California opens up to CBD

On October 6, California Governor Gavin Newsom signed into law AB 45, which authorizes the inclusion of hemp and cannabinoids (e.g. CBD), extracts or derivatives of hemp in foods and beverages, dietary supplements, cosmetics and processed pet foods, provided they contain, among other things, less than 0.3 % THC.

While the Farm Bill of 2018 legalized hemp at the U.S. federal level, federal and state agencies have been slow to clarify the types of products to which CBD can be added. Notably, the Food and Drug Administration (FDA) declared CBD-infused ingested products to be illegal adulterants under the Food, Drug and Cosmetic Act (FDCA), without issuing regulatory guidance.

The FDA's position on CBD has been echoed by many states, including California, which has treated CBD as an illegal adulterant since 2018 and banned the sale of this type of product to the general public.

What the new law does

The law AB 45 legalizes the production and sale outside cannabis dispensaries of certain CBD-infused foods, beverages and cosmetics, while establishing new labeling and advertising rules. It also restricts inhalable CBD products, such as e-cigarettes or vape pen, and incorporates all THC isomers into the count of total THC in a product, thus restricting the number of THC isomers. new Delta-8-THC-based products or Delta-10-THC.

The law also introduces a registration requirement for manufacturers of hemp-based products. It requires hemp extract in its final raw form (before being incorporated into a product) to be analyzed by an independent laboratory to ensure that the THC concentration does not exceed 0.3% and that no hazardous contaminants are present.

In terms of labelling, hemp-based products that are foods, beverages or dietary supplements will have to include:

• A label, scannable barcode, website or QR code linking to certificates of analysis, providing, among other things, the THC content of the batches tested
• Product expiry or use-by date, if applicable
• A statement to the effect that children or pregnant or breast-feeding women should avoid using the product before consulting their health professionals
• A statement that cannabinoids should be kept out of the reach of children
• The words «THE FDA HAS NOT EVALUATED THIS PRODUCT FOR ITS SAFETY OR EFFECTIVENESS».

CBD products will not be required to include any false «health claims» suggesting a relationship between the consumption of industrial hemp and health effects.

The law gives no indication of maximum portion sizes, concentration of active cannabinoids per serving, number of servings per product and similar requirements for food and beverages, what's available on THC.