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Does CBD get you high? What are the actual benefits? Will it show up on a drug test? Here’s everything you need to know about the product that’s suddenly everywhere.

There’s no question that CBD is the buzzy wellness product of the moment. If you live in a state where it’s currently legal, you might feel like CBD has gone from being sort of around to absolutely everywhere all at once. Coffee shops sell CBD lattes, spas offer CBD facials, beauty companies are rushing to release lotions with CBD or hemp oils in their formulas. And everyone from your anxious coworker to your arthritis-suffering dad wants to get their hands on some CBD gummies.

But even though it’s infiltrating pretty much every corner of the wellness world many people still find CBD a little confusing—especially when it comes to figuring out the right way to use it and how to make sure the stuff you’re buying is, you know, actually legit. Below, we asked experts to answer the most pressing questions about CBD.

OK, first things first. What is CBD?

CBD, short for cannabidiol, is a chemical compound from the cannabis plant. It’s a naturally occurring substance that’s used in products like oils and edibles to impart a feeling of relaxation and calm. Unlike its cousin tetrahydrocannabinol (THC), it’s not psychoactive.

So you’re saying CBD won’t get me high?

Nope. The cannabis plant is made up of two main players: CBD and THC. “CBD is the non-psychoactive portion of the plant, so what that means is you won’t have any effects like euphoria,” says Junella Chin, DO, an osteopathic physician and a medical cannabis expert for cannabisMD. “You won’t feel sedated or altered in any way.”

There are two possible exceptions to this. The first is that some people, for unknown reasons, just react differently to CBD. According to Dr. Chin, about 5% of people say they feel altered after taking CBD. “Usually they’re the same people who have side effects from Advil or Tylenol,” she says. You never know how your body will react to any new supplement, so when taking CBD for the first time, do so safely under supervision.

It’s also crucial to buy third-party-tested CBD for quality assurance (more on this later). Because the FDA doesn’t regulate CBD, it is possible to buy a product that is more or less potent than advertised, or even contains small amounts of THC.

Where does hemp come in to all this?

You’ve probably heard the terms cannabis, marijuana, and hemp all tossed around in relation to CBD. The plant Cannabis sativa has two primary species, hemp and marijuana. Both contain CBD, but there’s a much higher percentage in hemp, which also has very low (less than 0.3%) levels of THC compared to marijuana.

When people talk about hemp oil, they’re referring to oil extracted from the seeds of the hemp plant. There are no cannabinoids—CBD or THC—in hemp oil. This ingredient is packed with healthy fats and often appears in beauty products for its moisturizing benefits.

What are the health benefits of CBD?

The only CBD medication that is currently FDA-approved is Epidiolex, which the agency approved last year for the treatment of certain types of epilepsy. But many people swear CBD has helped with a slew of other health conditions, including back pain, osteoarthritis, even cancer.

“My practice has patients walking in every day asking about CBD,” says Houman Danesh, MD, director of integrative pain management for the Mount Sinai Hospital in New York City. But while there’s lots of anecdotal evidence, he says, “it’s still very difficult to say” what the real benefits are due to a serious lack of research.

“Right now, you just have pharmacies trying to make some sort of sense out of it and say, ‘Yes, it works for this,'” he says, “but that’s not the way medicine is practiced—it should be based on evidence, and there’s not a lot of evidence to really support these claims.”

Still, is CBD worth trying for pain management?

There are two main types of pain, Dr. Danesh says: musculoskeletal and nerve. “There could be benefit for both conditions,” he says.

The tricky part is that there’s some evidence suggesting CBD works best for pain when combined with a little THC, says Dr. Danesh. “Depending on what type of pain you have, you might be able to do just CBD, but sometimes you need CBD and THC.” This makes accessing a product that will actually help you more difficult due to different regulations in each state. In New York, where Dr. Danesh practices, for example, CBD is available over the counter. But as soon as you add THC, you need a prescription.

Figuring out how much you should take is challenging as well; the dosage that alleviates one patient’s pain might do very little for someone else. “And until we can study it, it’s the wild west,” Dr. Danesh says.

The takeaway? “I think CBD is a safe thing to try,” says Dr. Danesh. But he urges patients to push for more research by putting pressure on representatives to get national bills passed that allow scientists to look closer at CBD and the conditions that respond to it.

What about my anxiety—can CBD help with that?

CBD might be worth trying to manage symptoms of anxiety. “[CBD] tells your body to calm down and reminds you that you’re safe,” Dr. Chin says. “It mellows out the nervous system so you’re not in a heightened ‘fight or flight’ response,” she says, so people with anxiety may find it helps them feel more relaxed.

Still, one of the biggest misconceptions about CBD is that it’s a wonder drug. “A lot of times people think CBD is a cure-all, and it’s not,” Dr. Chin says. “You should also have a healthy lifestyle with plenty of exercise and good nutrition—CBD is not going to fix everything.”

I’ve heard of edibles, tinctures, vape pens… What’s the best way to take CBD?

