On October 7, 2021, California's Governor approved an amendment to AB-45 Industrial hemp products. The amendment legalizes the use of industrial hemp, including THC, as a cosmetic, beverage, and food additive. The statute sets out a framework for regulating industrial hemp products while giving the State Department of Health the authority to craft further regulations. Of note, the statute includes detailed requirements for advertising THC Food, beverage, and cosmetic products.
What does California's statute define as Industrial Hemp and THC?
The statute defines "Industrial hemp" as any part, or derivative of the plant Cannabis sativa L. Derivatives include THCA, THC, or any other cannabinoid that has psychoactive properties. However, the statute does not apply to any hemp products already approved by the FDA or those that had previously received a Generally Recognized As Safe (GRAS) designation.
THC is typically made from hemp-derived cannabidiol (CBD) through a temperature-and-pressure-based distillation process or chemical synthesis. Under the statute, permitted THC isomers, however derived, include Delta-8-THC, Delta-9-THC, and Delta-10-THC. Notwithstanding the foregoing, the Department may exclude isomers if it determines that they are unsafe. When THC is derived from CBD, Delta-9-THC is the most plentiful isomer, while Delta-8 and Delta-10 are less abundant. Delta-9 produces the typical high effect of cannabis products. Delta-8-THC reacts slower and has a slightly milder effect than Delta-9. Delta-10-THC produces a milder effect than Delta-8 but is less abundant and typically requires chemical synthesis to be made.
What products may THC be in according to California's statute?
According to AB-45, industrial hemp may be used in cosmetics, foods, food additives, dietary supplements, and herbs. In addition, hemp, except for THC isolate (THC's pure form), can be used for human or animal consumption. In contrast, industrial hemp is not allowed in medical devices, prescription drugs, products containing nicotine or tobacco, or alcoholic beverages unless explicitly approved by the FDA.
The Department may prohibit hemp's inclusion in products if 400they pose a risk to human or animal health. The Department also has the authority to regulate THC concentration, which the statute sets as a maximum THC concentration in final products at 0.3 percent by volume. In addition, the Department is authorized to set maximum serving sizes for individual industrial hemp products and the concentration of THC per serving size, along with food and beverage restrictions. The Department has yet to release THC concentration regulations.
What are the requirements for advertising THC food, beverage, and cosmetic products?
Manufacturers, distributors, and sellers who want to advertise industrial hemp products will need to comply with the guidelines set out in AB-45 and any additional regulations that the Department later releases. AB-45 prohibits these entities from directly targeting advertisements or marketing to children or pregnant or breastfeeding women. Additionally, these entities can only market or place advertisements where 70% of the audience is reasonably expected to be 18 or older.
The statute provides a detailed list of what industrial hemp product packaging and labeling needs to include. The foregoing must disclose where to obtain the certificate of analysis of the final form product batch performed by an independent testing laboratory. The certificate needs to include, among other information, the product name, batch number, and concentration of cannabinoids present in the subject product batch. Additionally, the label or packaging must include the statement, "THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY." Please note that violating any of these regulations may result in fines and/or civil penalties.
When the Department releases further advertising rules, a corresponding update will be posted on this blog. In the interim, please refer to the Federal Trade Commission's CBD Marketing Regulations and state jurisdiction equivalents.
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