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California Department of Public Health

SUBCHAPTER 5.

LABELING AND PACKAGING REQUIREMENTS
Manufactured Cannabis Safety Branch, CDPH Regulations

Table of Contents

Article 1. General Provisions

§40400. Applicability.

The requirements in this subchapter shall apply to finished cannabis products or dried flower and pre-rolls packaged for retail sale and shall not apply to cannabis or cannabis products that are transferred between licensees for the purpose of further processing or packaging.
Authority: Section 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26130, Business and Professions Code.

§40401. Release to Distributor as Finished Product.

§ 40401 (a) Prior to release of a cannabis product to a distributor, a licensee shall ensure that the product is in finished form and is labeled and packaged in its final form for sale.
§ 40401 (b) For purposes of this section, “final form” does not include:
(1) Labeling of cannabinoid content if the cannabinoid content is to be added to the label at the distribution premises after issuance of the Certificate of Analysis in accordance with Section 40409; or
(2) Placing the cannabis or cannabis product into child-resistant packaging as prescribed in Section 40417. This provision shall expire on December 31, 2019.
Authority: Section 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code.

Article 2. Labeling Requirements

§40403. General Provisions.

§ 40403 (a) Any information required to be listed on a label shall be written in English.
§ 40403 (b) A label shall be unobstructed and conspicuous so that it can be read by the consumer.
§ 40403 (c) All required label information shall be located on the outside container or wrapper of the finished product to be sold at a retailer. If the product container is separable from the outer-most packaging (e.g., a container placed inside of a box), the product container shall also include the following:
(1) For edible cannabis products, topical cannabis products, suppositories, or orally consumed concentrates, all of the information specified in Sections 40405 and 40406, except for cannabinoid content.
(2) For inhaled products (e.g., dab, shatter, and wax), the universal symbol as prescribed in Section 40412.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26120, Business and Professions Code.

§40404. Labeling Requirements: Pre-Rolls and Packaged Flower.

§40404 (a) The label for a package of pre-rolls or packaged flower shall include a primary panel that includes the following information in a type size no less than 6 point font and in relation to the size of the primary panel and container:
(1) Identity of the product;
(2) The net weight of cannabis in the package, listed in both metric and U.S. customary units; and
(3) Universal symbol, as prescribed in Section 40412.
§40404 (b) The label for a package of pre-rolls or packaged flower shall include an informational label that includes the following information in a type size no less than 6 point font and in relation to the size of the informational panel and container:
(1) The UID;
(2) The licensed cultivator or licensee packaging the product (either the legal business name or the registered name under which the business will operate listed on the license certificate), and its contact number or website address;
(3) The date of packaging for retail sale;
(4) The following statement in bold print: “GOVERNMENT WARNING: THIS PACKAGE CONTAINS CANNABIS, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. CANNABIS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. CANNABIS USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF CANNABIS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”
§40404 (c) Nothing in this section prohibits the inclusion of additional information on the label, provided that the label does not violate the requirements of Section 40410.
§40404 (d) The cannabinoid content for a package of pre-rolls or packaged flower shall be labeled as specified in Section 40409.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26120, Business and Professions Code.

§40405. Primary Panel Labeling Requirements: Manufactured Products.

§ 40405 (a) The label for a manufactured cannabis product shall include a primary panel that includes the following information in a type size no less than 6 point font and in relation to the size of the primary panel and container:
(1) The identity of the product in a text size reasonably related to the most prominent printed matter on the panel;
(2) The universal symbol as prescribed in Section 40412; and
(3) The net weight or volume of the contents of the package, listed in both metric and U.S. customary units.
§ 40405 (b) Cannabinoid content may be included on the primary panel. Cannabinoid content for manufactured cannabis products shall be labeled as specified in Section 40409.
§ 40405 (c) Nothing in this section prohibits the inclusion of additional information on the primary panel, provided that the label does not violate the requirements of Section 40410.

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

§40406. Additional Primary Panel Labeling Requirements: Edible Products.

In addition to the requirements of Section 40405, the primary panel of an edible cannabis product shall include the words “cannabis-infused” immediately above the identity of the product in bold type and a text size larger than the text size used for the identity of the product.
Authority: Sections 26012, 26013, 26120 and 26130, Business and Professions Code.
Reference: Section 26120, Business and Professions Code.

§40408. Informational Panel Labeling Requirements.