It really depends on what your goal is and why you’re taking CBD in the first place.

Some people don’t want to ingest anything and therefore prefer a topical CBD cream or ointment. “You can apply it to muscles, joints, and ligaments and still get a nice, localized release,” Dr. Chin says.

The biggest differences between tinctures, edibles, and vape pens are speed of delivery and how long the effects last. Vape relief is faster but wears off faster too—usually in about two hours, says Dr. Chin. “Say you wake up in the morning and pulled your back out, you might want to take CBD through a vape pen, which delivers in 10 minutes.”

Tinctures and edibles take longer to work but last four or five hours. “A tincture looks like a little liquid that you put under your tongue, and you feel relief within half an hour,” Dr. Chin says. “If you prefer to taste something, you choose an edible, whether it’s a capsule, gummy, or baked good.”

What should I look for when shopping for CBD products?

“There are literally hundreds of CBD brands at this point,” says Brandon Beatty, founder and CEO of Bluebird Botanicals and an executive vice president of the U.S. Hemp Roundtable. Here are a few things you should keep in mind when shopping.

• What does the label look like? We don’t mean the color or millennial font. If it’s a dietary supplement, it should have a back panel with an FDA disclaimer and warning section, according to Beatty. “Ideally, it would be preferable to have access to their third-party lab testing results too.”

• Speaking of which: Has it been third-party tested? Nearly every expert Health spoke to agreed that your CBD products should be tested by a third party to confirm the label’s accuracy. This is a real concern in the industry—take the 2017 Journal of the American Medical Association study, for example, which tested 84 CBD products and found that 26% contained lower doses than stated on the bottle. Look for a quality assurance stamp or certificate of analysis from a third party (aka not the actual brand) or check the retailer’s website if you don’t see it on the product’s label.

• What’s the dosing? This is a confusing one for many people. “A lot of brands don’t do a good job of clearly instructing their consumer on the dosing,” says Chris Roth, CEO and co-founder of Highline Wellness. When thinking about dosing, also consider whether your CBD is full-spectrum or isolate: Full-spectrum could include other cannabinoids like cannabidivarin or cannabigerol (this is important, since “there’s something called the ‘entourage effect’ when all together, they’re more effective than any one of them alone,” Roth explains), while isolate is 100% CBD. “Some people might only need 10 milligrams of full-spectrum CBD, but with isolate, even taking 80 or 100 milligrams might not have the same effect,” he says.

• Does it claim to cure any diseases? If so, hard pass. “You should avoid any company that makes disease claims,” says Beatty. “If so, it means they’re either willing to break the rules or they’re not aware of the rules.”

• Is there a batch number? You know how you check your raw chicken or bagged lettuce every time there’s a recall to make sure the one you bought isn’t going to make you sick? You should be able to do that with CBD products too. “This is a huge indicator as to whether they are following good manufacturing practices,” says Beatty. “There should be a way to identify this product in case it was improperly made so the company can carry out a recall.”

• Are there additional ingredients in there? As with any supplement, you want to know everything you’re ingesting in addition to the main event. For example, “sometimes I notice that [CBD manufacturers] will add melatonin,” says Dr. Chin.

• Are you buying it IRL? You can find CBD products in shopping malls, convenience stores, even coffee shops in many states right now. But when in doubt, natural grocers are a safe brick-and-mortar place to buy CBD, Beatty says. “Typically they have a vetting process that does some of the legwork for you.”

That all sounds good, but is it legal?

First, a little background. Industrial hemp was legal in the United States until Congress passed the Marihuana Tax Act in 1937. (“Some of our early presidents grew hemp,” notes Sarah Lee Gossett Parrish, a cannabis industry attorney based in Oklahoma.) Nearly 80 years later, the 2014 Farm Bill took the position that states can regulate the production of hemp and, as a result, CBD. Then last year, President Trump signed a new Farm Bill that made it federally legal to grow hemp.

This means that “consumers everywhere, if they’re compliant with their state, can grow hemp and use hemp products,” Parrish explains, “and among those will be CBD.”

In other words, the latest bill removed hemp from the Drug Enforcement Administration, or DEA’s, purview. “Hemp can now be grown freely under federal law, which, of course, is huge,” Parrish says. “But while it’s legal under federal law, it’s up to each state to set their own policy.”

These policies vary widely. Marijuana and CBD are currently fully legal for both medicinal and recreational purposes in Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, Washington, and Washington D.C. In 23 states, it’s legal in some form, such as for medicinal purposes. Another 14 states permit just CBD oil. But both are illegal in Idaho, Nebraska, and South Dakota. For more information, the organization Americans for Safe Access has a helpful guide to the specific laws in each state.

“It’s kind of ironic,” says Parrish. “With marijuana, we have got the federal government saying ‘No’ and a bunch of states saying ‘Yeah, it’s OK’—but with hemp, the feds say ‘Yeah, it’s OK,’ but we still have some states saying it’s not.”

Can you travel with CBD?

