SUBCHAPTER 4.

PRODUCTS

Manufactured Cannabis Safety Branch, CDPH Regulations

Article 1. Cannabis Product Standards

§40300. Prohibited Products.

The following types of products shall not be sold as cannabis products:

§ 40300 (a) Alcoholic beverages, as defined in section 23004 of the Business and Professions Code. This prohibition does not apply to tinctures that meet the requirements of Section 40308;

§ 40300 (b) Any product containing any non-cannabinoid additive that would increase potency, toxicity, or addictive potential, or that would create an unsafe combination with other psychoactive substances. Prohibited additives include, but are not limited to, nicotine and caffeine. This prohibition shall not apply to products containing naturally occurring caffeine, such as coffee, tea, or chocolate;

§ 40300 (c) Any cannabis product that must be held at or below 41 degrees Fahrenheit to keep it safe for human consumption, including, but not limited to, cream or custard-filled pies; pies or pastries which consist in whole or in part of milk or milk products, or eggs; and meat-filled pies or pastries. This prohibition shall not apply to juices or beverages that need to be held below 41 degrees Fahrenheit if the juice or beverage was processed in accordance with Section 40270, or to infused butter manufactured as permitted by subsection (g);

§ 40300 (d) Any thermally-processed low-acid cannabis product packed in a hermetically sealed container that, if it did not contain cannabis, would be subject to the manufacturing requirements of Title 21, Code of Federal Regulations, Part 113;

§ 40300 (e) Any acidified cannabis product that, if it did not contain cannabis, would be subject to the manufacturing requirements of Title 21, Code of Federal Regulations, Part 114;

§ 40300 (f) Any juice that is not shelf-stable or that is not processed in accordance with Section 40270;

§ 40300 (g) Dairy products of any kind, as prohibited by section 26001(t) of the Act, except that butter purchased from a licensed milk products plant or retail location that is subsequently infused or mixed with cannabis may be sold as a cannabis product;

§ 40300 (h) Meat products other than dried meat products prepared in accordance with Section 40272;

§ 40300 (i) Seafood products of any kind;

§ 40300 (j) Any product that is manufactured by application of cannabinoid concentrate or extract to commercially available candy or snack food items without further processing of the product. Commercially available candy or snack food items may be used as ingredients in a cannabis product, provided that they are used in a way that renders them unrecognizable as the commercially available items and the label, including the ingredient list, does not note that the final cannabis product contains the commercially available item;

§ 40300 (k) Any cannabis product that the Department determines, on a case-by-case basis, is attractive to children, as specified in Section 40410;

§ 40300 (l) Any cannabis product that the Department determines, on a case-by-case basis, is easily confused with commercially available foods that do not contain cannabis;

§ 40300 (m) Any cannabis product in the shape of, or imprinted with the shape, either realistic or caricature, of a human being, animal, insect, or fruit.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code; Section 37104, Food and Agricultural Code.

§40305. Requirements for Edible Cannabis Products.

§ 40305 (a) Except for cannabis, cannabis concentrate, or terpenes, no product ingredient or component shall be used in the manufacture of an edible cannabis product unless that ingredient or component is permitted by the United States Food and Drug Administration for use in food or food manufacturing, as specified in Substances Added to Food in the United States, available at https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm 115326.htm or is Generally Recognized as Safe (GRAS) under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (codified in 21 U.S.C 321(s) and 21 U.S.C. 348).

§ 40305 (b) Edible cannabis products that consist of more than a single serving shall be either:

(1) Scored or delineated to indicate one serving, if the edible cannabis product is in solid form. For purposes of this section, “delineated” includes directly marking the product to indicate one serving or providing a means by which a consumer can accurately identify one serving; or

(2) If the edible cannabis product is not in solid form, packaged in a manner such that a single serving is readily identifiable or easily measurable.

§ 40305 (c) An edible cannabis product consisting of multiple servings shall be homogenized so that each serving contains the same concentration of THC.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code.

§40306. Requirements for Topical Cannabis Products, Concentrates, and Other Cannabis Products.

§ 40306 (a) Except for cannabis, cannabis concentrate, or terpenes, topical cannabis products shall only contain ingredients permitted for cosmetic manufacturing in accordance with Title 21, Code of Federal Regulations, Part 700, subpart B (section 700.11 et seq.) (Rev. March 2016), which is hereby incorporated by reference.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26011.5, Business and Professions Code.

§40308. Orally-Consumed Products Containing Alcohol.

