IC 7.1-7-4-1 — Permit; application; fee; denial by the federal Food and Drug Administration
Chapter 4. Permit Requirements
Bills amending this section
Section text
Sec. 1. (a) Not later than January 1, 2027, a manufacturer of e-liquid or an e-liquid product that is manufactured or sold in Indiana must obtain a permit under this section. (b) A manufacturer of e-liquid may not mix, bottle, package, or sell e-liquid to retailers, consumers, or wholesalers in Indiana without a permit issued by the commission under this article. (c) A manufacturing permit issued by the commission before July 1, 2026, is valid for five (5) years. A manufacturing permit issued by the commission after June 30, 2026, is valid for two (2) years. (d) An initial application for a manufacturing permit must include the following: (1) The name, telephone number, and address of the applicant. (2) The name, telephone number, and address of the manufacturing facility. (3) The name, telephone number, title, and address of the person responsible for the manufacturing facility. (4) Verification that the facility will comply with applicable tobacco products good manufacturing practices promulgated under 21 U.S.C. 387f(e) of the federal Food, Drug, and Cosmetic Act. (5) Verification that the manufacturer will comply with the applicable ingredient listing required by 21 U.S.C. 387d(a)(1) of the federal Food, Drug, and Cosmetic Act. (6) Written consent allowing the state police department to conduct a state or national criminal history background check on any person listed on the application. (7) A nonrefundable initial application fee of three thousand dollars ($3,000). (8) Verification that the manufacturer will comply with all other state and federal laws related to e-liquids and e-liquid products. (9) An affirmation, made under the penalties for perjury, that the manufacturer will not, to the best of the manufacturer's knowledge, use any ingredients or e-liquids in the manufacturer's manufacturing process from a nation listed as a foreign adversary in 15 CFR 791.4. (10) Evidence of the federal Food and Drug Administration approval, authorization, or application status of each e-liquid or e-liquid product the manufacturer seeks to sell, source, import, or manufacture in the manner described under IC 7.1-7-2-12.5(b)(2). (e) The fees collected under subsection (d)(7) shall be deposited in the enforcement and administration fund established under IC 7.1-4-10. (f) Except as otherwise provided in this article, an applicant for a permit under this section must adhere to all state and federal laws applicable to e-liquids and e-liquid products, including rules and regulations promulgated by the federal Food and Drug Administration. (g) If the federal Food and Drug Administration denies a manufacturer's application for approval or authorization of an e-liquid or e-liquid product during the term of a permit issued under this section, the manufacturer must notify the commission of the denial and submit a supplemental application for a manufacturing permit on a form prescribed by the commission.
As added by P.L.176-2015, SEC.9. Amended by P.L.231-2015, SEC.9; P.L.214-2016, SEC.33; P.L.206-2017, SEC.23; P.L.49-2020, SEC.13; P.L.148-2026, SEC.24.
Source: official publisher (2026 edition)