McConnell puts pressure on FDA to expedite CBD rules

Published September 17, 2019 by Hemp Industry Daily

The senator most responsible for legalizing hemp is now trying to use a legislative finance maneuver to speed up federal rules on putting hemp extracts in food and beverages.

Senate Majority Leader Mitch McConnell, a Republican from Kentucky, introduced new language that would require the U.S. Food and Drug Administration (FDA) to issue an “enforcement discretion policy and appropriate regulatory activities” on the sale of hemp-derived CBD products.

FDA’s stance that it is illegal for CBD to be recognized as an ingredient for food, beverages or dietary supplements for interstate commerce continues is a “primary policy challenge” facing businesses in the hemp and CBD industries, the U.S Hemp Roundtable, an industry advocacy group, said in a Tuesday advisory.

The U.S. Senate Appropriations Subcommittee on Agriculture was set to review McConnell’s report Tuesday while the full Senate Appropriations Committee plans to review the language Thursday before it is sent to the Senate floor.

The maneuver would require FDA to:

• Provide Congress with a report outlining efforts to develop an enforcement discretion policy on hemp-derived CBD. A process for which CBD meets the definition of hemp will be evaluated for use in products within 90 days.
• Issue a formal enforcement discretion policy on products containing hemp-derived CBD within 120 days.
• Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process.
• Ensure that CBD manufacturers will be able to share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.

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In recognition of Canada’s legalization of recreational marijuana, we thought we would share this funny article! You gotta love Canada! Paradise Valley Products and Pacific CBD applaud our northern neighbor for a make sense decision in the legalization of marijuana.

Toronto police to Canadians: stop snitching on your neighbors about marijuana

Canada’s marijuana legalization law took effect on Wednesday — and the Toronto police force wants people to stop snitching.
By German Lopez@germanrlopezgerman.lopez@vox.com  Oct 17, 2018

The Toronto Police Service has a message for Canadians: Please stop narcing on your neighbors about marijuana.

With the official start of marijuana legalization in Canada on Wednesday, and retail stores opening across the country (although not in Ontario until April), the Toronto police force started a public awareness campaign to inform people that they should no longer snitch on their neighbors about marijuana use.

Some of that public awareness campaign took the form of a few snarky tweets, invoking truly absurd 911 calls (from people asking for directions to asking what to do with frozen meat during a power outage) alongside calls about marijuana as examples of what not to do. The tweets urged people to no longer call the police about “an adult smoking a joint,” “your neighbour’s pot plants,” or “[s]melling weed coming from your neighbour’s home.”

“Cannabis is no longer illegal on October 17, 2018,” the tweets declared.

The tweets are funny, but they also speak to the huge change that Canada has brought on. Marijuana has been illegal in Canada for generations. This has shaped people’s views in all sorts of ways, up to enabling neighbors to snitch on each other over cannabis use. Officials across Canada now have to work to change not just the laws, but also the social norms and rules at work here.

On Wednesday, more than 100 legal marijuana stores opened for business in Canada, supplied by around 120 licensed growers, according to the Associated Press. Hundreds more stores are expected to open in the years to come.

This will allow both Canadians and travelers to the country to legally buy marijuana for recreational use for the first time.

There’s one major exception: Ontario, Canada’s most populous province and where Toronto is located, won’t allow sales until April. The newly elected conservative government there said it needs more time after it replaced previous plans for government-run stores (similar to state-run liquor stores in the US) with plans for private outlets. But residents will be able to buy pot online and get it through the mail in the meantime, and grow up to four cannabis plants per residence.

The beginning of sales follows the passage in June of Canada’s Cannabis Act, which legalized marijuana possession, home growing, and sales for adults (18 and older). The federal government is overseeing remaining criminal sanctions (for, say, selling to minors) and the licensing of producers, while provincial governments are supervising sales, distribution, and related regulations — as such, provinces will be able to impose tougher rules, such as raising the minimum age. In Ontario, for example, the age has been set to 19.

The move makes Canada the first wealthy nation and the second country in the world to legalize pot for recreational use. Only the South American country of Uruguay legalized marijuana before. (The Netherlands, despite its reputation, has not fully legalized pot.)

Marijuana is still illegal in the US at the federal level, even though nine states have legalized for recreational use at varying degrees.

So Canada’s move is drawing a lot of attention around the world. And how it all shakes out could help determine whether legalization in Canada is a sign of things to come across the globe.

See the original article on Vox here. 

