BOSTON, Mass. (June 1, 2021) – A bill introduced in the Massachusetts House would update the state’s regulatory program for the manufacture of hemp extract and CBD products for human consumption and ensure the continued availability of CBD products in the state. This would not only further open up markets in Massachusetts; it would also take a crucial step given the FDA’s continued regulation and prohibition of cannabinoids.

Rep. Mark Cusak (D), along with a bipartisan coalition of seven representatives and senators, introduced House Bill 146 (H146) on March 29.  The legislation would specifically allow cannabinoids and other hemp extracts to be added to dietary supplements, food, beverages, cosmetics, and pet food, despite FDA prohibition on the same.

“Notwithstanding any other provision of law to the contrary, dietary supplements, food or food products that contain hemp or any part of the hemp plant, including the seeds and all naturally occurring cannabinoids, compounds, concentrates, extracts, isolates, resins, isomers, acids, salts, salts of isomers or cannabidiol derivatives, are not considered to be adulterated or misbranded based solely on the inclusion of hemp or any part of the hemp plant. The marketing, sale or distribution of dietary supplements, food or food products within the commonwealth that contain hemp or any part of the hemp plant may not be restricted or prohibited based solely on the inclusion of hemp or any part of the hemp plant.”

Massachusetts law does not specifically address hemp-derived CBD as a food additive, although products containing cannabidiol are widely available throughout the state. The enactment of H146 would ensure the state would continue to allow the sale of CBD and CBD products and allow the CBD market to continue to grow and flourish. This is crucial because despite removing the plant from the list of controlled substances, the federal government still prohibits the sale of CBD products under FDA rules.

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.”

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 H146 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.

WHAT’S NEXT

H146 was referred to the Joint Committee on Cannabis Policy where it must pass by a majority vote before moving forward in the legislative process.


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