The Food and Drug Administration (FDA) recently submitted a new CBD enforcement policy draft to the White House on Wednesday.
The FDA sent its Cannabidiol Enforcement Policy Draft Guidance for Industry to the White House Office of Management (OMB) and Budget for review. According to Hemp Industry Daily, the document includes long-awaited industry guidance on CBD from federal food and drug officials.
Once approved by the OMB, the content or even basic details of the draft, should be released to the public within the next few weeks.
Since the FDA was required to provide an update on its regulation policy for CBD, it did so in March. The update said, “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
When the report was submitted to Congress, FDA Commissioner Stephen Hahn said that “any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.”
The latest enforcement policy draft was submitted notably the same week the FDA announced separate guidance on conducting research into developing cannabis-based drugs, which was also sent to the OMB for review before being published.
While it’s uncertain what contents are in the newest draft guidance and if the document will ever be released to the public, the FDA has been consistently using enforcement discretion for CBD over the last two years since hemp and its derivatives were federally legalized by the 2018 Farm Bill.
The agency continues to issue warnings to cannabis companies throughout the country for violating certain cases. These cases include claiming CBD cures or treats Covid-19. Public notices have been given to the businesses regarding product recalls.
FDA also submitted a report to Congress outlining studies the agency has performed on the contents and quality of CBD products it has tested in the last 6 years.
The cannabis industry was also recently included earlier this month in a spending bill for FDA research into regulating CBD products.
Cannabis attorney Jonathan Havens, a partner in Washington D.C. with Saul Ewing & Lehr, said the recent draft might bring much needed clarity to the CBD industry.
Havens included in a LinkedIn post that the enforcement policy could be claims-based, serving size-based, product standards-based, or a combination of all three.
In an email to Hemp Industry Daily, Havens wrote, “On the standards front, it’s possible FDA could start to hold ingestible CBD marketers to the agency’s dietary-supplement regulations, for example good manufacturing practice requirements.”
Cannabis-industry leaders anticipate what the process for research and development will entail as well as what regulations will help maintain the production of only the safest products in the market.
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