In December 2017, California’s three cannabis licensing authorities – the Bureau of Cannabis Control (“BCC”), the California Department of Public Health (“CDPH”), and the California Department of Food & Agriculture (“CDFA”) – adopted emergency cannabis regulations designed to “clarify and make specific licensing and enforcement criteria for commercial cannabis businesses under the Medicinal and Adult-Use Regulation and Safety Act” (“MAUCRSA”). On June 6, 2018, the Bureau readopted the emergency regulations, which remained in effect through the remainder of 2018 and for the start of 2019. On January 16, 2019, the three licensing authorities “announced that the Office of Administrative Law (“OAL”) officially approved state regulations for cannabis businesses across the supply chain.” This means that the final, approved cannabis regulations took effect immediately and that the previous emergency regulations are no longer in effect.
It is important to note that many changes were made to the regulations prior to final promulgation, and if you previously created your business practices based upon the Emergency Regulations, you should review the Final Regulations to ensure your business practices remain compliant with current requirements. As such, this blog post is intended to highlight one notable change found in the final, approved CDPH Regulations (“Approved Regulations”) as compared to the readopted Emergency CDPH Regulations.
Emergency CDPH Regulations Section 40405(a)(4), titled “Primary Panel Labeling Requirements: All Manufactured Products,” required that the primary panel of a label on a manufactured cannabis product should include “[t]he THC content and CBD content for the package in its entirety, expressed in milligrams per package.” Now, under the final Approved Regulations, this subsection (a)(4) is removed; instead, Section 40405(b), states that “Cannabinoid content may be included on the primary panel. Cannabinoid content for manufactured cannabis products shall be labeled as specified in Section 40409.” (Emphasis added.)
Additionally, Approved Regulations Section 40401, “Release to Distributor as Finished Product” states that “(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,” but that “‘final form’ does not include labeling of cannabinoid content if the cannabinoid content is to be added to the label at the distribution premise after issuance of the Certificate of Analysis in accordance with Section 40409.” (Emphasis added.)
Section 40409, which previously did not exist within the Emergency Regulations and is a new section promulgated within the Approved Regulations, details the requirements for “Cannabinoid Content Labeling.” (Please find the full text of CDPH Regulations Section 40409 (with emphasis added) below.) Of note within Section 40409(a) are the following two statements (with emphasis added):
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.
These two sections are important first, because they allow a manufacturer more leeway in determining where to place important information such as cannabinoid content, rather than requiring such content be on the primary panel; and second, because it clearly states that cannabinoid content is not required to be added to the label prior to release of the product to a distributor.
This latter point is perhaps the most important to many within the cannabis industry, because under the Emergency Regulations, if the cannabinoid content was inaccurately labeled on a cannabis product, as determined by laboratory testing, the product batch would be determined to have failed laboratory testing and would have to be remediated in accordance with a corrective action plan approved by CDPH (See Emergency Regulations Section 40310).
Under the Approved Regulations, a product batch may still fail laboratory testing for inaccurate labeling of cannabinoid or terpenoid content and may be remediated by relabeling the product; however, the Approved Regulations appear to allow manufacturers to avoid this route altogether. Instead, it appears that manufacturers can arrange for their distributor to label the cannabis product with the cannabinoid content indicated on the Certificate of Analysis after testing is complete. This change in the regulations may help manufacturers to avoid the stress of a failed product batch and the hurdle of remediation related to inaccurate labeling.
To read the full text of CDPH’s Approved Regulations Section 40409 regarding Cannabinoid (THC and CBD) Content Labeling (with emphasis added), see below. If you have questions about the final Approved Regulations and how they may impact your business, contact our cannabis compliance attorneys at Rogoway Law Group.
Section 40409. Cannabinoid Content Labeling.
- 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:
- 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.
- For a topical cannabis product or a cannabis concentrate without serving designations, THC and CBD content, expressed in milligrams per package.
- 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.
- Packages of infused pre-rolls shall be labeled with either:
- The cannabinoid content in milligrams; or
- The cannabinoid content of the dried flower expressed as a percentage and the added cannabinoid content in milligrams.
- 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.”
- A manufacturer may arrange for cannabinoid content labeling at the distribution premises after issuance of the Certificate of Analysis in accordance with the following:
- 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;
- 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;
- 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;
- 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.