The U.S.\u00a0Food & Drug Administration is under growing pressure to finally regulate products that contain cannabidiol (CBD), the cannabinoid that has had a meteoric rise to health-fad status in part because it is non-intoxicating. Hemp-derived CBD was legalized under the 2018 Farm Bill, but food and drug products prepared with it remain technically illegal until the FDA creates regulations.<\/p>\n
Legislation that would further push the FDA to move on the CBD matter is even currently\u00a0pending before Congress<\/a>.<\/p>\n But there is some hope for imminent action. As\u00a0Marijuana Moment<\/a> noted, on July 12, the FDA\u2019s acting chief information officer Amy Abernethy\u00a0tweeted<\/a>\u00a0that the \u201cFDA is expediting its work to address the many questions about cannabidiol (CBD),\u201d describing it as \u201can important national issue with public health impact and an important topic for American hemp farmers and many other stakeholders.\u201d<\/p>\n \u201cWe are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety,\u201d Abernethy\u00a0continued<\/a>. \u201cTo understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature and have an open public docket.\u201d<\/p>\n Market Watch<\/a>\u00a0reports that cannabis stocks rose in response to those tweets. But they came on the heels of a more formal FDA statement explaining the agency\u2019s delay in promulgating the regs \u2014 and citing some disturbing claims about the potential health impacts of CBD.<\/p>\n The statement\u00a0posted to the FDA website<\/a>\u00a0on June 19 is entitled: \u201cWhat You Need to Know (And What We\u2019re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.\u201d\u00a0<\/p>\n The statement says that the FDA \u201crecognizes the significant public interest\u201d in CBD. It makes note of the FDA\u00a0hearing on the matter<\/a>\u00a0held on May 31, and last year\u2019s FDA approval of \u201cone prescription drug product\u201d containing CBD, Epidiolex<\/a>. But by way of explaining the delay in the regs, the statement lowers the boom: \u201cHowever, there are many unanswered questions about the science, safety and quality of products containing CBD.\u201d<\/p>\n After citing questions about \u201ccumulative exposure\u201d (e.g. from using multiple CBD products on the same day) and\u00a0the effects of CBD on special populations (e.g., children and the elderly), the statement cites recent research purporting to link CBD use to liver damage. The wording appears to raise caveats about making CBD products available on an over-the-counter basis.<\/p>\n According to the statement, during its review of the marketing application for\u00a0Epidiolex, the FDA \u201cidentified certain safety risks, including the potential for liver injury. These are serious risks that can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how these risks might be managed when CBD is used far more widely, without medical supervision and not in accordance with FDA-approved labeling.\u201d<\/p>\n The study was published in the journal\u00a0Molecules<\/a>\u00a0and examined at the effects of CBD on the livers of mice. The mice were given doses that aligned with the human equivalent of the maximum dose of CBD in Epidiolex, according to the report. The researchers found that CBD quickly had a detrimental effect. \u201cCBD exhibited clear signs of hepatotoxicity,\u201d the study authors wrote, raising \u201cserious concerns about potential drug interactions, as well as the safety of CBD.\u201d<\/p>\n Speaking with health and nutrition website\u00a0Nutra<\/a>, the study\u2019s lead author, Igor Koturbash of the\u00a0University of Arkansas at Little Rock, said: \u201cI don\u2019t want to say that CBD is bad and we should ban it. But in my opinion, there is clearly not enough research.\u201d<\/p>\n Project CBD<\/a>, the California-based nonprofit dedicated to promoting and monitoring research into CBD, recently wrote up a\u00a0scathing dismissal<\/a>\u00a0of the liver damage claims. It states that this \u201csensational claim was based on a dubious study.\u201d<\/p>\n For starters, the Little Rock study made no actual testing of humans, which Project CBD calls \u201ca hugely important distinction.\u201d The critique also questions the claim that the mice were tested with doses proportional to those used by humans, asserting that \u201cin the real world CBD consumers are not ingesting 0.25% of their body weight\u201d \u2014 the maximal dose used in the study.<\/p>\n Project CBD also questions the wisdom of drawing conclusions about human consumption from \u201cmega-dosing mice.\u201d It states:\u00a0\u201cThe maximum human dosage recommended for the CBD-isolate Epidiolex is 20 mg\/kg, which is over 100x less than what the Little Rock researchers force-fed their experimental mice. They also tried smaller doses (ranging between 61.5 to 615 mg\/kg) of CBD, which was given daily for 10 consecutive days.