Pursuant to the authority vested in the Commissioner of Health by section 1701 of the Public 
Health Law, Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of 
New York is amended to add a new Chapter XIV , Part 100 6 to be effective upon publication of a 
Notice of Adoption in the New York State Register.   
 
A new Chapter XIV, Part 100 6 is added to read as follows:  
 
Chapter XIV Vapor Products  
Part 100 6. Ingredient Disclosures for Vapor Products and E -Cigarettes  
1006.1. Definitions.  
As used in this Part:  
(a) "Vapor products" shall mean any vapor product, as defined by Public Health Law § 1399 -aa, 
intended or reasonably expected to be used with or for the consumption of nicotine.  
 
(b) "Electronic cigarette" or "e -cigarette" shall mean an electronic cigarette or e -cigarette as 
defined by Public Health Law § 139 9-aa. 
 
(c) "Ingredient" shall mean each of the following:  
(i) any intentionally added ingredient  present in any quantity in a vapor product;  
(ii) a byproduct or contaminant, present in a vapor product in any quantity equal to or 
greater than one-half of one percent of the content  of such product by weight;  2 
 (iii) a byproduct present in a vapor product in any quantity less than one -half of one 
percent of the content of such product by weight, provided such element or compound is 
a chemical of concern; and  
(iv) a contaminant present in a vapor product  in any quanti ty less than one -half of one 
percent of the content  of such product by weight, provided such element or compound is 
a chemical of concern.  
 
(d) "Intentionally added ingredient" shall mean any element or compound  that a manufacturer 
has intentionally added to a vapor product at any  point in such product's supply chain, or at any 
point in the supply  chain of any raw material or ingredient used to manufacture such product.  
 
(e) "Byproduct" shall mean any element or compound in the finished vapor product, or in  the 
vapor produced during consumption of a vapor product, which:  
(i) was created or formed during the manufacturing  process as an intentional or 
unintentional consequence of such manufacturing process at any point in such product's 
supply chain, or at an y point in the supply chain of any raw material or ingredient used to  
manufacture such product; or  
(ii) is created or formed as an intentional  or unintentional consequence of the use of an e -
cigarette or consumption  of a vapor product. "Byproduct" shall i nclude, but is not limited 
to, an unreacted raw material, a breakdown product of an intentionally added  ingredient, 
a breakdown product of any component part of an e -cigarette, or a derivative of the 
manufacturing process.  3 
  (f) "Contaminant" shall mean any  element or compound present in a vapor product as an 
unintentional consequence of manufacturing. Contaminants include, but are not limited to, 
elements or compounds present in  the environment which were introduced into a product, a raw 
material, or  a prod uct ingredient as a result of the use of an environmental medium,  such as 
naturally occurring water, or other materials used in the manufacturing process at any point in a 
product's supply chain, or at any  point in the supply chain of any raw material or i ngredient used 
to manufacture such product.  
 
(g) "Manufacturer" shall mean any person, firm, association, partnership, limited liability 
company, or corporation which produces, prepares, formulates, or compounds a vapor product or 
e-cigarette, or  whose bra nd name is affixed to such product. In the case of a vapor  product or e -
cigarette imported into the United States, "manufacturer"  shall mean the importer or first 
domestic distributor of such product if  the entity that manufactures such product or whose brand 
name is affixed  to such product does not have a presence in the United States.  
 
(h) “Chemical of Concern” shall  mean any element or compound identified on the following 
lists: 
 (i) United States Food and Drug Administration’s Harmful and Potent ially Harmful 
Constituents in Tobacco Products and Tobacco Smoke , as published in the Federal 
Register on April 3, 2012 (77 Fed. Reg. 20034 – 20037) and available for public 
inspection and copying at the Regulatory Affairs Unit, New York State Department o f 
Health, Corning Tower, Empire State Plaza, Albany, NY 12237 ; and 4 
  (ii) United States Food and Drug Administration’s proposed additions to the Harmful and 
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke as published  
in the Federal R egister on August 5, 2019 (84 Fed. Reg. 38032  – 38035 ) and available for 
public inspection and copying at the Regulatory Affairs Unit, New York State 
Department of Health, Corning Tower, Empire State Plaza, Albany, NY 12237 . 
  