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DEA moves some CBD medicines off Schedule 1, a limited expansion of cannabis access

Published September 27, 2018

The U.S. Drug Enforcement Administration has taken some cannabidiol out of the most restrictive class of controlled substances, a move that allows the sale of the first non-synthetic, cannabis-derived medicine to win federal approval.

It’s a decision that immediately affects CBD producers but also signals the agency’s first admission that the plant has medical value.

The DEA announced Thursday that drugs including CBD with THC content below 0.1% are now considered Schedule 5 drugs, as long as they have been approved by the U.S. Food and Drug Administration.

It is the first time the agency has lowered any type of cannabis from Schedule 1.

 The action came three months after the FDA approved its first non-synthetic, cannabis-derived medicine, a CBD preparation for rare types of epilepsy. The drug, Epidiolex, is made from cannabis grown in the United Kingdom.

The DEA announcement means Epidiolex will be distributed through traditional pharmaceutical channels, from a doctor’s prescription to a drug store, instead of through a medical marijuana dispensary or designated MMJ caregiver.

Marijuana businesses cheered the DEA change as a signal that opposition to cannabis is starting to crumble.

“We’re one step closer to finally ending prohibition and legitimizing the industry,” said James Minutello, CEO of Leaf Logix, a Glendale, California, company that makes business management software for the cannabis industry.

Original article By Hemp Industry Daily Staff

This is an abridged version of a story that appears at HempIndustryDaily.com

TRADE-IN YOUR IBUPROFEN FOR CANNABIS

Suffering from inflammation? Consider cannabis.

BY BONNI GOLDSTEINM MD ON AUGUST 15, 2018

Pain from inflammation can and will likely affect all adults at some point in their lives, and for some, become chronic conditions that interfere with a normal quality of life.

Over-the-counter (OTC) and prescription anti-inflammatory medications are easily available, readily prescribed, and very commonly used.  The most common anti-inflammatory medications are called NSAIDs: non-steroidal anti-inflammatory drugs. Based on consumer survey responses, more than 17 million Americans take NSAIDs on a daily basis, with more than 70 million prescriptions and more than 30 billion OTC NSAID tablets sold annually in the United States.

OTC NSAIDS include aspirin, ibuprofen, naproxen and prescription NSAIDs include celecoxib, diclofenac, etodolac and ketoprofen.  NSAIDs work by blocking enzymes called COX-1 and COX 2. These enzymes produce a group of compounds that our cells make called prostaglandins.  Prostaglandins made by COX-1 enzymes activate your platelets (for blood clotting) and protect the lining of your stomach and intestines. Prostaglandins made by COX-2 enzymes are made in response to injury or infection, regulating inflammation.  Most NSAIDs work non-selectively on both enzymes (except for celecoxib which is a COX-2 inhibitor). This lack of selectivity becomes an issue because pain and inflammation relief from NSAIDs come from blocking COX-2, but unfortunately COX-1 is also blocked, causing unwanted adverse side effects.

Pain from inflammation can and will likely affect all adults at some point in their lives, and for some, become chronic conditions that interfere with a normal quality of life.

Over-the-counter (OTC) and prescription anti-inflammatory medications are easily available, readily prescribed, and very commonly used.  The most common anti-inflammatory medications are called NSAIDs: non-steroidal anti-inflammatory drugs. Based on consumer survey responses, more than 17 million Americans take NSAIDs on a daily basis, with more than 70 million prescriptions and more than 30 billion OTC NSAID tablets sold annually in the United States.

OTC NSAIDS include aspirin, ibuprofen, naproxen and prescription NSAIDs include celecoxib, diclofenac, etodolac and ketoprofen.  NSAIDs work by blocking enzymes called COX-1 and COX 2. These enzymes produce a group of compounds that our cells make called prostaglandins.  Prostaglandins made by COX-1 enzymes activate your platelets (for blood clotting) and protect the lining of your stomach and intestines. Prostaglandins made by COX-2 enzymes are made in response to injury or infection, regulating inflammation.  Most NSAIDs work non-selectively on both enzymes (except for celecoxib which is a COX-2 inhibitor). This lack of selectivity becomes an issue because pain and inflammation relief from NSAIDs come from blocking COX-2, but unfortunately COX-1 is also blocked, causing unwanted adverse side effects.

