FDA Says It Is Speeding Up The CBD Regulation Process

FDA Says It Is Speeding Up The CBD Regulation Process

By Kyle Jaeger – July 13, 2019

The Food and Drug Administration (FDA) said on Friday that it was “expediting” its efforts to develop rules for CBD and plans to issue a report on the department’s progress by early fall.

FDA Acting Chief Information Officer Amy Abernethy tweeted that “FDA is expediting its work to address the many questions about cannabidiol (CBD),” describing it as “an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.”

Dr. Amy Abernethy✔@DrAbernethyFDA

1/3 FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.

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3:44 PM - Jul 12, 2019

The Food and Drug Administration (FDA) said on Friday that it was “expediting” its efforts to develop rules for CBD and plans to issue a report on the department’s progress by early fall.

FDA Acting Chief Information Officer Amy Abernethy tweeted that “FDA is expediting its work to address the many questions about cannabidiol (CBD),” describing it as “an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.”

View image on Twitter

Dr. Amy Abernethy✔@DrAbernethyFDA

1/3 FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.

42

3:44 PM - Jul 12, 2019

“We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety,” she said. “To understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature, and have an open public docket.”

Dr. Amy Abernethy✔@DrAbernethyFDA

Replying to @DrAbernethyFDA

2/3 We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety. To understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature, and have an open public docket.

19

3:44 PM - Jul 12, 2019

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The FDA public hearing on May 31 involved testimony from numerous industry stakeholders and policymakers, who emphasized the importance of developing regulations so that hemp-derived CBD products could be lawfully marketed as food items and dietary supplements.

Because CBD exists as an FDA-approved drug and hasn’t previously been added to the food supply, former FDA Commissioner Scott Gottlieb said that the rulemaking process to create an alternative regulatory framework could take years without congressional action.

Sen. Ron Wyden (D-OR) said in a letter to the agency last month that their timeline is “fully unacceptable” and urged FDA to speed up the process.

Senate Majority Leader Mitch McConnell (R-KY), who helped federally legalize hemp and its derivatives through the 2018 Farm Bill, echoed that point in a meeting with FDA Acting Commissioner Ned Sharpless.

There are still a few more days before the deadline for the public and stakeholders to weigh in with FDA regarding the health and safety risks, manufacturing and product quality and marketing standards of CBD, Abernethy said, urging people to “submit comments & data by 7/16/19.”

Dr. Amy Abernethy✔@DrAbernethyFDA

Replying to @DrAbernethyFDA

3/3 Over 100 speakers presented at the May 31st public hearing. There are 3417 comments on the public docket with 4 days to go. Please submit comments & data by 7/16/19. We plan to report on our progress around end of summer/early fall. https://www.regulations.gov/docket?D=FDA-2019-N-1482 …

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3:44 PM - Jul 12, 2019

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Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds;...

Docket Folder Summary

regulations.gov

See Dr. Amy Abernethy's other Tweets

“We plan to report on our progress around end of summer/early fall,” she said.

David Mangone, director of government affairs at Americans for Safe Access, offered some tips on how to best submit comments to FDA in a video link in an email to the organization’s supporters on Friday. He also talked to Marijuana Moment in April about best practices for submissions.

Separately, another FDA official will keynote a major hemp industry conference in August, where questions about the status of department rulemaking on CBD will likely be a main focus.

The U.S. Department of Agriculture, another federal agency playing a key role in regulating CBD post-Farm Bill, said it plans to issue an interim final rule on the compound next month.

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