California legalizes CBD

CBD is now officially legal in California. On October 6, 2021, California Governor Gavin Newsom signed AB 45 into law. This allows for the inclusion of hemp and cannabinoids (CBD), extracts or derivatives of hemp in dietary supplements, foods, beverages, cosmetics, and processed dog food provided they contain less than 0.3% THC.

While hemp was legalized at the federal level with the passing of the 2018 Farm Bill, both federal and state agencies have been slow to clarify the types of which hemp-derived products, such as CBD, may be added. “The FDA still has not published any guidance regulations since December 2018 when it considered CBD an illegal adulterant under the Federal Food Drug and Cosmetic Act “(Jdsupra).

Under AB 45, the law establishes a registration requirement for manufactures of hemp products. This requires testing by an independent laboratory of hemp extract in its final raw form to ensure that the THC concentration does not exceed 0.3% or include unsafe contaminants. This also requires hemp products that are food, beverages or dietary supplements to include a label/scannable barcode/website/or QR code linking the certificates of analysis providing the THC content. A product expiration or best by date, and three different statements indicating that children or those who are pregnant and/or breastfeeding should avoid using the product prior to consulting with health professionals. Also, a statement that cannabinoids should be kept out of reach of children and the statement ” The FDA has not evaluated this product for safety or efficacy”.  Furthermore, this law prohibits the labeling, advertising or marketing of any untrue ” health-related statements” which is defined as ” a statement related to health..[that] suggests a relationship between the consumption of industrial hemp or industrial hemp products and health benefits or effects of health”.

The law does not provide any guidance on maximum serving sizes, active cannabinoid concentrate per serving size and the number of servings per container. AB 45 provides that when federal law authorizes hemp products, the Department ” shall adopt new regulations either as necessary pursuant to the federal law or deemed necessary to protect consumers”.  The labeling requirements will apply to products manufactured 90 days or more after the enactment of the bill.

Lastly, the AB 45 law requires a hemp product manufacturer to obtain an industrial hemp enrollment or oversight authorization from the Department. The Department will then charge a fee for this authorization that will be deposited into the Industrial Hemp Enrollment and Oversight fund. The bill further provides that the California Department of Food and Agriculture , State Department of Public Health, and the Department of Cannabis Control work together to facilitate compliance and enforcement against unlicensed manufacturers and hemp products that do not meet applicable requirements.