That same 2018 Farm Bill means you can now travel between states with legit CBD products. “Flying with CBD should pose no issues now,” Parrish says. However, if you’re traveling with a tincture, be mindful of TSA limits on how much liquid you can carry on an airplane, she adds. (You can also mail CBD products, just like “companies that comply with the Bill can ship their hemp-derived CBD products anywhere in the U.S.,” Parrish notes.)

Will CBD show up on a drug test?

It should not, as long as you’re buying third-party tested CBD with no added THC, says Dr. Chin. But she does point out that athletes, who often are required to take drug tests that are more sensitive, “could potentially test positive” for trace amounts of THC if they’ve been using CBD products.

Can I give it to my dog?

Tempted to give your pup one of those CBD dog biscuits? “Generally we expect CBD products to be safe, and they could show some benefit for anxiety in pets,” says John Faught, DVM, a veterinarian based in Austin, Texas.

But the challenge when considering CBD products for pets is the same as with people: lack of research. “I believe there are good products out there today, but I also don’t know how to distinguish them at this time,” Faught says.

Source: health.com | Original Link

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With the growing awareness of CBD as a potential health aid there’s also been a proliferation of misconceptions. Find questions and responses to common misinformation.

It doesn’t get you high, but it’s causing quite a buzz among medical scientists and patients. The past year has seen a surge of interest in cannabidiol (CBD), a non-intoxicating cannabis compound with significant therapeutic properties. Numerous commercial start-ups and internet retailers have jumped on the CBD bandwagon, touting CBD derived from hemp as the next big thing, a miracle oil that can shrink tumors, quell seizures, and ease chronic pain—without making people feel “stoned.” But along with a growing awareness of cannabidiol as a potential health aid there has been a proliferation of misconceptions about CBD.

#1 “CBD is medical. THC is recreational.”

Project CBD receives many inquiries from around the world and oftentimes people say they are seeking “CBD, the medical part” of the plant, “not THC, the recreational part” that gets you high. Actually, THC, “The High Causer,” has awesome therapeutic properties. Scientists at the Scripps Research Center in San Diego reported that THC inhibits an enzyme implicated in the formation of  amyloid beta plaque, the hallmark of Alzheimer’s-related dementia. The federal government recognizes single-molecule THC (Marinol) as an anti-nausea compound and appetite booster, deeming it a Schedule III pharmaceutical, a category reserved for drugs with little abuse potential. But whole plant cannabis, which is the only natural source of THC, continues to be classified as a dangerous Schedule I drug with no medical value.

#2 “THC is the bad cannabinoid. CBD is the good cannabinoid.” 

The drug warrior’s strategic retreat: Give ground on CBD while continuing to demonize THC. Diehard marijuana prohibitionists are exploiting the good news about CBD to further stigmatize high-THC cannabis, casting tetrahydrocannabinol as the bad cannabinoid, whereas CBD is framed as the good cannabinoid. Why? Because CBD doesn’t make you feel high like THC does. Project CBD categorically rejects this moralistic, reefer madness dichotomy in favor of whole plant cannabis therapeutics. (Read the foundational science paper: A Tale of Two Cannabinoids.)

#3 “CBD is most effective without THC.”

THC and CBD are the power couple of cannabis compounds—they work best together. Scientific studies have established that CBD and THC interact synergistically to enhance each other’s therapeutic effects. British researchers have shown that CBD potentiates THC’s anti-inflammatory properties in an animal model of colitis. Scientists at the California Pacific Medical Center in San Francisco determined that a combination of CBD and THC has a more potent anti-tumoral effect than either compound alone when tested on brain cancer and breast cancer cell lines. And extensive clinical research has demonstrated that CBD combined with THC is more beneficial for neuropathic pain than either compound as a single molecule.

#4 “Single-molecule pharmaceuticals are superior to ‘crude’ whole plant medicinals.” 

According to the federal government, specific components of the marijuana plant (THC, CBD) have medical value, but the plant itself does not have medical value. Uncle Sam’s single-molecule blinders reflect a cultural and political bias that privileges Big Pharma products. Single-molecule medicine is the predominant corporate way, the FDA-approved way, but it’s not the only way, and it’s not necessarily the optimal way to benefit from cannabis therapeutics. Cannabis contains several hundred compounds, including various flavonoids, aromatic terpenes, and many minor cannabinoids in addition to THC and CBD. Each of these compounds has specific healing attributes, but when combined they create what scientists refer to as a holistic “entourage effect” or “ensemble effect,” so that the therapeutic impact of the whole plant is greater than the sum of its single-molecule parts. The Food and Drug Administration, however, isn’t in the business of approving plants as medicine.

#5 “CBD is not psychoactive.”

CBD is not an intoxicant, but it’s misleading to describe CBD as non-psychoactive. When a clinically depressed patient takes a low dose of a CBD-rich sublingual spray or tincture and has a great day for the first time in a long time, it’s apparent that CBD is a powerful mood-altering compound. Better to say, “CBD is not psychoactive like THC,” than to simply assert that CBD is not psychoactive. CBD won’t make a person feel stoned, but it can impact a person’s psyche in positive ways.

