In a move clearly meant to have a chilling effect on the nascent medicinal cannabis industry, the federal Food and Drug Administration has sent warning letters to eight sellers of THC-free cannabidiol oil-based products (CBDs):
The “PowerPoint” version is basically this:
• For years now, retailers have been selling CBD concentrates and infused products in dispensaries, supplement shops, and direct over the internet. As it is free of THC, it has been treated as a “supplement” under FDA rules, and legal to sell in all 50 States.
• In 2007, a UK-based pharmaco (GW Pharmaceuticals) began applications to the FDA for Phase II and Phase III testing of a proposed new drug containing CBD, pending early success in clinical trials.
• Late last year, the FDA finally approved GW’s application for Phase II and III clinical testing.
• So now, the FDA is circling back and telling current product providers that CBD is no longer recognized as a “supplement”, but as a new “drug”, pending regulation, and that all such providers must remove any/all health claims on their websites/literature related to those products.
Their main argument stems from the assertion that (from the formal letter):
“FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence[pre-2007, apparently], FDA has concluded that this is not the case for CBD.” (emphasis mine)
That is an extremely arrogant assertion to make. It certainly presumes that nothing that occurred before either the existence of GW Pharma or the FDA itself should “count” with regards to whether CBD was marketed as a “dietary supplement or conventional food” prior to GW’s 2007 application. This is, of course, absurd in the extreme.
I think that this order can – and must – be fought, vigorously, and straightforwardly. Cannabis and its extracts has always contained CBD and has been sold or marketed for centuries containing that substance. The history of GW Pharmaceuticals dates back only to 1998.
These companies mentioned in the article receiving FDA warning letters are selling straightforward extracts containing CBD that are not chemically distinguishable from ancient extracts made a century (or four millennia) in the past. It is said that Queen Victoria herself used CBD-rich cannabis for menstrual cramps in the 19th century.
Claiming that the name, CBD oil, is or could be required on a product in order to establish that it has been marketed or sold prior to the application is simply a bridge too far, even for the FDA, which, these days, appears to a huge number of people as nothing but a wholly-owned subsidiary of Big Pharma. Academic literature identifying CBD dates back to the 1940’s and was based on extracts of cannabis that themselves date back thousands of years.
(1) Red oil of hemp
Structure of Cannabidiol, a Product Isolated from the Marihuana Extract of Minnesota Wild Hemp (1940)
Isolation of Cannabinol, Cannabidiol and Quebrachitol from Red Oil of Minnesota Wild Hemp (1940)
(3) Literature on Red Oil that clearly indicates sale and use dates back at least to 1918 in “The Dispensatory of the United States of America“
(4) There are further references published in 1896. – Charas. The resin of Indian hemp. (1896)
It is not credible to suggest that if such oil appeared in literature of 1896 or 1918 that it was neither offered for sale nor used.
But these materials were used since at least 1100 AD in the middle east, and prior to that in India.
With literature indicating sale and use of the product dating back almost 1000 years, and, in the USA, and with 102 years passing between easily available literature recording its use and the inception of GW Pharmaceuticals, it is ludicrous to contend that these preparations made from hemp cannot be sold and used as herbal products. They clearly fall under the heading of nutraceuticals.
Indeed, from the original linked story above, the well-intentioned founders of GW, finding a lack of CBD available to test, proposed to the British government that it sanction a grow op so they could perform their own extractions. This happened, but now the situation has clearly metastasized into an overbearing regulatory nightmare, that must be resisted at all costs, else this industry risks becoming the proverbial infant being strangled in the crib.
But there is certainly great cause for hope. By calling all providers together, and getting support from them all, a good attorney could fight this for years and make a royal stink in the press to rival Tim Cook’s battle with the FBI.
These companies have until the deadline to remove the marketing or information links that cite claims as to the health effects of CBD. But, that is all. They are free to continue selling products, as the products themselves are lawful. In fact, these FDA warnings are common in all areas of unregulated supplements; these letters are sent out every month/week. Bill Faloon, co-founder of the Life Extension Foundation, has been fighting these battles with the FDA for 3 decades. LEF is bigger than ever.
Almost all companies and brands tested this year passed with flying colors. They are not contaminated. They contain what is stated on the bottle. There are many companies selling great quality CBD rich hemp extracts. In this case, only the retailers were cited for making claims, not the original manufacturers, who know better than to make health claims.
Additionally, the FDA needs to become more aware of the huge amount of hemp grows going on, specifically for CBD and other non-psychoactive cannabinoid extractions. Hemp cultivars around the world are now being bred specifically for CBD extraction. That genie is clearly out of the bottle, and no amount of ham-fisted regulation from the FDA is going to stop it now. I suspect they are doing the bidding of Big Pharma, who are naturally terrified of the billions in profits they will lose when a tipping point of patients realize that there are natural substances that are better at treating certain ailments – even cancer in some instances – that are relatively cheap, safe, and effective. People who use cannabinoids for chronic pain mitigation are no longer stuck using expensive and addicting oxycodone and similar opioids.
And finally, I would note that (1) all else aside, this applies only to interstate commerce. Any company that operates within state lines is outside FDA jurisdiction and (2) I would humbly add that, while these supplement providers may not be able to advertise any longer (at least for now) the medicinal benefits of CBD, that doesn’t prevent the rest of us, who are not directly in that business, to shout them from the rooftops. As well we should. Spread the word.
Thomas Andrew Olson is a Founder and CFO of CMD Services, LLC
He can be reached at: tao (at) cmdservicesllc dot com.
(This post included research from Brian Hanley.)