Yesterday, a final California Assembly committee unanimously passed a bill that would allow the legal sale of food and food additives containing CBD within the state, This will not only open up markets in California, but it is also a crucial step given the FDA’s continued prohibition of the same.
Assm. Cecilia Aguiar-Curry (D-Winters) introduced Assembly Bill 228 (AB228) on Jan. 17. Under the proposed law, a food, beverage, or cosmetic would not be considered adulterated by the inclusion of industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp. In effect, this would prohibit state restrictions on the sale of food, beverages, or cosmetics that include industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp.
On March 26, the Assembly Business and Professions Committee passed AB228 by a 20-0 vote. It previously passed the Assembly Health Committee 15-0. Yesterday, the Assembly Appropriations Committee passed it by a vote of 18-0.
Enactment of AB228 would end state prohibition on the sale CBD and CBD products based on federal law. This is crucial because despite removing the plant from the list of controlled substances late last year, the federal government still prohibits the sale of CBD products under FDA rules.
Last summer, the California Department of Health declared that CBD-infused food, drink and dietary supplements cannot be sold by retailers that are not licensed under the state’s medical marijuana law. According to the department, the state must follow federal law.
“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]
Passage of AB228 would effectively deem CBD safe for human and animal consumption and end 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 will now be 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 maintains that the sale of CBD or any food products containing the substance is illegal.
To date, the agency hasn’t changed its position on CBD. In a recent congressional hearing, former FDA Commissioner Scott Gottlieb said he understands that Congress wants a pathway to CBD availability, but said “it is not a straightforward issue” due to the fact that the agency has approved CBD for treatment of epilepsy and it is ““subject of substantial clinical investigation.” Both of these factors prohibit CBD from being sold as a “health supplement” and from being added to food.
Gottlieb said, “the law does allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply.” He said the first step would be a public meeting “sometime in April”
In effect, the agency can continue to enforce these same rules 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.
With the passage of AB228, California would not interfere with the sale of CBD products regardless of continued federal prohibition. And without state cooperation, the FDA would 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. In fact, state regulation hasn’t even stopped the sale of CBD products in California.
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.
WHAT HAPPENS NEXT
AB228 now moves to the full Assembly for further consideration.