United States: THC Food, Drink, and Cosmetics Advertising in California
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On October 7, 2021, the Governor of California approved an amendment to AB-45 Industrial hemp products. The amendment legalizes the use of industrial hemp, including THC, as a cosmetic, drink and food additive. The act establishes a framework for regulating industrial hemp products while giving the State Department of Health the power to develop new regulations. It should be noted that the law includes detailed requirements for the advertising of food, drink and cosmetic products for THC.
What does California law define as industrial hemp and THC?
The law defines “industrial hemp” as any part or derivative of the Cannabis sativa L plant. Derivatives include THCA, THC or any other cannabinoid with psychoactive properties. However, the law does not apply to hemp products that have already been approved by the FDA or those that have already received a generally recognized as safe (GRAS) designation.
THC is typically made from hemp-derived cannabidiol (CBD) via a distillation process or chemical synthesis based on temperature and pressure. By law, THC isomers allowed, regardless of their origin, include Delta-8-THC, Delta-9-THC and Delta-10-THC. Notwithstanding the above, the Department may exclude isomers if it determines that they are dangerous. When THC is derived from CBD, Delta-9-THC is the most abundant isomer, while Delta-8 and Delta-10 are less abundant. Delta-9 produces the high effect typical of cannabis products. Delta-8-THC reacts more slowly and has a slightly milder high than Delta-9. Delta-10-THC produces a milder high than Delta-8 but is less abundant and generally requires chemical synthesis.
What products can THC contain according to California law?
According to AB-45, industrial hemp can be used in cosmetics, food, food additives, dietary supplements, and herbs. Additionally, hemp, with the exception of THC isolate (pure form of THC), can be used for human or animal consumption. In contrast, industrial hemp is not permitted in medical devices, prescription drugs, products containing nicotine or tobacco, or alcoholic beverages unless explicitly approved by the FDA.
The Ministry can prohibit the inclusion of hemp in 400 products if they present a risk to human or animal health. The Ministry also has the power to regulate the concentration of THC, which the law sets as the maximum concentration of THC in final products at 0.3% by volume. In addition, the Ministry is authorized to set maximum servings for individual industrial hemp products and the concentration of THC per serving, as well as restrictions on food and beverages. The ministry has not yet issued any regulation on the concentration of THC.
What are the requirements for advertising THC food, drink and cosmetics?
Manufacturers, distributors and sellers who wish to advertise industrial hemp products will need to comply with the guidelines set out in AB-45 and any additional regulations subsequently issued by the ministry. AB-45 prohibits these entities from directly targeting advertising or marketing directed at children or at pregnant or breastfeeding women. In addition, these entities may only market or place advertisements when 70% of the audience should reasonably be 18 years of age or older.
The law provides a detailed list of what the packaging and labeling of industrial hemp products must include. The above should indicate where to obtain the certificate of analysis of the batch of products in final form carried out by an independent testing laboratory. The certificate must include, among other information, the name of the product, the batch number and the concentration of cannabinoids present in the batch of product in question. In addition, the label or package must include the statement “THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFECTIVENESS”. Please note that violation of any of these regulations may result in fines and / or civil penalties.
When the Ministry publishes other advertising rules, a corresponding update will be posted on this blog. In the meantime, please refer to the Federal Trade Commission CBD Marketing Regulations and state jurisdiction equivalents.
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