#6 “Psychoactivity is inherently an adverse side effect.”

According to politically correct drug war catechism, the marijuana high is an unwanted side effect. Big Pharma is keen on synthesizing medically active marijuana-like molecules that don’t make people high—although it’s not obvious why mild euphoric feelings are intrinsically negative for a sick person or a healthy person, for that matter. In ancient Greece, the word euphoria meant “having health,” a state of well-being. The euphoric qualities of cannabis, far from being an unwholesome side effect, are deeply implicated in the therapeutic value of the plant. “We should be thinking of cannabis as a medicine first,” said Dr. Tod Mikuriya, “that happens to have some psychoactive properties, as many medicines do, rather than as an intoxicant that happens to have a few therapeutic properties on the side.”

#7 “CBD is sedating.”

Moderate doses of CBD are mildly energizing (“alerting”). But very high doses of CBD may trigger a biphasic effect and can be sleep-promoting. If CBD-rich cannabis flower confers a sedating effect, it’s likely because of a myrcene-rich terpene profile. Myrcene is a terpene with sedative and painkilling properties. CBD is not intrinsically sedating, but it may help to restore better sleeping patterns by reducing anxiety.

#8 “High doses of CBD work better than low doses.”

CBD isolates require higher doses to be effective than whole plant CBD-rich oil extracts. But that doesn’t mean single-molecule CBD is a better therapeutic option than CBD-rich cannabis, which has a wider therapeutic window than a CBD isolate. Reports from clinicians and patients suggest that a synergistic combination of CBD, THC, and other cannabis components can be effective at low doses – as little as 2.5 mg CBD and/or 2.5 mg THC. Some patients may require significantly higher doses of CBD oil to obtain satisfactory results. Keep in mind that CBD and THC and cannabis in general have biphasic properties, meaning that low and high doses can produce opposite effects. An excessive amount of CBD could be less effective therapeutically than a moderate dose.

#9 “CBD converts to THC in a person’s stomach.”

Orally administered CBD is well-tolerated in humans. But concerns about possible harmful side effects, which might limit CBD’s therapeutic utility and market potential, were raised by misleading reports that CBD converts to high-causing THC in the stomach. It does not (read the evidence). There have been extensive clinical trials demonstrating that ingested CBD—even doses above 600 mg—does not cause THC-like psychoactive effects. On the contrary, CBD in sufficient amounts can lessen or neutralize the THC high. The World Health Organization studied the issue and gave CBD a clean bill of health in a 2017 report that asserted: “Simulated gastric fluid does not exactly replicate physiological conditions in the stomach [and] spontaneous conversation of CBD to delta-9-THC has not been demonstrated in humans undergoing CBD treatment.”

#10 “CBD is fully legal in the United States because it’s no longer a controlled substance.”

Not quite. The 2018 Farm Bill legalized the cultivation of industrial hemp (defined as cannabis with less than 0.3 percent THC) in the United States and removed various derivatives of hemp, including CBD, from the purview of the Drug Enforcement Administration (DEA) and the Controlled Substances Act. But the federal Food and Drug Administration (FDA) views CBD as a pharmaceutical drug. And because it has already approved CBD as a pharmaceutical (Epidiolex) for treating two forms of pediatric epilepsy, the FDA maintains that it is illegal to sell hemp-derived CBD as a dietary supplement. The DEA, meanwhile, retains jurisdiction over CBD derived from marijuana (cannabis with more than 0.3 percent THC), which is still prohibited under federal law. Rooted in reefer madness racism and enforced disproportionately against people of color, marijuana prohibition is akin to the Confederate statue still standing – a testament to enduring bigotry and social injustice.

#11 “Legalizing CBD, but not cannabis, adequately serves the patient population.”

Seventeen U.S. states have enacted “CBD only” (or, better said, “low THC” or “no THC”) laws. And 30 states have legalized medical marijuana (not just CBD) in one form or another. Some states restrict the sources of CBD-rich products and specify the diseases for which CBD can be accessed; others do not. But a CBD-rich remedy with little THC doesn’t work for everyone. Parents of epileptic children have found that adding some THC (or THCA, the raw, unheated version of THC) helps with seizure control. For some epileptics (and many other people), THC-dominant products are more effective than CBD-rich products. Most patients are not well served by CBD-only laws. They should have access to a broad spectrum of whole plant cannabis remedies, not just low THC medicine. Anything less is a national scandal. One size doesn’t fit all with respect to cannabis therapeutics, and neither does one compound or one product or one strain.

#12 “CBD is CBD—It doesn’t matter where it comes from.”

