Key Takeaways From FDA’s Historic CBD Regulations Meeting

Key Takeaways From FDA’s Historic CBD Regulations Meeting

By Kyle Jaeger – May 31, 2019

Advocates, industry representatives, regulators, health professionals and marijuana legalization opponents stood up before the Food and Drug Administration (FDA) on Friday to share their perspectives on how to best approach regulating the cannabis compound CBD.

Dr. Ned Sharpless✔@FDACommissioner

 · May 31, 2019

Today, FDA is holding a public hearing to obtain scientific data & info about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis/cannabis-derived compounds. Read my opening remarks: https://go.usa.gov/xmHnY 

Dr. Ned Sharpless✔@FDACommissioner

There are lots of questions, including many related to safety we will need to answer to ensure that FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.

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The first-of-its-kind public meeting is meant to inform the FDA’s approach as it considers developing alternative pathways to regulate cannabidiol, which is not currently permitted in the food supply or as a dietary supplement.

Here’s a look at the discussions that took place at the event:

Advocates and opponents

Jonathan Miller, general counsel at U.S. Hemp Roundtable, said there is “an urgent need for an efficient regulatory framework for CBD” and noted that it was the intent of Congress to provide for the marketing of hemp-derived CBD products when it passed the 2018 Farm Bill, federally legalizing the crop and its derivatives.

Interestingly, Miller said his organization has been working with lawmakers in recent weeks to draft standalone legislation to regulate CBD if the FDA determines that the task is too complicated for the agency to complete on its own. Senate Majority Leader Mitch McConnell (R-KY), who led the charge on hemp legalization, previously suggested that further legislative action may be necessary to unlock the full potential of the hemp economy.

The National Cannabis Industry Association (NCIA), which represents a wide range of industry stakeholders, made a similar argument in its testimony.

Andrew Kline, the group’s director of public policy, said “we strongly recommend [that] FDA act quickly to clarify the regulatory environment.”

“Because there are significant confusions in the market, businesses don’t know what is legally permissible and some are making health claims in the absence of clear regulatory guidance,” he said. “Most significantly, banks and payment processors don’t understand [the regulatory rules] and as a result many CBD companies are at risk of losing financial services.”

NCIA also provided the panel with extensive written testimony it compiled from more than 100 industry representatives, scientists and attorneys in support of establishing clear regulatory guidelines for CBD.

“The bottom line is this: an overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal safety concerns,” Kline said. He added that the FDA should create universal testing and labeling requirements to “help protect the public from health and safety risks.”

On the opposing side, members of the anti-legalization group Smart Approaches to Marijuana (SAM) Canada and the Marijuana Victims Alliance offered testimony that touched on CBD regulations but mostly served to express opposition to marijuana reform more broadly.

“The public is up against a narrative that is at war with science,” SAM Canada’s Pamela McColl said. She claimed that marijuana is addictive, leads people to harm themselves and damages DNA.

“The subversion of truth and science and what is going on in North America [is a source of] great concern and reason to pause and do risk assessments on these drugs and analyze the influence of the billionaires and in the industry that have influenced public sentiment and dictated a very deceitful campaign,” she said.

Sally Schindel, the representative from Marijuana Victims Alliance, said that her son committed suicide, which she attributed in large part to his cannabis use.

“What we need is our federal government enforcing federal laws,” she said. “We need FDA to be more involved and take a leading role in marijuana research and policy formation.”

Shawn Hauser, a hemp and cannabinoid attorney with the law firm Vicente Sederberg LLP, represented the Cannabis Trade Federation at the hearing. “The appropriate regulation of products containing lawful cannabinoids already exists, and that data arising out of the state-regulated regime supports such regulation,” she said.

But “whether right or wrong, the current situation has created a vacuum. It opens the door to bad actors,” which ought to inform the FDA’s next steps.

“Cannabis products can be safely regulated under the existing dietary supplement framework and where products are intended for non-medicinal purposes, it is appropriate to regulate them as such,” she said. “The years of data from these state regulatory regimes are an important source of data for the agency to consider in determining the regulatory pathway. We stand ready to advance to the next level as a partner with FDA in effective federal regulation of cannabinoid products.”

