FDA News

FDA seeks public input on cannabidiol

The FDA is scheduled to hold a hearing Friday, May 31, that seeks to help broaden the agency’s knowledge and help clear up the public’s uncertainty about cannabidiol, or CBD, according to a press release.

During his tenure, then-FDA Commissioner Scott Gottlieb, MD, said interest in CBD has grown tremendously in the past few years, and along with it, confusion.

“Stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products,” Gottlieb said in the release, one of the last issued while he was commissioner.

Published studies have also suggested that uncertainty surrounding CBD goes beyond the FDA, causing frustration and other concerns.

“Despite its rapidly growing popularity and use, the regulatory status of CBD in the United States is convoluted,” Jamie Corroon, MPH, of the Center for Medical Cannabis Education in Del Mar, California, and Rod Kight, attorney and principal of Kight Law Office LLC in Asheville, North Carolina, wrote in Cannabis Cannabinoid Research.

The lack of consistency among federal and state governments regarding CBD was also cited as a potential reason for the inadequate labels found on 58 of the 84 products with CBD that were tested by Marcel O. Bonn-Miller, PhD, of the department of psychiatry at the University of Pennsylvania Perelman School of Medicine, and colleagues.

“The overlabeling of CBD products in this study is similar in magnitude to levels that triggered warning letters to 14 businesses in 2015-2016 from the U.S. Food and Drug Administration,” the researchers wrote in JAMA.

Marijuana plant 
Cannabidiol, which according to the Mayo Clinic is a chemical found in marijuana that does not contain tetrahydrocannabinol (THC), is the subject of a FDA hearing scheduled for Friday, May 31.
Source:Adobe

An expert told Healio Primary Care another reason for Friday’s hearing.

“These discussions arose because CBD can be derived from industrial hemp, which has very low [tetrahydrocannabinol] and was removed from the list of controlled substances in the December 2018 Farm Bill,” said Rajesh Aggarwal, MD, interim director of the Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University.

Gottlieb said in the press release that Friday’s hearing and a public comment period that is underway seek data in several areas, including health risks when CBD is taken in doses not consistent with FDA-approved labeling and without a medical professional present, the gradual exposure to CBD if people obtain it across a broad range of consumer products, whether some threshold levels of CBD could be permitted in foods without undermining the drug approval process or depreciating commercial incentives for a future clinical study of the relevant drug.

“We’re [also] seeking comments, data and information on ... what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (eg, ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and how cannabis-derived compounds interact with other substances such as drug ingredients. ... We hope that information we receive through the public hearing ... will help inform our consideration of these and other important scientific, technical and policy questions,” he said.

Another expert said the hearing should not be seen as the federal government moving toward legalizing marijuana.

“Steps to such legalization involve a broad political consensus, quite apart from the FDA’s stance on the scientific evidence supporting the therapeutic use of any particular drug or device,” J.H. Atkinson, MD, co-director of the University of California, San Diego, Center for Medicinal Cannabis Research (CMCR), said in an interview.

He added that two colleagues at CMCR have been invited to speak at Friday’s hearing, continuing a tradition the center has had in furnishing federal entities such as the FDA with cannabis-related guidance, such as simplifying the regulatory process, delivering faster reviews of research procedures and allowing faster supply of the cannabis products needed for such research.

Those who want to provide the FDA with comment on CBD can go to https://www.regulations.gov/document?D=FDA-2019-N-1482-0001 and click the “Comment Now” button. Public comment will be accepted until July 2. – by Janel Miller

References:

Bonn-Miller MO, et al. JAMA. 2017;doi:10.1001/jama.2017.11909.

Corroon J, et al. Cannabis Cannabinoid Res. 2018;doi:10.1089/can.2018.0030.

Disclosure: Healio Primary Care could not confirm relevant financial disclosures at the time of publication.

 

The FDA is scheduled to hold a hearing Friday, May 31, that seeks to help broaden the agency’s knowledge and help clear up the public’s uncertainty about cannabidiol, or CBD, according to a press release.

During his tenure, then-FDA Commissioner Scott Gottlieb, MD, said interest in CBD has grown tremendously in the past few years, and along with it, confusion.

“Stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products,” Gottlieb said in the release, one of the last issued while he was commissioner.

Published studies have also suggested that uncertainty surrounding CBD goes beyond the FDA, causing frustration and other concerns.

“Despite its rapidly growing popularity and use, the regulatory status of CBD in the United States is convoluted,” Jamie Corroon, MPH, of the Center for Medical Cannabis Education in Del Mar, California, and Rod Kight, attorney and principal of Kight Law Office LLC in Asheville, North Carolina, wrote in Cannabis Cannabinoid Research.

The lack of consistency among federal and state governments regarding CBD was also cited as a potential reason for the inadequate labels found on 58 of the 84 products with CBD that were tested by Marcel O. Bonn-Miller, PhD, of the department of psychiatry at the University of Pennsylvania Perelman School of Medicine, and colleagues.

“The overlabeling of CBD products in this study is similar in magnitude to levels that triggered warning letters to 14 businesses in 2015-2016 from the U.S. Food and Drug Administration,” the researchers wrote in JAMA.

Marijuana plant 
Cannabidiol, which according to the Mayo Clinic is a chemical found in marijuana that does not contain tetrahydrocannabinol (THC), is the subject of a FDA hearing scheduled for Friday, May 31.
Source:Adobe

An expert told Healio Primary Care another reason for Friday’s hearing.

“These discussions arose because CBD can be derived from industrial hemp, which has very low [tetrahydrocannabinol] and was removed from the list of controlled substances in the December 2018 Farm Bill,” said Rajesh Aggarwal, MD, interim director of the Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University.

Gottlieb said in the press release that Friday’s hearing and a public comment period that is underway seek data in several areas, including health risks when CBD is taken in doses not consistent with FDA-approved labeling and without a medical professional present, the gradual exposure to CBD if people obtain it across a broad range of consumer products, whether some threshold levels of CBD could be permitted in foods without undermining the drug approval process or depreciating commercial incentives for a future clinical study of the relevant drug.

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“We’re [also] seeking comments, data and information on ... what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (eg, ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and how cannabis-derived compounds interact with other substances such as drug ingredients. ... We hope that information we receive through the public hearing ... will help inform our consideration of these and other important scientific, technical and policy questions,” he said.

Another expert said the hearing should not be seen as the federal government moving toward legalizing marijuana.

“Steps to such legalization involve a broad political consensus, quite apart from the FDA’s stance on the scientific evidence supporting the therapeutic use of any particular drug or device,” J.H. Atkinson, MD, co-director of the University of California, San Diego, Center for Medicinal Cannabis Research (CMCR), said in an interview.

He added that two colleagues at CMCR have been invited to speak at Friday’s hearing, continuing a tradition the center has had in furnishing federal entities such as the FDA with cannabis-related guidance, such as simplifying the regulatory process, delivering faster reviews of research procedures and allowing faster supply of the cannabis products needed for such research.

Those who want to provide the FDA with comment on CBD can go to https://www.regulations.gov/document?D=FDA-2019-N-1482-0001 and click the “Comment Now” button. Public comment will be accepted until July 2. – by Janel Miller

References:

Bonn-Miller MO, et al. JAMA. 2017;doi:10.1001/jama.2017.11909.

Corroon J, et al. Cannabis Cannabinoid Res. 2018;doi:10.1089/can.2018.0030.

Disclosure: Healio Primary Care could not confirm relevant financial disclosures at the time of publication.