(1) any intentionally added ingredient present in any quantity in a vapor product;

(2) 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;

(3) 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

(4) a contaminant 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.

(1) 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 any point in the supply chain of any raw material or ingredient used to manufacture such product; or

(2) 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 include, 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.

(1) United States Food and Drug Administration’s Harmful and Potentially 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 of Health, Corning Tower, Empire State Plaza, Albany, NY 12237; and

(2) 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 Register 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.

(b)(1) For each vapor product, the information posted pursuant to this section shall include, at a minimum:

(i) 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.

(ii) A list naming each ingredient of such vapor product. 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 respect to the order of predominance by weight.

(iii) 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. This includes but is not limited to health-related documents required by section 387d 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.

(iv) Where applicable, a statement disclosing that an ingredient of such product is a chemical of concern.

(v) For each ingredient that is a chemical of concern, an evaluation of the availability of potential alternatives and potential hazards posed by such alternatives.

(2) For each e-cigarette, the information posted pursuant to this section shall include, but shall not be limited to:

(i) 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.

(ii) A list naming any toxic metal as a constituent of any heating element included in such e-cigarette.

(iii) A list naming each byproduct that may be introduced into vapor produced during the normal use of such e-cigarette.

(iv) 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 387d 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.

(v) Where applicable, a statement disclosing that an ingredient is published as a chemical of concern.

(vi) 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 alternatives.

(1) 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

(2) Valuable data or information which is used in a manufacturer’s business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.

(1) the specific information requested to be considered proprietary information, including, where applicable, page, form, line, chart or table designation;

(2) the confidential nature of the record, including a description of the nature and extent of the injury to the manufacturer’s competitive position such as unfair economic or competitive damage which would be incurred were the information to be disclosed;

(3) whether the information is treated as confidential by the manufacturer, including whether it has been made available to any other manufacturer or to the public;

(4) whether any patent, copyright, or similar legal protection exists for the information;

(5) whether the public disclosure of such information is otherwise restricted by law, and the specific source and contents of such restrictions;

(6) the date upon which such information will no longer need to be kept confidential, if applicable;

(7) whether the request itself constitutes information which, if disclosed, would defeat the purpose for which proprietary status is sought;

(8) 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;

(9) the value of the information to the manufacturer and to its competitors;

(10) 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;

(11) any other factors considered relevant.

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 electronic 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 health 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 vaping associated pulmonary illnesses has not be identified, it was 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 requires vaping and electronic cigarette manufacturers to submit an ingredient list for each of their products, there is no requirement for 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 requires manufacturers to disclose to the public all ingredients used to make both the vaping liquid and the components of the electronic cigarette. Additionally, the law requires manufacturers to disclose to the public any byproduct or contaminant present in the vaping liquid, electronic 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 identify chemicals of concern that pose a greater potential 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 an intentionally 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 either replace or remove substances with greater potential for harm from vaping products and electronic cigarettes sold in NYS. Additionally, having ingredient, byproduct, and contaminant information readily available for vaping products and electronic cigarettes that are sold for use in NYS will provide a valuable source of information if these types of devices are associated with an outbreak of illnesses in the future.

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:

Costs to Private Regulated Parties:

There will be costs to private regulated parties associated with compliance with this proposed rule. The requirements in this proposed rule do not deviate from requirements set forth in Article 17 of the Public Health Law. Costs to manufacturers would include analyzing their vaping liquid, e-cigarette device, and the aerosol produced by the device for the presence of chemicals of concern, toxic metals, contaminants, and byproducts that are not already known to the manufacture (e.g., the manufacture would already know the presence of intentionally added ingredients or contaminants that were disclosed to the manufacturer from the source of their raw materials). Costs will also be associated with the requirement to conduct and submit an evaluation of the availability of potential alternatives to any chemical of concern or toxic metal identified in their product or the aerosol produced by their product and the potential hazards posed by alternatives. Additionally, there will be costs associated with development of a public-facing website to disclose all intentionally added ingredients (regardless of the amount present), toxic metals, contaminants (great than or equal to 0.5% by weight of the product or at any amount if it is a chemical of concern), and byproducts (great than or equal to 0.5% by weight of the product or at any amount if it is a chemical of concern), and flagging these as chemicals of concern or toxic metals if applicable. Manufacturers have already been required to disclose their ingredients and health-related studies to the U.S. Food and Drug Administration (US FDA) so these requirements will not constitute an additional cost to the manufacturers. Additionally, the department’s list of chemicals of concern comes from the US FDA’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 cigarettes. Manufacturers are already required to report the levels of these harmful or potentially harmful chemicals to the US FDA. The Department recognizes that this requirement will add additional costs to private regulated parties because the US FDA has allowed manufacturers to test for and disclose a reduced number of these chemicals since 2012 (US FDA issued industry guidance in 2012 identifying a subset of 20 chemicals that industry would be required to test for and disclose). The proposed regulation does not adopt this truncated list of chemicals and therefore manufacturers would be required to test for and disclose the presence of any chemical from the full list of chemicals 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.

