Mexico Could Make History By Treating CBD Like A Supplement, As It Should Be

As Mexico transitions to a federal medical marijuana program, lawmakers’ leeway toward cannabidiol (CBD) could help the so-called “miracle” compound become as common and low-drama as vitamins and minerals.

Last year, Mexico drew international attention when its government moved to legalize medicinal marijuana, perhaps using a more direct path than its neighbors to the north. On June 19, 2017 President Enrique Peña Nieto signed a bill into law that officially legalized the cultivation, production, and use of medical cannabis products with less than 1% tetrahydrocannabinol (THC) in Mexico.

Known for its psychoactive effects (and some related therapeutic uses), THC is one of at least 113 chemical compounds known as cannabinoids that are found in marijuana and hemp (both belonging to genus cannabis) and may stimulate the body’s endocannabinoid system in various ways.

Both THC and CBD are found in higher quantities in marijuana than in hemp, but unlike its chemical cousin, CBD has been shown to be non-intoxicating and to have fairly astounding applications — potential and otherwise — for preventing and treating numerous health conditions. And while THC (for all its strengths) can have negative effects for some users, science has deemed CBD almost unavoidably benign.

In the United States, unlike Mexico, CBD products have been marginally legal under federal law for decades, but only in low concentrations and if derived from (lots of) hemp, and not the more potent marijuana; until pretty recently, hemp has frequently gotten a hard time from lawmakers, too.

As a result, U.S. products claiming to contain CBD have been significantly under-regulated, inconsistently enforced, and effectively unavailable to most would-be patients and preventative users — despite the fact that studies increasingly suggest that many or most of us should consider it as an option for our personal health regimens.

According to Raul Elizalde, President of HempMeds Latin America, Mexico’s distinctive new law will give producers the freedom to start putting CBD in everyday health products; it could also give consumers unprecedented access to this seemingly healthful substance.

“A good point about this regulation in Mexico is that any product with a THC concentration higher than 1% can still be registered with the government, and sold as a prescription,” Elizalde commented by phone.

“But the best part is that [cannabinoids] with below 1% THC content can be in medicine, supplements, lotions, food, anything. This is very, very good for our country, and I think we’re one of the very first in the world to take that path.”

Even setting aside its compelling health uses, “The Mexican government understands that CBD is not a danger to public health, so regulating quantity just doesn’t make sense,” Elizalde said. “Usually people take around 60 mg per day for medicinal purposes, but studies showing no health risks have tested dosages of up to 250 mg per kilogram weight of the patient before researchers basically gave up. But you don’t see products like that.”

In other words, someone who weighs a little more than me could rest easy consuming 15,000 mg of CBD a day.

Spending anywhere from $800 to $1500 in the current market for that dose and (depending on the product) consuming that much volume could still be unsettling, though.

At this point in our understanding of CBD, Elizalde said, governments and the public need to be aware of the level of safety and medical value that science has established — and to learn to separate their ideas of medical and recreational marijuana products.

For one thing, he said, medical patients are still being hurt due to stigma and hesitation (variously warranted or not) around recreational marijuana, as both a product and an industry. “Medical and recreational are totally different,” he said. “Nobody buys CBD to get high, nobody buys it to try to abuse it, and the only thing that will happen if it’s scheduled [as a controlled substance] is that it will become a black-market drug.”

“But it’s not a drug,” he added. “It’s a supplement.”

Elizalde explained that he himself didn’t know much about marijuana’s medical value until his family had a need for CBD, but no way to get it in Mexico. “I was not involved in the cannabis industry or movement, I came from a very conservative family, but my daughter suffers from Lennox-Gastaut syndrome, a very hard kind of epilepsy,” he said.

While his young daughter Graciela suffered nearly 400 seizures per day, he and his wife were “desperately trying to find a treatment that worked,” Elizalde said. That included all the anti-epilepsy drugs on the market, including new ones in development, and even brain surgery, but nothing helped. And then they came across CBD, which has shown significant ability to reduce epileptic seizures, and fought a court battle to allow them to import it from the U.S. to Mexico.

In 2016, the family won their case, and started importing CBD to supplement Graciela’s other medications, at it’s often used. Graciela is doing “much better” with the added CBD, and the reduction in seizures was quickly “very good,” Elizalde said: rather than 400 seizures a day, Graciela now experiences closer to 20.

“When we started treatment, she could not even go out to dinner with us; every 30 minutes, she was having a crisis,” Elizalde said. “Now she’s showing improvement in her physical therapies, in her swimming lessons, in her interactions with her sisters — she can now look her parents in the eyes.”

“It’s something I never believed was going to happen, and less so with a supplement. It changed her life, but also mine and my whole family’s.”

