FDA Sends Warning to CBD Companies

The Food and Drug Administration (FDA) has sent warning letters to multiple companies involved in the distribution of products containing cannabidiol (CBD).

fdaThe FDA sent warning letters today to four CBD-related companies claiming them to be making unsubstantiated claims “related to more than 25 different products spanning multiple product webpages, online stores and social media websites”. The companies are Natural Alchemist (California), Greenroads Health (Florida), That’s Natural! Marketing & Consulting (Colorado), and Stanley Brothers Social Enterprises LLC (also Colorado).

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes”, states a Wednesday press release. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

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Government Seeking Public Comments on Cannabidiol (CBD)

The government is seeking public comments on a variety of substances, including the cannabis-derived compound cannabidiol, commonly referred to as CBD.

Specifically, the Food and Drug Administration (FDA) is “requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances”, including CBD. According to t he FDA, these comments “will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs.” WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. The notice requesting comments is required by the Controlled Substances Act (the CSA).

Currently CBD is defined as a schedule I controlled substance, putting it on equal footing as hard drugs like heroin. This is despite numerous states allowing CBD for medical use, and despite a plethora of research showing its medical efficacy.

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Tennessee CBD Bill Signed Into Law by Governor

Tennessee’s governor has signed into law a bill that allows the medical use of cannabidiol (CBD) after FDA approval.

Senate Bill 385 was signed into law today by Governor Bill Haslam. The measure was approved unanimously through both the House of Representatives (90 to 0) and Senate (33 to 0); it took effect immediately upon receiving Governor Haslam’s signature.

According to its official summary, Senate Bill 385; “Exempts cannabidiol products approved as prescription medications by the United States Food and Drug Administration (FDA) from the definition of“marijuana” under title 39, chapter 17, part 4.”

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Tennessee CBD Bill Passed Unanimously by Legislature

The Tennessee Legislature has passed a bill to allow the medical use of cannabidiol (CBD) after FDA approval.

House Bill 694 passed the Senate earlier this month with a 33 to 0 vote, and today passed the House with a vote of 90 to 0. It will now be sent to Governor Bill Haslam for consideration; Haslam has the option of signing it into law, allowing it to become law without his signature, or vetoing it (though a veto could be overridden by a 2/3rds vote in the legislature).

House Bill 694 excludes from the state’s definition of marijuana any “cannabidiol product approved as a prescription medication by the United States food and drug administration [FDA]”.

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Trump Close to Naming Marijuana Legalization Advocate to head FDA

According to Rachel Maddow, Trump is “close to naming” Jim O’Neil as head of the Food and Drug Administration (FDA).

Jim O’Neil. (Photo: OsloFreedomForum.com)

O’Neil is not only a supporter of legalizing marijuana, he has publicly worked towards it. He previously served on the Board of Directors for the Coalition for Cannabis Policy Reform (CCPR).

According to their website, CCPR is; “a nonpartisan organization dedicated to replacing the harmful policy of cannabis prohibition with reasonable regulation, based on science, through ballot initiatives, legislative collaboration and public education campaigns.”

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Trump Administration Confirms Marijuana Legalization Advocate Being Considered to Head FDA

Sean Spicer, President Donald Trump’s Press Secretary, has confirmed previous reports that Jim O’Neil is being considered to lead the Food and Drug Administration.

O’Neil is not only a strong supporter of legalizing marijuana, he has actively worked towards it as a Board of Directors member for the Coalition for Cannabis Policy Reform, which helped legalized cannabis in California.

According to Spicer, both O’Neil and biotech executive Balaji Srnivasan “are being considered” for head of the FDA.

Both O’Neil and Srnivasan have connections with billionaire Peter Thiel, who co-founded Paypal and was an early investor in Facebook. Thiel is a supporter of Donald Trump and also supports legalizing marijuana.

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Study: CBD Oil ‘Highly Promising’ as Treatment for Pediatric Epilepsy

By Paul Armentano, NORML Deputy Director

Cannabis oil.
Cannabis oil.

The administration of cannabis oil extracts high in cannabidiol reduces seizure frequency in children with intractable epilepsy, according to clinical data published online ahead of print in the journal Seizure.

Israeli researchers retrospectively evaluated the effects of CBD oil in a multicenter cohort of 74 patients with intractable epilepsy. Participants in the trial were resistant to conventional epilepsy treatment and were treated with CBD extracts for a period of at least three months. Extracts in the study were provided by a pair of Israeli-licensed growers and were standardized to possess a CBD to THC ratio of 20 to 1.

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FDA Gives Fast Track Approval to Cannabis Medicine for Newborns

Baby is holding father's finger for the first timeGW Pharmaceuticals, a biopharmaceutical company with a focus on cannabinoid-based medicines, has received fast track approval from the U.S. Food and Drug Administration (FDA) for a medicine designed to treat newborns deprived of oxygen during childbirth, which can lead to brain damage and death.

The FDA gave approval to an intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy (NHIE), which is a form of acute or sub-acute brain injury caused by asphyxia that occurs during birth. The medicine has already received approval from the European Medicines Agency to treat perinatal asphyxia, an alternate term to describe the same condition as NHIE.

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Wyoming and Arkansas Governors Sign Bills to Nullify FDA Restrictions on Terminally-ill Patients

Arkansas Governorfda Asa Hutchinson and Wyoming Governor Matt Mead have both signed into law bills that nullify some FDA (Food and Drug Administration) restrictions that prevent terminally ill patients from using experimental treatments.

Senate Bill 4 (Arkansas) and Senate File 3 (Wyoming) would both allow a patient suffering from a terminal disease who has considered all other approved treatment options to try experimental treatments or drugs not yet approved by the FDA if recommended by a physician.

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University of Alabama Receives FDA Approval to Produce, Administer and Study Cannabis Extracts

Cannabis tincture.
Cannabis tincture.

The University of Alabama has received approval from the Food and Drug Administration (FDA) to begin cultivating, administering and studying the impact of low-THC (tetrahydrocannabinol), high-CBD (cannabidiol) cannabis extracts on childhood and adult seizure disorders.

In April, Alabama Governor Robert Bentley signed into law Senate Bill 174 which authorizes the University of Alabama’s Department of Neurology to prescribe, produce and distribute low-THC cannabis extracts – such as cannabis oil and tinctures – to those with seizure disorders. The oil must be primarily CBD, and can contain no more than 3% THC.

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