Dr. Amy Abernethy✔@DrAbernethyFDA

We appreciate the substantial public contribution to the in-person cannabis/CBD meeting today at FDA. Getting started now with our first presentations. Webcast link here: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/scientific-data-and-information-about-products-containing-cannabis-or-cannabis-derived-compounds … pic.twitter.com/vtU2C3H8Zv

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Regulators

Represents from state regulatory agencies in Virginia, Florida, North Carolina and Pennsylvania also addressed the uncertainty that’s prevalent throughout the industry without updated FDA guidelines.

“Currently, states are struggling with the lack of sound scientific research available in CBD and long-term health impacts, including those to children,” Pam Miles of the Virginia Department of Agriculture, said. She added that her department “is hopeful that FDA will begin to supply significant leadership as it related to CBD, including research related to its health impacts.”

Brenda Morris, representing the Florida Department of Agriculture and Consumer Services, talked about the “patchwork of laws” surrounding CBD and how that has fostered an environment where “anything is allowed.”

“Without the FDA’s guidance and leadership, individual states may carve out their own regulatory exceptions for CBD,” Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services, said, noting that his state’s hemp industry has greatly expanded in recent years. “We urge the FDA to resolve the statutory issues and properly establish a legal pathway for CBD products to enter the market place.”

Dr. Ned Sharpless✔@FDACommissioner

I’d like to thank @DrAbernethyFDA, Lowell Schiller & the FDA staff for organizing a productive hearing on products containing cannabis/cannabis derivatives. Also, thanks to the public for your comments & participation. You can submit comments through 7/2. https://go.usa.gov/xmTR8  pic.twitter.com/Ai8w3zuHy7

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Health and consumer advocates

The Alzheimer’s Association argued that existing research is insufficient to substantiate claims about the therapeutic potential of cannabis for Alzheimer’s and dementia. The group said the “lack of evidence creates a substantial risk for individuals and their families.”

The American Epilepsy Society expressed similar concerns, despite CBD being an FDA-approved drug in the treatment of seizures in the form of Epidiolex.

“We support reducing regulatory barriers to research of cannabis-derived compounds,” a representative for the group said. “We strongly urge the FDA to classify the compounds and drugs under the complete jurisdiction of the FDA. We also advocate for ongoing studies on the efficacy of cannabis drugs.”

Ashley Morgan of the American Veterinary Medical Association told the FDA panel that “we believe there is therapeutic potential in the development of cannabis-derived and cannabis-related compounds and we would like to see the potential realized.”

“We believe FDA must seriously consider the need for efficacy and safety data when therapeutic claims are made” about CBD products, she said. “To facilitate the development of such products for veterinary use is imperative [for the FDA to] provide pathways to ensure the regulatory clarity and predictability and economic viability of the industry. The agency must make enforcement priorities known and consistently and intentionally act on the priorities.”

Another interesting testimony came from Larry Walker at the University of Mississippi, which is currently the site of the nation’s only federally authorized marijuana manufacturer for research purposes. He raised some concerns about potential adverse effects of CBD but made a series of recommendations to the FDA about how to minimize risks.

“A possible path forward, it seems to us, is prudent to have a multitrack approach with these products that are cannabis-related,” Walker said.

“It would be outstanding if the FDA could conduct some basic studies in this realm. It is a national need,” he said. “We need a national testing program for cannabinoid quality and standardization, a national adverse reporting program for whatever products are out there and a rapid response program for products where there are serious incidents. We need analytical backup on many of these things where the serious incidents have occurred. Finally, if possible, together research outcomes in the state medical programs.”

Sue Sisley, an internal medicine physician at the Scottsdale Research Institute, expressed frustration over the fact that the DEA “has not processed” applications to increase the number of authorized manufacturers for research-grade cannabis “despite members of Congress repeatedly urging” the agency to do so.

“Sadly, because of the limitations with the current drug supply, we are forced to import study drugs from a Canadian manufacturer and that is disappointing to us,” she said. “We would like to see our own domestic variety of domestic manufacturers. The point is that researchers need access to options. Scientists need options when it is to embolden scientific freedom.”

James Beck, representing the Parkinson’s Foundation, noted that while traditional pharmaceuticals can treat some of the symptoms Parkinson’s patients experience, many remain unaddressed, leaving the community “seeking alternative ways in which to control the symptoms.”

He said that marijuana doesn’t seem to treat tremors, but “it may be helpful on a targeted level for nonmotor symptoms, sleep, anxiety.”

“Bottom line, we really need more research to understand the utility of cannabis for Parkinson’s disease,” Beck said. “I don’t know that there’s very other circumstances we have a drug that is life-saving.”

