FDA News

FDA receives ‘substantial’ response to information request on CBD

About 100 people provided an FDA panel with study data, real-life anecdotes or proposed ideas as it establishes regulatory framework for cannabidiol, or CBD, at a public hearing on Friday.

The lack of reliable data surrounding CBD was the impetus for the hearing, the FDA said. Through more than 8 hours of testimony, the agency received a plethora of information.

Medicinal anecdotes

Some speakers, like Debra Kimless, MD, board-certified anesthesiologist, pain medicine specialist and chief medical officer for Pure Green, discussed CBD’s medicinal benefits.

She referenced a trial of 16 patients with pain who were given sublingual CBD, noting that some patients’ pain scores dropped an average of 50%, and some had pain relief start within 8 minutes and last 24 hours.

“The one adverse effect [reported] was an overwhelming sense of well-being,” Kimless said. “With CBD safety and efficacy, a parallel path can coexist with the traditional FDA drug path along with current state-regulated programs.”

Need for regulation

Other speakers such as Russell Kamer, MD, primary care physician and co-founder of Partners in Safety, championed the development of FDA regulations that eliminate risky purchasing environments.

“Some patients get it from drug stores or chiropractors. Others purchase it online, at gas stations, even from flea markets. They think they are getting a [tetrahydrocannabinol]-free, safe product. … [But some] 20 mg CBD tablets can have a milligram of THC. … A person taking two or three tablets would have significant exposure to THC,” Kamer said.

Building on Kamer’s point, Rosemary Mazanet, MD, PhD, chief scientific officer of Columbia Care, was among those who said the FDA must ensure CBD products are properly labeled and dosed to ensure their quality.

“A 2017 report in JAMA … showed 69% [of 84] cannabinoid products were labeled incorrectly, 43% were underlabeled, 26% were overlabeled and some of them had THC. This is alarming,” Mazanet said.

Michelle Peace, PhD, forensic toxicologist and associate professor of forensic science at Virginia Commonwealth University, also testified Friday about patients who thought they were purchasing legitimate CBD products, only to discover after becoming ill that they were tampered with during the manufacturing and/or distribution process.

In reflecting on her testimony with Healio Primary Care, she said she hoped the FDA would quickly establish nationwide, standardized packaging processes and age limits for who can purchase items containing CBD.

Marijuana plant 
About 100 people provided an FDA panel with study data, real-life anecdotes or proposed ideas to the FDA as it establishes regulatory framework for cannabidiol, one of the chemical compounds in cannabis, in a public hearing on Friday.

Source:Adobe

“The FDA needs to set rules now that establish on how products with CBD are made, as well as enact and enforce legislation that mandates purchasers be older than 21 years,” Peace said in an interview. 

She expressed concern that the longer the FDA waits to complete those tasks, the greater the chance a negative side of tobacco product history will repeat itself.

E-cigarettes first hit the market in 2007, but the FDA did not start regulating them until 2016. We can’t wait 5 to 10 years with CBD to get uniform packaging standards and age requirements,” Peace said.

To date, the lack of standards such as “peer-reviewed guidelines” have led to “false claims” and “shoddy quality standards” surrounding it, according to Peter Pitts, a former FDA associate commissioner and current president of the Center for Medicine in the Public Interest.

“The potential for health and harm through chronic use [must also be considered]. What does serious research tell us? Hardly anything. Anecdotes are not data. We must not repeat the mistakes of the opioid crisis,” Pitts said.

Others pointed out a potentially negative side to the FDA’s involvement with CBD.

“[Regulation of CBD] has nothing to do with public health, just profit. I witnessed dangerous and unethical practices that were harmful to patients’ physical and mental health,” said Anne Hassel, a physical therapist and former employee of the cannabis industry in Massachusetts.

An expert told Healio Primary Care before Friday’s hearing that its purpose was not to start the process of legalizing marijuana. Regardless, there were still some who testified about marijuana, blaming it for “addiction,” “violence,” “suicidal thoughts,” and “a gateway to more drugs.”

