In early April, Virginia Governor Ralph Northam signed Senate Bill 918, approving industrial hemp extract, such as cannabidiol (“CBD”), as a food, subjecting it to applicable laws and regulations. The bill defines “food” as “any article that is intended for human consumption. . . [and] does not mean drugs as defined in [Va. Code] § 54.1-3401.” The bill establishes requirements for the production and manufacture of hemp extracts and authorizes the Virginia Board of Agriculture and Services to adopt regulations regarding contaminant tolerances, labeling, and batch testing. Virginia is just the latest of many states that have taken steps to regulate industrial hemp and its extracts in the wake of the 2018 Farm Bill, which legalized industrial hemp at the federal level; however, Virginia joins those states classifying CBD as a food or ingredient, which appears to be contrary to the Food and Drug Administration’s (“FDA”) view of federal law governing the subject.
The 2018 Farm Bill defined hemp as cannabis and its derivatives containing no more than 0.3 percent of the psychoactive compound delta-9-tetrahydrocannabinol (“THC”). The law gave the United States Department of Agriculture (“USDA”) the authority to regulate its production, but preserved the FDA’s authority over hemp products. In October 2019, USDA issued an interim final rule establishing rules and regulations governing the production of hemp, but FDA has not issued a rule regarding hemp products. In the absence of federal regulation, states, and in some instances localities, are taking actions to regulate the product.
While FDA has not promulgated regulations regarding CBD, it has released a statement saying that “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements.”
Some states, such as Washington, California, and North Carolina have made it clear that until CBD is an FDA approved food additive, state law also prohibits its use in food and beverages. Some localities have followed suit, most notably, New York City’s Department of Health banned food products containing CBD, resulting in the confiscation of edible CBD products. Other states, including Colorado and Florida, consider hemp extract to be a food ingredient and subject to applicable regulations. Regardless of how states have chosen to regulate hemp products, reports make it clear that state regulators see a need to ensure some regulation of these products are in place.
Please note that the legal status of marijuana is not indicative of a state’s stance on the regulation of hemp extracts. As an example, both Washington and California have legalized recreational marijuana use but prohibit hemp extracts in food and beverages. While pending legislation in California suggests this is subject to change in that state, producers and manufacturers of hemp extract should be careful not to assume that the legal status of marijuana is in any way connected to a state’s regulation of hemp extracts.
So far, FDA’s CBD-related actions have been focused on health-related marketing claims and it remains to be seen how, or if, the federal government will respond to the states’ decisions regarding regulation of hemp extracts. In the meantime, any manufacturers or producers of hemp extract should remain aware of applicable state guidance on the issue.