- Delivery Method:
- VIA UPS and Electronic Mail
- Issuing Office:
- Center for Tobacco Products
Dear Jason Gang:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://westsidevapor.com and determined that the electronic nicotine delivery system (ENDS) products are manufactured and offered for sale or distribution to customers in the United States. The FDA also completed a compliance check inspection of your retail establishment on August 7, 2021. This Warning Letter is a notification from FDA advising you that Westside Vapor / Vapor Station was observed to be in violation of federal tobacco laws and regulations.
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 and 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 21 C.F.R. § 1100.1. Therefore, ENDS products are required to be in compliance with the requirements in the FD&C Act.
Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the FD&C Act. These products include, but are not limited to, ENDS (including e-cigarettes and e-liquids), cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.
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://westsidevapor.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order, including: Westside Vapor Mint/Ice/Menthol Flavors – Peppermint and Westside Vapor Mint/Ice/Menthol Flavors – Spearmint.
The e-liquid 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. In addition, these products are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act.
Tobacco Product Sold to an Individual Under the Age of 21 is Misbranded
In addition, on August 7, 2021, an inspector representing the FDA completed an inspection of your establishment located at 8519 Navarre Road SW, Massillon, OH 44646. During this inspection, the establishment was in violation because you or your employee sold an ENDS product to a person under 21 years of age.
The violation observed during the August 7, 2021, inspection includes the following:
1. A person under 21 years of age was able to buy a Hyde Aloe Grape ENDS product on August 7, 2021, at approximately 11:36 AM in the establishment.
It is unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age. Doing so violates Section 906(d)(5) of the FD&C Act.
The listed violation causes your ENDS product to be “misbranded” under Section 903 of the FD&C Act (21 U.S.C. § 387c).
Conclusion and Requested Actions
Your firm is a retailer and registered manufacturer with over 380 products listed with FDA. FDA received your Premarket Tobacco Product Application (PMTA) assigned STN PM0001038 on September 5, 2020. However, FDA issued a negative action for PMTA STN PM0001038 in the form of a Marketing Denial Order determination on September 9, 2021, which covers 313 products. As discussed above, new tobacco products that do not have the required FDA marketing authorization order in effect, including your e-liquid products covered by PMTA STN PM0001038 that resulted in a Marketing Denial Order determination, are adulterated and misbranded.
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. Products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. For information on how FDA intends to prioritize enforcement resources with regard to the marketing of certain adulterated and misbranded ENDS and other deemed new tobacco products, please refer to the FDA’s guidance titled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market.
It is your responsibility to ensure that all of 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 lead to regulatory 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.
We will periodically inspect your establishment and review your promotional activities (e.g., website(s)) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly 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 actions to address any violations and bring your 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 your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Please note that this warning letter does not constitute final agency action, but if you have evidence or information that you believe demonstrates that this notice was issued in error, you should also preserve any evidence or information relevant to this warning letter in the event FDA initiates regulatory action at a later date. 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 numbers, RW2101693 and 21OH028515, 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
Attn: James Jarvis
144 N. Hamilton Rd.
Gahanna, OH 43230
Attn: Jason Gang
1360 S Cleveland Massillon Rd
Copley, OH 44321
Canal Winchester Vapor Station
Attn: Jason Gang
6286 Gender Rd
Canal Winchester, OH 43110
Chillicothe Vapor Station
Attn: Jason Gang
1534 N Bridge St
Chillicothe, OH 45601
Attn: Jason Gang
839 W Maple St
Hartville, OH 44632
Alliance Vapor Station
Attn: Jason Gang
640 W State St
Alliance, OH 44601
Canton Vapor Station
Attn: Jason Gang
2850 Whipple Ave Nw
Canton, OH 44708
Attn: Jason Gang
588 E Broad St
Etna, OH 43062
Attn: Gerri L Jarvis
Domains By Proxy, LLC
Liquid Web, L.L.C