1006.2. Ingredient Disclosure  
(a) Manufacturers of vapor products or e -cigarettes distributed, sold, or offered for sale in this 
state, whether at retail  or wholesale, shall furnish to the Commissioner for public record and post 
on such manufacturer's website , in a machine -readable format, the information described in this 
Section.  
(b) (i) For each vapor product, the information posted pursuant to this section shall include , at a 
minimum : 
(a) Manufacturer information including name  and address  of the business enti ty and 
contact information  for a point -of-contact, including name, address, telephone number, 
and email address . 
(b) A list naming each ingredient of such vapor product  and all expected functions of 
each ingredient. The ingredients must be listed  in descending order of predominance by 
weight in such product, except that ingredients present at a weight below one percent 
may be listed following other ingredients without re spect to the order of predominance by 
weight .  
(c) The nature and extent of investigations and research performed by or for the 
manufacturer concerning the effects on human health of such product or its ingredients . 5 
 This includes but is not limited to heal th-related documents required by section 
904(a)(4) of Title 21 of the United States Code (a copy of which is available for copying 
and inspection at the Regulatory Affairs Unit, New York State Department of Health, 
Corning Tower, Empire State Plaza, Albany,  New York 12237) . Any investigations and 
research that was developed after the  required submission of health -related documents to 
the United States Food and Drug Administration must also be posted .  
(d) Where applicable, a statement disclosing that an ingr edient of such product is a 
chemical of concern . 
(e) For each ingredient that is a chemical of concern , an evaluation of the availability of 
potential alternatives and potential hazards posed by such alternatives.  
(ii) For each e -cigarette , the information  posted pursuant to this  section shall include, but shall 
not be limited to:  
(a) Manufacturer information including name and address of the business entity and 
contact information for a point -of-contact, including name, address, telephone number, 
and email address.  
(b) A list naming any toxic metal, including but not limited to lead, manganese, nickel, 
chromium, or zinc, as a constituent of any heating  element included in such e -cigarette . 
(c) A list naming each byproduct that may be introduced into vapor  produced during the 
normal use of such e -cigarette . 
(d) The nature and extent of investigations and research performed  by or for the 
manufacturer , or that the manufacturer is aware of,  concerning the effects on human 
health of  such product or such ingredients . This includes but is not limited to health -
related documents required by section  904(a)(4)  of Title 21 of the United States Code (a 6 
 copy of which is available for copying and inspection at the Regulatory Affairs Unit, 
New York State Department of Health, Corning Tower, Empire State Plaza, Albany, New 
York 12237). An y investigations and research that was developed after the required 
submission of health -related documents to the United States Food and Drug 
Administration must also be posted.  
(e) Where applicable, a statement disclosing that an ingredient is  published as a chemical 
of concern . 
(f) For each constituent of any heating element identified as a toxic  metal and ingredient 
published as a chemical of concern, an evaluation of the availability of potential 
alternatives and potential hazards posed by such alterna tives.  
 
1006.3 Proprietary Information  
(a) For purposes of this Part only, proprietary information may consist of any information subject 
to disclosure pursuant to this Part the disclosure of which would compromise a manufacturer's 
competitive position. Any proprietary information submitted or divulged to the Department of 
Health pursuant to this Part shall not be available for, or subject to, public disclosure.  Proprietary 
information shall include, but is not limited to, any:  
(i) Commercially valuable plan, formula, process, or device that is used for the making,  
preparing, or processing of vapor products, e -cigarettes, or their components, and that can 
be said to be the end product of either innovation or substantial effort. There must be a 
direct relationship between the proprietary information and the productive process; or  
(ii) Valuable data or information which is used in a manufacturer’s business and is of a  7 
 type customarily held in strict confidence or regarded as privileged and not dis closed to any 
member of the public by the person to whom it belongs.  
 