It may be possible to extract CBD oil from some low-resin industrial hemp cultivars, but fiber hemp is by no means an optimal source of CBD. Industrial hemp typically contains far less cannabidiol than high-resin CBD-rich cannabis flower tops. Huge amounts of industrial hemp are required to extract a small amount of CBD, thereby raising the risk of contaminants because hemp is a “bio-accumulator” that draws toxins from the soil. But the debate over sourcing CBD is quickly becoming moot, as plant breeders focus on developing high-resin cannabis varietals (marijuana) that satisfy the legal criteria for industrial hemp – with THC measuring less than 0.3 percent and CBD levels exceeding 10 percent by dry weight. “Pure” CBD extracted and refined from industrial hemp or synthesized in a lab lacks critical medicinal terpenes and other plant compounds that interact with CBD and THC to enhance their therapeutic benefits.

Source: projectcbd.org | Original Link

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On June 25, 2018, the U.S. Food and Drug Administration (FDA) announced its first-ever approval of a marijuana-derived pharmaceutical drug. Epidiolex (cannabidiol or CBD) was approved for the treatment of two rare, pediatric seizure disorders, Lennox-Gastaut syndrome and Dravet syndrome.1 On September 27, 2018, the Drug Enforcement Administration (DEA) announced its scheduling of Epidiolex – and future drug products containing CBD derived from marijuana with no more than 0.1 percent tetrahydrocannabinols – in Schedule V of the Controlled Substances Act (CSA).2  These events represent historical milestones in the journey of Cannabis from a source of textiles and medicines in the early nineteenth century to an illicit drug and now an FDA-approved drug.

Cannabidiol (CBD) is one of more than a hundred cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis), a plant more well-known colloquially as “marijuana” or hemp [Please see Author’s Note below].3  CBD was first isolated in 1940 and characterized structurally in 1963.4,5 With projected retail sales of CBD products -hemp, marijuana and pharmaceutical – as high as $1.9 billion by 2020, CBD is poised to become the darling of the medical Cannabis movement.6

Convoluted Law

Despite its rapidly growing popularity and use, the regulatory status of CBD in the United States remains convoluted, even after the approval and scheduling of Epidiolex. The source of CBD is critically important in determining its legal status. The most common source, botanically speaking, is the plant Cannabis sativa L. (Cannabis), which encompasses both marijuana and hemp. There are various schema for differentiating marijuana from hemp (e.g. Genotype, phenotype, Drug-type Cannabis v. fiber-type Cannabis, etc.), but from a regulatory standpoint, the difference between marijuana and hemp is based on chemical composition, specifically as it relates to the concentration of delta-9 Tetrahydrocannabinol (THC), the primary intoxicating compound found in Cannabis. Hemp is legally defined as a cultivar of Cannabis sativa with low concentrations of THC. Although limitations on THC concentrations for hemp differ internationally, THC concentrations cannot exceed three tenths of one percent (0.3%) in the United States. Hemp-derived and marijuana-derived CBD each have their own unique regulatory status and consequent legal implications.

Despite the scheduling of Epidiolex, CBD from marijuana is still deemed a Schedule I controlled substance by the DEA pursuant to the 1970 Controlled Substances Act. As such, CBD from marijuana is deemed to have no accepted medical use, a lack of accepted safety for use under medical supervision, and a high potential for abuse.1,7-11 While the scheduling of Epidiolex represents the first time that the DEA has acknowledged that marijuana has a “currently accepted medical use”, it did not change the regulatory status of CBD itself.

On May, 22, 2018, the DEA issued an internal directive which stated, “Products and materials that are made from the Cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA”.12 Although these statements clarified that CBD derived from a source other than marijuana was not a controlled substance, they did not specifically state that CBD from industrial hemp was lawful. Furthermore, these parts of the plant are not viable sources of CBD. As a result, confusion remains.

CBD can also be extracted from some hemp cultivars. Historically, hemp has been bred as an industrial crop in order to produce fabrics, rope, and other textiles from its long stalks.13 Despite not being explicitly defined or mentioned in the CSA, has been considered a controlled substance by the DEA since the passage of the CSA in 1970.

On December 20, 2018, The Hemp Farming Act of 2018, S. 2667 (2018 Hemp Bill) became law and formally and definitively removed hemp from the list of controlled substances. The 2018 Hemp Bill redefines hemp as all parts of the Cannabis Sativa plant that do not exceed 0.3% delta-9 THC by dry weight, including “derivatives,” “extracts” and “cannabinoids.”14 Importantly, the 2018 Hemp Bill explicitly removes popular hemp products, including hemp-derived CBD, from the purview of the CSA.

Prior to the passage of the 2018 Hemp Bill, domestically cultivated hemp was only federally lawful when cultivated under a state-sanctioned pilot program. In 2017, a total of 23,343 acres of hemp were cultivated across 19 states. As of this writing, 41 states have passed legislation to allow them to take advantage of hemp pilot programs under the 2014 Farm Bill.15 Today, only a minority of the hemp-derived CBD products available in the US are derived from domestically cultivated hemp. This will change as the 2018 Hemp Bill fosters greater investment in this area.

