AUGUSTA, Maine (March 28, 2019) – Yesterday, Maine Gov. Janet Mills signed a bill into law allowing the sale of food and food additives containing CBD within the state, This will not only open up markets in Maine, but it is also a crucial step given the FDA’s continued regulation of CBD.
Rep Craig Hickman (D-Winthrop), along with a bipartisan coalition of three cosponsors, introduced House Bill 630 (LD630) on Feb. 5. The new law clarifies that food, food additives and food products containing hemp-derived cannabidiol produced and sold within the state are not adulterated. In effect, this legalizes the sale of CBD in Maine. Under the law, sellers cannot claim that food, food additives or food products that contain hemp can diagnose, treat, cure or prevent any disease, condition or injury without approval pursuant to federal law.
LD630 passed both the House and Senate by greater than 2/3 majority. With Gov. Mills’ signature, the new law went into immediate effect.
Passage of LD630 ensures the state will not continue to ban the sale 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.
As the legislative findings in LD630 explain, up until the passage of this bill, the health inspection program run by the Maine Department of Health and Human Services was sending letters to retail food establishments in the state and regulators from the Department of Agriculture, Conservation and Forestry were contacting pet stores explaining that any food or food products containing hemp-derived cannabidiol must be removed from shelves, even if those food or food products were not introduced into interstate commerce.
Simply put, the state of Maine was following the DEA’s lead and enforcing a complete ban on CBD. That has now ended.
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, 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 LD630, Maine will not interfere with the sale of CBD products produced in the state regardless of continued federal prohibition. The legislative findings assert:
“Any compliance with the letters or statements from the Department of Health and Human Services or the Department of Agriculture, Conservation and Forestry, which expand the federal Food and Drug Administration’s authority to regulate only food that enters into interstate commerce, will undermine state sovereignty, diminish the livelihoods of Maine hemp farmers, food producers and retailers and deprive the people of Maine of the food that they consider necessary for their own or their animals’ health and well-being.”
Without state cooperation, the FDA will likely have trouble regulating it in Maine.
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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