ALBANY, N.Y. (Dec. 13, 2019) – Last Monday, New York Governor Andrew Cuomo signed a bill into law that creates a licensing program for the manufacture of CBD products for human consumption and will ensure continued availability of CBD products in the state. This will not only open up markets in New York; it also takes a crucial step given the FDA’s continued regulation and prohibition of cannabinoid.
A coalition of three Democrats sponsored Senate Bill 6184 (S6184). The legislation revises the state’s industrial hemp laws to align them with federal legalization of the plant. It also creates a licensing and regulatory structure for the production, processing, transportation, distribution, and sale of hemp extract, including but not limited to the licensing of cannabinoid growers, manufacturers, extractors and retailers. The new law specifically authorizes the growth, sale, distribution, transportation and processing of industrial hemp and products derived from it.
Prior to the passage of S6184, New York law did not specifically address hemp-derived CBD, although products containing cannabidiol are available throughout the state. The new law ensures that the state will continue to allow the sale of CBD and CBD products. 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.
S6184 does not have specific rules about how CBD can be used in food and beverages, but gives broad rule-making authority to state agencies. The state plans to host a summit in early 2020 to discuss further regulations.
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 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, 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 rulemaking to establish a framework to allow it to be put into the food supply.”
The FDA held its first public meeting relating to CBD last May. 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.”
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 enactment of S6184, New York will allow 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 the Sooner State.
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.
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