Vaperz Cedar Park – 616659 – 11/12/2021
Anonymous (not verified)
Fri, 01/14/2022 – 14:14
Dear Mr. Robertson:
On August 10, 2021, the U.S. Food and Drug Administration’s (FDA or the agency) Center for Tobacco Products (CTP) issued a Warning Letter to International Vaperz LLC, d/b/a Vaperz Cedar Park (the Firm, or you). The August 10, 2021 Warning Letter provided the Firm notice that the identified tobacco product is misbranded subsection 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)), and adulterated under subsection 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). The Warning Letter requested that the Firm submit a written response 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.
International Vaperz LLC, d/b/a Vaperz Cedar Park has not submitted a written response to the Warning Letter.
The Warning Letter was delivered to the Firm via UPS on September 11, 2021, and electronic mail on September 10, 2021 to email@example.com.
On August 26, 2021, FDA held a telephone discussion with the Firm, including Mr. Stephen Roberston, Owner, to discuss the Warning Letter. Mr. Robertson stated that the Firm did not submit a Premarket Tobacco Product Application and that the tobacco product cited in the Warning Letter are still offered for sale. Mr. Robertson stated that he understood the purpose for the Warning Letter and that he would provide a written response to FDA by September 16, 2021.
On September 1, 2021, FDA sent a follow up email to Mr. Robertson at firstname.lastname@example.org requesting a written response to the Warning Letter by September 16, 2021. The email was returned to FDA as “not deliverable.”
On September 23, 2021, FDA sent a follow up letter via UPS to the Firm requesting a written response to the Warning Letter by October 14, 2021.
To date, FDA has not received a written response from the Firm.
Your failure to respond to the Warning Letter does not absolve you of your responsibility to comply with federal law. You should take prompt action to address the violations referenced in the Warning Letter, as well as any violations that are the same as or similar to those violations, and you should take any necessary actions 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. Please note that any adulterated and/or misbranded tobacco products offered for import into the United States may be detained or refused admission.
If you have any questions about the content of this letter, please contact CTPVapeInspections@fda.hhs.gov.
Division of Enforcement and Manufacturing
Office of Compliance and Enforcement
Center for Tobacco Products
1050 North Lakeline Boulevard
Cedar Park, TX 78613
FDA – WEB CONTENT MANAGEMENT SYSTEM