(b) A manufacturer submitting information to the Department pursuant to this Part may designate 
part or all of the information in such records as exempt from disclosure. The Manufacturer may 
make this designation either at the time the records are submitte d to the Department or within a 
reasonable time thereafter. Such  designation must be in writing  and must set forth the reasons 
why the information should be excepted from disclosure  as proprietary information, including, as 
appropriate:  
(i) the specific information requested to be considered proprietary information , including, 
where applicable, page, form, line, chart or table designation;  
(ii) the confidential nature of the record, including a description of the nature and extent 
of the injury to the manuf acturer’s competitive position such as unfair economic or 
competitive damage which would be incurred were the information to be disclosed;  
(iii) whether the information is treated as confidential by the manufacturer , including 
whether it has been made avai lable  to any other manufacturer or to the public ; 
(iv) whether any patent, copyright, or similar legal protection exists for the information ; 
(v) whether the public disclosure of such information  is otherwise restricted by law, and 
the specific source and contents of such restrictions;  
(vi) the date upon which such information will no longer need to be kept confidential, if 
applicable;  
(vii) whether the request itself constitutes information which , if disclosed, would defeat 
the purpose for which proprietary status is sought;  8 
 (viii) whether the information is known outside of the business of the manufacturer , and 
the extent to which the record is known by the employees and others involved in the 
business of the manufacturer ; 
(ix) the value of the information to the manufacturer and to its competitors;  
(x) the amount of effort or money expended by the manufacturer  in developing the 
information , and the ease or difficulty with which the information could be properly 
acquired or duplicated by others;  
(xi) any other factors considered relevant.  
(c) When information designated as  proprietary information has been submitted to the 
Department , it shall be excepted from disclosure and maintained apart by the Department from 
all other records until 15 days after the entitlement to such exception has been finally determined 
by the Commissioner or such further time as ordered by a court of competent jurisdiction.  
(d) A denial of an exception from disclosure requested pursuant to this section shall be final.  
(e) The Commissioner shall not approve any exceptions under this  section with respect to any 
ingredient that is a chemical of  concern on one or more lists identified by the Commissioner . 
 
1006.4 Schedule of Disclosure  
Manufacturers shall furnish the information required to be posted pursuant to this section within 
thirty days of the effective date hereof , and every two years thereafter. In addition, such 
manufacturers shall furnish such information : prior to the sale of any new vapor product or e -
cigarette ; when the formulation of a currently disclosed product is changed such that the 
predomina nce of the ingredients in such product is changed , prior to the product being sold at 
retail;  or at such other times as may be required by the Commissioner . 9 
  
1006.5 Penalties  
Any manufacturer who violates any of the provisions of, or who fails to perform a ny duty 
imposed by this Part shall be liable, in the case of a first violation, for a civil penalty not to 
exceed five thousand dollars. In the case of a second or any subsequent violation, the liability 
shall be for a civil penalty not to exceed ten thous and dollars for each such violation.  
  
  10 
 Regulatory Impact Statement  
Statutory Authority:  
The Commissioner of Health is authorized by Section 1701  of the Public Health Law 
(PHL) to promulgate regulations implementing Article 17 of the Public Health Law, pertaining 
to the public disclosure of the ingredients of vapor products and electronic cigarettes.  
 
Legislative Objectives:  
The legislative objective of PHL Article 17 is to increase public awareness of the 
ingredients found in vapor products and el ectronic cigarettes, and to improve the public health by 
ensuring consumers are aware when such ingredients are potentially harmful.  
 