In addition to industrial hemp, CBD may also be lawful if it is derived from “non-psychoactive hemp” imported into the US. Non-psychoactive hemp is the term used by the Ninth Circuit Court of Appeals in a pair of companion cases filed against the DEA by a national trade organization, the Hemp Industries Association (HIA), regarding a DEA rule, which would have made it illegal to import any hemp products that contained any THC, including trace amounts.16,17 In a February 6, 2004 ruling, the Court found that the DEA had exceeded its authority in enacting the rule and struck it down as void and unenforceable.18

In its ruling – which did not specifically mention CBD – the Court used the term “non-psychoactive hemp”, and in a footnote stated, “The non-psychoactive hemp used in Appellants’ products is derived from industrial hemp plants grown in Canada and in Europe, the flowers of which contain only a trace amount of the THC contained in marijuana varieties grown for psychoactive use” (emphasis added). Confusion remains as to whether the Court, in effect, legalized the whole hemp plant for importation, including the “flowering tops”, so long as it contains no more than trace amounts of THC, or whether it simply reiterated the mature stalks exception in a different context. That distinction has never been addressed. Cases addressing hemp, which both preceded and succeeded this ruling, do not resolve the issue.9

Despite the confusion and the stance of the FDA and DEA, hemp-derived CBD products can currently be purchased both online and over-the-counter (OTC) throughout most of the country as if they were dietary supplements. In contrast, marijuana-derived CBD products can only be purchased by qualifying patients in states with medical marijuana laws (30 states, and the District of Columbia as of this writing) or by consumers in states with adult-use/recreational laws (9 states and the District of Columbia as of this writing).19

Before Epidiolex

To complicate matters further, prior to the approval of Epidiolex, the FDA explicitly stated that “CBD products are excluded from the dietary supplement definition” because of CBD’s status as an Investigational New Drug (IND) under the Food, Drug and Cosmetic Act (FD&C Act).20 CBD is no longer an Investigational New Drug (IND). It is an approved one. As a result, CBD cannot be included in a dietary supplement.

This preclusion is not entirely novel. In a somewhat similar case, Biostratum, a pharmaceutical company, requested the FDA take action against manufacturers of pyridoxamine-containing dietary supplements because Biostratum had submitted an IND application for pyridoxamine dihydrochloride.21 It took the FDA three and a half years to formally conclude that these products were in violation of its regulations. Products containing pyridoxamine and being sold as dietary supplements are not currently permitted.

There is another precedent which informs predictions of how the FDA might alter its enforcement approach going forward. In April 1997, Pharmanex, a dietary supplement manufacturer was advised by the FDA that its mevinolin-containing dietary supplement, named Cholestin, was a drug, not a dietary supplement. Mevinolin, also known as monocalin K, is a constituent of red yeast rice and has been shown to lower elevated cholesterol levels.22 Mevinolin is chemically identical to lovastatin (brand name Mevacor), an FDA-approved drug manufactured by Merck. The FDA concluded that Cholestin was manufactured to contain concentrations of lovastatin that exceeded traditional red yeast rice products, and the product was thus more similar to a drug than any red yeast rice product available OTC.23 While Cholestin is no longer available, many red yeast rice products remain on the market with naturally occurring concentrations of lovastatin.

In the Cholestin case, the FDA’s argument hinged on the concentration of lovastatin in red yeast rice products exceeding some traditional standard. The vast majority of hemp-derived CBD oil products available today contain concentrations by weight of CBD below 5%, as compared to Epidiolex, which is > 99% CBD.24 Given this precedent, it is possible, and perhaps even likely, that the FDA will restrict products that are enriched with isolated CBD but not hemp extracts that contain naturally occurring concentrations of CBD.

With FDA-approval of Epidiolex, and the FDA’s public proclamation that CBD products are excluded from the statutory definition of a dietary ingredient, the future of online and over-the-counter CBD products is uncertain. The FDA has the authority to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act) against products which are enriched with CBD. It is worth noting that the FDA is a public health agency with a myriad of competing priorities and a limited enforcement budget. When considering an enforcement action, the FDA weighs multiple factors, including benefits and harms.20 To date, harms associated with hemp-derived CBD products have been largely undocumented.

In the absence of strict FDA enforcement and oversight, widespread mislabeling of CBD products exists. Independent research has confirmed that the CBD content in almost 70% of CBD products available online could be mislabeled (43% of products were underlabeled and 26% were overlabeled for actual CBD content).25 The FDA sent warning letters to 25 companies in 2015-16 for violations of FDA rule.26 The FDA has also sent cease and desist letters to companies for making drug claims about CBD products, including claims that they treat, or even cure, cancer.27

Conclusion

The current legal and regulatory status of CBD is both complex and evolving, particularly with regard its legal status vis-a-vis the CSA and its regulatory status under the FD&C Act. While the implications of these complexities are widespread, restrictions in clinical research, in particular, have hindered the understanding of important safety and efficacy considerations. As a result, individuals are currently using CBD products to treat medical conditions without the support of informed healthcare providers.28

Although the approval of Epidiolex has precipitated the scheduling of drug products containing CBD derived from marijuana with no more than 0.1 percent tetrahydrocannabinols, it is less clear how it will influence the FDA’s enforcement priorities relating to hemp-derived CBD products. Increased enforcement could result in decreased access.