Side effects and complications of NSAIDs are common and serious.  In one study, the risk of NSAIDs adverse drug reactions was found to be 26% (Gor 2011).  Complications include upper gastrointestinal bleeding and ulcers, heartburn, ringing in the ears, headaches, dizziness, liver or kidney problems, leg swelling, high blood pressure, heart attack, heart failure, stroke, and death.  In June of 1999, The New England Journal of Medicine estimated that 16,500 NSAID-related deaths occur among Americans with rheumatoid arthritis and osteoarthritis every year (Wolfe 1999). Over 100,000 NSAIDs users are hospitalized per year for gastrointestinal complications A review of 17 studies found that 11% of preventable drug-related hospital admissions could be attributed to NSAIDs (Howard 2007).  In 2005, U.S. Food and Drug Administration issued a public health advisory warning people of the increased cardiovascular risks of NSAIDS, and again in 2007 they published a medication guide for NSAIDs recommending the lowest dose possible for patients using these drugs. In January 2016, the FDA strengthened the existing label on all NSAIDs to warn that there was an increased chance of heart attack and stroke.  Some NSAIDs, such as rofecoxib (brand name Vioxx) and valdecoxib (brand name Bextra) have been taken off the market due to their risks clearly outweighing their benefits and pharmaceutical company “misrepresentation.”

As a cannabis physician, I find these statistics and multiple FDA warnings appalling.  Using dangerous drugs instead of a healing and non-toxic plant is simply ridiculous.

Over the past two decades, multiple studies have proven the anti-inflammatory benefits of phytocannabinoids and terpenoids, compounds that abound in the cannabis plant (Pertwee, 1999, Klein 2005, Nagarkatti 2009, Booz, 2011, Xiong 2012, Mecha 2013, and more). The plant cannabinoids have many different mechanisms of action in their anti-inflammatory properties, including the blockage of pro-inflammatory compounds that are made in the body as a result of injury or illness. CBDA, cannabidiolic acid, the raw non-psychoactive cannabinoid precursor to CBD, showed significant COX-2 enzyme blockage when compared to placebo, two NSAIDs and other cannabinoids (Takeda 2008).  Dr. Ethan Russo and Dr. Geoffrey Guy, in their excellent 2005 study, report that the phytocannabinoids work synergistically (the “entourage effect”) to provide balanced and nontoxic medicinal effects when compared with single molecule anti-inflammatories (Russo and Guy, 2005).

Patients suffering with inflammation have many choices when it comes to cannabis medicine.  Along with the ability to choose “non-smokable” delivery methods, such as tinctures, edibles, topical balms and vaporizers, patients now have many choices of which combination of cannabinoids to use.  For instance, one can take cannabis medicine that is THC-rich, CBD-rich, combination CBD+THC, THCA, CBDA and/or CBG. Some cannabis medicine suppliers are combining raw and heated cannabinoids in tinctures to increase the anti-inflammatory benefits.  Many patients are benefitting from drinking the juice of raw cannabis plants. In my medical practice, I have seen thousands of patients eliminate or reduce the need for NSAIDs, reducing their risks of side effects and possibly even death, with the use of cannabis.

For more information:

A complete list of NSAIDs can be found here: www.webmd.com/osteoarthritis/guide/anti-inflammatory-drugs#1-5
If you have high blood pressure, heart failure or chronic kidney disease, this is why you should not take NSAIDs (see number 3): www.choosingwisely.org/societies/american-society-of-nephrology/

Dr. Bonni Goldstein, a Los Angeles-based physician, is the author of Cannabis Revealed and the medical diretor of Canna-Centers, which offers educational seminars and webinars on cannabis therapeutics.

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HEMP FARMING ACT 2018
Making great strides towards legalization

As promised, U.S. Senate Majority Leader Mitch McConnell (R-KY) filed the Hemp Farming Act or S.2667 on Thursday, April 12.

Additionally, House Bill 5485, a companion to S.2667, was introduced by Reps. James Comer (R-KY) and Jared Polis (D-CO).

If passed, the Hemp Farming Act of 2018 would remove industrial hemp from the list of controlled substances and federally legalize the commercial cultivation of the crop.

Passage of this legislation would:

• Include U.S. grown hemp in the USDA National Organic Program. 
• Establish the legality of interstate hemp commerce.
• Open the door to research opportunities.
• Allow access to public water rights for hemp farmers.
• Protect the legality of production and consumption of the whole hemp plant.

S.2667 would provide American farmers with the commercial benefit from the economic opportunity of hemp and support the U.S. consumer market for hemp.

Article from https://ushempwholesale.com/

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CBD VS.  Pharmaceutical:  How  Do They Compare?

by Delilah Butterfield - May 23, 2017

NASEM’s study confirmed that there is substantial evidence that cannabis is useful in the treatment of some common and severe medical ailments. The include chronic pain, multiple sclerosis, and chemotherapy-induced nausea and vomiting, all conditions which would otherwise require the use of harsh pharmaceutical drugs.

