May 18, 2021
Proposition 65 was enacted to protect consumers from carcinogens and toxic chemicals that may cause reproductive damage by enforcing businesses to include warning labels on products having such chemicals. Proposition 65 is also known as California’s 1986 Safe Water and Toxic Enforcement Act.
California’s Proposition 65 requires all cannabis businesses in the supply chain, including manufacturers, distributors, and retailers to include warning labels on the cannabis products they sell. The proposition is a mandate for any company that sells products in California, irrespective of the geographical location of the company.
Cannabis smoke was added to the list of approximately 1,000 chemicals by California’s Office of Environmental Health Hazard Assessment (OEHHA) in 2009 and Delta-9-Tetrahydrocannabinol (THC) was added to the list in January 2021. Cannabis or hemp-derived products containing measurable amounts of THC, even if less than 0.3%, must have warning labels before they are sold in California. The law is also applicable for products, such as edibles, capsules, tinctures, topicals, and vape cartridges, that are not smoked. Both Cannabis smoke that has carcinogenic properties and THC which has the potential to cause reproductive damage are now listed under Proposition 65 and require warning labels. Companies violating proposition 65 are liable to face legal actions and hefty fines.
Is your cannabis business still not compliant with the statutory labeling requirements? The addition of THC, effective from January 3, 2021, requires all cannabis businesses to comply with Proposition 65 for public safety. The majority of the companies in California or those supplying products to California are already complying with Proposition 65 by including warnings of cannabis smoke on respective products. However, now there is a need for companies to expand their warnings to THC as well. Products not emitting cannabis smoke would also be subject to Proposition 65 if they contain THC.
Companies can forgo warning labels on products containing chemicals listed under Proposition 65 if the level of the chemicals is not more than the safe harbor level. The safe harbor level for a chemical is a threshold level above which the companies are required to include warning labels if their products contain those chemicals. However, there is no safe harbor level established for cannabis smoke or THC. This creates a burden for cannabis businesses as they are now required to include warning labels on their products even if the products contain insignificant amounts of THC.
Proper testing is required to determine the levels of cannabis smoke or THC in a product. Carrying out an extensive testing process might not be possible for many companies as the process tends to be costly. However, they can send their products to ISO/IEC 17025 compliant third-party cannabis testing laboratories for accurate and reliable testing. It is of utmost importance as failure to maintain warning labels could result in expensive lawsuits against businesses and may permanently jeopardize a company’s market reputation. Guidance from an experienced legal firm in the cannabis industry could help businesses meet the specified requirements of Proposition 65. Cannabis companies, including CBD/THC testing laboratories, need to be well prepared in advance to avoid any potential roadblocks and to comply with necessary regulations.
Along with maintaining the warning labels to indicate the amount of cannabis smoke or THC in a product, the businesses should also comply with the other labeling requirements underlined by the California Department of Public Health (CDPH). Under the Proposition 65 mandate, the companies are also prohibited from knowingly discharging listed chemicals into any drinking water resources in the state. Failure to comply with the regulations could lead to enforcement actions by government agencies and the fine imposed could be as high as USD 2,500 per day per violation. A cannabis company must include warning labels for a chemical within 12 months from the date it was added to the chemical list under Proposition 65.
Product labeling not only helps cannabis businesses to track products through the supply chain but also helps them follow statutory labeling requirements that may vary from one state to another. A Cannabis LIMS enables businesses, including CBD/THC testing laboratories, to generate custom labels containing product-specific information, such as composition, warning statements, intended use, recommended storage conditions, and expiry date. A LIMS also eliminates the need for manual labeling of products which is error-prone and time-consuming. The labeling requirements vary from time to time. Hence, businesses must choose a configurable cannabis LIMS that is flexible enough to meet the evolving labeling requirements in addition to the testing and quality workflows.
The Proposition 65 mandate requires all cannabis businesses to include warning labels on their products if they contain chemicals listed under Proposition 65. According to the update in the proposition, effective January 3, 2021, it is mandatory for cannabis companies to apprise consumers if their products contain THC. It also states that no warning is required for certain carcinogenic chemicals at specific, low levels, posing no significant risk. There has been no safe harbor level limit for cannabis smoke and THC, and hence products that contain negligible amounts of THC must also include warning labels. Cannabis companies must adhere to these regulations to avoid heavy fines and must apprise consumers of the potential health risks associated with their products if any. Consumer safety should be the top priority of any cannabis business for long-term sustainability. Companies can take legal advice to stay in compliance with Proposition 65. A LIMS can help cannabis businesses, including CBD/THC testing laboratories, meet the changing labeling requirements.