“Andy had been a kid with dreams … but by age 25 he was in a downward spiral. He had severe cannabis use disorder, serious mental illness, multiple suicide attempts and court-ordered mental health care. … Sadly, [this] is not an isolated story,” said Sally Schindel, a mother whose son began using marijuana medicinally but ultimately died from its use.

Societies’ stances

Healio Primary Care asked several leading medical societies for their stance on CBD.

The American Academy of Family Physicians said it does not currently have a specific policy on CBD and referred Healio Primary Care to its website. Per a statement found there, the AAFP supports decriminalization of possession of marijuana for personal use, opposes its recreational use and recognizes the benefits of intervention and treatment for that latter purpose in lieu of prison time for everyone.

“The AAFP also recognizes that several states have passed laws approving limited recreational use and/or possession of marijuana. Therefore, the AAFP advocates for further research into the overall safety and health effects of recreational use, as well as the effects of those laws on patient and societal health,” the website statement reads.

The ACP declined comment for this story and AMA had not responded to Healio Primary Care’s request before this story’s posting.

Next steps

In tweets on Friday, an official within the FDA expressed gratitude for the input received.

“We appreciate the substantial public contribution to the in-person cannabis/CBD meeting,” said Amy Abernethy, MD, PhD, FDA’s principal deputy commissioner and co-chair of an interagency working group that will review the evidence and ascertain what options the FDA can implement.

She also encouraged further comment on the subject through an online docket https://www.regulations.gov/docket?D=FDA-2019-N-1482 which will remain open until July 2 at 11:59 p.m. More than 900 public comments had been submitted as of this story’s posting.

Abernathy said it will take the FDA some time to sift through the evidence it receives regarding CBD.

“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,” she said in a tweet Friday afternoon. – by Janel Miller

Disclosures: Abernathy is employed by the FDA. Healio Primary Care could not confirm the other speakers’ relevant financial disclosures before publication.

 

About 100 people provided an FDA panel with study data, real-life anecdotes or proposed ideas as it establishes regulatory framework for cannabidiol, or CBD, at a public hearing on Friday.

The lack of reliable data surrounding CBD was the impetus for the hearing, the FDA said. Through more than 8 hours of testimony, the agency received a plethora of information.

Medicinal anecdotes

Some speakers, like Debra Kimless, MD, board-certified anesthesiologist, pain medicine specialist and chief medical officer for Pure Green, discussed CBD’s medicinal benefits.

She referenced a trial of 16 patients with pain who were given sublingual CBD, noting that some patients’ pain scores dropped an average of 50%, and some had pain relief start within 8 minutes and last 24 hours.

“The one adverse effect [reported] was an overwhelming sense of well-being,” Kimless said. “With CBD safety and efficacy, a parallel path can coexist with the traditional FDA drug path along with current state-regulated programs.”

Need for regulation

Other speakers such as Russell Kamer, MD, primary care physician and co-founder of Partners in Safety, championed the development of FDA regulations that eliminate risky purchasing environments.

“Some patients get it from drug stores or chiropractors. Others purchase it online, at gas stations, even from flea markets. They think they are getting a [tetrahydrocannabinol]-free, safe product. … [But some] 20 mg CBD tablets can have a milligram of THC. … A person taking two or three tablets would have significant exposure to THC,” Kamer said.

Building on Kamer’s point, Rosemary Mazanet, MD, PhD, chief scientific officer of Columbia Care, was among those who said the FDA must ensure CBD products are properly labeled and dosed to ensure their quality.

“A 2017 report in JAMA … showed 69% [of 84] cannabinoid products were labeled incorrectly, 43% were underlabeled, 26% were overlabeled and some of them had THC. This is alarming,” Mazanet said.