Regarding CBD’s role as a medicinal treatment or supplement, Elizalde also pointed out that “medicinal” and “pharmaceutical” don’t mean the same thing, nor should they under the law.

“In the future, we will have medicines that use CBD, but it will not be limited to medicines. That’s the way it should be,” he said. “Just like Vitamin C: you can find it in medicines, but also supplements and oranges.”

“If you [consume] Omegas, this will help with your brain. If you take Vitamin C, it will help with your immunity. CBD is something that has been studied for reducing inflammation, anxiety, seizure, pain, and if you only allow its use as a drug, you will limit its benefits to only a few persons.”

Elizalde said that regulating CBD as a medicine would limit the number of products out there, and likely result in only one or two pharmaceutical companies getting to sell it as a medicine by prescription.

“I know some pharmaceutical companies try to register CBD, but you could always sell hemp oil, which has CBD, so it’ll be a matter of legality and how you sell and market your product.” He continued, “You can’t own something that’s botanical, and having a patent on a botanical system or molecule is almost impossible.”

At present, access to CBD and other marijuana products in Mexico still remains limited despite last year’s legal change.

Voice of San Diego reported in March, “Currently, Poway-based Medical Marijuana, Inc. is the only company from which Mexicans can get legal permits to import cannabidiol or CBD products with a doctor’s prescription. In 2016, it started a Mexican subsidiary, HempMeds Mexico, to lobby for broader medical marijuana regulations in the country.”

Since California legalized adult recreational on January 1, 2018, many Mexicans living near the border have also been taking advantage of the state’s easier access to different marijuana products, the site reported.

Going forward, however, Elizalde and others are hopeful that Mexico will be able to cultivate a thriving medicinal and recreational marijuana marketplace, as well as start to repair the decades of damage caused by the cross-border drug war.

“In a country where we have suffered so much from drug violence, we know that drug policy is wrong. Last year, our president said that drug policy has failed,” Elizalde commented. “I think we need to do something different, and maybe that difference is to make marijuana recreational, make it legal, so that states could regulate it, and promote regulation over prohibition.”

Following Mexico’s recent presidential election, and some supportive deliberations about CBD by the World Health Organization, Elizalde and others have the chance to get their wish, though the work’s not done yet.

Last week, president-elect Andrés Manuel López Obrador, who’ll have the job of overseeing rule-making and regulations around Mexico’s new marijuana law, unveiled a plan to change the country’s drug strategy in several big ways.

Olga Sanchez, the proposed interior minister for López Obrador, said that an integral part of the government’s security strategy will be “transitional justice,” which “typically involves leniency for those who admit guilt, truth commissions to investigate atrocities and the granting of reparations for some victims,” Reuters summarized.

Sanchez also told Reuters, “Not only will it be amnesty, it will be a law to reduce jail time … We will propose decriminalization, create truth commissions, we will attack the causes of poverty, we will give scholarships to the youth and we will work in the field to get them out of the drug situation.”

In the mean time, businesses, patients, and recreational users on both sides of the border will likely be watching Mexico’s progress closely. And perhaps waiting to see which way the wind blows before they distribute seeds, or light up.

Given the present out-of-pocket cost for a few weeks’ worth of modest CBD doses, which a family member of mine takes to supplement her pharmaceutical (and insurance-paid) seizure drug, I’ll definitely be among them.

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Federal farm bill could boost CBD industry

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The federal government doesn’t appear ready to deal with the lingering legal questions of marijuana, but hemp is another matter.

Kevin Liebrock, chief operating officer at Bluebird Botanicals in Colorado, said the federal farm bill, will in all likelihood, legalize hemp as a cash crop.

“When you have someone like U.S. Sen. Mitch McConnell, who has been a die-hard conservative for a long time, and he’s supporting hemp,” Liebrock said. “I think that shows we’ve reached a tipping point for sure.”

Lex Pelger, chief science officer with Bluebird, said hemp can be used in everything from clothing to fiber. But he said the market for growth will be cannabidiol oil. Cannabidiol, or CBD, is extract that has been used to treat seizures, pain and other things.

Pelger said CBD oil is already available in most states, including Illinois. But because it’s associated with marijuana there is a stigma.

Hemp CBD, he said, could change that.

“If you’re trying to introduce this into places that haven’t had an experience with cannabis, and are really scared of it,” Pelger explained. “Hemp is a really great way to get started.”

Pelger said hemp CBD and marijuana-based CBD are almost identical. In fact, he said hemp CBD may provide more benefits for treating seizures and other medical conditions.

Illinois just legalized CBD for use in schools, but it must be administered by a parent.

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Here’s what’s next now that the FDA has approved a cannabis drug for seizures

The US Food and Drug Administration approved the first cannabis-derived drug this week, but it can’t be sold until the Drug Enforcement Administration changes how it classifies the specific compound used. So what’s next?

