Producers of CBD products must also appraise their quality-control procedures to ensure safe products are hitting the market.
As we forecasted last December at a past legal alert, the U.S. Food and Drug Administration continues to noodle the emerging cannabidiol (CBD) product marketplace. CBD is the primary non-psychotropic compound at 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 comprising CBD. [1]
To date, the FDA has only approved one prescription drug[2], and zero non-prescription drugs, including CBD. Regardless of if CBD is listed as an inactive or active ingredient, drug products containing CBD may not be lawfully marketed without obtaining an approved new drug application from the FDA. [3]
The current warning letters pertained to improper promotion of”pain relief” products where CBD was recorded as an inactive ingredient. [4] The FDA claimed the products were marketed to treat wounds, diseases, pains and aches. Along with improper advertising, the FDA warned against insufficient quality-control procedures as required by 21 CFR § 211, the Current Good Manufacturing Practice for Finished Pharmaceuticals. [5]
In response to the letters, the FDA required manufacturers to establish action plans to ensure quality components and merchandise testing are based on federal regulations. The FDA also plans to conduct studies of tested batches to address patient safety dangers. In its press release, the FDA main deputy commissioner said that the FDA remains”focused on researching possible pathways for CBD products to be lawfully marketed,” but may continue to take action against businesses who don’t comply with its regulations. [6]
