FDA says 'CBD has the potential to harm you'

A matcha shop that offers drinks with drops of CBD oil.

CBD products can be found almost everywhere these days and many people have been turning to cannabis and cannabis-related products for unprescribed pain relief. Notably, for the first time FDA has directly stated that it "is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food".

"We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD 'can't hurt, '" Dr. Amy Abernethy, the FDA's principal deputy commissioner, said in a statement.

CBD-infused products could be potentially harmful to consumers' health, according to the FDA.

The FDA has indicated that it can not conclude that CBD is generally recognized as being safe among qualified experts for use in human or animal foods based on lack of scientific information supporting the safety of CDB in food.

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In its warning letters, FDA cites these firms for selling CBD products as dietary supplements despite the fact that FDA has not authorized CBD as a legal ingredient for dietary supplements or food. While there can be physical changes to the body from consuming CBD, some risks can occur without people even realizing, like liver injury, male reproductive toxicity and the risk of impacts to other medication being taken simultaneously. Curaleaf Holdings, which received an FDA warning letter over its CBD health claims in July, fell 1.3 percent to C$7.86 on the Canadian Securities Exchange. The agency's update also highlighted potential negative behaviors by some companies marketing CBD products, including circulating of "misleading, unproven, and false product claims" and, in the case of manufacturing, a potential "lack of appropriate processing controls and practices [that] can put consumers at additional risks".

It is not too late for FDA to do the right thing: it should explicitly open the dietary supplement lane to CBD and be the "cop on the beat" enforcing the whole range of dietary supplement laws and regulations against those products.

As evidence, the FDA cites its own testing showing many consumer products oftentimes don't have the amount of CBD they're advertised to contain (other studies, including one released last week, have found similar results). The agency noted its efforts so far to gather information about CBD, including the FDA an open meeting held on May 31 of this year and comments it recently collected via public docket. Instead, America's top health regulator warned consumers that cannabis compounds, specifically cannabinoids (CBD), could be risky. "This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products while maintaining the agency's rigorous public health standards".

Said MacKay: "CV Sciences is disappointed that FDA's consumer update, released simultaneously with the warning letters, used an inappropriately alarmist tone".

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations.

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