SACRAMENTO, Calif. (June 3, 2021) – On Monday, the California Assembly passed a bill that would authorize the legal sale of food and food additives containing CBD within the state, despite an ongoing FDA prohibition on the same.
Asm. Cecilia Aguiar-Curry (D-Winters) filed Assembly Bill 45 (AB45) last December. The legislation would allow cannabinoids and other hemp extracts to be added to dietary supplements, food, beverages, cosmetics and pet food, despite FDA prohibition on the same. The bill declares that a dietary supplement, food, beverage, cosmetic, or pet food is not adulterated by the inclusion of industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp as long as it meets state specifications.
The enactment of this legislation would end state prohibition on the sale of CBD and CBD products based on federal law. This is crucial because despite removing the plant from the list of controlled substances, the federal government still prohibits the sale of CBD products in food under FDA rules.
On June 1, the Assembly passed AB45 by a 64-9 vote with some technical amendments.
FOLLOWING THE FEDS
In 2018, the California Department of Health declared that CBD-infused food, drink and dietary supplements is illegal, despite years of cannabis legalization within the state. According to the department, the state must follow federal law on CBD in food.
“Although California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.” [Emphasis added]
Although CBD-infused food and drink remain widely available in California the state has attempted to enforce this ban. The Associated Press reported that California health inspectors raided Johnathan Eppers’ Los Angeles warehouse and impounded about $100,000 worth of Vybes, a popular CBD oil-infused beverage. Eppers told the AP that about 50 California retailers dropped the product and he moved his production facilities to Texas.
The enactment of this legislation would end state enforcement completely by deeming CBD safe for human and animal consumption, and ending state prohibition of CBD products.
2018 Farm Bill and CBD
With the passage of the farm bill, the federal government now treats industrial hemp as an agricultural commodity instead of a controlled substance. While the DEA will no longer have the authority to regulate hemp, the provisions of the farm bill have no bearing on FDA rules and regulations regarding CBD. In fact, a section in the farm bill makes this explicit.
Section 297D, paragraph (c)(1) “Regulations and Guidelines; Effect on Other Law” states “nothing in this subtitle shall affect or modify the Federal Food, Drug, and Cosmetic Act.”
Practically speaking, the passage of the farm bill does not mean CBD is now federally legal in all 50 states, as some hemp supporters claim. In fact, the FDA still maintains a strict prohibition on the sale of CBD in the U.S.
To date, the FDA has only approved one medication with cannabidiol as an active ingredient – Epidiolex for the treatment of seizures. But the FDA classifies CBD as “a drug for which substantial clinical investigations have been instituted.” Under federal law, that designation means the FDA maintains full control over the substance and it cannot be marketed as a “dietary supplement.” The agency also maintains that the sale of CBD or any food products containing the substance is illegal.
“It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”
The FDA further declares, “It is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.” Under the federal definition of “interstate commerce,” this includes virtually all CBD products.
The FDA held its first public meeting relating to CBD in May 2019. FDA principal deputy commissioner Amy Abernethy said there is a need to “further clarify the regulatory framework to reduce confusion in the market,” and “Key questions about product safety need to be addressed. Data are needed to determine safety thresholds for CBD.”
The FDA evaluation process is ongoing. In March 2020, FDA Commissioner Dr. Stephen Hahn delivered a report to Congress on CBD.
“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”
According to NutraIngrediants.com, food and dietary supplement industry stakeholders said the report offers “little hope of a timely regulatory solution.”
A January 2021 FDA report shows the FDA has indeed made little headway in promulgating a new policy.
In effect, the agency can continue to prohibit the sale of CBD and its addition to food and beverages even with the passage of the 2018 farm bill. While farmers can now legally grow hemp for commercial purposes, including the production of fiber, biofuel, building products, paper, clothes and even food products that don’t contain CBD, the sale of cannabinol or food products containing CBD remain federally-illegal, as it has been all along unless the FDA changes its policy or Congress passes legislation specifically legalizing CBD.
The enactment of AB45 would further open the door to the production and sale of CBD products produced in the state regardless of continued federal prohibition.
Without state cooperation, the FDA will likely have trouble regulating it in California.
Despite past and ongoing federal prohibition, CBD is everywhere. A New York Times article asserted that “with CBD popping up in nearly everything — bath bombs, ice cream, dog treats — it is hard to overstate the speed at which CBD has moved from the Burning Man margins to the cultural center.”
This was happening when both the DEA and FDA prohibited CBD. It will undoubtedly continue as long as market demand remains and states don’t interfere. The FDA can’t effectively enforce prohibition without the assistance of state and local officials.
According to the FDA, the agency prioritizes enforcement based on a number of factors, including “agency resources and the threat to public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.”
Even with both the FDA and DEA theoretically enforcing federal laws and regulations banning CBD, state and local action have already nullified federal prohibition in practice and effect. There’s no reason to think that won’t continue as long as states maintain the same stance on CBD as they did under the 2014 farm bill. Simply put, the federal government lacks the personnel and resources to crack down on CBD – even if the FDA wants to.
AB45 will move to the Senate for further consideration. At the time of this report, it had not received a committee assignment. Once it’s referred to a committee, it must pass by a majority vote before moving forward in the legislative process.