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 TITLE 905 ALCOHOL AND TOBACCO COMMISSION  
 
Emergency Rule  
LSA Document  #16-163 
 
DIGEST  
 
Temporarily adds noncode provisions for licensing requirements for e -liquid manufacturers.  
Statutory authority: IC 4-22-2-37.1 ; IC 7.1 -7-3-3.  Repeals LSA Document #16 -145(E) posted at 
20160406 -IR-905160145ERA.  Effective April 13 , 2016 .  
 
SECTION  1. (a) The purpose of this document  is, in the absence of federal regulations, to protect 
public health and safety by:   
(1) ensuring the safety and securi ty of e -liquid manufactured for sale in Indiana;  
(2) ensuring that e -liquid manufactured or sold in  Indiana conform s to appropriate standards of  
identity, strength, quality, and purity; and  
(3) ensuring that e -liquid is not contaminated or adulterated by the incl usion of ingredients or 
other substances that might pose unreasonable threats to public health and safety.   
 
(b) This document  applies to the commercial manufacturing, bottling, selling, bartering, or 
importing of e -liquid products in Indiana and the sale, po ssession, and use of e -liquid products in 
Indiana.   
 
SECTION  2. Any e -liquid or nicotine product, including non refillable sealed cartridge electronic 
cigarettes, sold for use in Indiana may not be sold to anyone less than  eighteen (18) years of age.  
 
SECTION  3. (a) The definitions in IC 7.1 -7-2 and this SECTION  apply throughout this document.  
 
(b) “Commission” or “ATC” means the Indiana Alcohol and Tobacco Commission . 
 
(c) “Packaging” means the process by which e -liquid is bottled in a tamper evident p ackage with a 
child resistant cap a nd labeled in compliance with IC  7.1-7.  The term does not include the process of 
preparing to ship or distribute already manufactured and packaged e -liquid.  
 
SECTION  4. (a) Anyone involved in manufacturing an e -liquid f or sale to retailers or distributors  of 
e-liquid  in Indiana must first obtain an e -liquid manufacturer’s permit from the commission.    
 
(b) The commission shall accept initial applications and issue manufacturing permits until June 30, 
2016.     
 
(c) The a pplication must  include the following:  
(1) Name, address , and telephone number  of the applicant.  
(2) Name, telephone number , and address  of the manufacturing facility.  
(3) Full legal  name, address, date of birth, Social S ecurity number , and primary telephone  contact 
number for each owner.  
(4) Full legal n ame, telephone number,  date of birth, Social S ecurity number, title, and address of 
the facility manager s responsible for the manufacturing facilit y. 2 
 (5) The projected output in liters per year of e -liquid of the manufacturin g facility.  
(6) Floor plans , marked as confidential  under IC  7.1-7-3-2, of the manufacturing facility that show  
the layout of the entire manufacturing facility including  the following :  
(A) The clean room . 
(B)  The storage room where sample  bottle s are stored as required by IC  7.1-7-4-6. 
(C) All entrances, exits, and interior doors.   
(D) All areas open to the public , including areas used  for sales or distribution  of e-liquids .  
(7) An executed  security  agreement showing compliance with the  requirements of IC 7.1 -7-4-
1(d)(3) and IC 7.1 -7-4-6(b)(10) through IC 7.1-7-4-6(b)(15).  A security agreement will b e treated  as 
confidential  and only be released pursuant to a court order . 
(8) A verified statement from the secur ity firm that includes  the following : 
(A) Name of at least one (1) employee of the security firm who is accredited or certified by 
the Doo r and Hardware Institute as an architectural hardware consultant.   
(B) Name of at least one  (1) employee of the security firm who is accredited or certified as a 
certified rolling steel  fire door technician by the International Door Association or the Institute 
of Door Dealer Education and Accreditation.  
(C) Name of the employee of the s ecurity firm who is a locksmith.   
(D) Statement that the security  firm has at least one (1) year of commercial ex perience, in the 
preceding year, with the following:  
(i) Video surveillance system design and installation  with remote viewing capability from 
a secure facility.  
(ii) Owning and operating a security monitoring station with ownership control and use of 
a redundant offsite back up security monitoring station.  
(iii) Operating a facility that modifies commercial hollow metal doors, frames, and 
borrowed lights with authorization to apply the Underwriters Laboratories label . 
(9) Statement that no individuals, corporations, limited liability companies, limited liability 
partnerships, partnerships or stock owners, members, or partners of such entities with an 
interest, either directly or indirectly, in the security company have any interest, either directly or 
indirectly, in any e -liquid manufacturer, distributor, or retailer.  
(10) A verified statement  that all products manufactured for distribution in Indiana contain only 
the ingredients listed in IC 7.1 -7-5-1(a).  
(11) An addendum , marked as confidential, that provides a  product listing that complies wit h 
SECTION  8 of this document.  
(12) A verified statement that the facility will comply with manufacturing processes required by IC 
7.1-7 and this document.  
(13) A verified statement  that equipment used is easily cleanabl e as defined in 410 IAC 7 -24-27(a).  
(14) Written consent to allow a law enforcement officer to conduct a state or national criminal 
history background check on any person listed on the application.  
(15) Written consent allowing the commission, or its duly appointed agents, after a permit is 
issued t o the applicant, to enter during normal business hours the premises where the e -liquid  is 
manufactured to conduct physical inspections, sample the product to ensure the e -liquid meets 
the requirements for e -liquid set forth in this article, and perform an  audit.  
(16) A nonrefundable application fee of  one thousand  dollars ( $1,000 ). 
(17) Any other information as deemed appropriate by the commission to complete review of the 
application.  
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 (d) The applicant is responsible for notifying the commission  within ten (10) business days if  any 
information in the initial application changes .  Failure to make a timely and accurate notification 
about information changes may result in the denial or revocation of the application.  
 
