As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2025, which is no later than the 3rd year after the year in which this rule is being adopted.

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. Public comments were received from eight industry stakeholders. All of the comments and the Department’s responses are summarized below.

COMMENT: Several commenters claimed that requirements within the proposed regulation are preempted by the federal Family Smoking Prevention and Tobacco Control Act (TCA). The comments specify that states are prohibited from establishing requirements that differ from TCA’s requirements with respect to premarket review and labeling.

RESPONSE: The proposed rule implements ingredient disclosures for vapor products and e-cigarettes that are mandated by PHL § 1701. No changes were made to the proposed rule as a result of this comment.

COMMENT: Several commenters claimed that the proposed rule unlawfully compels speech by requiring companies to publicly disclose information on their websites.

RESPONSE: The proposed rule implements ingredient disclosures for vapor products and e-cigarettes that are mandated by PHL § 1701. No changes were made to the proposed rule as a result of this comment.

COMMENT: Several commenters claimed that the proposed rule’s protections for proprietary information do not provide the same level of confidential treatment as is afforded by the FDA. One commenter recommended that the proposed rule be modified to align with protections offered to submitters of confidential or trade-secret information under the Freedom of Information Act.

RESPONSE: The proposed rule implements the specific limits on treatment of proprietary information and the definition for such information found in PHL § 1701, which permits the withholding of information from public disclosure provided the disclosure of such information “would compromise such manufacturer’s competitive position.” No changes were made to the proposed rule as a result of this comment.

COMMENT: Several commenters indicate that the proposed rule significantly underestimates the cost that will be incurred by the industry to comply with these requirements. The commenters point to costs associated with collecting and producing extensive amounts of information that the FDA has not required for their Premarket Tobacco Product Application (PMTA) process as well as the costs and challenges associated with testing products for the identified chemicals of concern, byproducts, or contaminants and disclosing those ingredients. One commenter recommended that the Department accept a summary of manufacturer research that was required to be submitted by US FDA.

RESPONSE: The Department acknowledged there would be costs incurred by the regulated community in the updated “Costs to Private Regulated Parties” and “Compliance Costs” sections of the proposed rule. The proposed rule implements ingredient disclosures for vapor products and e-cigarettes that are mandated by PHL § 1701. The Department has determined that a summary of the manufacturer research that was required to be submitted by US FDA would be acceptable. This will be clarified in future guidance pertaining to the proposed rule. No changes were made to the proposed rule as a result of this comment.

COMMENT: Two commenters claim that the proposed rule is arbitrary and capricious because it interferes with FDA regulatory oversight for reasons that are not explained or justified.

RESPONSE: The proposed rule implements ingredient disclosures for vapor products and e-cigarettes that are mandated by PHL § 1701. No changes were made to the proposed rule as a result of this comment.

COMMENT: Two commenters highlighted provisions within the proposed rule that go further than what is required by the FDA through their PMTA process. They specifically point out that the FDA only requires disclosure of 20 chemicals from there Harmful and Potentially Harmful Constituents (HPHC) list whereas the proposed rule defines “chemicals of concern” as being all of the chemicals on FDA’s HPHC list (112 chemicals) as well as vitamin E acetate. The proposed rule requires an alternatives assessment for chemicals that are identified as chemicals of concern whereas the FDA does not have this requirement. The FDA also limits their definition of “ingredient” to those that are intentionally added whereas the proposed rule includes contaminants and byproducts in the definition of ingredients. Additionally, the FDA only required submission of health documents that were developed within a specific window of time whereas the proposed rule requires all health documentation. The commenters indicate this is arbitrary and capricious because there is a lack of sound reasoning for the additional requirements.

RESPONSE: The legislative objective of Article 17 of the PHL is to increase public awareness of the ingredients found in vapor products and electronic cigarettes, and to improve public health by ensuring consumers are aware when such ingredients are potentially harmful. The proposed rule does not deviate from the requirements set forth in Article 17 of the PHL. No changes to the proposed rule are necessary as a result of these comments.

COMMENT: Two commenters indicated that the Department has not performed any studies or meaningful analysis to determine the impact on consumers and behavior as a result of this proposed rule.

RESPONSE: The proposed rule implements ingredient disclosures for vapor products and e-cigarettes that are mandated by PHL § 1701. No changes were made to the proposed rule as a result of this comment.

COMMENT: Several commenters recommended that the proposed rule should exempt products that have been authorized by the US Food and Drug Administration (FDA) through their Premarket Tobacco Product Application (PMTA) process. Commenters pointed to the State’s e-cigarette flavor ban (Public Health Law Article 13-F Section 1399-MM-1) as an example of where this type of exemption is currently used in New York.

RESPONSE: The legislative objective of Article 17 of the PHL is to increase public awareness of the ingredients found in vapor products and electronic cigarettes, and to improve public health by ensuring consumers are aware when such ingredients are potentially harmful. The proposed rule implements ingredient disclosures for vapor products and e-cigarettes that are mandated by PHL § 1701. No changes were made to the proposed rule as a result of these comments; however, the Department will take these comments under advisement for future rulemaking.

COMMENT: Several commenters recommended that the State delay rulemaking until the FDA acts on all PMTAs that are currently under review.

RESPONSE: The vapor product and e-cigarette ingredient disclosures required by PHL § 1701 are currently in effect and cannot be waived or delayed by the Department. The proposed rule is necessary to implement these requirements for ingredient disclosure. No changes were made to the proposed rule as a result of this comment.

COMMENT: One commenter indicated that the proposed rule only applies to e-cigarette and vapor products used for nicotine. However, the impetus for this law was the outbreak of lung injury cases in 2019 that were likely due to black-market vaping products used for cannabis consumption. The commenter recommends that the requirements be expanded to cannabis containing e-cigarette and vaping products, however they acknowledge that this would likely require a change to the Article 17 of the Public Health Law.

RESPONSE: Article 17 of the PHL specifically identifies vapor products and e-cigarettes used for the consumption of nicotine. It does not include vapor products and e-cigarettes used for the consumption of tetrahydrocannabinol, the main psychoactive compound in cannabis. The Department modified the proposed rule to include vitamin E acetate as a chemical of concern, but no other changes to the proposed rule were made as a result of these comments.