The food and Drug Administration is studying whether or not legal cannabis is safe in food and supplements. FDA plans to make recommendations on how to regulate the growing number of cannabis-derived products.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” said FDA Principal Deputy Commissioner Janet Woodcock.
Patrick Cournoyer, the head of the FDA office that develops the agency’s cannabis strategy said, the agency wants to know whether CBD can be eaten safely every day for a long period of time, or if it can be eaten during pregnancy. He said that the agency has concerns about future fertility issues.
Congress legalized hemp and resulting products in 2018 and allowed the FDA to regulate the products that come out. Ever since then, the makers of products like CBD oil and such have operated without federal rules. Some states have imposed their own set of rules, but they aren’t perfect.
Bigger organizations have yet to invest in the industry as they’re waiting on FDA’s stand. Almost everyone is waiting for FDA to decide whether cannabis-derived products can be treated as food and supplement or they’ll be treated as drugs.
Yet, since the legalization of hemp, cannabis-based products have exploded in the market. According to a report by FDA, it’s said that the $4.6 billion market is set to grow 4 times by the end of 2026.
What’s FDA Has To Say Now?
As of now, FDA says that CBD and similar substances can’t be included in food products, or can’t be sold as food supplements. If any company is selling CBD-infused products and claiming it has healing properties, they have to prove it first with clinical trials. Companies with products like these have to meet the agency’s standard for new drugs.
Cannabis plants contain several cannabinoid chemicals, including CBD. There’s another main chemical known as THC, and it’s what causes high during marijuana use. While THC s psychoactive, CBD is not. And some researchers and companies have claimed that it can ease some pain.
Research on CBD is in the early stages. The National Institute of Health is researching how the substance works in the body and how effective it is to relieve pain. According to some users, CBD may be harmful for some people.
What is FDA-Approved Epidiolex?
FDA has green-lighted a new drug named Epidiolex, it contains CBD for the treatment of specific kinds of epilepsy in patients of 2 years of age and older. According to NIH, during the testing phase of the drug, some people had sleeplessness, some had diarrhea, and some had liver problems.
FDA’s Next Move Regarding CBD
FDA will decide within months on how regulated the CBD market should be. However regulated it may be, FDA will impose some policies and rules regarding the use of CBD in new products.
“I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” said Norman Birenbaum, a senior adviser in the agency working on the issue. “You’ve got a widely unregulated market.”
The FDA regulates medicines, medical devices, dietary supplements, and foods. In the last couple of years, it has started overseeing the manufacturing, and distribution of tobacco products.
As drinks, snacks, and other products containing cannabis have spread, a lot of companies and lawyers have been waiting for FDA’s move, before diving into the space.
“We still have members that want to get into this space, but they want to do it legally,” said Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association, an industry trade group.
