WARNING LETTER
Honest Living Vape Shoppe & Apothecary
MARCS-CMS 641756 —
November 10, 2022
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Emily Cole
Recipient Title
Owner
Honest Living Vape Shoppe & Apothecary
2620 West Tennessee Street
Suite 1
Tallahassee
,
FL
32304
United States
edaviscole@gmail.com
Issuing Office:
Center for Tobacco Products
United States
November 10, 2022
WARNING LETTER
Dear Ms. Cole:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Honest Living LLC d/b/a Honest Living Vape Shoppe & Apothecary manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products 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 or contain nicotine from any source, and intended for human consumption.  Certain tobacco products, including e-liquid 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, 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 e-liquid 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.
Tobacco Products Manufactured in an Unregistered Establishment Are Misbranded
During inspection, FDA observed that you did not register your manufacturing establishment, located at 2620 West Tennessee Street, Suite 1, Tallahassee, FL 32304, as required by section 905(c) of the FD&C Act (21 U.S.C. § 387e(c)). Specifically, section 905(c) states that “[e]very person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person's name, place of business, and such establishment.”
Because your establishment was not registered in accordance with section 905(c) of the FD&C Act, your tobacco products that were manufactured, prepared, propagated, compounded, or processed at that establishment are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). In addition, the failure to register your establishment in accordance with section 905 is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).
Tobacco Products Not Listed with FDA Are Misbranded
FDA has determined that your tobacco products are not included in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)). Section 905(i)(3)(A) of the FD&C Act (21 U.S.C. § 387e(i)(3)(A)) requires that each person who registers with FDA under section 905 biannually report to FDA a list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the FDA under section 905(i).
Because your tobacco products are not included in a product listing in accordance with 905(i) of the FD&C Act (21 U.S.C. § 387e(i)), these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). Additionally, the failure to provide any information required by section 905(i) of the FD&C Act is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization 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)).
FDA has determined that you manufacture, sell, and/or distribute to customers in the United States the following e-liquid products without a marketing authorization order: Lychee and White Peach e-liquid products.
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 FDA marketing authorization orders 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, they 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 was not provided as required by section 905(j) of the FD&C Act. The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being adulterated or misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). 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)).
FDA has not received an application from your firm requesting marketing authorization for your Lychee and White Peach e-liquid products. These products and any other new tobacco product on the market without the statutorily required premarket authorization are adulterated and misbranded and are subject to enforcement action at FDA’s discretion.
Conclusion and Requested Actions
It is your responsibility to ensure that all of your tobacco products 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 and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list.  You should take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones 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 actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative 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.  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, ER2200669, in your response and direct your response to the following address:
DEM-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 CTPCompliance@fda.hhs.gov.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
11/10/2022
Regulated Product(s)
Tobacco