WARNING LETTER
E-Vaped Co
MARCS-CMS 608874 —
July 31, 2020
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Stacey Arrecis
E-Vaped Co
2701 O St, Suite 3
Lincoln
,
NE
68510-1342
United States
staceyarrecis@gmail.com
evaped.stacey@gmail.com
Issuing Office:
Center for Tobacco Products
United States
July 31, 2020
WARNING LETTER
Dear Stacey Arrecis:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.evapedstore.com and determined that 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)), 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)) and 21 C.F.R. § 1100.1. Therefore, e-liquids 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 Act. These products include, but are not limited to, electronic nicotine delivery systems (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
.
The FD&C Act requires “new tobacco products” to have premarket authorization. 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 Product Without Required Marketing Authorization is Adulterated and Misbranded
Our review of the website https://www.evapedstore.com revealed that you manufacture and offer for sale or distribution to customers in the United States the following e-liquid product without a marketing authorization order: E-Vaped Pacman.
The e-liquid product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act. In addition, it is misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act. Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).
Tobacco Product Sold to a Person Under the Age of 21
FDA’s investigation of the website https://www.evapedstore.com revealed that you sold an e-liquid product to a person under the age of 21.
1
Specifically, during our investigation of https://www.evapedstore.com, a person younger than 21 years of age purchased E-Vaped Pacman e-liquid from your website. No retailer may sell tobacco products to a person younger than 21 years of age under section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). 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 section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Because this tobacco product is sold or distributed to persons younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Modified Risk Tobacco Product Violations
FDA has determined that your e-liquid products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.
Our review of the website https://www.evapedstore.com revealed that you sell or distribute e-liquid products that are described as presenting a lower risk of tobacco-related disease or being less harmful than one or more other commercially marketed tobacco products, containing a reduced level of a substance or presenting a reduced exposure to a substance, or not containing or being free of a substance. For example, the advertising on the website https://www.evapedstore.com includes the following claims regarding your e-liquid products:
“What are the benefits of using e-cigarettes?...Satisfies like a cigarette, but without tobacco, tar, smoke or known harmful chemicals – so you don’t have to ‘quit’ a habit you enjoy! No second hand smoke for those you care about (and for those who just drive you crazy about it!)”
“Is ‘vaping’ healthier than cigarette smoking?...However, there is no tobacco, tar, smoke, or any known cancer-causing chemicals in e-cigs vapor, and 4000 fewer chemicals than in cigarettes! Cigarettes are KNOWN killers!”
A tobacco product is considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A modified risk tobacco product application under section 911(d) of the FD&C Act (21 U.S.C. § 387k(d)) is required to provide scientific evidence and other information to support issuance of an order under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Your e-liquid products are modified risk tobacco products because your website explicitly or implicitly advertises them as presenting a lower risk of tobacco-related disease or being less harmful than one or more other commercially marketed tobacco products, containing a reduced level of a substance or presenting a reduced exposure to a substance, or not containing or being free of a substance. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
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. 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 adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should promptly correct any 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.
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, RW2001377, 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:
E-Vaped Co.
Attn: Stacey Arrecis
1601 SW Lacey Ln
Lincoln, NE 68522-1897
Google LLC
google-cloud-compliance@google.com
Register.com, Inc.
abuse@web.com
Perfect Privacy, LLC
4gcmv783uqhjc9b17t6jnusf91@domaindiscreet.com
___________________________
1
Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products from age 18 years to 21 years. For more information, please see
https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21
.
Content current as of:
09/29/2020
Regulated Product(s)
Tobacco