As we have previously discussed in our Tobacco Law Blog, the Agriculture Improvement Act of 2018 (2018 Farm Bill) legalized “industrial hemp” (a term used to refer to strains of the plant containing less than 0.3% delta-9 tetrahydrocannabinol (THC)) and its derivatives by removing hemp from the list of federally illegal controlled substances. While this watershed law legalizes the production of hemp, and by extension hemp-derived CBD, it does not regulate processed hemp-derived CBD products, such as CBD-infused food and dietary supplements. Rather, the law preserved FDA’s authority to regulate processed hemp products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In response to FDA’s inaction on formal regulation of CBD, Congress is considering legislation that would allow CBD to be used in food, beverages, and dietary supplements and require FDA to establish regulations. The success of the legislation remains uncertain, and states have stepped in to fill the void.
Some details of AB 45 are similar to the policies of other states that explicitly permit the sale of CBD products, and other details are quite different. Notably, AB 45 has drawn criticism from some hemp industry groups in California due to its prohibition on the manufacture or sale of inhalable, or smokable, hemp products in California until the legislature establishes a tax on such products.
AB45 defines “THC”—the intoxicating cannabinoid compound notorious for marijuana’s effects—to include THCA, and any THC, including delta-8 THC, delta-9 THC and delta-10 THC.
Blockbuster hemp ingredient CBD is now officially legal in California in dietary supplements, foods, beverages and cosmetics, as Gov. Gavin Newsom signed AB 45 into law.
“The law is fairly clear about this,” she said.
Specifics of AB45
Beyond FDA standing firm on its stance that CBD is illegal in supplements—which of course has not stopped more than 3,000 brands from entering the market nationwide—the agency says it is concerned about CBD safety.
One, the California Department of Public Health (DPH) will need to develop regulations around the sale of CBD into products for sale at the full range of retail outlets. This is expected to take several months.
What the FDA thinks about California legalizing CBD
That makes California the 19 th state to restrict or ban delta-8 THC. The other states are Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Kentucky, Idaho, Iowa, Michigan, Mississippi, Montana, New York, North Dakota, Rhode Island, Utah, Vermont and Washington.
Recently, acting FDA commissioner Janet Woodcock described the CBD situation as a “stalemate.”