F.D.A. WARNING LETTER Challenging ‘Health Claims of CBD’
MARCS-CMS 579289 — JUL 22, 2019
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://curaleafhemp.com External Link Disclaimer in April and June 2019 and has determined that you take orders there for the products “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 versions) and “Bido CBD for Pets” (3 versions), all of which you promote as products containing cannabidiol (CBD).1 We have also reviewed your social media websites at www.facebook.com/CuraleafHemp External Link Disclaimer and https://twitter.com/curaleafhemp External Link Disclaimer; these websites direct consumers to your website, https://curaleafhemp.comExternal Link Disclaimer, to purchase your products. FDA has determined that your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New and Misbranded Human Drug Products
Based on our review of your website, your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Examples of claims observed on your website and social media accounts in April 2019 that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your product webpage for CBD Disposable Vape Pen (Relieve):
• “[F]or chronic pain.”
On your product webpage for CBD Tincture (Relieve):
• “[S]oothing tincture for chronic pain.” …..
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“The war on drugs”: what a bombastic, vainglorious phrase that is.
‘Look at me’ says the politician or pundit who uses it approvingly, ‘look how tough I am’ .
But for the politician or pundit who uses it disapprovingly, there are equal and opposite pretences: ‘look at me – see how reasonable I am, how realistic!’
But the war on drugs isn’t a war at all. It is an ongoing and complex process of law enforcement. It has different components which are handled in different ways by different jurisdictions and with differing degrees of effort, intelligence and success. Generalisations are impossible – except one: unlike war, law enforcement is never ‘won’.
Unless rendered obsolete by broader economic, social or technological change, crimes are rarely, if ever, eliminated. Theft, fraud, counterfeiting, people trafficking, knife crime, smuggling, tax evasion: there’s no end to any of those – and yet the ‘war’ against them all continues because the aim is not victory, but containment.
The complaint that government action against an undesirable activity ‘will only drive it underground’ overlooks the fact that this is better than the alternative – i.e. having it out in the open. There are certain things that law-abiding people are entitled not to have normalised; not to have their children see; not have to struggle against alone without the law on their side. And that’s especially important for the poorest and most marginalised communities.
None of that means we should abandon those who slip into the clutches of drug dependency – and want help…a compassionate, rehabilitative approach to drug dependency and legalising drugs are two different things – and the former does not require the latter. Indeed, the criminal justice system can play an active and constructive role. The fear of getting caught, the shock of conviction, the mandating of treatment and the restriction of supply can all help in the process of getting people off drugs and keeping them off.
Here’s another two things that can go together: the availability of a legal, regulated and abundant supply of drugs and a thriving criminal trade in the same or similar substances. In theory, legalisation should mean no more illegal supply – after all, why go to some guy down an alleyway when you could go to a licensed outlet with unadulterated products sold in standard units?
In practice, it’s more complicated than that – as America’s opioid epidemic proves beyond doubt. Far from pushing out the pushers, the over-prescription of entirely legal opioid-based medications has created new opportunities for them. By expanding the size and the demographic diversity of the opioid dependent population, the legal trade has expanded the market for illegal opioids including heroin. If your prescription has run out, or you need something cheaper (or stronger or perhaps merely different) then the dealers will sort you out. Of course, the product may or may not be cut with super-strength synthetic opioids like fentanyl – which is key factor in the epidemic’s horrific and worsening death toll.
Remember, all of this has happened in the context of a regulated and abundant supply of unadulterated opioids, and yet everything that isn’t supposed to happen has happened. The criminal trade hasn’t just survived, it has extended its reach – and innovated in all sort of dangerous new ways.
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Music festival pill-testers continue to skirt the truth in their campaign to expand their services beyond Canberra. At last weekend’s Splendour in the Grass music festival at Byron Bay in northern NSW, the equipment was again on show, with claims that lives are saved with testing.
Testing is about identifying deadly contaminants, but the inconvenient truth out of the NSW coronial inquest into the series of drug deaths at music festivals is all deaths were due to an ecstasy (MDMA) overdose combined with environmental factors such as the weather, hydration and other drugs.
But it gets worse. Under sustained questioning last weekend, Canberra emergency physician and testing proponent David Caldicott continued to muddy the waters, claiming that upgrading to more advanced gas chromatography (GCMS) would allow more accurate measuring of the dosage.
It fell to toxicologists to mop up with the details, explaining that GCMS could establish dose only with additional testing and infrastructure — in other words, transporting expensive mobile laboratories to every music festival in the country. To determine an actual MDMA dose, the entire pill needs to be sacrificed for testing, defeating the point of the test for users who want their expensive pill back. Only suppliers with batches to sell would benefit
Caldicott’s methods open up a canyon of concerns, defended on the flimsiest of grounds — that it’s done overseas. Australia’s festival temperatures can be double Amsterdam’s, presenting serious risks of hyperthermia and dehydration. Combining even small MDMA doses with caffeine, alcohol and other drugs here can be lethal. So many consume pills before arriving at events that about a tenth of ACT clients required a second assessment to determine if they were too intoxicated to counsel.
Startlingly, the ACT trial had no age check to prevent minors being counselled or police checks to prevent suppliers sending in samples of their inventory for assessment.
The decision to discard pills is left to the user, which opens up possibilities such as on-selling, cocktailing with other drugs in an attempt to dilute the danger or, worse, retribution against festival dealers who supply about a third of the material.
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Over 90% of parents who have used marijuana over the past year also reported using alcohol, according to a new study
Parents who used marijuana and drank alcohol over the past year had some of the biggest risks for carrying out physical abuse…Parents who have used marijuana in the past year are more likely than non-users on average to discipline their kids through corporal punishment (like a slap or spank), physical abuse (like a hit on the head or a kick) and also nonviolent tactics (like loss of privileges or time-outs), according to a new study examining 2009 data on the impact of substance use on parenting.
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Professor Jennifer D. Thomas, co-director of the Center for Behavioral Teratology at San Diego State University who co-authored the rodent study told Newsweek: "Although it has been known that prenatal alcohol exposure can adversely affect later behavioral development, this study suggests that prenatal cannabis exposure can also influence behavioral development, and that effects may be more severe when combined with alcohol.
"These results are important, as pregnant women may not be aware that cannabis could be harmful to their child," warned Thomas.
Gregory Cole, Professor and Chair of the Department of Biological and Biomedical Sciences at North Carolina Central University who co-authored the zebrafish study, told Newsweek: "This study is significant because it indicates that exposure of embryos to even small amounts of alcohol and cannabis during development may have long-term effects on behavior, with alterations in behavior being exhibited during adolescence.
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