Israeli researchers have found more compelling evidence that medical cannabis is an effective therapy for children on the autism spectrum. In this soon-to-be-published study in the journal Neurology, researchers treated autistic children with high concentrations of CBD, a non-intoxicating cannabinoid found in the cannabis plant.
Conditions in 80% of the children improved. Alternatively, the children had not shown improvement with conventional drug therapies.
The Study Up-Close
The study was led by the director of pediatric neurology at Jerusalem’s Shaare Zedek Hospital, Dr. Adi Aran, who treated the 60 children with a high-CBD cannabis oil (20% CBD and 1% THC). The children were treated for at least seven months with the oil.
After the treatment period, parents answered assessment questionnaires to characterize their child’s condition. Questions were asked about behavioral changes, anxiety levels and ability to communicate.
Here’s what they reported:
80% of parents noted a decrease in problematic behaviors, with 62% reporting significant improvements.
Half of the children had improved communication.
40% reported significant decreases in anxiety. (Note: one-third of the study participants began the study with no anxiety.)
Just as Israel is a pioneer in medical cannabis research, Aran is a pioneer in cannabinoid therapy for autism. Aran originally began a 2017 project to test 120 autistic children. It was the first study of its kind worldwide, and was made possible by the Israeli government’s funding and progressive approach to cannabis research.
Aran said that when word of the study got out, his waiting lists were soon full with many families from all over Israel who wanted to participate.
Autism spectrum disorders are neurodevelopmental in nature, usually appearing in infancy or early childhood and lasting a lifetime. More severe cases have debilitating symptoms including compulsive, repetitive behaviors and impaired social skills and communication. Some children cannot speak at all. Autism affects around 1% of people worldwide.
The causes of autism are not understood and there is no cure—and the prevalence is climbing. In April 2018, the CDC updated its autism prevalence estimates to 1 in 59 children, up from 1 in 166 children in 2004. Doctors traditionally treat symptoms with antipsychotic medications, which have harmful side effects. Some children do not respond to these medications.
Aran began small autism research studies after similar cannabis studies on epilepsy, a disease that affects about 20% of autistic children. While studying epilepsy, researchers discovered that certain cannabis compounds would likely also help some autism symptoms. Less than 2% of the general population has epilepsy, but up to 33% of people with autism also suffer from epilepsy.
Neuroscientist Dr. Thomas Deuel of the Swedish Hospital in Seattle says there is definitely a connection. While scientists do not clearly understand the reasons behind the relationship, they suspect that the different brain development that occurs in autistic children is more likely to create circuits that cause epileptic seizures.
That link has caused many parents to seek out cannabis treatments for their autistic children. Parents certainly have anecdotal evidence of the effectiveness of CBD oils on their autistic children, but mainstream medicine has remained skeptical due to the lack of data. With most conditions treated with cannabis, anecdotal evidence and personal experience far outweigh actual peer-reviewed scientific research.
What’s Next for CBD Research?
In 2015, Harvard University and Boston Children’s Hospital published a baseline review of cannabis and autism studies to date, showing that the research did show promise, but nothing definitive could be said about cannabis’ ability to improve pediatric patients. The Harvard review stated that most research was animal-based and did not yet show translational impacts to human subjects. In fact, the review concluded with the cautionary statement that cannabis treatments should be used as a last resort after all conventional therapies have failed. Indeed, a widespread reluctance exists within the pediatric community to study the effects of cannabis in children, due to the potential of harmful side effects.
Since 2015, only a few small studies have been conducted, with promising results. One of the biggest impacts to spur on future research has been the U.S. Food and Administration (FDA) approval of Epidiolex, a CBD oil-based elixir manufactured by British drug developer GW Pharmaceuticals as a treatment for two rare types of childhood epilepsy. Scientists took notice at the amazing body of evidence that GW Pharmaceuticals presented regarding the effects of the drug.
Now, New York University (NYU) neurologist Dr. Orrin Devinsky, the same scientist who did research on Epidiolex, is now conducting two studies on CBD effects on children aged 5 to 18 with moderate to severe autism. The only other doctor who is currently doing studies like this is Aran.
Since autism and epilepsy go hand in hand, CBD is showing promise for treating both conditions.
Perhaps as doctors begin to see the effects of Epidiolex, and review research like that of Aran’s and Devinsky’s autism studies, many more will begin to delve further into use of medical cannabis.
(CNN)Cannabidiol, the non-psychoactive ingredient in hemp and marijuana, could treat opioid addiction, a new study says. Given to patients with heroin addiction, cannabidiol, also known as CBD, reduced their cravings for the illicit drug as well as their levels of anxiety.
“The intense craving is what drives the drug use,” said Yasmin Hurd, the lead researcher on the study and director of the Addiction Institute of Mount Sinai. “If we can have the medications that can dampen that [craving], that can greatly reduce the chance of relapse and overdose risk.”
