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FDA Continues to Referee the CBD Market 

by Daniel S. Zinsmaster

Published: April, 2021

Submission: April, 2021

 



Those in the CBD sector should be mindful of their marketing tactics, as the FDA continues to police the industry. Manufacturers of CBD products must also evaluate their quality-control procedures to ensure safe products are hitting the marketplace.


As we forecasted this past December in a previous legal alert, the U.S. Food and Drug Administration continues to referee the emerging cannabidiol (CBD) product market. CBD is the primary non-psychotropic compound in the Cannabis sativa plant. Last week, the FDA released a press announcement regarding the warning letters it issued to companies that it alleged were illegally marketing drugs labeled as containing CBD.[1]


To date, the FDA has only approved one prescription drug[2], and zero non-prescription drugs, containing CBD. Regardless of whether CBD is listed as an active or inactive ingredient, drug products containing CBD may not be legally marketed without first obtaining an approved new drug application from the FDA.[3]


The recent warning letters pertained to inappropriate marketing of “pain relief” products where CBD was listed as an inactive ingredient.[4] The FDA claimed the products were improperly marketed to treat wounds, infections, aches and pains. In addition to improper marketing, the FDA warned against inadequate quality-control procedures as required by 21 CFR § 211, the Current Good Manufacturing Practice for Finished Pharmaceuticals.[5]


In response to its letters, the FDA required manufacturers to establish action plans to ensure quality units and product testing are in compliance with federal regulations. The FDA also plans to conduct audits of tested batches to address patient safety risks. In its press release, the FDA principal deputy commissioner stated that the FDA remains “focused on exploring potential pathways for CBD products to be lawfully marketed,” but will continue to take action against companies who do not comply with its regulations.[6]


For more information regarding federal quality-control regulations and CBD marketing, please contact your Dinsmore attorney.


 


[1] See, https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief.


[2] The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome, and Dravet syndrome. See, https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare.


[3] Id. “Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug.”


[4] See, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/honest-globe-inc-597177-03152021 and https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biolyte-laboratories-llc-603584-03182021.


[5] Id.


[6] See, https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief.


 

 


*Ashley Durner is a law clerk and not licensed to practice.


 



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