SECTION  5. (a) The c ommission  shall complete its review and take final acti on upon the application 
within sixty  (60) days after receiving all information and documentation required by IC 7.1 -7 and this 
document , including, but not limited to , the following : 
(1) The completed application form.  
(2) The certification by the security firm that the manufacturing facility is in compliance with the 
requirements of IC 7.1 -7-4-1(d)(3) and IC 7.1 -7-4-6(b)(10) through  IC 7.1-7-4-6(b)(15).   
(3) A fully compliant service  security  agreement is executed wi th the final copy submitted to 
commission . 
(4) Product listing that complies with SECTION  8 of this document .  
(5) Payment of the application fee.  
(6) Floor plan.  
(7) Any other outstanding matters  required by the commission  are satisfied .  
 
(b) An approved manufacturer’s permit will not be required for renewal until five (5) years after  
the date of the initial application’s approval or the last renewal.  
(c) For an out of state or out of country manufacturing facility that the commission  is unable to 
physically inspect, arrangements may  be made for an independent provider  approved by the 
commission  to perform such inspec tion. The out of state approved inspection provider  will be 
required to submit the results of the inspection directly to the commissio n via first class mail.   
(d) All costs associated with the inspection and reporting may be assessed to  the applicant.   
 
SECTION  6. (a) Applications for renewals of existing permits must be submitted to the commission  
on an application form prescribed by the commission  at least  sixty ( 60) days before  the expiration 
date of the existing permit  and must include the following:  
(1) The name, address, and telephone number of the applicant . 
(2) The name, address, and telephone number of the manufacturing facility . 
(3) The full legal name, address, and primary telephone contact number for each owner . 
(4) The full legal name, address, and primary telephone contact number for each facility manager 
responsible for the manufacturing facility . 
(5) The annual output in liters of e -liquid of the manufacturing facility for the five (5) years 
preceding the year of the application.  
(6) Certification by the applicant that the applicant will continue to use the security protocol 
approved by the commission with the applicant’s initial applicatio n.  However, if the applicant 
desires to change the previously approved security protocol, the applicant shall submit the 
suggested changes to the commission for approval.  
(7) Evidence that the security firm complies with the requirements of IC 7.1 -7 by eithe r:  
(A) a verified statement by the security company that the information provided in the 
initial application or most recent renewal applicant continues to be correct; or  
(B) a verified statement a s required by SECTION  4(a)(7) of this document  that includes any 
changes to the security company . 
(8) A verified statement that all products manufactured for distribution in Indiana contain only the 
ingredients listed in IC 7.1 -7-5-1(a).  4 
 (9) A verified statement  that the manufacturing process used  by the applicant complies  with the 
require ments of IC 7.1 and this document .  
(10) Written consent allowing law enforcement  to conduct a state or national criminal history 
background check on any person listed on the application.  
(11) Written consent allowing the commission, if a permit is renew ed to the applicant, to enter 
the premises where the e -liquid is manufactured to conduct physical inspections, sample the 
product to ensure the e -liquid meets the requiremen ts of e -liquid set forth in IC  7.1-7, and 
perform an audit.   
(12) A nonrefundable appli cation fee in the amount of five hundred  dollars  ($500).   
(13) Any other information as deemed appropriate  by the commission that is relevant to the 
renewal application.  
 
(b) The applicant is responsible for notifying the commission  within ten (10) business day s if any 
information in the initial application changes.  Failure to make a timely and accurate notification 
about information changes may result in the denial of the application . 
 
