{"id":37016,"date":"2019-07-24T11:26:03","date_gmt":"2019-07-24T19:26:03","guid":{"rendered":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2019\/07\/24\/worlds-largest-marijuana-company-has-the-largest-problem-with-the-u-s-government\/"},"modified":"2019-07-25T00:41:48","modified_gmt":"2019-07-25T08:41:48","slug":"worlds-largest-marijuana-company-has-the-largest-problem-with-the-u-s-government","status":"publish","type":"post","link":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2019\/07\/24\/worlds-largest-marijuana-company-has-the-largest-problem-with-the-u-s-government\/","title":{"rendered":"\u2018World\u2019s Largest Marijuana Company\u2019 Has the Largest Problem With the U.S. Government"},"content":{"rendered":"<\/p>\n

Less than a week after closing yet another stock-heavy deal to make a claim to be the\u00a0\u201clargest marijuana company in the world,\u201d<\/a>\u00a0Massachusetts-based\u00a0Curaleaf<\/a> received\u00a0a very troubling letter<\/a>\u00a0from the federal government.<\/p>\n

Curaleaf has spent most of 2019 swooping up cannabis business licenses in recreational states. Last week, Curaleaf announced it would pay $875 million for Grassroots, a company based in Illinois, where lawmakers legalized recreational cannabis in May. Earlier in the year, Curaleaf closed a $950 million all-stock deal for Portland, Oregon-based Cura Cannabis.<\/p>\n

But CBD is also central to Curaleaf\u2019s business plan \u2014 and in a way that is\u00a0apparently violating the Food and Drug Administration\u2019s guidelines<\/a>\u00a0on how to advertise and market products containing the widely popular, poorly understood cannabis compound.<\/p>\n

As Bloomberg reported<\/a>, various Curaleaf products including the \u201cCBD Lotion,\u201d \u201cCBD Pain-Relief Patch,\u201d \u201cCBD Tincture\u201d and \u201cCBD Disposable Vape Pen\u201d sold on\u00a0www.curaleafhemp.com<\/a>\u00a0and advertised on Facebook and Twitter \u201care unapproved new drugs sold in violation\u201d of federal law, the FDA informed the company in a letter sent Monday.<\/p>\n

Products that claim to cure or relieve pain or other realities of the human condition are strictly regulated in the United States under the Food, Drug, and Cosmetic Act, a series of laws passed to protect consumers from patent medicine and snake-oil hucksters. Currently, no cannabis product is so regulated \u2014 including products derived from hemp, which most CBD products sold in the country are.<\/p>\n

You can sell CBD products all you want under the Farm Bill signed into law by President Donald Trump in December as vaguely defined \u201cwellness products;\u201d you just can\u2019t tell a would-be customer that your CBD product will cure specific ills \u2014 at least not until such claims undergo rigorous FDA examination.<\/p>\n

And that\u2019s exactly what Curaleaf is doing, the FDA said in its letter.<\/p>\n

\u201cBased on our review\u201d of the products advertised on Curaleaf\u2019s website and related claims regarding their efficacy, they are marketed as drugs and are \u201cintended 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,\u201d the FDA wrote. \u201cNew drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA.\u201d<\/p>\n

Among Curaleaf\u2019s claims that drew negative attention from the FDA, the agency said in a press release Tuesday, are statements suggesting that CBD cures cancer, treats Parkinson\u2019s disease, treats Alzheimer\u2019s disease, treats depression and anxiety and can \u201creduce the severity of opioid-related withdrawal.\u201d<\/p>\n

There are some findings that suggest CBD may play a role in the treatment of these conditions, but they are still very preliminary and do not support easy-to-remember marketing pitches like the above.<\/p>\n

Other violations noted by the FDA include improper labeling and similar violations with its CBD products intended for animals. The FDA gave Curaleaf 15 days to respond to the allegations.<\/p>\n

A Curaleaf company representative told Bloomberg that the FDA\u2019s warning is \u201cunder review\u201d and that the company plans to comply \u201cwith FDA requirements for all the products that it markets.\u201d<\/p>\n

Products containing\u00a0CBD<\/a>\u00a0have exploded in availability and popularity over the past year, a craze that only intensified after the Farm Bill clarified that hemp production and processing are legal in the United States.\u00a0Hemp is cannabis sativa containing 0.3 percent THC by volume or less<\/a>; cannabis sativa with more THC is considered marijuana and illegal under federal law.<\/p>\n

Exactly what companies can do with CBD is under review at the FDA, which held a hearing in May and received comments from members of the public up until July 16. In the meantime, the FDA has been clear that CBD can\u2019t be sold as a drug and can\u2019t be added to food and beverages.<\/p>\n

It\u2019s not entirely clear if Curaleaf drew FDA attention because it is so big, or because it was making such a big deal about being so big, a deal that helped boost its stock prices, or because the claims were particularly bold.<\/p>\n

\u201cThe agency continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA,\u201d the FDA\u2019s statement issued Tuesday read.<\/p>\n

A \u201chigh-level internal working group\u201d at the FDA tasked with figuring out how American companies can market CBD has yet to release its findings.<\/p>\n

The FDA has approved some CBD drugs for use on humans, but GW Pharmaceuticals\u2019 Epidiolex, intended to relieve severe epilepsy in children, underwent lengthy FDA trials beforehand.<\/p>\n

Until this week, Curaleaf products could be found in national chain drugstores like CVS, which inked a deal with Curaleaf earlier this year. Following the FDA\u2019s letter, a CVS representative told Bloomberg that those products would be removed from the store\u2019s shelves.<\/p>\n

The FDA\u2019s letter to Curaleaf represents what is so far the highest-profile problem a legal cannabis company has had with the federal government under the Trump Administration. The fact that it was a CBD company \u2014 a company that markets products in all 50 states, whereas recreational cannabis businesses are still firewalled off from interstate business \u2014 is no accident.<\/p>\n

TELL US,<\/strong>\u00a0what do you the FDA will say about CBD?<\/p>\n

The post \u2018World\u2019s Largest Marijuana Company\u2019 Has the Largest Problem With the U.S. Government<\/a> appeared first on Cannabis Now<\/a>.<\/p>\n


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\nRead More: \u2018World\u2019s Largest Marijuana Company\u2019 Has the Largest Problem With the U.S. Government<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Less than a week after closing yet another stock-heavy deal to make a claim to be the\u00a0\u201clargest marijuana company in the world,\u201d\u00a0Massachusetts-based\u00a0Curaleaf received\u00a0a very troubling letter\u00a0from the federal government. Curaleaf has spent most of 2019 swooping up cannabis business licenses in recreational states. Last week, Curaleaf announced it would payContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":9,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[6726,50,136,3995,5833,1170,5014,90],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/37016"}],"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\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=37016"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/37016\/revisions"}],"predecessor-version":[{"id":37017,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/37016\/revisions\/37017"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=37016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=37016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=37016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}