Any orally-consumed product that contains more than 0.5% alcohol by volume as an ingredient, and is not otherwise an alcoholic beverage as defined in Business and Professions Code section 23004, shall be packaged in a container no larger than two (2) fluid ounces and shall include a calibrated dropper or other similar device capable of accurately measuring servings.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26011.5, Business and Professions Code.

Article 2. Cannabinoid Concentration Limits

§40315. THC Concentration Limits.

§ 40315 (a) An edible cannabis product shall not contain more than:

(1) 10 milligrams THC per serving; and
(2) 100 milligrams THC per package.

§ 40315 (b) Notwithstanding subsection (a), a package containing an edible product that is an orally-dissolving product, such as sublingual lozenges or mouth strips, may contain up to 500 milligrams THC per package, if:

(1) The cannabis product consists of discrete servings of no more than 10 milligrams THC per piece;
(2) The cannabis product is labeled “FOR MEDICAL USE ONLY;” and
(3) The cannabis product is only available for sale to a medicinal-use customer.

§ 40315 (c) A topical cannabis product or a cannabis concentrate shall not contain more than 1,000 milligrams THC per package.

§ 40315 (d) Notwithstanding subsection (c), a topical cannabis product or a cannabis concentrate may contain more than 1,000 milligrams THC per package, but not more than 2,000 milligrams THC per package, if the product is labeled “FOR MEDICAL USE ONLY” and is only available for sale to a medicinal-use customer.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26011.5, 26120 and 26130, Business and Professions Code.

Article 3. Failed Product Batches

§40330. Failed Product Batches.

§ 40330 (a) A finished cannabis product batch that fails any regulatory compliance laboratory testing requirement established by the Bureau pursuant to section 26100 of the Act shall be destroyed unless:

(1) The cannabis product batch may be remediated by relabeling pursuant to subsection (d); or

(2) A corrective action plan for remediation or reprocessing is approved by the Department pursuant to subsection (e).

§ 40330 (b) Remediation or reprocessing of a failed product batch or the use of a harvest batch that has failed any regulatory compliance laboratory test shall comply with the requirements and procedures established by the Bureau in Section 5727 of Title 16 of the California Code of Regulations, in addition to the requirements of this article.

§ 40330 (c) Except as provided in subsections (d) and (f), edible cannabis products that fail regulatory compliance laboratory testing shall not be remediated or reprocessed and shall be destroyed. If any edible cannabis product that has failed regulatory compliance laboratory testing is remediated, reprocessed, or otherwise mixed with another batch of cannabis product in violation of this section, such action shall render the final cannabis product adulterated, regardless of the defect level of the final cannabis product.

§ 40330 (d) A cannabis product batch that fails regulatory compliance laboratory testing for cannabinoid or terpenoid content may be remediated by relabeling the product with the correct information from the laboratory certificate of analysis, provided that the THC limits in Section 40315 are met. In addition, the following conditions apply:

(1) The manufacturer licensee shall notify the Department within 3 business days of notification by a distributor that the product failed cannabinoid content testing and is required to be relabeled.

(2) Notification shall be given to the Department by email and shall include a copy of the certificate of analysis for the batch and the name and license number of the licensee relabeling the product.

§ 40330 (e) Except as provided in subsection (d), a cannabis product batch or a harvest batch that fails regulatory compliance laboratory testing or quality assurance review shall not be remediated or reprocessed unless the Department has approved a corrective action plan submitted by the manufacturer licensee. The corrective action plan shall include, at minimum, a description of how the product or harvest batch will be remediated so that the product or harvest batch, or any product produced therefrom, will meet all regulatory compliance laboratory testing and quality assurance requirements. Edible cannabis products may only be remediated by relabeling or repackaging as provided in subsection (f). Corrective action plans will be reviewed by the Department on a case-by-case basis.

§ 40330 (f) Edible cannabis products that fail regulatory compliance laboratory testing because the per package limit of THC has been exceeded may be remediated by repackaging under the following conditions:

(1) The Department has approved a corrective action plan for repackaging the product;

(2) The product batch is returned to the manufacturer that packaged the product;

(3) The product itself is not altered in any way; and

(4) The product is labeled to accurately state the contents.

§ 40330 (g) All remediation of harvest or product batches shall be documented in the batch production records. Remediated products, harvest batches, or products produced therefrom, shall be tested and undergo quality assurance review in accordance with the requirements established by the Bureau in Chapter 2 of Division 42 of Title 16 of the California Code of Regulations prior to retail sale.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26131, Business and Professions Code.