SECTION  7. (a) As used in this SECTION , “sample” means the three (3) ten  (10) milliliter sample 
bottles from each production batch of more than two (2) liters required to  be stored or maintained by 
IC 7.1-7-4-6(b)(15).   
 
(b) Permits  are transferable to another person or location only with commission  approval . 
 
(c) Permits shall be transferable  upon a showing to the commission  that:  
(1) t he permit has not been suspended or revoked and is in good standing; and  
(2) t he new permit holder and location meet  all of the requirements as required by this document . 
 
(d) An e -liquid manufacturer transferring the location of the permit shall maintain the samples in 
a secure, limited access area during the transfer of location by complying with the following:  
(1) The e -liquid manufacturer must notify the commission of t he anticipated date the samples will 
be removed from the original location and the anticipated date the samples will be moved into 
the new location.   
(2) Samples may only be removed from the secure, limited access area with recorded video 
surveillance at the original location by designated employees of the e -liquid manufacturer.  
(3) Samples removed from the secure, limited access area with recorded video surveillance at the 
original location must be placed immediately in a secure, limited access container  or vehicle for 
transporting to the new permit location.  
(4) Video surveillance may not be removed or disconnected from the secure, limited access area 
until all samples are removed to the secure, limited access container or vehicle.  
(5) The secure, limi ted access area for the storage of samples at the new location must have 
operational video surveillance before samples may be placed in the area.  
(6)   The e -liquid manufacturer must notify the commission of the completion of the transfer 
within five (5) days after  the completion of the relocation of the samples and equipment.  
(7) The e -liquid manufacturer must maintain a list of employees who  had access to the samples 
during the transfer for a period of three (3) years.   
 
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 SECTION  8. (a) The manufacture r shall provide a product listing to the commission  at the time of 
the initial application for all e -liquid products manufactured in production batches of more than two 
(2) liters.  
 
(b) The product listing shall include:  
(1) the product name;  
(2) for each product, the percentage of nicotine; and  
(3) the original date of manufacture  of each product .  
 
(c) The manufacturer shall notify the commission  within thirty (30) days of the following:  
(1) T he manufacture of a new e -liquid product manufactured in  product ion batches of more than 
two (2) liters  and the original date of manufacture .  
(2) T he manufacture of an existing e-liquid product under a new or amended product name  and 
the or iginal date of manufacture under the new or amended product name . 
(3) T he discontinua tion and final manufacture date of an e -liquid product .  
(4) T he final date of manufacture of a discontinued product.  
 
(d) The manufacturer shall maintain a record of each ingredient used in a production batch for 
three (3) years that includ es the following information for each ingredient:  
(1) The ingredi ent, as listed in IC 7.1 -7-5-1. 
(2) The manufacturer of each ingredient .  
(3) The batch from the manufacturer of each ingredient, if applicable.   
The manufacturer shall provide the ingredient information for a production batch to the 
commission upon request.  
 
SECTION  9. In order to comply with IC 7.1 relating to e -liquid manufacturing , the manufacturing 
facility must demonstrate compliance  with the  following:  
(1) An e -liquid container must use a child proof cap that has the child resistance effectiveness  set 
forth in 16 CFR 1700.15(b)(1).  
(2) An e-liquid container mu st use a tamper evident package.  
(3) E-liquid containers must be labeled . 
(4) Label s on e -liquid con tainer s must identify all active ingredients , including percentage of 
nicotine . 
(5) Labels on e -liquid containers must include a batch number.  
(6) Labels on e -liquid containers must include a means for the commission to obtain the 
manufacturing date either through a scannable code or printed on the label.  
(7) The label on an e -liquid container must include a scannable code, including a quick response 
code, tied to the batc h number . 
(8) An e -liquid container label or tamper resistant packaging may  include a “best if used by ” date.  
An e -liquid container must be distributed by the manufacturer and sold by the manufacturer or 
the retailer by the earlier of either the “best if used by “or   two (2) y ears of the date of 
manufacture.   
(9) The m anufacturing facility must conduct all mixing and bottling activities in a clean room  as 
defined in IC  7.1.  
(10) The m anufacturer must take reasonable s teps to ensure th at an unauthorized ingredient is  
not inc luded in any e -liquid produced by ma nufacturer for sale in Indiana.  6 
 (11) The m anufacturer must take reasonable steps to ensure that all ingredients used in the 
production of e -liquid are stored in a secure area accessib le only by authorized personnel.   
(12) The manufacturer must maintain a  remotely monitored security system at the facility in  all 
areas where e -liquid is mixed , bottled, packaged, and stored.  
(13) The manufacturer sh all have  an exclusive high sec urity key system that limits access to areas 
where e -liquid is mixed, bottled, and stored to authorized personnel only.  
(14) The manufacturer’s facility must be subject to twenty -four (24) hour video recording where e -
liquids are  mixed, bottled, and stored .  The video recordings must be retained for at least thirty 
(30) days  and are subject to  commission  audit  for quality , purity, and compliance reviews . 
(15) The m anufacturer must take reasonab le steps to ensure that only aut horized personnel have 
access to secured areas of the facility where e -liquid is mixed, bottled, and packaged.  
(16) The m anufacturer must store and maintain three (3) ten (10) milliliter sample bottles fro m 
each production batch of more than two (2) liters for a period of not less than three (3) years in a 
secure, limited access area with recorded video surveillance . 
(17) A production log must be maintained listing  the following:  
(A) Date and time  the e-liquid was produced . 
(B) The name of the  product manufactured . 
(C) The amoun t of the product produced in liters .  
(D) The code and  batch number.  
(E) Any person  responsible for the mixing and bottling . 
 