\u201d Project CBD calls these dosages \u201cridiculous,\u201d even when \u201callometric scaling\u201d is factored in \u2014 that is, estimating an equivalent dose for a larger organism. (The formation \u201cmg\/kg\u201d refers to milligrams of medication per kilograms of the body weight.)<\/p>\n The Project CBD critique also charges that the Little Rock study is full of \u201cstrange statements, problematic publishing and unreasonable experimental design.\u201d For example, the researchers say that \u201c75% of mice gavaged with 615 mg\/kg developed a moribund condition,\u201d but only six mice received that dose, and 75% of 6 is 4.5. That means that the Little Rock researchers were claiming that four-and-a-half mice died from CBD but one-and-half mice survived. Obviously, that\u2019s impossible.<\/p>\n Then, there were double standards in the research, Project CBD continues: \u201cThe authors disparage the significance of positive medical findings about CBD (such as CBD\u2019s anti-inflammatory and antioxidant properties) by citing only\u00a0in vitro\u00a0<\/em>research. Yet a sentence later, they tout a score of harms allegedly attributable to CBD based on\u2026\u00a0in vitro<\/em>\u00a0and preclinical work.\u201d\u00a0In vitro\u00a0<\/em>refers to research carried out in a test-tube or petri dish rather than an actual organism.<\/p>\n \u201cOnly one of the citations is based on human research, and it did not show toxicity,\u201d writes Project CBD. That 2017 human study, led by Saoirse O\u2019Sullivan and published in the\u00a0Journal of Clinical Investigation<\/a>, actually showed a decrease in blood pressure after consuming CBD (600 mg or roughly 10 mg\/kg). O\u2019Sullivan and her colleagues at the University of Nottingham concluded that CBD may have \u201ca role in the treatment of cardiovascular disorders.\u201d Project CBD charges that the Arkansas team \u201cmisrepresents O\u2019Sullivan\u2019s work as proof that CBD is cardiotoxic.\u201d\u00a0<\/p>\n Project CBD concludes that the Little Rock study is \u201ca hit piece against CBD, not legitimate scientific work.\u201d<\/p>\n The critique notes that there have been efforts before to \u201csearch for a lethal dose of cannabinoids.\u201d One early effort to kill an animal with a gigantic dose of THC was described in a\u00a01972 paper<\/a>\u00a0by scientists at the Mason Research Institute in Worcester, Mass. \u201cIn their quest to prove the dangers of THC, they attempted to kill almost 400 rats, a couple dozen beagle dogs and some rhesus monkeys. The rat dosages ranged from 225-3600 mg\/kg of orally administered THC, a higher amount than the CBD dosage used in the Little Rock experiment.\u201d\u00a0<\/p>\n The researchers were presumably disappointed when the monkeys failed to die \u2014 even when they were dosed with nearly 1% of their bodyweight. \u00a0It turned out that rats could be killed by THC, but it took roughly 1,000 mg\/kg. Extrapolating with allometric scaling, this translates to about 10 grams of pure THC for a human \u2014 far more than anyone would ever consume.<\/p>\n We welcome further examinations of the Little Rock study. But the most in-depth deconstruction offered so far is that by Project CBD. And its conclusions can be summed up in the pithy dictum of popular wisdom:\u00a0Don\u2019t believe the hype<\/a>.<\/p>\n TELL US<\/strong>, what kind of CBD research would you like to see conducted?<\/p>\n The post FDA Promotes CBD Liver Damage Scare, Though Advocates Remain Skeptical<\/a> appeared first on Cannabis Now<\/a>.<\/p>\n
The U.S.\u00a0Food & Drug Administration is under growing pressure to finally regulate products that contain cannabidiol (CBD), the cannabinoid that has had a meteoric rise to health-fad status in part because it is non-intoxicating. Hemp-derived CBD was legalized under the 2018 Farm Bill, but food and drug products prepared withContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":190,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[50,136,767,1302,11594,53,5814],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/36927"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/190"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=36927"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/36927\/revisions"}],"predecessor-version":[{"id":36928,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/36927\/revisions\/36928"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=36927"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=36927"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=36927"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Fears of Liver Damage<\/h4>\n
How Worried Should We Be?<\/h4>\n
Not Very, Says Project CBD<\/h4>\n
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\nRead More: FDA Promotes CBD Liver Damage Scare, Though Advocates Remain Skeptical<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"