Ln
Apple Valley, CA 92307
joe@thebrokesmoker.com
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Content current as of:
10/22/2019
Regulated Product(s)
Tobacco