U.S. FDA calls for new regulatory framework for use of cannabis compound CBD

Neptune Wellness Solutions

26/01/2023 18:30

Jan 26 (Reuters) - The U.S. Food and Drug Administration
said on Thursday it does not intend to make any new guidance on
the use of the popular cannabis compound CBD in food and
supplements, saying the United States needs to develop a new
framework to ensure its safe use.
    The health regulator said it would work with Congress to
develop a new, cross-agency regulatory framework. The FDA denied
three citizen petitions that had requested the agency to provide
guidance. 
    The agency said the current safety standards for dietary
supplements or food additives are not appropriate for
cannabidiol, based on data and studies it has reviewed and
conducted.
    "We have not found adequate evidence to determine how much
CBD can be consumed, and for how long, before causing harm," FDA
Principal Deputy Commissioner Janet Woodcock said.     
    Cannabidiol is a non-psychoactive compound derived from
cannabis. Long-term use of the compound has raised several
safety concerns including potential harm to the liver and to the
male reproductive system.
    The FDA has generally pursued limited enforcement activity
regarding CBD, focusing primarily on food and beverage products
that make unsubstantiated health claims.
    The FDA said that available data did not show how CBD
products could meet the safety standard for substances in animal
food, and it did not intend to provide new rules allowing the
use of the compound in animal food either. 
    "A new regulatory pathway for CBD is needed that balances
individuals' desire for access to CBD products with the
regulatory oversight needed to manage risks," the agency said.  
    Cannabis products, excluding Jazz Pharmaceuticals Plc's
 JAZZ.O  epilepsy drug Epidiolex, are illegal at the federal
level in the United States, although some states allow their
use.
 (Reporting by Nandhini Srinivasan and Sriparna Roy in
Bengaluru; Editing by Caroline Humer and Arun Koyyur)
 ((Sriparna.Roy@thomsonreuters.com;))