N.J. Admin. Code § 17:30-11.6

Current through Register Vol. 56, No. 17, September 3, 2024

Section 17:30-11.6 - Ingredients in cannabis products

(a) A cannabis manufacturer must ensure all ingredients included in the products are compliant with the standards in this section and used only within the ingredient manufacturer's recommendations.

(b) All ingredients used to manufacture cannabis products shall be United States PharmacopeiaNational Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substances. If a USP-NF, AR, ACS, or FCC grade substance ingredient is not available, the cannabis manufacturer shall establish the purity and safety of the ingredient by reasonable means, which may include lot analysis, manufacturer reputation, or reliability of source study.

(c) Components used in the manufacturing of cannabis products, such as aliquots, triturates, stock solutions, buffering agents, or isotonic solutions may be prepared in advance and stored as cannabis manufacturer stock. The preparation of such products shall be documented in accordance with the requirements outlined in this subchapter.

(d) Inactive and active ingredients for inhalable products shall be as follows:

1. Inactive ingredients for vaporized formulations shall be as follows:

i. Vaporized formulations may not include inactive ingredients that are additives, cutting agents, and artificial flavorings known to be harmful including, but not limited to:

(1) Polyethylene glycol (PEG);

(2) Propylene glycol (PG);

(3) Vegetable glycerin, glycerine, or glycerol (VG);

(4) Vitamin E acetate or tocopherol acetate (VEA);

(5) Acetic acid; or

(6) Any other ingredient listed in the August 5, 2019, published Food and Drug Administration Established List of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke, or the Food and Drug Administration Notice of Proposed Additions to the Established List of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke, which is incorporated herein by reference, as amended and supplemented; and

ii. Any inactive ingredient used in a vaporized formulation must be listed as an allowable ingredient in products using the Respiratory (Inhalation) Route of Administration, as published by the Food and Drug Administration Inactive Ingredients Database, through June 30, 2021, which is incorporated herein by reference, as amended and supplemented; and must be used in an amount less than or equal to the "Potency Amount" allowed for the ingredient.

(1) Except that medium-chain triglyceride oil (MCT) may be used in a vaporized formulation in less than or equal to 13 percent of the vaporized formulation;

2. Inactive ingredients for oil intended for inhalation using a pressurized metered dose inhaler may include an inactive ingredient, including a pressurized propellant, that is listed as an allowable ingredient in products using the Respiratory (Inhalation) Route of Administration and the Aerosol, Metered Dosage Form in the Food and Drug Administration Inactive Ingredients Database, and that is used in an amount less than or equal to the "Potency Amount" allowed for the ingredient; and

3. Permitted active ingredients for cannabis products intended for inhalation and vaporized formulations shall be as follows:

i. Cannabis products intended for inhalation and vaporized formulations may include oil, cannabis-derived ingredients including terpenes, and botanically-derived terpenes.

(1) Except that the total amount of terpenes in a cannabis product intended for inhalation or vaporized formulation may not exceed 10 percent of the product.

(e) A cannabis manufacturer may seek a waiver to an inactive ingredient requirement at (d)1 above by providing evidence that demonstrates the safety of the ingredient in aerosol form for the inhalation route of administration within the maximum potency per unit dose, including, but not limited to:

1. Peer-reviewed studies, especially studies that demonstrate the safety of the ingredient after heating and in combination with cannabis concentrate; and

2. Approval for use as an allowable ingredient in products using the inhalation route of administration by an international body or government agency in another country equivalent to the Food and Drug Administration or another U.S. state department of health.

(f) Any inactive ingredient used in an ingestible cannabis product must be listed as an allowable ingredient in products using the Oral, Buccal, or Sublingual Routes of Administration, as applicable, in the Food and Drug Administration Inactive Ingredients Database and must be used in an amount less than or equal to the " Maximum Potency per unit dose" allowed for the ingredient.

(g) Any inactive ingredient used in a dermal cannabis product must be listed as an allowable ingredient in products using the Topical and Transdermal Routes of Administration, as applicable, in the Federal Food and Drug Administration Inactive Ingredients Database and must be used in an amount less than or equal to the "Potency Amount" allowed for the ingredient.

(h) Food and Drug Administration documents, incorporated by reference in this section, may be accessed as follows:

1. The most recently published Food and Drug Administration Established List of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke is available at http://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list;

2. The Food and Drug Administration Notice of Proposed Additions to the Established List of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke (August 5, 2019) is available at http://www.federalregister.gov/documents/2019/08/05/2019-16658/harmful-and-potentially-harmful-constituents-in-tobacco-products-established-list-proposed-additions; and

3. The most recently published Food and Drug Administration Inactive Ingredients Database is available at http://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-database-download.

N.J. Admin. Code § 17:30-11.6

Adopted by 53 N.J.R. 1583(a), effective 8/19/2021

Amended by 55 N.J.R. 402(a), effective 3/6/2023