UNPA / Farm bill becomes law; FDA’s Gottlieb issues statement on status of cannabis, CBD and use in dietary supplements

Dear Colleagues,

In an early Christmas gift to many consumers and various industries, the president today signed the 2018 farm bill, which includes the Hemp Farming Act of 2018. The passage of this legislation ends the 80-year listing of non-psychoactive cannabis as a Schedule 1 drug.

Moments after the bill being signed into law, FDA Commissioner Scott Gottlieb issued a statement, addressing and clarifying the agency’s position on hemp and cannabis derivatives, acknowledging the widespread consumer interest and use of these products.

Read Gottlieb’s full statement here.

• Of major interest to UNPA members, Gottlieb addressed the issue of cannabis-derived compounds being sold as dietary supplements and noted that while currently illegal (see below), the agency “has the authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement,” and is evaluating whether it should pursue such a process.
• FDA reiterated that the sales of foods or products containing “added CBD or THC” are illegal. However, Gottlieb says there are “pathways” available for the sale of these products into interstate commerce, including through “approved” therapeutic claims.
• Foods and products from the cannabis plant not containing CBD or THC are now allowed for sale without food additive approval due to three GRAS notices related to hulled hemp seeds, hemp seed protein and hemp seed oil that the agency acknowledged without question regarding safety.
• The agency continues to be concerned about the number of drug claims being made about non-approved products claiming to contain CBD or other cannabis-derived compounds.

Gottlieb also announced that the agency would hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products.

We will certainly provide more information as it becomes available.

With warm regards,
Larisa and Frank
 
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm?utm_campaign=122018_Statement_FDA%20statement%20on%20regulation%20of%20cannabis-containing%20products&utm_medium=email&utm_source=Eloqua