As we have discussed in a past blog, the threat of litigation for CBD manufacturers remains a high concern as long as FDA does not establish a clear legal pathway for CBD. CBD manufacturers now operate in a gray area when producing and marketing ingestible CBD products, including food and supplements.
Over the past months the threat of class action litigation has become a reality as several cases work their way through the courts and as demand letters are becoming more common. Three recent lawsuits have been brought based in large part on FDA’s position that CBD is illegal in food and supplements. FDA has taken this position in public statements while FDA works toward “a pathway for regulation” as it has promised in numerous public statements, including on December 20, 2018, the day the 2018 Farm Bill, which removed hemp and hemp derived CBD from the Controlled Substance Act Schedule as a prohibited drug.
The Warning Letters issued by FDA to CBD companies, with the most recent batch issued in November, have highlighted illegal drug claims but have also emphasized that CBD in ingestibles is per se illegal under the statutory provisions governing food and supplements. The governing statutes include provisions that preclude an “article” a molecule, such as CBD, from being an ingredient in a food or drug once the article has been in the process of approval as a prescription drug active ingredient. [Read More @ GreenspoonMarder]