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]
Your email address will not be published. Required fields are marked *
Save my name, email, and website in this browser for the next time I comment.
Notify me of follow-up comments by email.
Notify me of new posts by email.
LUXEMBOURG is to become the first European country to permit adult-use cannabis after the Government announced measures to permit households to cultivate up to four domestic plants. The announcement, earlier today, applies to to all citizens over the age of 18 with the new regulations also allowing for the sale and import of seeds. However,…
FRIDAY, Oct. 22, 2021 (HealthDay News) — Researchers may be one step closer to developing the equivalent of a Breathalyzer for detecting marijuana use. In an early study, scientists found that their rapid test was able to reliably detect THC in people’s saliva in under 5 minutes. THC, short for tetrahydrocannabinol, is the active ingredient…
New York Labor Law 201-D This document is intended to address some of the most common situations or questions in the workplace related to adult-use cannabis and the Marijuana Regulation and Taxation Act (“MRTA”). This document does not address the medical use of cannabis. For further assistance with New York Labor Law and the MRTA, please…
New York’s Cannabis Control Board issued regulations Thursday to allow medical marijuana users and their caregivers to grow their own supply at home. The proposal, now open to public comment for 60 days, would permit the cultivation of up to six marijuana plants in a private residence. The regulation will take effect after the commentary…