N.Y. Comp. Codes R. & Regs. tit. 10 § 1006.1

Current through Register Vol. 46, No. 45, November 2, 2024

Section 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 § 1399-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;

(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 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.

(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 any 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 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.

(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 product 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 ingredient 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 brand 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 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

(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 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.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1006.1

Adopted New York State Register May 18, 2022/Volume XLIV, Issue 20, eff. 5/18/2022