§ 40408 (a) The label for a manufactured cannabis product shall include an informational panel that includes the following:
(1) The name of the licensed manufacturer (either the legal business name or the registered name under which the business will operate listed on the license certificate) that manufactured the cannabis product and its contact number or website address;
(2) The date of the cannabis product’s manufacture and packaging;
(3) The following statement in bold print: “GOVERNMENT WARNING: THIS PRODUCT CONTAINS CANNABIS, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. CANNABIS PRODUCTS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. THE INTOXICATING EFFECTS OF CANNABIS PRODUCTS MAY BE DELAYED UP TO TWO HOURS. CANNABIS USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF CANNABIS PRODUCTS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”
(4) The statement “FOR MEDICAL USE ONLY,” if:
(A) The cannabis product is intended by the manufacturer only for sale to medicinaluse customers;
(B) The product is an orally-dissolving edible product containing more than 100 milligrams THC per package, as specified in Section 40315(b); or
(C) The product is a topical cannabis product or concentrate containing more than 1,000 milligrams THC per package, as specified in Section 40315(d).
(5) A list of all product ingredients in descending order of predominance by weight or volume;. If any product ingredient contains subingredients, the list shall either:
(A) Include the common name of the ingredient followed by a parenthetical listing of all ingredients in descending order by weight or volume; or
(B) List all subingredients as individual ingredients in descending order of predominance.
(C) This paragraph shall not apply to flavoring, which shall instead be compliant with the requirement of 21 C.F.R. 101.22 (Rev. Jan 2009), hereby incorporated by reference.
(6) If the cannabis product contains an ingredient, flavoring, coloring, or an incidental additive that bears or contains a major food allergen, the word “contains,” followed by a list of the applicable major food allergens;
(7) The names of any artificial colorings contained in the product;
(8) If an edible cannabis product, the amount, in grams or milligrams, of sodium, sugar, carbohydrates, and total fat per serving;
(9) Instructions for use, such as the method of consumption or application, and any preparation necessary prior to use;
(10) The product expiration date, “use by” date, or “best by” date, if any;
(11) The UID and the batch or lot number; and
(12) If the cannabis product is perishable or is perishable after opening, the statement, “KEEP REFRIGERATED” or “REFRIGERATE AFTER OPENING,” as applicable.
§ 40408 (b) The informational panel text shall be in a text size of no less than 6 point font and in relation to the size of the primary panel and container.
§ 40408 (c) Except for the information required by paragraph (a)(11), the requirements of subsection (a) may be fulfilled through the use of supplemental labeling, which may include, but is not limited to, a package insert, fold-out or booklet label, or a hanging tag.
§ 40408 (d) Cannabinoid content may be included on the informational panel. Cannabinoid content for manufactured cannabis products shall be labeled as specified in Section 40409.
§ 40408 (e) Nothing in this section prohibits the inclusion of additional information on the informational panel provided that the label does not violate the requirements of Section 40410.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26120 and 26121, Business and Professions Code.

§40409. Cannabinoid Content Labeling.

§ 40409 (a) Each package for retail sale of cannabis product, cannabis flower, or pre-rolls shall be labeled with the cannabinoid content on either the primary panel or an informational panel. Cannabinoid content may be included on the product label at the manufacturing premises prior to release to a distributor as described in subsection (b) or it may be added to the product at the distribution premises after issuance of the regulatory compliance testing Certificate of Analysis for the batch as described in subsection (c). Cannabinoid content labeling shall include the following:
(1) For an edible product or a cannabis concentrate for which the manufacturer has established serving designations, THC and CBD content, expressed in milligrams per serving and milligrams per package.
(2) For a topical cannabis product or a cannabis concentrate without serving designations, THC and CBD content, expressed in milligrams per package.
(3) Packages of pre-rolls or cannabis flower that do not include cannabinoids other than that naturally occurring in the plant material are not required to list cannabinoid content in milligrams. Instead, such packages shall be labeled with the cannabinoid content expressed as a percentage.
(4) Packages of infused pre-rolls shall be labeled with either:

(A) The cannabinoid content in milligrams; or

(B) The cannabinoid content of the dried flower expressed as a percentage and the
added cannabinoid content in milligrams.

§ 40409 (b) A manufacturer that includes the cannabinoid content on the product label prior to release to a distributor shall label products as specified in paragraphs (1) through (4) of subsection (a), as appropriate to the product. For THC or CBD concentration that is less than two (2) milligrams per serving or per package, the THC or CBD may be labeled as “<2.0 mg per serving” or “<2.0 mg per package.”
§ 40409 (c) A manufacturer may arrange for cannabinoid content labeling at the distribution premises after issuance of the Certificate of Analysis in accordance with the following:
(1) Each package of cannabis product in the batch shall be labeled with the cannabinoid content as specified in subsection (a) that is indicated on the Certificate of Analysis, as well as any other cannabinoid that is 5 percent or greater of the total cannabinoid content;
(2) The manufacturer shall identify a location for the cannabinoid content label on the outer packaging of the product. The location shall be sufficient in size for the required cannabinoid content to be printed in at least 6 point font;
(3) The cannabinoid content label shall be affixed to the identified location on the outer packaging of the product and shall not obscure any other label information.
§ 40409 (d) Nothing in this section precludes the labeling of terpenes or additional cannabinoid content on the product, provided that such information is verified by the Certificate of Analysis.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26120, Business and Professions Code.

§40410. Labeling Restrictions.