Local government will incur no new costs.

Local Government Mandates:

The proposed regulation imposes 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 products 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.

Alternatives:

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.

Compliance Schedule:

The regulation will be effective upon publication of a Notice of Adoption in the New York State Register.

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 requirements 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:

There will be costs to private regulated parties associated with compliance with this proposed rule. The requirements in this proposed rule do not deviate from requirements set forth in Article 17 of the Public Health Law. Costs to manufacturers would include analyzing their vaping liquid, e-cigarette device, and the aerosol produced by the device for the presence of chemicals of concern, toxic metals, contaminants, and byproducts that are not already known to the manufacture (e.g., the manufacture would already know the presence of intentionally added ingredients or contaminants that were disclosed to the manufacturer from the source of their raw materials). Costs will also be associated with the requirement to conduct and submit an evaluation of the availability of potential alternatives to any chemical of concern or toxic metal identified in their product or the aerosol produced by their product and potential hazards posed by alternatives. Additionally, there will be costs associated with development of a public-facing website to disclose all intentionally added ingredients (regardless of amount present), toxic metals, contaminants (great than or equal to 0.5% by weight of the product or at any amount if it is a chemical of concern), and byproducts (great than or equal to 0.5% by weight of the product or at any amount if it is a chemical of concern), and flagging these as chemicals of concern or toxic metals if applicable. Manufacturers have already been required to disclose their ingredients and health-related studies to the U.S. Food and Drug Administration (US FDA) so these requirements will not constitute an additional cost to the manufacturers. Additionally, the department’s list of chemicals of concern comes from the US FDA’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 cigarettes. Manufacturers are already required to report the levels of these harmful or potentially harmful chemicals to the US FDA. The Department recognizes that this requirement will add additional costs to private regulated parties because the US FDA has allowed manufacturers to test for and disclose a reduced number of these chemicals since 2012 (US FDA issued industry guidance in 2012 identifying a subset of 20 chemicals that industry would be required to test for and disclose). The proposed regulation does not adopt this truncated list of chemicals and therefore manufacturers would be required to test for and disclose the presence of any chemical from the full list of chemicals 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 proposed rule was sent via e-mail to several professional associations representing vapor product manufacturers for input.

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 Flexibility 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.

Changes made to the last published rule do not necessitate revision to the previously published Rural Area Flexibility Analysis and Job Impact Statement.

The New York State Department of Health (the Department) received several comments to the proposed rulemaking adding a new Part 1006 to Title 10 of the Code, Rules and Regulations of the State of New York relating to ingredient disclosures for vapor products and e-cigarettes. The proposed rule implements requirements for ingredient disclosure set forth in Section 1701 of the Public Health Law (PHL). Public comments were received from three industry stakeholders.

Comments were primarily focused on the need to clarify definitions and provide additional guidance, as well as considerations for how the United States Food and Drug Administration (US FDA) is proceeding with regulation of these products. In response to these comments, revisions were made to the proposed rule to clarify certain definitions. Commenters also expressed concerns with requirements in the proposed regulation that were identical to requirements within PHL § 1701. No revisions were made to the proposed rule in response to these comments and the commenters were referred back to PHL § 1701. Additionally, commenters suggested that the fiscal implications for companies from the proposed rule were not adequately addressed in the Regulatory Impact Statement. The "Cost to Private Regulated Parties" and the "Compliance Costs" sections of the rulemaking package were modified to address these comments. The remaining comments challenged the state's legal authority to require vape and e-cigarette companies to disclose this information. No revisions were made to the proposed rule based on these comments.