FDA Official: Agency is 'actively' exploring CBD regulations as it continues to monitor Kratom

A top FDA official said that the FDA is “actively exploring” a possible regulatory framework for CBD and plans to give the issue priority in the coming year. The agency is also looking into issues relating to kratom.

Kimberlee Trozeciak, FDA Deputy Commissioner for Legislation, Policy, and International Affairs, discussed the FDA’s cannabis and kratom concerns during a webinar held by the Alliance for a Strong FDA in this month.

Trzeciak responded that FDA will be addressing the issue of setting up “an adequate regulatory framework for CBD” later this year or in 2019.

The FDA official was then asked about the “prioritization” of its work in regards to cannabis and kratom regulation. She said that officials take a variety of factors into account as they address these substances.

She said that CBD, kratom, and other products are sold in almost every neighborhood. “One of the things we have been thinking about here at FDA is, using CBD as an instance, what does the regulatory structure for those products look?”

She said that based on the information she had, the products in question would not be able meet the current safety standards for food and dietary supplements. This was a reference to the position of the FDA after they declined to adopt regulations for non-intoxicating CBD, which was legalized by the 2018 Farm Bill.

Trzeciak asked, “What can be done in terms of regulatory instruments to ensure that the product will be marketed and that the consumers are aware of the product’s contents and that we have the basic information we need about the market?” “I think of it as a common regulatory tool we use across all the products we regulate.”

She also added, that FDA is “working with Congress to this effort,” which could include possible rulemaking regarding CBD product packaging and labeling.

She asked: “For instance, how can we make sure the agency is aware of adverse events being reported so that we can identify these trends and ensure the product being manufactured or produced is safe and high-quality?”

Kratom reformers say that the deputy commissioner’s remarks represent a shift in the policy perspective of the agency on this issue. In the past, FDA didn’t engage in the kratom discussion nearly as much as other agencies like the National Institute on Drug Abuse.

FDA Deputy commissioner Signals Shifts in FDA Policy for #Kratom, and CBD Regulation. New FDA Study Finds “kratom seems to be well tolerated” at all dosage levels.

Read & download full doc https://t.co/mZltcHFxv7 pic.twitter.com/AN3UpH7IR7

American Kratom Association February 27, 2020 HTML0

FDA was criticized by hemp stakeholders and legislators for its decision to not regulate CBD despite the fact that it is widely available on the market. It has insisted, however, that additional congressional approval is needed to develop such regulations.

In a letter sent to House Energy and Commerce Committee leadership, 28 nonprofits from across the country and state that focus on hemp and dietary supplement said that “the timing has never been better” for an FDA hearing to explore regulatory pathways to enable the legal marketing of hemp products to humans and animals.

The committee, in response to FDA’s lack of action last summer, issued a request for information (RIF) asking experts for their opinions on how best to regulate hemp. Hundreds of people responded with their perspectives and recommendations.

Senators Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer, filed legislation last July that would a datagoogleinterstitial=”false” href=”https://www.marijuanamoment.net/congressional committee schedules hearing to press the FDA on lack of cbd regulations next week as bipartisan lawmakers file bills to address the issue/” rel=”noopener Ron Wyden (DOR), Rand Paul R-KY and Jeff Merkley D-OR, along with Rep. Earl Blumenauer D-OR, filed legislation in July last year that would eliminate regulatory barriers FDA claims prevent it from allowing hemp marketing.

The House Oversight and Accountability Subcommittee on Health Care and Financial Services also held an hearing on FDA’s inaction on CBD last year. This was a unique meeting, where members from both parties criticized the FDA’s position.

The National Association of State Departments of Agriculture, or NASDA, is also calling for Congress to raise the THC limit on legal hemp as part of its 2024 policy priority.

Stakeholders and legislators from both sides of the aisle have long criticized the 0.3 percent THC hemp limit that was set under the 2018 Farm Bill, which federally legalized this crop. One Justice Department researcher questioned the reasoning behind the restriction and suggested that it was based on an article from the 1950s which was adopted as federal law.

The Congressional Research Service recently explained how different policy priorities among industry stakeholder could complicate the task updating the next Farm Bill’s hemp provisions. However, there are many areas of agreement between the top industry groups.

One of these shared interests is amending law to increase the THC limitation to one percent for hemp that complies with the law. This proposal was also addressed by a separate bill from Rep. Chellie Pingree (D-ME 2022).

Uncertain if Congress will tackle the Farm Bill in 2018. The 2018 version of the Farm Bill was due to expire by the end last year. However, it was extended through a bill signed by President Joe Biden.

In addition, FDA is also engaged in drug policy reform debates as a result of a federal review currently underway into marijuana scheduling. This led the FDA to make recommending. Moving cannabis from Schedule I into Schedule III of Controlled Substances Act.

FDA has recently announced its scientific review of marijuana. This process involved a thorough analysis of research as well as a look at hundreds of social media posts to see how users described cannabis’ therapeutic effects.

In the first week of this month, FDA officials joined scientists for a meeting to discuss Next Steps in Research on Psychedelic Medicine.

The meeting was held just months after FDA released historic draft guidance on psychedelics research . This provided scientists with a structure to conduct research that could lead them to develop novel medicines.

FDA has also accepted a recent application to examine MDMA-assisted treatment as a treatment option to treat post-traumatic disorder (PTSD), and agreed to expedite the analysis.