Complicated Regulatory Odyssey Steers FDA Toward Rule On CBD In Supplements
Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.
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FDA has little in the way of good information it can list on its CBD policy agenda so far, says Principal Deputy Commissioner Amy Abernethy. At recent regulatory conference, she said, "Like it or not, there is a massive human experiment going on right now. There’s CBD in most different product categories and people of many different backgrounds with potential vulnerabilities taking CBD."
During first-ever congressional hearing on federal policies for lawful use of cannabis, House Energy and Commerce Health Subcommittee Chairwoman Anna Eschoo says with $2m appropriated to develop a regulation on CBD’s use in non-drug products during, FDA should deliver.
In addition to FDA and FTC attention, pediatric claims by Rooted Apothecary could get attention of US lawmakers, who FDA is asking to authorize it to more directly enforce against adulterated supplements. Violative claims include “Increasing evidence suggests that CBD oil is a powerful option for pain and autism. It seems like an attractive and safe option for children.”