Part II: Labels must include a multitude of details
Previously, we discussed the kinds of products that are prohibited under the California’s emergency regulations and requirements regarding THC content and serving sizes. But the California Department of Public Health’s emergency regulations regarding cannabis-infused edibles also contains strict packaging and labeling requirements. Here are the key things to know about these requirements:
Recreational cannabis is legal only for people who are 21 years or older. A major concern of the regulations is preventing underage people from consuming cannabis products, whether accidentally or not. Edibles in particular have a high potential for being mistaken for regular food products and being accidentally eaten by children. To that end, the regulations specify that the packaging for edible cannabis products must: (a) protect the product from contamination; (b) be tamper-evident, meaning that it is sealed so that it cannot be opened without obviously breaking the seal; (c) be child-resistant; (d) not imitate packaging for products typically marketed to children; (e) be opaque so that you cannot see what’s inside; and (f) if containing more than one serving, be resealable so that child resistance is maintained.
The label and packaging can’t have content that imitates candy packaging or labeling, or include anything that might appeal to children, such as cartoons or other images, characters or phrases popularly used to advertise to children.
Food manufacturers know that making sure labels are compliant with federal Food and Drug Administration regulations is important. In addition to compliance with FDA labeling requirements regarding nutrition information, ingredient statements and claims, edible cannabis products must also comply with labeling requirements under the California regulations.
The labeling on packages of edibles must have two components: a primary panel and an informational panel.
The primary panel must include:
- The identity of the product in a text size reasonably related to the most prominent printed matter on the panel, and the words “cannabis-infused” immediately above in a text size larger than the text size used for the identity of the product;
- The universal symbol below, printed conspicuously and legibly, not less than a half-inch by a half-inch;
- Net weight or volume of the contents; and
- THC and CBD content of the package, as well as the THC and CBD content per serving, all expressed in milligrams.
The informational panel must include:
- Name and contact number or website address of the manufacturer;
- Date of manufacture and packaging;
- 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.”
- If for medicinal use, the statement “FOR MEDICAL USE ONLY”;
- A list of all product ingredients in descending order of predominance by weight or volume;
- If the product contains a major food allergen, the word “contains” followed by a list of such allergens;
- The names of any artificial food colorings contained in the product;
- The amount, in grams, of sodium, sugar, carbohydrates, and total fat per serving;
- Instructions for use, such as the method of consumption or application, and any preparation necessary prior to use;
- The product expiration date, “use by” date, or “best by” date, if any; and
- The UID (the unique identifier for use in the track-and-trace system established by the Department of Food and Agriculture) and, if used, the batch number.
The label can’t contain any claims that the cannabis was grown in a California county if it was not actually grown there and can only name the California county in which it was actually grown. Beware of using a brand name that includes a place name, unless you know that the cannabis was grown there.
As is the case under existing federal and state laws with respect to regular food products, the label for cannabis edibles can’t have any false or misleading information and can’t make any health-related claims that are untrue or misleading.
However, the label can include a statement of effects — information on the characteristic anticipated effects if the manufacturer has substantiation that the information is truthful and not misleading, as long as there are no claims of health benefits. With false or misleading information on labels and packaging, not only do businesses face the risk of running afoul of the California cannabis laws and losing their license, but as traditional food companies well know, they also open themselves up to lawsuits from consumers.
It’s important to note that cannabis is considered a controlled substance under the federal Controlled Substances Act, and despite legalization in California, trafficking in cannabis — including the manufacture and sale of edibles — remains illegal under federal law. Possible negative consequences, including federal criminal prosecution and tax liability, still exist. Along with the requirements outlined here, there are other requirements under California law with regard to obtaining a manufacturing license, testing, advertising, distribution and sales of edible cannabis products.
It’s important to first seek legal advice and to proceed with caution.
Karen Balderama is a partner with Wendel Rosen Black & Dean LLP in Oakland, California. She can be reached at firstname.lastname@example.org. This article is the second of a two-part series on edibles regulations in California. Part I, covering the manufacturing requirements, was published in the August issue of Marijuana Venture and online at www.MarijuanaVenture.com.