Both the FDA and the Federal Trade Commission (FTC) issued a warning letter to another CBD company for making unsubstantiated health claims.
The letter alleges that Rooted Apothecary, a Florida-based CBD producer, illegally marketed its CBD products as treatments for Parkinson’s disease, autism, ADHD, and chronic pain. Although these claims aren’t stated on Rooted Apothecary’s packaging, the FDA said they were made on the company’s social media accounts and website. The company was also accused of marketing some of its products as “dietary supplements,” which is also banned for CBD products.
“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” the FDA’s Acting Commissioner Ned Sharpless said in a news release. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”
Rooted Apothecary has not yet publicly responded to the FDA’s warning, nor has it taken down its CBD-related health claims as of this writing. However, at the bottom of each page on its site, there is a disclaimer which says, “These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.”
According to the FDA’s warning letter, the company has 15 business days as of Tuesday to respond to the agency regarding what steps it’s taking to correct the issue.
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The FDA’s warning-letter campaign against CBD producers has been going on for years. In 2017, the agency issued letters to four CBD companies for making cancer-treatment claims. The latest round of letters to other CBD companies, prior to the newest one issued Tuesday, went out in April.
In order for a product to be legally marketed with health claims in the US, it must be subjected to rigorously controlled testing in animal and human clinical subjects. The process is incredibly expensive and can take years to complete. But even then, the FDA still may not approve the product for treating illnesses. Furthermore, the FDA and the DEA are incredibly stubborn about approving medical studies for cannabis treatments, due to marijuana’s restrictive Schedule I drug status. Late last year, however, the US government removed hemp, a non-intoxicating form of cannabis, from federal scheduling, effectively legalizing the plant and its CBD extracts at the national level.
While hemp-sourced CBD may be legal, it remains largely unregulated. Some unregulated CBD products pose serious health risks, demonstrated by the “synthetic marijuana” poisonings caused by spiked CBD vapes last year in Utah and South Carolina. Over 80 people reported becoming incredibly sick from the contaminated CBD products.
CBD, a non-intoxicating component of cannabis with medical properties, has been investigated as a treatment for seizures since the 1930s. For decades since then, Raphael Mechoulam, PhD, and his research teams at the University of Tel Aviv have published several studies showing that CBD could treat a host of illnesses, such as seizure disorders and adverse effects from cancer treatments. The US government has quietly funded Mechoulam’s research for the past 50 years, Newsweek reported in 2015.
And to top off the federal government’s wishy-washy stance regarding CBD, the US Department of Health and Human Services, which oversees the FDA, long held a patent for CBD-based medicines designed to protect the brain, but the patent application expired this month.
Last year, the FDA approved the first US drug derived from weed, Epidiolex. It's a CBD-based pharmaceutical that treats two rare seizure disorders that are extremely difficult to control. Any doctor in the US can legally prescribe it, even in states where marijuana or hemp are banned.
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