- Officials at the FDA are telling consumers that products that contain cannabidiol may not be as safe as they think.
- The FDA has also sent warning letters to 15 companies that sell products with cannabidiol.
- Officials say most of these products haven’t been tested by the FDA and may have serious side effects.
Cannabidiol (CBD) may not be as safe as consumers and the companies marketing these products think they are, according to officials at the Food and Drug Administration (FDA).
As part of its proclamation, the agency sent warning letters to 15 companies that sell products containing CBD.
This nonintoxicating cannabis compound has been promoted as a treatment for a wide variety of conditions, from chronic pain and anxiety to Alzheimer’s disease and cancer.
That concerns officials at the FDA.
“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,’” FDA Principal Deputy Commissioner Amy Abernethy, MD, said in the agency’s announcement.
To date, only one CBD product has been approved by the FDA: Epidiolex, a prescription drug used to treat rare pediatric epilepsy disorders.
However, the consumer market has been flooded with CBD oils, creams, and lotions as well as CBD-infused food and beverages. These are sold at vape shops, markets, gas stations, health food outlets, and other stores.
Some of these are marketed with claims that run afoul of FDA regulations.
“CBD cannot be marketed to treat specific conditions,” David Cunic, a physical therapist and founder of UCS Advisors, told Healthline. “It has to be treated and marketed under the same terms and conditions as over-the-counter vitamins and health foods products.”
Laboratory testing has also raised concerns about the quality of some CBD products on the market.
“A number of questions remain regarding CBD’s safety — including reports of products containing contaminants, such as pesticides and heavy metals — and there are real risks that need to be considered,” Abernethy said.
The agency says it’s investigating reports of “unsafe levels” of contaminants such as pesticides, heavy metals, and THC.
The FDA has updated its consumer fact sheet on CBD, highlighting some of its concerns.
The agency cites data showing that CBD has the potential to cause liver injury, interact with medications, decrease male testosterone production, and inhibit sperm growth.
There are also many unknowns about CBD, such as the cumulative effect when using different products containing CBD.
And the health effects that CBD may have on vulnerable populations, such as children and pregnant or breastfeeding women.
The FDA said in the consumer fact sheet that it “has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
The 15 warning letters sent by the FDA to companies were for illegally marketing CBD products as treating diseases, adding CBD to food intended for human and animal consumption, or selling CBD products as dietary supplements.
The FDA has previously sent warning letters to other companies.
Consumer interest in CBD is strong, partially due to social media buzz and marketing by companies selling products containing CBD.
The strongest scientific evidence is for using CBD to treat seizure disorders in children.
But a growing number of studies also show that CBD may have a role in treating certain health conditions, such as anxiety, insomnia, and chronic pain.
Beyond that, research is limited. And much of the CBD hype is just that — hype.
The FDA said in the release that it “continues to explore potential pathways for various types of CBD products to be lawfully marketed,” including working to address safety concerns.
Cunic thinks the FDA’s oversight of the CBD products will strengthen the industry.
“The FDA is looking over studies and data to make a safe recommendation for the public,” he said. “The industry does need guidelines and clinical data to back up the recommendations. Once the FDA sets a standard, the CBD industry will have a framework to work under and flourish.”
More research needs to be done to confirm how much CBD healthy people and those with a medical condition can safely take.
This includes carrying out clinical trials needed for products to receive FDA approval.
There are other concerns with CBD products on the market. The FDA’s testing showed that some products don’t “contain the levels of CBD they claimed.”
Researchers at Johns Hopkins Medicine even found that vaping high CBD, low THC cannabis may produce positive results on urine drug tests.
Another concern is that people may be relying on CBD to treat their health problems rather than seeking out proven treatments.
“Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products,” said the FDA in last week’s release.