Congress Continues to Seek Regulatory Clarity on CBD from FDA

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  • A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry,” wrote the lawmakers.
  • Expressing concern about FDA’s estimate that a rulemaking process could span 3 to 5 years, the lawmakers stated, “We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.” These include: first, announce a policy of enforcement discretion and, second, consider issuing an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive.
  • This is not the first request from Congress to FDA to provide legal clarity on the use of CBD in foods and dietary supplements.
    • As previously reported on this blog, in a January 12, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements.
    • Congresswomen Chellie Pingree (D-Maine), who was the lead author on the September 19 letter, points out in a press release that she first wrote to FDA in February 2019 requesting guidance on legal pathways for food products containing CBD.
    • Last week, we reported on an amendment to the Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).
  • We will continue to report on developments in the regulation of CBD by FDA.

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Peter F.

Peter F.

We study the effects of cannabidiol (CBD), a non-psychoactive component of cannabis that does not produce the high associated with smoking or using it."There is a lot of debate on the health effects of marijuana and the use of cannabinoids, which are a group of compounds found in marijuana that have anti-inflammatory, pain-relieving, anti-nausea and anti-emetic properties. However, there is a lack of solid scientific evidence to guide us in the application of cannabis therapeutics."

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