Michelle Peace, PhD, forensic toxicologist and associate professor of forensic science at Virginia Commonwealth University, also testified Friday about patients who thought they were purchasing legitimate CBD products, only to discover after becoming ill that they were tampered with during the manufacturing and/or distribution process.

In reflecting on her testimony with Healio Primary Care, she said she hoped the FDA would quickly establish nationwide, standardized packaging processes and age limits for who can purchase items containing CBD.

Marijuana plant 
About 100 people provided an FDA panel with study data, real-life anecdotes or proposed ideas to the FDA as it establishes regulatory framework for cannabidiol, one of the chemical compounds in cannabis, in a public hearing on Friday.

Source:Adobe

“The FDA needs to set rules now that establish on how products with CBD are made, as well as enact and enforce legislation that mandates purchasers be older than 21 years,” Peace said in an interview. 

She expressed concern that the longer the FDA waits to complete those tasks, the greater the chance a negative side of tobacco product history will repeat itself.

E-cigarettes first hit the market in 2007, but the FDA did not start regulating them until 2016. We can’t wait 5 to 10 years with CBD to get uniform packaging standards and age requirements,” Peace said.

To date, the lack of standards such as “peer-reviewed guidelines” have led to “false claims” and “shoddy quality standards” surrounding it, according to Peter Pitts, a former FDA associate commissioner and current president of the Center for Medicine in the Public Interest.

“The potential for health and harm through chronic use [must also be considered]. What does serious research tell us? Hardly anything. Anecdotes are not data. We must not repeat the mistakes of the opioid crisis,” Pitts said.

Others pointed out a potentially negative side to the FDA’s involvement with CBD.

“[Regulation of CBD] has nothing to do with public health, just profit. I witnessed dangerous and unethical practices that were harmful to patients’ physical and mental health,” said Anne Hassel, a physical therapist and former employee of the cannabis industry in Massachusetts.

An expert told Healio Primary Care before Friday’s hearing that its purpose was not to start the process of legalizing marijuana. Regardless, there were still some who testified about marijuana, blaming it for “addiction,” “violence,” “suicidal thoughts,” and “a gateway to more drugs.”

“Andy had been a kid with dreams … but by age 25 he was in a downward spiral. He had severe cannabis use disorder, serious mental illness, multiple suicide attempts and court-ordered mental health care. … Sadly, [this] is not an isolated story,” said Sally Schindel, a mother whose son began using marijuana medicinally but ultimately died from its use.

Societies’ stances

Healio Primary Care asked several leading medical societies for their stance on CBD.

The American Academy of Family Physicians said it does not currently have a specific policy on CBD and referred Healio Primary Care to its website. Per a statement found there, the AAFP supports decriminalization of possession of marijuana for personal use, opposes its recreational use and recognizes the benefits of intervention and treatment for that latter purpose in lieu of prison time for everyone.

“The AAFP also recognizes that several states have passed laws approving limited recreational use and/or possession of marijuana. Therefore, the AAFP advocates for further research into the overall safety and health effects of recreational use, as well as the effects of those laws on patient and societal health,” the website statement reads.

The ACP declined comment for this story and AMA had not responded to Healio Primary Care’s request before this story’s posting.

Next steps

In tweets on Friday, an official within the FDA expressed gratitude for the input received.

“We appreciate the substantial public contribution to the in-person cannabis/CBD meeting,” said Amy Abernethy, MD, PhD, FDA’s principal deputy commissioner and co-chair of an interagency working group that will review the evidence and ascertain what options the FDA can implement.

She also encouraged further comment on the subject through an online docket https://www.regulations.gov/docket?D=FDA-2019-N-1482 which will remain open until July 2 at 11:59 p.m. More than 900 public comments had been submitted as of this story’s posting.

Abernathy said it will take the FDA some time to sift through the evidence it receives regarding CBD.

“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,” she said in a tweet Friday afternoon. – by Janel Miller

Disclosures: Abernathy is employed by the FDA. Healio Primary Care could not confirm the other speakers’ relevant financial disclosures before publication.