On the other hand, passage of the 2018 Hemp Bill could liberate the supply chain and prevent enforcement by creating a de facto legal market for hemp-derived CBD products that is separate and distinct from the medical market for Epidiolex. Or, perhaps products with low concentrations of CBD will remain below FDA enforcement priorities, as in the case of red yeast rice.

Source: Projectcbd.org | Original Link

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Intro to CBD

Cannabidiol (CBD) is a naturally occurring compound found in the resinous flower of cannabis, a plant with a rich history as a medicine going back thousands of years. Today the therapeutic properties of CBD are being tested and confirmed by scientists and doctors around the world. A safe, non-addictive substance, CBD is one of more than a hundred “phytocannabinoids,” which are unique to cannabis and endow the plant with its robust therapeutic profile.

CBD is closely related to another important medicinally active phytocannabinoid: tetrahydrocannabinol (THC), the compound that causes the high that cannabis is famous for. These are the two components of cannabis that have been most studied by scientists.

Both CBD and THC have significant therapeutic attributes. But unlike THC, CBD does not make a person feel “stoned” or intoxicated. That’s because CBD and THC act in different ways on different receptors in the brain and body.

CBD can actually lessen or neutralize the psychoactive effects of THC, depending on how much of each compound is consumed. Many people want the health benefits of cannabis without the high – or with less of a high.

The fact that CBD is therapeutically potent as well as non-intoxicating, and easy to take as a CBD oil, makes it an appealing treatment option for those who are cautious about trying cannabis for the first time.

CBD: The Multipurpose Molecule

Many people are seeking alternatives to pharmaceuticals with harsh side effects – medicine more in synch with natural processes. By tapping into how we function biologically on a deep level, CBD can provide relief for chronic pain, anxiety, inflammation, depression and many other conditions.

Extensive scientific research – much of it sponsored by the U.S. government – and mounting anecdotal accounts from patients and physicians highlight CBD’s potential as a treatment for a wide range of maladies, including (but not limited to):

• Autoimmune diseases (inflammation, rheumatoid arthritis)
• Neurological conditions (Alzheimer’s, dementia, Parkinson’s, multiple sclerosis, epilepsy, Huntington’s chorea, stroke, traumatic brain injury)
• Metabolic syndrome (diabetes, obesity)
• Neuropsychiatric illness (autism, ADHD, PTSD, alcoholism)
• Gut disorders (colitis, Crohn’s)
• Cardiovascular dysfunction (atherosclerosis, arrhythmia)
• Skin disease (acne, dermatitis, psoriasis)

CBD has proven neuroprotective effects and its anti-cancer properties are being investigated at several academic research centers in the United States and elsewhere. A 2010 brain cancer study by California scientists found that CBD “enhances the inhibitory effects of THC on human glioblastoma cell proliferation and survival.” This means that CBD makes THC even more potent as an anticancer substance. Also in 2010, German researchers reported that CBD stimulates neurogenesis, the growth of new brain cells, in adult mammals.

How Does CBD Work?

CBD and THC interact with our bodies in a variety of ways. One of the main ways they impact us is by mimicking and augmenting the effects of the compounds in our bodies called “endogenous cannabinoids” – so named because of their similarity to the compounds found in the cannabis plant. These “endocannabinoids” are part of a regulatory system called the “endocannabinoid system”.

The discovery of the endocannabinoid system has significantly advanced our understanding of health and disease. It has major implications for nearly every area of medical science and helps to explain how and why CBD and THC are such versatile compounds – and why cannabis is such a widely consumed mood-altering plant, despite its illegal status.

The endocannabinoid system plays a crucial role in regulating a broad range of physiological processes that affect our everyday experience – our mood, our energy level, our intestinal fortitude, immune activity, blood pressure, bone density, glucose metabolism, how we experience pain, stress, hunger, and more.

What happens if the endocannabinoid system doesn’t function properly? What are the consequences of a chronically deficient or overactive endocannabinoid system?

In a word, disease.

Cutting-edge science has shown that the endocannabinoid system is dysregulated in nearly all pathological conditions. Thus, it stands to reason that “modulating endocannabinoid system activity may have therapeutic potential in almost all diseases affecting humans,” as Pal Pacher and George Kunos, scientists with the U.S. National Institutes of Health (NIH), suggested in a 2014 publication.

By modulating the endocannabinoid system and enhancing endocannabinoid tone, CBD and THC can slow – or in some cases stop – disease progression.

Pharmaceutical CBD

There’s a lot of excitement about the healing potential of CBD – with good reason.

But it wasn’t until June 25, 2018, that the U.S. Food and Drug Administration (FDA) recognized cannabidiol as a real medicine by approving Epidiolex, an almost pure pharmaceutical CBD formulation, as a treatment for two severe pediatric seizure disorders, Lennox-Gastaut syndrome and Dravet syndrome.