Needs and Benefits:  
On August 16, 2019, the New York State Department of Health issued a statewide health 
advisory to hea lth care providers following reports regarding severe pulmonary illness  in people 
who had reported use of  vapor products  prior to symptom onset . New York State took immediate 
action in an effort to identify commonalities among the cases , provide guidance to health care 
providers, and issue warnings to consumers to halt use of vaping products until the cause of 
illness could be identified. While a definitive cause for this vap ing associated pulmonary 
illnesses has not be identified, it wa s postulated that use of vitamin E acetate as a diluent  in the 
vaping liquid  was the likely source of the surge in cases .  
This public health crisis highlighted the lack of  vaping and electronic cigarette  ingredient 
information available to the public , health care providers, or public health professionals working 
to identify a potential cause for these illnesses.  While the U.S. Food and Drug Administration 11 
 requires vaping and electronic cigarette manufactu rers to submit an ingredient list for each of 
their products, there is no requirement f or the ingredient  information  to be made easily accessible 
to the public.  
In order to educate New Yorkers  about  the contents of  the vaping products and electronic 
cigarettes  they purchase for use , and to help protect the public health where such products 
contain chemicals of concern, the Legislature enacted a new Article 17 of the PHL, in Chapter 56 
of the Laws of 2020, which  requir es manufacturers to disclose to the public all ingredien ts used 
to make both the vaping liquid and the components of the electronic cigarette. Additionally, the  
law require s manufacturers to disclose to the public any byproduct or contaminant present in th e 
vaping liquid, ele ctronic cigarette, or vaping aerosol produced when the e -cigarette is used.  The 
proposed regulations are necessary to implement this  law.  
In particular, the proposed regulations identif y chemicals of concern that pose a greater 
potenti al for human health risks from exposure. This regulation will require manufacturers to 
highlight if any portion of their  product (the vaping liquid, electronic cigarette, or the aerosol 
emitted from these products)  contains a n intentional ly added  ingredient, a byproduct, or a 
contaminant that has been identified as a  chemical of concern . This will allow New Yorkers to 
make informed decisions about the products they purchase for use. It will also encourage 
manufacturers to find innovative ways to e ither replace or remove substances with greater 
potential for harm from  vaping products and  electronic cigarette s sold in NYS . Additionally, 
having ingredient, byproduct, and contaminant information readily available for vaping products 
and electronic ciga rettes that are sold for use in NYS will provide a valuable source of 
information if these types of devices ar e associated with an outbreak of illnesses in the future.  12 
 In accordance with PHL Article 17, the proposed regulations provide for procedures 
necessary to protect the confidentiality of vapor product manufacturer’s proprietary information, 
except with regard to those ingredients identified in the proposed regulation as chemicals of 
concern.  
 
Costs to Private Regulated Parties:  
The cos t to manufacturers is expected to  be minimal. Manufacturers have already been  required 
to disclose their ingredients  and health -related studies  to the U.S. Food and Drug Administration . 
Additionally, the department’s list of chemicals of concern  comes from  the U.S. Food and Drug 
Administration ’s established list of  harmful or potentially harmful constituents of tobacco 
products  (93 chemicals)  as well as their proposed list of 19 additional chemicals that would be 
specific to vap or products and electronic cigarettes . Manufacturers are already required to report 
the levels of these harmful or potentially harmful chemicals to the U.S. Food and Dr ug 
Administration. The only additional requirement for manufacturers resulting from these 
regulations is to post each product’s ingredient, byproduct, and contaminant information on their 
website. They must also  highlight if any of their ingredients, bypro ducts, or contaminants have 
been identified as a  chemical of concern.  
 
Costs to State Government and Local Government:  
The Department of Health will incur costs for enforcement. Exact costs cannot be 
predicted at this time because the extent of the need for enforcement cannot be fully determined. 
Some of the cost however may be offset by fines and penalties imposed pursuant to the Public 
Health Law.   13 
 Local government will incur no new costs.  
 
