N.J. Admin. Code § 17:30-11.5

Current through Register Vol. 56, No. 21, November 4, 2024

Section 17:30-11.5 - Prohibited manufacturing; authorized forms; authorized amounts

(a) A cannabis manufacturer shall not manufacture cannabis products that contain drug products that appear on the Federal Food and Drug Administration's List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.

(b) A cannabis manufacturer may manufacture oil for use in an electronic smoking device as vaporized formulation, in a pressurized metered dose inhaler, or in topical or oral formulations.

(c) A cannabis manufacturer is authorized to manufacture the following forms:

1. A cannabis concentrate, either in solid form or liquid form. This includes "wax," "shatter," oil, and cannabis extracts and resins produced using non-chemical processes. This also includes oil for use in an electronic smoking device;

2. A cannabis-infused product, either in solid form or liquid form, containing either usable cannabis or cannabis concentrate along with an additional ingredient that includes, but is not limited to:

i. Vaporized formulation;

ii. Drops, tinctures, and other sublabial and sublingual forms;

iii. Oral lozenges and other buccal forms;

iv. Ingestible forms that meet the requirements of this subchapter;

v. Topical formulations and transdermal forms; and

vi. Suppositories; and

3. Any other form authorized by the Commission, including a form authorized in accordance with the Commission's power to waive requirements pursuant to N.J.A.C. 17:30- 3.7.

(d) A cannabis manufacturer shall manufacture cannabis products such that:

1. For inhalable products, each package of finished cannabis product shall contain no more than 1/4 ounce or 7.09 grams of usable cannabis or equivalent weight dependent on form;

2. For ingestible products, each package of finished cannabis product shall contain no more than 100 mg of active THC;

3. Each single serving of a cannabis product shall contain no more than 10 mg of active THC, or the equivalent weight, as best determined based on THC potency, dependent on form, except that each single serving beverage shall contain no more than five mg of active THC.

i. Each single serving of a cannabis product or beverage shall have a cannabinoid concentration that is within 90 to 110 percent of the specified milligram serving size claimed for that cannabis product.

ii. Each single serving shall be demarcated in accordance with N.J.S.A. 24:6I-35.a(8)(g);

4. No ingestible product shall be in the shape of, or a shape bearing the likeness or containing characteristics of, a realistic or fictional human, animal, or fruit, or part thereof, including artistic, caricature, or cartoon renderings. However, this provision does not prohibit cannabis products from including fruit or vegetable flavors, provided the manufacturer is compliant with the regulations for active and inactive ingredients pursuant to NJ.A.C. 17:30-11.6(d). The shape of a cannabis leaf is permissible.

5. A commercially manufactured or trademarked food product shall not be used as an ingestible product, provided that a commercially manufactured or trademarked food product may be used as a component of an ingestible product or part of a product's recipe, so long as the commercially manufactured or trademarked food product is used in a way that renders it unrecognizable in the final ingestible product and the product is not advertised as containing the commercially manufactured or trademarked food product; and

6. Each ingestible product shall have a universal symbol marked, stamped, or imprinted directly on it, in accordance with N.J.S.A. 24:6I-35.a(8)(h).

7. The manufacturing of all ingestible products shall be limited to packaged "non-TCS food" or "shelf stable food." "Non-TCS food" or "shelf stable food" means food that is able to be safely stored at room temperature in a sealed container without the need for time or temperature control methods in order to limit pathogenic microorganism growth or toxin formation.

(e) Ingestible products shall only be in the following forms:

1. Syrups or single-serve beverages;

2. Pills, capsules, or tablets;

3. Oral suspensions; and

4. A non-TCS food item, such as chocolates, gummies, baked goods, butters, jams, and jellies.

(f) Ingestible products shall not:

1. Be an alcoholic beverage, as defined at N.J.S.A. 33:1-1;

2. Contain tobacco or nicotine;

3. Require cooking or baking by the consumer;

4. Require storage in sterile conditions by the consumer; or

5. Contain any controlled dangerous substance, as defined at N.J.S.A. 24:21-2.

(g) All ingestible products shall have active ingredient homogeneity to ensure uniform disbursement of cannabinoids.

N.J. Admin. Code § 17:30-11.5

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

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

Amended by 56 N.J.R.2091(d), effective 10/21/2024