Jacqueline French of the Epilepsy Foundation said that the group wants the FDA to “preserve access to CBD for those who need it as a life-saving medication.” However, she emphasized the need to create “manufacturing standards” to avoid contamination from mold and other contaminants.

Americans for Safe Access’s Heather Despres talked about standards that her organization has developed, recommending that the FDA consider integrating some of their best practices on “cultivation, manufacturing, distribution and laboratory operations.”

“There are many challenges facing the cannabis industry. There are solutions available,” she said. “We have worked with state regulators to develop and implement a standard, [and] we look forward to working with you, together, to help implement those standards.”

FDA reaction

Amy Abernethy, the FDA principal deputy commissioner who helped organize the public meeting, identified several themes that emerged during the talks.

In general, there is a need to “further clarify the regulatory framework to reduce confusion in the market,” to provide that clarification in timely manner, to collect data on CBD to ensure that the products are safe and to create labeling standards so consumers know what they’re getting.

Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Appreciate the many comments at today’s public hearing at FDA. Important messages, data and stories are coming throughout the day and via public docket. I’m impressed by all of the members of the public that have traveled to FDA to share their comments.

Dr. Amy Abernethy✔@DrAbernethyFDA

Here is some of what I am hearing… First, there is a need to further clarify the regulatory framework to reduce confusion in the market. The product questions apply to people and animals.

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Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Replying to @DrAbernethyFDA

Given the rapid expansion of the market, timely clarification of the path forward is critical, but it’s our responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.

Dr. Amy Abernethy✔@DrAbernethyFDA

Key questions about product safety need to be addressed. Data are needed to determine safety thresholds for CBD; datasets/information should be objective, of adequate quality and available for transparent review. Lab testing and data analyses need to be replicable.

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Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Replying to @DrAbernethyFDA

There are both positive supporters of cannabis-cannabis derived products including CBD and also concerned citizens worried that widely available products can be harmful.

Dr. Amy Abernethy✔@DrAbernethyFDA

Consumers need consistent information and labeling. State/government entities need support in knowing what to do. And we really need to understand the implications for children when they take CBD-containing products at different dosage ranges. More updates later today.

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Another theme that seemed to develop is the lack of information about dosing guidelines. Several experts who testified were unable to give clear answers to the FDA panel when asked about what the proper doses are in different contexts, and what their affects on consumers are.

Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Thanks again to all who contributed to today’s public meeting on cannabis/cannabis-derived products/CBD. We all want a way forward. Here is some more about what I have heard today about this quickly evolving space…

Dr. Amy Abernethy✔@DrAbernethyFDA

Many people use these products. For CBD, info presented suggests that many consumers think that regulatory pathways are fully in place to keep products safe. Meanwhile speakers reinforced that regulatory pathways are unclear. We must sort this out in service of public health.

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Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Replying to @DrAbernethyFDA

One speaker suggested: “Distinguish between medication setting with physician oversight vs safe use in mass market setting without physician oversight. Need clear differentiation between FDA-approved medicines and consumer-focused foods and supplements.”

Dr. Amy Abernethy✔@DrAbernethyFDA

Today’s meeting illuminated many different issues encountered by manufacturers, researchers, local governments, etc (e.g., labeling, marketing, access to research product, terminology, manufacturing, standards).

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Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Replying to @DrAbernethyFDA

New research was presented today; researchers are asked to submit the data to the public docket - thank you. This information will be included in our ongoing review of literature & databases to develop a summary of what we reliably know and where new research is needed.

Dr. Amy Abernethy✔@DrAbernethyFDA

Systematic studies are needed. It sounds like a number of studies are available or underway. We also wonder if real-world evidence derived from electronic health records, personal monitors, administrative data, etc, can be used to address critical questions in this space.

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Dr. Amy Abernethy✔@DrAbernethyFDA

 · May 31, 2019

Replying to @DrAbernethyFDA

I want to clarify a question from today: FDA supports cannabis researchers in a variety of ways and has issued detailed guidance on submitting IND applications to conduct human studies with drugs derived from plants like cannabis. See questions 16 & 17 https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers …

FDA Regulation of Cannabis and Cannabis-Derived Products: Q&A

fda.gov

Dr. Amy Abernethy✔@DrAbernethyFDA

I suspect that the public docket will expand our understanding, add new information, and reinforce observations today. We will work as quickly as possible to define a way forward. Appreciate a speaker’s observation: “You guys have a tough job. Good luck with that.” Indeed.

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