• The FDA warning had come after Curaleaf made unsubstantiated claims that their CBD (cannabidiol) based products can treat serious diseases.
   
• Curaleaf has been asked to respond within 15 days with its plans to mitigate the violations.

Curaleaf Holdings Inc., (Curaleaf), a medical and wellness cannabis operator in the U.S., has reportedly received a warning from the U.S. Food and Drug Administration (FDA) for marketing CBD products using unsubstantiated claims that they treat serious illnesses.

Curaleaf shares tumbled by as much as 8% after the FDA issued the warning. CBD is a non-intoxicating component of cannabis plant which is said to have health benefits, however, there hasn’t been a lot of research to support these claims yet.

According to reports, The FDA began regulation of CBD in 2018, after hemp was legalized under the Farm Bill, and made it clear that it classifies CBD as a drug since it had been the main ingredient of Epidiolex, America’s only cannabis-based drug that is FDA-approved, to treat serious childhood epilepsy.

The FDA issued the warning letter to Curaleaf for selling prohibited and unauthorized products containing CBD with claims that they treat serious ailments such as Alzheimer’s disease, cancer, pet and pain anxiety and opioid withdrawal among others.

FDA Commissioner Ned Sharpless stated that as the FDA continues to examine pathways for legal marketing of products that contain cannabis and components derived from cannabis, its main motive would still be the promotion and protection of public health. Sharpless further stated that sale of unauthorized products using unsubstantiated claims could put a patient’s life at risk by causing them to avoid crucial medical care.

For the record, FDA has instructed companies to not use CBD in food and beverages, however, it tolerates its presence in topical products until firms don’t make any serious health claims.

Curaleaf has been asked to respond within 15 days with its plans to mitigate the violations. Failure to correct the violations could result in legal action, including confiscation of product and injunction.

Source Credits: https://www.marketwatch.com/story/curaleaf-shares-tumble-8-after-fda-warning-letter-over-cbd-health-claims-2019-07-23