Local Government Mandates:  
 The proposed regulation impos es no new mandates on local governments.  
 
Paperwork:  
All manufacturers of vapor products will be required to report to the Commissioner the 
ingredients of their products, and related health studies as defined herein. However, 
manufacturers of vapor product s are already required to report this information to the U.S. Food 
and Drug Administration . As such, additional paperwork is anticipated to be minimal.  
 
Duplication:  
The proposed  regulations would not duplicate any  State or federal regulations.  
 
Alternat ives:  
The proposed regulations implement mandatory disclosure requirements imposed by 
PHL Article  17. As such, no alternatives were considered.   
 
Federal Standards:  
 21 U.S.C. 387d, and regulations promulgated thereunder, requires that vapor product 
manufactures disclose their product’s ingredients and health -related studies to the U.S. Food and 
Drug Administration . 
 14 
 Compliance Schedule:  
The regulation will be effecti ve upon publication of a Notice of Adoption in the New 
York State Register.  
 
Contact Person:  
  
Katherine E. Ceroalo  
New York State Department of Health  
Bureau of Program Counsel, Regulatory Affairs Unit  
Corning Tower Building, Room 2438  
Empire State Plaza  
Albany, New York 12237  
(518) 473 -7488  
(518) 473 -2019 (FAX)  
REGSQNA@health.ny.gov  
 
 
 
 
 
 
  15 
 Regulatory Flexibility Analysis for Small Business and Local Governments  
 
Effect of Rule:  
 All vapor product  manufacturers will be required to comply with the proposed rule, 
which implements the requirements of PHL Article 17.  Some vapor product manufacturers may 
be small businesses; however, the effect of the rule is anticipated to be minimal as the 
requiremen ts largely mirror federal reporting requirements.  
No local governments will be impacted by the proposed regulations.  
 
Compliance Requirements:  
The proposed regulations will require manufacturers of vapor products to disclose, to the 
Commissioner and to the public, their product’s ingredients as well as health -related studies 
regarding such ingredients.  
 
Professional Services:  
As vapor product manufacturers are already required to report ingredients and health -
related studies to the  U.S. Food and Drug Administration , additional professional services should 
not be necessary.  
 
Compliance Costs:  
The cost to manufacturers is expected to be minimal. Manufacturers have already been 
required to disclose their ingredients and health -related s tudies to the U.S. Food and Drug 
Administration. Additionally, the department’s list of chemicals of concern comes from the U.S. 16 
 Food and Drug Administration’s established list of harmful or potentially harmful constituents of 
tobacco products (93 chemical s) as well as their proposed list of 19 additional chemicals that 
would be specific to vapor products and electronic cigarettes. Manufacturers are already required 
to report the levels of these harmful or potentially harmful chemicals to the U.S. Food and Drug 
Administration. The only additional requirement for manufacturers resulting from these 
regulations is to post each product’s ingredient, byproduct, and contaminant information on their 
website. They must also highlight if any of their ingredients, byp roducts, or contaminants have 
been identified as a chemical of concern.  
 
Economic and Technological Feasibility:  
There are no economic or technology impediments to any of the proposed rule changes.  
 
Minimizing Adverse Impact:  
Adverse impacts on manufacturers are expected to be minimal. Manufacturers have 
already been required to disclose their ingredients and health -related studies to the U.S. Food and 
Drug Administration.  
 
Small Business and Local Government Participation:  
A copy of the draft p roposed rule was sent via e -mail to several professional associations 
representing vapor product manufacturers for input.  
 
