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FDA Says Most CBD Products May Not Be Safe, and Warns 15 Companies to Stop Selling Them

cbd oil
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CBD products may be trendy, but health officials are worried that these products — which are often marketed illegally — may not be safe.

Yesterday (Nov. 26), the U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies that sell CBD products because the products violate federal law. The agency also issued an update to consumers about the popular products, and stressed that there is limited evidence for their safety.

CBD, short for cannabidiol, is a chemical found in cannabis that does not induce a mind-bending high. Although drug developers have long sought to uncover the potential health benefits of CBD, to date, only one CBD product has survived the FDA approval process — a prescription drug to treat  rare forms of childhood epilepsy. Nonetheless, consumers can now purchase any number of unapproved CBD products, from oils to chocolate bars to pet foods, from companies that claim their goods deliver therapeutic benefits or help treat disease. 

Related: Mixing the Pot? 7 Ways Marijuana Interacts with Medicines (opens in new tab)

These companies have broken federal law by marketing the unproven health benefits of their CBD products, mixing the drug into food, or advertising CBD as a dietary supplement, the FDA announced yesterday. What's more, these companies may have placed their customers at unknown risk, the FDA said.    

"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. In reality, the FDA does not have enough data to say whether CBD can be "generally recognized as safe," and several reports raise questions about the unintended health consequences of consuming the compound. 

For instance, when scientists first tested the safety of the approved CBD epilepsy drug, they noted that CBD could inflict damage to the liver. If taken without medical supervision, the damage could prove more extensive, the FDA said in a consumer update on cannabis-derived compounds. Several studies indicate that CBD may alter how the body breaks down other drugs, either increasing or decreasing their potency. In addition, studies in animals suggest the compound may impede the function of testes and sperm, deplete testosterone levels and impair male sexual behavior. 

Some reports have uncovered contaminants "such as pesticides and heavy metals" in CBD products, the FDA said. Other studies highlight the potential side effects of taking the compound, including sleep disruption, diarrhea, abdominal pain and mood changes. And questions still linger about how repeated CBD exposure might affect someone over time.

Moreover, the compound may trigger unknown effects in vulnerable populations, including pregnant people and children. Some of the companies called out today specifically market products "for infants and children," who may not metabolize and excrete the drug as adults do, the agency noted.   

"As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we'll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns," Abernethy said. 

Related: Aspirin to Zoloft: The Scoop on 5 Medicines

The FDA defines a "drug" as any non-food product intended to treat a disease, have a therapeutic use, or affect the structure or function of the body. By this definition, many CBD products count as drugs and should be subject to the same scrutiny as other pharmaceuticals, Abernethy said. In addition, the FDA will continue to evaluate the safety and regulation of CBD products intended for "non-drug uses," according to the consumer update. 

"This overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate," Abernethy said. The agency encouraged consumers to speak with health care professionals about how to treat diseases and conditions with existing drugs, and to be wary of  "unsubstantiated claims" associated with CBD products. 

The FDA requested that the companies issued letters respond within 15 working days and report how they plan to correct the violations.

Originally published on Live Science. 

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Nicoletta Lanese
Staff Writer

Nicoletta Lanese is a staff writer for Live Science covering health and medicine, along with an assortment of biology, animal, environment and climate stories. She holds degrees in neuroscience and dance from the University of Florida and a graduate certificate in science communication from the University of California, Santa Cruz. Her work has appeared in The Scientist Magazine, Science News, The San Jose Mercury News and Mongabay, among other outlets.

  • dpukala
    Is there any information on the companies that the FDA sent that letter too?
  • Rachael
    Yes, the full list of companies is in the FDA statement:
  • Ingersol
    You know what else might not be safe? The water in Flint Michigan. How about some warning letters and criminal prosecution there.

    in the mean time, CBD has been consumed by humans for thousands of years. There is no reason to believe that it is any more dangerous than all the other bottles at the supplement store.
  • lively
    well said!
  • tedviens
    The title of this piece does not reflect the message of the FDA news release about its warning letter. The warning letters sent to the 15 companies were to protest medical type claims made by these companies about their products. The subsequent warnings about the "dangers" of CBD were nonscientific prejudicial industry supporting propaganda.

    Alcoholic drinks are the primary threat to our liver in our modern American diet. Second is the monosaccharide Fructose which causes seven out of the ten most poisonous attacks on the liver as are caused by this alcohol. The common table sugar we eat in large quantities as it mixes with our saliva is broken down into glucose, which is healthy for us, and fructose which is not.

    Where was I? Ah yes, on to FDA lie two in the pharma industry promoting propaganda casually dropped into their warning letter. The dangers of pesticides and poisonous heavy metals. Let us put this into context, every non-organic produce of any kind has measurable pesticides and heavy metals often exceeding the worse levels found in any of the CBD ingredient used in any of the CBD products on the market.

    And then I read the next paragraph in the official US government FDA news release. Good grief almighty, what a glorious pure piece of fear-mongering.
  • Rdawg
    The FDA signed off on opioids, and we have seen the first hand destruction of them, are we really going to consider anything they have to say anymore?
  • AtlasShrugged
    ''Pregnant people”? Seriously? Inclusivity gone mad at the expense of science.
  • Jennifer
    admin said:
    CBD may pose unknown health risks and cannot be marketed as a dietary supplement, food or therapeutic cure-all.

    FDA Says Most CBD Products May Not Be Safe, and Warns 15 Companies to Stop Selling Them : Read more
    admin said:
    CBD may pose unknown health risks and cannot be marketed as a dietary supplement, food or therapeutic cure-all.

    FDA Says Most CBD Products May Not Be Safe, and Warns 15 Companies to Stop Selling Them : Read more
    I nearly died from taking FDA approved antiepileptic medications. I have a bone condition from years of prescribed medications. I'm sure those medications used to zombify manic depressives are safe.
    Somebody's getting filthy rich drugging out epileptics.
  • johnhuntersc
    Yes, be very afraid, but don't pay any attention to the myriad of other unnatural drugs the FDA has approved with minor side effects like uncontrollable bleeding, explosive diarrhea and sudden death.
  • Jim Phelps
    Rachael said:
    Yes, the full list of companies is in the FDA statement:
    The way to begin to support these oils man be beneficial is to run a deuterium analysis on them. A low deuterium level or low d/h ratio is shown to be a high health benefit and these companies can show the oils help metabolic energy levels in the same sense as grass fed butters, oilve oils, coconut oils and so on, all of which fall into the low d/h ratio for beneficial to health oils.

    The FDA as well as Big Pharma will run as the deuterium analysis appears for all things in foods, as especially medicines that the lack-luster Pharma try to pass off as beneficial.

    Start with deuterium analysis for these oils, then show the metabolic energy levels of ATP change toward higher.