The medical use of cannabis has been a divisive topic of conversation for decades now, but in recent years, more and more people have been pushing for its acceptance. Derived from the cannabis plant, there are a plethora of cannabis products available for consumption, but most are made from the two most prominent cannabinoids found in the plant: cannabidiol (CBD), which is often revered for its health benefits, and tetrahydrocannabinol (THC), which is what produces the psychological effects that make people feel high. Despite the rising public acceptance of these products, however, there is still plenty of concern from federal regulators. In fact, the U.S. Food and Drug Administration (FDA) just released an urgent new warning targeted at CBD users. Read on to find out what the agency is alerting consumers about now.
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Following the 2012 legalization of marijuana in Colorado, 17 other states and Washington, D.C., have since made it legal for people to use and sell various cannabis products. But recreational marijuana has not been federally legalized, and only one cannabis product has been federally approved by the FDA. In 2018, the agency approved Epidiolex, which contains CBD, for the treatment of certain seizures—making it the first and only FDA-approved drug that “contains a purified drug substance derived from marijuana.” This is only available through a prescription as well.
In a recent crackdown against unapproved cannabis products, the FDA issued an alert on May 4, notifying consumers that it has sent warning letters to five different companies illegally selling delta-8 products in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). According to the FDA, delta-8 THC is a cannabinoid that is not naturally “found in significant amounts” in the cannabis plant, so concentrated amounts of this substance are typically synthetically manufactured from other cannabinoids like CBD through the use of additional—and potentially harmful—chemicals.
“This action is the first time the FDA has issued warning letters for products containing delta-8 THC,” the agency noted.
The warning letters were issued to the following companies: ATLRx Inc., BioMD Plus LLC, Delta & Hemp, Kingdom Harvest LLC, and M Six Labs Inc. According to the agency, the citations address these companies selling products as “unapproved treatments for various medical conditions or for other therapeutic uses,” as well as several violations related to drug misbranding and the addition of delta-8 THC in foods.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” FDA Principal Deputy Commissioner Janet Woodcock, MD, said in a statement.
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The FDA noted that several of the companies were also warned about additional violations of the FD&C Act, particularly concerning CBD products. The violations included “marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.”
“It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” the agency explained. “The FDA 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.”
One of the companies has also been marketing CBD products for food-producing animals, according to the FDA. The agency warned that this could also impact consumers, as there are “potential safety concerns related to human food products” such as meat, milk, and eggs produced from animals that are given CBD, “as there is a lack of data on safe CBD residue levels.”
This isn’t the first time the FDA has had to send warning letters in regards to CBD products. Over the past several years, a number of companies have been cited by the agency for “illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases.”
The FDA has been sending warning letters since at least 2015, and 12 companies—including the five just issued—have been cited in the first five months of 2022 alone. Alongside the warnings, the agency has also tested the chemical content of cannabinoid compounds in some of the products sold by these companies and “many were found to not contain the levels of CBD” they were claiming to when marketing to buyers.
“Consumers should beware purchasing and using any such products,” the FDA advises.
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