Epidiolex treats serious forms of childhood epilepsy and contains the compound cannabidiol (CBD). Though CBD comes from cannabis, it won’t cause anyone to get high; it’s the compound THC that is psychoactive. But because it comes from cannabis and cannabis overall is classified as a Schedule I drug with “no currently accepted medical use and a high potential for abuse,” pharmaceutical companies aren’t allowed to sell it unless the DEA reclassifies CBD.

It is likely that the DEA will reclassify CBD in the next 90 days, says Stephanie Yin, an analyst at Informa Pharma Intelligence. (Epidiolex manufacturer GW Pharmaceuticals has said the same.) Most likely, according to Yin, it will be changed to Schedule IV or Schedule V, which are schedules that include other anti-seizure medications and anxiety drugs like Xanax and Klonopin.

THIS WILL ENCOURAGE OTHER COMPANIES TO DEVELOP CBD DRUGS FOR EVERYTHING FROM PAIN TO MULTIPLE SCLEROSIS

This doesn’t mean that cannabis as a drug will be removed from Schedule I though. Yin points out that the FDA already approved two nausea drugs — dronabinol and nabilone — that use synthetic versions of THC. The DEA scheduled these drugs as Schedule III and II, respectively, but still didn’t reschedule cannabis. Plus, FDA Commissioner Scott Gottlieb said in a press release that Epidiolex approval “is not an approval of marijuana or all of its components.”

If these synthetic THC drugs can be approved and rescheduled, and CBD can be rescheduled, what’s keeping the DEA from rescheduling cannabis itself? “Cannabis contains so many different compounds and strains,” explains Yin. “The FDA has just approved this singular product through stringent testing and doses and specific concentrations. It’s gone through rigorous clinical reviews and FDA review, but the FDA is likely to still crack down on claims made with other products.”

To be clear, there are already plenty of CBD products easily available, from supplements to oils to various beauty products like soap. But it’s one thing to sell them as supplements, and another to sell them as drugs. “You can get vitamin C from oranges at the grocery store, or you can get a clinical preparation of vitamin C to treat a disease, and those two items are treated very differently,” says Chris Stubbs, chief science officer of hemp farming and genetics company GenCanna. Clinical CBD is much more tightly regulated.

Still, the reclassification will likely make medical cannabis more legitimate. Rite Aid, for example, has already said it will fill prescriptions for Epidiolex, which is likely to be available at pharmacies in the fall. (It won’t be available in dispensaries because FDA-approved drugs can only be sold at places with a pharmaceutical license.) And GW Pharmaceuticals is already investigating other CBD-derived drugs to treat different forms of epilepsy, as well as forms of brain cancer and schizophrenia. “This approval is definitely going to encourage other companies to investigate [other cannabis] compounds for different diseases,” she says, “from pain to Alzheimer’s to multiple sclerosis to Tourettes’. Basically a whole spectrum of diseases.”

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U.S. approves first prescription drug made from marijuana

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The FDA approved a CBD-based medication to treat two rare forms of epilepsy that begin in childhood

WASHINGTON — U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

The Food and Drug Administration approved the medication, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood. But it’s not quite medical marijuana.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant — but not the one that gets users high. It’s not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.

British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.

FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. But it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.

Physicians say it’s important to have a consistent, government-regulated version.

“I’m really happy we have a product that will be much cleaner and one that I know what it is,” said Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

Several years ago, Allison Hendershot considered relocating her family to Colorado, one of the first states to legalize marijuana and home to a large network of CBD producers and providers. Her 13-year-old daughter, Molly, has suffered from severe seizures since she was 4 months old. But then Hendershot learned about a trial of Epidiolex at New York University.

“I preferred this to some of those other options because it’s is a commercial product that has gone through rigorous testing,” said Hendershot, who lives in Rochester, New York.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer “drop” seizures — in which her entire body goes limp and collapses.

CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

The impact of Monday’s approval on these products is unclear.

The FDA has issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer’s. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

Most CBD producers sidestep the issue by making only broad claims about general health and well-being.

Industry supporters downplayed the impact of the FDA approval.

“I don’t know a mom or dad in their right mind who is going to change what’s already working,” said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation’s largest CBD companies. “I really don’t think it’s going to affect us much.”

Jackson’s group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.

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A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

The new medication enters an increasingly complicated legal environment for marijuana.

Nine states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. Last year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

GW Pharmaceuticals makes the drug in the U.K. from cannabis plants that are specially bred to contain high levels of CBD. And the company plans to continue importing the medicine, bypassing onerous U.S. regulations on manufacturing restricted substances.

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