Already, pharmaceutical companies have created cannabis-like drugs for multiple sclerosis and nausea and vomiting. Yet these options are often expensive and are not widely available to patients.

The pharmaceutical choices for chronic pain are far worse. Most patients are prescribed opioid pain medications, which are addictive and come with a high risk of fatal overdose.

Rates of opioid overdose are on the rise. In 2015, over 33,000 people died after overdosing on opioids. Some opioids available today are considered 30 to 50 times stronger than heroin, which has long been thought to be one of the most addictive narcotic drugs.

As a result, many patients turn to cannabis over opioid painkillers. One such patient was Arby Barosso, the man behind a rising CBD hemp oil company, Green Roads World. After years of battling arthritis and injuries, Barosso found himself addicted to his pain medication.

Arby Barosso: Fighting pharma addiction with CBD

Arthritis of the hip landed Barosso a 20-day visit to the hospital which prevented him from playing football and resulted in multiple surgeries. After facing substantial time in the operating room, Barosso was left with handfuls of prescription drugs. Morphine, Demerol, and Percoset all made the list.

Over time, Barosso couldn’t wait to get his next dose. In Barosso’s words, he,

"[…] became a slave of this drug, because you’d drive 20 minutes if you had to just to get it in your system."

His addiction to pharmaceutical drugs came at a high price.

"I was going through a tough time and I allocated that time into doing a lot of research, which enforced my decision to move out of Colorado and fully immerse myself into the CBD industry."

Chronic pain is one of the most common reasons for medical cannabis recommendations. Specifically, many patients are seeking cannabis products high in cannabidiol (CBD).

CBD is a cannabis chemical that doesn’t cause the famous “high”. Instead, research suggests that CBD is a strong anti-inflammatory and analgesic. It is also considered safe to consume, with no known side effects.

For Barosso, CBD was influential in recovery. Now, he is committed to providing patients with the highest quality CBD on the market through Green Roads World. He says,

"CBD has changed my life. I’ve been on CBD and sober now since September 4, 2013."

Green Roads World offers a wide variety of CBD hemp oils, edibles, capsules and more. A giving company, Green Roads World wants to help others overcome major health challenges. They currently sponsor 50 families who need access to quality CBD but do not have the means.

All of Green Road World’s CBD products are laboratory tested by a third party and contain 99.9 percent pure CBD.

To learn more about Green Roads World, visit their website at GreenRoadsWorld.com.

Original article: http://herb.co/2017/05/23/arby-barosso-green-roads-world/

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CBD Saved This Little Girl’s Life After Only 3 Treatments

by Todd Farmington  - June 5, 2017

When pharmaceuticals wouldn’t work, the parents of 12-year-old Annalise Lujan turned to CBD to keep their daughter’s seizures under control, which changed her life.

The power of cannabis oil

Last April, in the middle of a gymnastics meet, Annalise Lujan started vomiting and then lost all feeling in her legs. As her parents rushed her to the hospital, the 12-year-old fell into a crippling seizure, which saw her put into a medically induced coma.

"One day, she was just a healthy young lady, going to school, participating in her community and her gymnastics, and the next day, she was fighting for her life. – Maryann Estrada-Lujan, Annalise’s mother"

18 days later, Lujan was flown to a specialist unit at Phoenix Children’s Hospital, which is where she was diagnosed with the rare for of epilepsy, Febrile Infection-Related Epilepsy Syndrome.

The condition caused Lujan to have continuous seizures, which can lead to not only brain injury but also death. That’s why, until doctors had an effective method to prevent her seizures, she couldn’t be brought out of the coma.

And as regular anti-epilepsy medication doesn’t work on this particular condition, her mother, Maryann Estrada-Lujan, decided to research other options.

Green is good

Estrada-Lujan began treating her daughter with CBD hemp oil, which brought her daughter out of the coma after just three treatments. Now, after using cannabidiol, Lujan is no longer plagued by the constant seizures, allowing her to start therapy to regain her cognitive abilities.

Maryann told Kristi's Kids, in less than 48-hours after her first treatment, Annalise’s seizures all but stopped.

"She opened her eyes, and she was scared. She was afraid. She cried. And, I whispered to her that she was very strong, she’s beautiful, and she’s strong, and she needed to keep breathing, and she did."

"CBD oil saved her life."

In order to treat Annalise with CBD hemp oil, her doctor had to get rapid approval from the FDA and DEA. They’re hopeful that through the information gained in Annalise case that no other family will have to experience this living nightmare.

"We have a long recovery ahead of us. But, we’re definitely on the right track now."

Original article: http://herb.co/2017/06/05/annalise-lujan/