WARNING LETTER
Puckerfish, LLC
MARCS-CMS 610614 —
September 11, 2020
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Matt Dawson
Puckerfish, LLC
205 S. Spring St.
Bucyrus
,
OH
44820
United States
info@puckerfish.net
Issuing Office:
Center for Tobacco Products
United States
September 11, 2020
WARNING LETTER
Dear Matt Dawson:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.puckerfishvape.com and determined that the e-liquid 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 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 several e-liquid 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)) because your website advertising several e-liquid products fails to include the required nicotine warning statement.
E-Liquid Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded
Our review of the website http://www.puckerfishvape.com revealed that the advertising for several e-liquid 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 CFR 1143.3(b), for example: Puckerfish Coffee, Puckerfish Choco, and Puckerfish Flewps. 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). 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 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
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., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may result in FDA taking regulatory action. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and 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 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, RW2001446, 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 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, USPS, and Electronic Mail
cc:
Puckerfish, LLC
1625 W. 4th St.
Ontario, OH 44906
Puckerfish Vape
75 Amberwood Pkwy Ste G
Ashland, OH 44805
Desiant, LLC
Attn: Barna Kasa
P.O. Box 340453
Columbus, OH 43234
support@desiant.com
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
09/29/2020
Regulated Product(s)
Tobacco