SECTION  10. (a) The commission may  require an e -liquid manufacturer to have up to  three (3) 
different products tested annually by one (1) of three  (3) independent laboratories approved by the 
commission for safety, quality, and purity purposes.  
 
(b) The commission will select the three (3) products to be tested pursuant to subsection (a)  from 
the product listing pro vided to the commission u nder SECTION  8 of this document .  
 
(c) Failure by the e -liquid manufacturer to submit or pay the costs of a product testing required by 
subsection ( a) will result in disciplinary action by the commission that  may include fines, suspension, 
and revocation of the permit.  
 
(d) The commission may require the laboratory to test for any of the following:  
 (1) Nicotine.  
 (2) Ingredients listed on the label.   
 (3) Contaminants.  
 (4) Illegal drugs.  
 
(e) At the discretion of the commission, products that test positive for ingredients other than 
those listed on the label or on the ingredient list maintain ed by the e -liquid manufacturer under 
section 8 of this document may  be subject to retesting at the cost  of the e -liquid manufacturer.  
 
 
SECTION 11. Permit violations proceedings for e -liquid manufacturing permits shall be conducted 
pursuant to 905 IAC 1 -37-1.  
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 SECTION 12.  (a) If an initial or renewal applicati on for an e -liquid manufacturer  permit is deni ed by 
the commission, the commission shall give written notice of the action to the applicant.  
  
(b) Upon receipt of notice of the commission’s action, the applicant shall have fifteen ( 15) days to 
file:  
(1) a  petition for administrative appeal; and  
(2) a  brief objecting to the commission’s action.  
 
(c) The brief shall state any basis on which the applicant believes the application was denied in 
error.  
 
(d) The commission shall provide for one (1) automatic extension of the fifteen ( 15) day period at 
the request of the application if made within the original fifteen ( 15) days.  
 
(e) Failure of the applicant to file objections within the fifteen ( 15) day period shall constitute a 
waiver of any administrative appeal from the commission’s action.  
 
(f) At the discretion of the commission, a hearing may be conducted by the full commission, any 
individual member of the commission, or a duly authorized agent of the commission.  
 
(g) The commission may conduct a prehearing conference.  The hearing judge for the prehearing 
conference shall set the time and place of the conference and give reasonable notice to the applicant.  
 
(h) The hearing officer shall set the time and place of the hearing on the denial and give 
reasonable notice to the applicant.  At t he hearing, the applicant may present evidence by presenting 
testimony, under oath or affirmation, documentary evidence, or written evidence.  
 
 (i) If the decision by the commission is ultimately appealed by the applicant, the hearing officer 
may consider  any evidence presented in the original investigation, the commission hearing, or at the 
appeal hearing.  
 
(j) If the appeal is based on the denial of an application for renewal of an existing license, the 
applicant may request an extension of the life of the license to allow him  or her  to continue operating 
pending the appeal procedure.   
 
(k)  Following the hearing, the hearing officer shall issue proposed findings of fact, conclusions of 
law, and order to the commission for its final approval.  
 
(l) Such  proposed findings of fact, conclusions of law, and order shall be served on the applicant 
for his or her  written objection , which is due to the commission within fifteen ( 15) days of the 
applicant’s  receipt.  
 
(m) At the conclusion of the time for receipt of written objections, the commission shall approve, 
deny, or modify the proposed findings of fact, conclusions of law, and order.  
 
(n) In the case of denial of an application, the commission shall inform the ap plicant that its 
decision may be subject to judicial review.  8 
  
SECTION 13. LSA Document #16 -145(E) posted at 20160406 -IR-905160145ERA is repealed.