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  1. Warning Letters

WARNING LETTER

StemStix, Inc. MARCS-CMS 607933 —

Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Maryam Rahimi
StemStix, Inc.

8201 Newman Avenue, Suite 302
Huntington Beach, CA 92647
United States

sales@stemstix.com
info@stemstix.com
lucac@mystemjuice.com
Issuing Office:
Center for Tobacco Products

United States

June 5, 2020                 

WARNING LETTER

 

Dear Maryam Rahimi:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.mystemjuice.com and the Instagram account of StemStix, Inc. (https://www.instagram.com/stemjuice).  FDA has determined that the e-liquids 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 FD&C Act.  These products include, but are not limited to, ENDS (including e-cigarettes), 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 Products Without Required Marketing Authorization are Adulterated and Misbranded

Our review of the website https://www.mystemjuice.com revealed that you manufacture and offer for sale or distribution to customers in the United States the following e-liquid products without a marketing authorization order: STEMJUICE – Tobacco, STEMJUICE – Menthol, STEMJUICE - Tobacco Blend, and STEMJUICE - Tobacco Mix.

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.  In addition, they 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. 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)).

Misbranded Tobacco Products for False or Misleading Advertising

FDA has determined that your e-liquid products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the website advertising is false or misleading in any particular. For example, the website https://www.mystemjuice.com includes the following statement regarding your e-liquid products:

  • “Our e-liquid has undergone tests with the Food and Drug Administration, ensuring its quality and safety. We gave [sic] begun the PMTA process, so you can be assured that our product is safe for consumption and use.”

Specifically, the first sentence above is false and misleading.  It states that your products have “undergone tests with the Food and Drug Administration”, and states that the testing ensures the quality and safety of your products.  This statement is false because FDA has not conducted testing on your products, and it is misleading in that it implies that FDA has ensured the quality and safety of your products when in fact FDA has not.  The second sentence is misleading because, among other things, it suggests that, because you have begun the premarket tobacco product application (PMTA) process, your e-liquid products are necessarily safe for consumption and use.

A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Because your website advertising regarding e-liquid products contains false or misleading statements in any particular, your e-liquid products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).

Modified Risk Tobacco Product Violations

FDA has also 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.mystemjuice.com and the Instagram account of StemStix, Inc. (https://www.instagram.com/stemjuice) 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 website https://www.mystemjuice.com and the Instagram account https://www.instagram.com/stemjuice include the following claims regarding your e-liquid products:

  • “STEMJUICE is the least toxic vape on the market”
  • “Lose the toxic chemicals, not the flavor”  
  • “#STEMJUICE is Made in the USA us [sic] We removed toxic chemicals to give you a cleaner vape experience…Revitalize your lungs with STEMJUICE.”
  • “We replaced the bad stuff with the good”
  • “Breathe easy, with STEMJUICE” followed by “MADE WITHOUT…Aldehyde, Formaldehyde, Diacetyl, Propylene Glycol, Hydrogen Cyanide, Vitamin E Acetate”
  • “We use plant stem cell extracts from fresh green apples grown in Switzerland, providing a natural source for our e-juices. These are not only safe to include in e-juices, but can even improve your lung vitality.”
  • “Our e-liquid has undergone tests with the Food and Drug Administration, ensuring its quality and safety. We gave [sic] begun the PMTA process, so you can be assured that our product is safe for consumption and use.”

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 and webpages describe 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), and in any other media in which you advertise comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  Failure to address any violation of the type described above may result in FDA initiating 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 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 immediately 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, RW2001336, 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

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