This was the first time since the peak of the reefer madness era 80 years ago – when “marihuana” became a crime instead of a cure — that the federal government had given an official thumbs-up for a cannabis-derived product.

In response to the FDA’s historic decision, the Drug Enforcement Administration (DEA) announced in September 2018 that it had removed Epidiolex from Schedule I classification, a category reserved for dangerous drugs with no medical value. Henceforth, Epidiolex would be considered a Schedule V drug, the least dangerous designation under the Controlled Substances Act.

But the DEA kept cannabis and CBD itself on Schedule I as an illegal narcotic. In the world according to Uncle Sam, pharmaceutical CBD is officially the only good cannabinoid while the rest of the plant remains an ‘evil’ weed.

Given CBD’s reputation as a popular, artisanal remedy, one would think that Epidiolex would command a lot of “off label” attention. After all, physicians often prescribe pharmaceuticals off label to treat conditions that were not the actual focus of clinical trials. But the costly price tag for Epidiolex (more than $30,000 annually) precludes off label prescribing as well as affordable access for tens of millions of Americans without health insurance.

CBD Oil

For those who can’t obtain pharmaceutical CBD, there are numerous internet storefronts, community markets, coffee shops, health clubs, chiropractic offices, upscale boutiques and gas stations that retail various hemp-derived CBD oil products, including pure CBD isolates comparable in chemical make-up to Epidiolex.

CBD oil products and flower with varying levels of THC and CBD are also available for smoking or vaping at cannabis dispensaries in states that have legalized the herb for therapeutic use.

In response to massive consumer demand, a huge, unregulated market in CBD oil products reached a critical mass in 2018. A surge of consumer interest in all things CBD was suddenly newsworthy with hosanas of praise coming from athletes, film stars, soccer moms, and parents of desperately ill children.

CBD oil has been touted as a curative for the sick and a preventive for the healthy, an all-purpose palliative for pets as well as people of all ages.

But along with a growing awareness of cannabidiol as a potential health aide, there has also been a proliferation of misconceptions about CBD and cannabis therapeutics.

The CBD Challenge

CBD is a molecule, not a miracle. Many people could benefit significantly from legal access to a wide range of cannabis remedies, not just low-THC or no-THC products. CBD alone may not always do the trick. There is compelling evidence that CBD works best in combination with THC and the full spectrum of other cannabis components.

Figuring out how to optimize one’s therapeutic use of cannabis is the driving force behind the great laboratory experiment in democracy known as medical marijuana that’s been unfolding state-by-state and country-by-country in recent years.

The advent of potent cannabis oil concentrates, non-intoxicating CBD-rich products, and innovative, smokeless delivery systems has transformed the therapeutic landscape and changed the public conversation about cannabis.

It’s no longer a matter of debating whether cannabis has merit as an herbal medication – today the key challenge is discerning how to utilize cannabis for maximum therapeutic benefit. Given its low-risk profile, many people are using CBD as an add-on therapy to their existing treatment plans.

But most health professionals know little about CBD or cannabis therapeutics and they lack sufficient expertise to adequately counsel patients regarding dosage, modes of administration, CBD/THC synergies, and any risk factors, including interactions with other drugs.

Instead, the onus has been on a loose-knit community of self-reliant patients, supportive families and a few pioneer physicians who’ve learned a lot through trial and error and shared information about how to navigate promising avenues of cannabis therapy.

What About CBD from Hemp?

What began as a grassroots populist rebellion against cannabis prohibition would morph into a multibillion-dollar market catalyzed by the rediscovery of CBD as a wellness option. CBD oil is red hot and it seems that everyone – do-gooders as well as profiteers – wants a piece of the action.

CBD has also catalyzed the rebirth of the U.S. hemp industry, which lay dormant for decades because of drug war politics. The 2018 Farm Bill includes a provision that legalizes the cultivation of hemp (cannabis with less than 0.3 percent THC) in large part because of the popularity and driving economic force of CBD.

Growing hemp is now a legitimate agricultural enterprise in the United States. But extracting CBD-rich oil from hemp biomass and marketing CBD oil concentrates and isolates for ingestion and inhalation steps on Big Pharma’s toes and is frowned upon by the DEA and the FDA.

Legalities aside, hemp-derived cannabidiol is just a mouse click or a phone tap away for anyone willing to roll the dice and purchase CBD oil products that are manufactured with little regulatory oversight.

The upside of all this is easy access to CBD oil; the downside is inconsistent quality.

Many hemp-derived CBD oil products are mislabeled as to cannabidiol and THC content. And poorly processed CBD oil may be tainted with toxic solvent residues, pesticides, corn syrup, artificial flavors and colors, and other contaminants.

Fortunately, good quality CBD oil products are also available for the conscientious consumer – the label reader, the brand researcher – who understands that cannabis and CBD are best used as part of a healthy lifestyle.

Source: Projectcbd.org | Original Link

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