Cannabis product labeling shall not contain any of the following:
§ 40410 (a) The name of a California county, including any similar name that is likely to mislead consumers as to the origin of the product, unless one hundred percent of the cannabis contained in the product was grown in that county.
§ 40410 (b) Content that is, or is designed to be, attractive to individuals under the age of 21, including but not limited to:
(1) Cartoons;
(2) Any likeness to images, characters, or phrases that are popularly used to advertise to children;
(3) Any imitation of candy packaging or labeling; or
(4) The terms “candy” or “candies” or variants in spelling such as “kandy” or “kandeez.”
§ 40410 (c) Any information that is false or misleading.
§ 40410 (d) Any health-related statement that is untrue or misleading. Any health-related statement must be supported by the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), and for which there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims.
§ 40410 (e) If the product is an edible cannabis product, a picture of the product contained therein.
§ 40410 (f) For purposes of this section, false or misleading information includes any indication that the cannabis or cannabis product is organic, unless the National Organic Program (Section 6517 of the federal Organic Foods Production Act of 1990 (7 U.S.C. Section 6501 et seq.)) authorizes organic designation and certification for cannabis and the cannabis or cannabis product meets the requirements for such designation and certification. This includes use of the word “organic” on the labeling or variants in spelling such as “organix.”
§ 40410 (g) Any labeling in violation of Section 5040.1 of Division 42 of Title 16 of the California Code of Regulations.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26062.5, 26063, 26120, 26121 and 26154, Business and Professions Code.

§40411. Statement of Characteristic Anticipated Effects.

A cannabis product may include information on the characteristic anticipated effects of the cannabis product if the manufacturer has substantiation that the information is truthful and not misleading. Such information may be located on the informational panel of the label or as an insert included in the cannabis product package. For purposes of this section, “characteristic anticipated effect” includes any physiological effect (a temporary effect on the body related to the consumption of cannabis) that is common to or expected from the particular cannabis strain, but excludes any claim of health benefits (i.e. claims of therapeutic action as a result of the consumption of cannabis).
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26120 and 26130, Business and Professions Code.

§40412. Universal Symbol.

§ 40412 (a) The primary panel of a cannabis product shall be marked, stamped, or otherwise imprinted with the universal symbol.
§ 40412 (b) The symbol shall replicate the following in form:
§ 40412 (c) The symbol shall be black in color. For packaging that is dark in color, the symbol may be made conspicuous by printing the symbol on, or outlining the symbol with, a contrasting color.
§ 40412 (d) The symbol shall be no smaller in size than one half (.5) inch by one half (.5) inch and shall be printed legibly and conspicuously.
§ 40412 (e) The symbol shall not be altered or cropped in any way other than to adjust the sizing for placement on the primary panel.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26120, 26121 and 26130, Business and Professions Code.

Article 3. Packaging

§40415. Packaging.

A package used to contain cannabis or a cannabis product shall comply with the following requirements:
§ 40415 (a) The package shall protect the product from contamination and shall not expose the product to any toxic or harmful substance.
§ 40415 (b) The package shall be tamper-evident, which means that the product packaging is sealed so that the contents cannot be opened without obvious destruction of the seal.
§ 40415 (c) If the product has multiple uses, the package shall be resealable.
§ 40415 (d) The package shall not imitate any package used for products typically marketed to children.
§ 40415 (e) If the product is an edible product, the package shall be opaque. Amber bottles shall be considered opaque for purposes of this section.
§ 40415 (f) Notwithstanding subsection (e), opaque bottles used to contain a cannabis beverage product may utilize a single, vertical, clear strip of no wider than 0.25 inches for the purpose of determining serving amounts.
§ 40415 (g) The package shall be child-resistant, as described in Section 40417.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26120 and 26121, Business and Professions Code.

§40417. Child-Resistant Packaging Requirements.

§ 40417 (a) Beginning January 1, 2020, a package containing cannabis or cannabis products transferred to a distributor for retail sale shall be child-resistant, as follows:
(1) An edible product, an orally-consumed concentrate, or a suppository shall be child-resistant for the life of the product. A package that contains more than a single serving is not required to be child-resistant if each individual serving is packaged in child-resistant packaging.
(2) Cannabis or a cannabis product intended to be inhaled or a cannabis product that is applied topically may utilize packaging that is child-resistant only until first opened, if the package is labeled with the statement “This package is not child-resistant after opening.”
§ 40417 (b) The following packages are considered child-resistant for purposes of this Article:
(1) Any package that has been certified as child-resistant under the requirements of the Poison Prevention Packaging Act of 1970 Regulations (16 C.F.R. §1700.15(b)(1)) (Rev. July 1995), which is hereby incorporated by reference.
(2) A bottle sealed with a pry-off metal crown cork style bottle cap, provided that the bottle contains only a single serving.
(3) Plastic packaging that is at least 4 mils thick and heat-sealed without an easyopen tab, dimple, corner, or flap, provided that the package contains a cannabis product described in subsection (a)(2) or is a cannabis product that is only a single serving.
§ 40417 (c) Until the date specified in subsection (a), the child-resistant package requirement specified in section 26120 of the Act may be met through the use of a child-resistant exit package at retail sale.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26120 and 26121, Business and Professions Code.

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