 
 17 
 Cure Period:  
Chapter 524 of the Laws of 2011 requires agencies to include a “cure period” or other 
opportunity for ameliorative action to prevent the imposition of penalties on a party subject to 
enforcement when developing a regulation or explain in the Regulatory Fle xibility Analysis why 
one is not included. The penalties described in the regulations mirror those already established in 
PHL Article 17. As such, this proposed regulation does not create a new penalty or sanction, and 
no cure period is necessary.  
  18 
 Rural  Area Flexibility Analysis  
Types and Estimated Numbers of Rural Areas:  
 This rule applies uniformly throughout the state, including rural areas. Rural areas are 
defined as counties with a population less than 200,000 and counties with a population of 
200,000 or greater that have towns with population densities of 150 persons o r fewer per square 
mile.  The following 43 counties have a population of less than 200,000 based upon the United 
States Census estimated county populations for 2010  (https://www.census.gov/quickfacts/ ).   At 
present, it is unknown how many vapor product manufacturers are located in these counties.  
.Allegany County  .Greene County  .Schoharie County  
.Cattaraugus County  .Hamilton County  .Schuyler County  
.Cayuga County  .Herkimer County  .Seneca County  
.Chautauqua County  .Jefferson County  .St. Lawrence County  
.Chemung County  .Lewis County  .Steuben County  
.Chenango County  .Livingston County  .Sullivan County  
.Clinton County  .Madison County  .Tioga County  
.Columbia County  .Montgomery County  .Tompkins County  
.Cortland County  .Ontario County  .Ulster County  
.Delaware County  .Orleans County  .Warren County  
.Essex County  .Oswego County  .Washington County  
.Franklin County  .Otsego County  .Wayne County  
.Fulton County  .Putnam County  .Wyoming County  
.Genesee County  .Rensselaer County  .Yates County  
 .Schenectady County   
   
 The following counties have a population of 200,000 or greater and towns with 
population densities of 150 persons or fewer per square mile.  Data is based upon the United 
States Census estimated county populations for 2010.  At present, it is unknown how many vapor 
product manufacturers are located in these counties.  
 
  
 .Albany County  .Monroe County  .Orange County  
.Broome County  .Niagara County  .Saratoga County  
.Dutchess County  .Oneida County  .Suffolk County  
.Erie County  .Onondaga County   19 
 Reporting, Recordkeeping, Other Compliance Requirements and Professional Services:  
All manufacturers of vapor products will be required to report to the Commissioner the 
ingredients of their products, and related health studies as defined herein. However, 
manufacturers of vapor products are already required to report this information to the U.S. Food 
and Drug Administration. As such, additional recordkeepi ng is anticipated to be minimal.  
As vapor product manufacturers are already required to report ingredients and health -
related studies to the U.S. Food and Drug Administration, additional professional services should 
not be necessary.  
 
Costs:  
The cost to ma nufacturers is expected to be minimal. Manufacturers have already been 
required to disclose their ingredients and health -related studies to the U.S. Food and Drug 
Administration. Additionally, the department’s list of chemicals of concern comes from the U. S. 
Food and Drug Administration’s established list of harmful or potentially harmful constituents of 
tobacco products (93 chemicals) as well as their proposed list of 19 additional chemicals that 
would be specific to vapor products and electronic cigarette s. Manufacturers are already required 
to report the levels of these harmful or potentially harmful chemicals to the U.S. Food and Drug 
Administration. The only additional requirement for manufacturers resulting from these 
regulations is to post each produc t’s ingredient, byproduct, and contaminant information on their 
website. They must also highlight if any of their ingredients, byproducts, or contaminants have 
been identified as a chemical of concern.   
 
 20 
 Minimizing Adverse Impact:  
Adverse impacts on manu facturers are expected to be minimal. Manufacturers have 
already been required to disclose their ingredients and health -related studies to the U.S. Food and 
Drug Administration.  
 
Rural Area Participation:  
A copy of the draft proposed rule was sent via e -mail to several professional associations 
representing vapor product manufacturers for input.  
 
  21 
 Job Impact Statement  
A Job Impact Statement for these amendments is not being submitted because it is 
apparent from the nature and purposes of the amendments tha t they will not have a substantial 
adverse impact on jobs and/or employment opportunities.