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Dear Michael Daneshrad:
On April 27, 2020, the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) issued a Warning Letter informing you that your e-liquid product (e.g. Pink Sticks) was adulterated under section 902(6)(A) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 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. In addition, a conference call was held between FDA and VapeCentric, Inc. (VapeCentric) on August 17, 2020.
On May 18, 2020 and September 27, 2020, FDA received response letters from Phil Daman, Esq. at Daman & Associates, LLP on behalf of VapeCentric, representing that corrective actions were taken to address the violation identified in the Warning Letter and related concerns.
Based upon our evaluation, it appears the stated corrections have been made.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the FD&C Act and its implementing regulations or other relevant legal authority. This letter will not preclude regulatory action should violations be observed in the future.
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
5015 Blackpool Avenue
Oak Park, CA 91377
Phil Daman, Esq.
369 Lexington Ave., 3rd Floor
New York, NY 10017