The available medications for opioid addiction, such as buprenorphine and methadone, act in a similar way, curbing cravings. But they are still not widely used. According to the National Institute on Drug Abuse, just one-third of US patients with opioid dependence in private treatment centers actually receive these kinds of medications. According to the 2016 surgeon general’s report on addiction, only 1 in 5 people who needed treatment for opioid use disorders was receiving any sort of therapy.
Public health experts say there are obstacles to getting these drugs, which are approved by the US Food and Drug Administration, widely distributed. Because methadone and buprenorphine are still opioids, who can prescribe and how much can be prescribed are highly regulated. In addition, treatment with these medications can require frequent visits with practitioners. “It’s really burdensome,” Hurd said.
Concerns about diversion and addiction to these drugs remain, despite their success in reducing mortality by up to 59% a year in the year after treatment.
‘So many people are dying’
Nearly 400,000 Americans have died of opioid-related causes since 2000, just slightly fewer than the number of American troops who died in World War II. “So many people are dying, and there is a need for developing medications,” Hurd said.
For their study, published Tuesday in the American Journal of Psychiatry, Hurd and her colleagues looked at 42 adults who had a recent history of heroin use and were not using methadone or buprenorphine.
Recruited from social services groups, halfway houses and treatment centers, the participants had used heroin for an average of 13 years, and most had gone less than a month without using. They had to abstain from any heroin use for the entire trial period.
The participants were divided into three groups: one group given 800 milligrams of CBD, another 400 milligrams of CBD and another a placebo. All the participants were dosed once daily for three consecutive days and followed over the next two weeks.
During those two weeks, over the course of several sessions, the participants were shown images or videos of nature scenes as well as images of drug use and heroin-related paraphernalia, like syringes and packets of powder that resembled heroin. They were then asked to rate their craving for heroin and their levels of anxiety.
A week after the last administration of CBD, those who had been given CBD had a two- to three-fold reduction in cravings relative to the placebo group. Hurd said the difference between the two CBD groups was insignificant.
The research team also measured heart rate and cortisol, the “stress hormone,” and found that the levels in those who got CBD were significantly lower than those who hadn’t received the drug.
The researchers used Epidiolex, the first FDA-approved cannabis-based medication, as their source of CBD.
With many CBD products on the market now the exact concentration of CBD is uknown. In addition, they may have additives such as pesticides and even lead. But, Hurd said, with Epidiolex the exact concentration and other ingredients in the drug is known, which was key. “We are developing a medicine. We are not developing a recreational cannabis,” she said.
Participants reported very few bad reactions, such as mild diarrhea, headache and tiredness.
These findings are similar to those of a pilot study Hurd ran, but she says the next step is to do a longer-term study, following subjects for up to six months.
The study’s potential was not lost on others.
“This is an extremely significant paper. We need to utilize every possible treatment in helping people with chronic pain to find other ways to manage their symptoms and in people with opiate addiction to find relief,” said Dr. Julie Holland, a psychiatrist in New York and former assistant professor of psychiatry at the New York University School of Medicine.
“CBD not only manages the anxiety and cue/craving cycle, it also diminishes the original pain and inflammation that leads to opiate use in the first place,” said Holland, who was not involved with the new study.
Hurd said there are still a lot of questions to answer in the next study, including the best dose, how many times it needed to be administered and the mechanism in the brain that is working to diminish the cravings.
But she was optimistic about the implications. “It’s not addictive. No one is diverting it. It doesn’t get you high, but it can reduce craving and anxiety,” she said. Ultimately, “this can really help save lives.”
Building materials, textiles, and plastics, in this 3-part series, we’ll explore some of the ways hemp is set to change the world.
Concrete, steel, and wood pale in comparison as a sustainable building material to the plant known to grow like a weed — hemp.
With construction consuming a whopping 40% of the world’s global energy and resources, it is imperative that this industry moves towards more sustainable practices in the face of climate change’s many threats. This means moving away from building materials which are mined from the earth or harvested from rapidly depleting forests, and making the switch to renewable resources — and hemp is the perfect material for the job, in the form of a mixture known as hempcrete.
What is Hempcrete?
Hempcrete is a building composite similar to concrete, except it’s made by wet-mixing hemp hurds (woody fibers from the plant core) with a lime-based binder and water. This mixture can then be cast into molds or applied directly as a wet loose-fill material which hardens once dried, serving several construction and insulation purposes.
For instance, hempcrete may come in modular block form — similar to concrete masonry units — for building structures. It may also be used to form insulated walls, with the only other material being the wooden structural frame.
Moreover, hempcrete can be used in combination with other building materials to form both floors and roofs, providing an insulating layer. Astonishingly, hempcrete can even be used today for load-bearing walls. UK Hempcrete has a new system consisting of adapted hempcrete blocks and reinforced concrete.
Photo credit to UK Hempcrete
Hempcrete is also an ideal building material to be used to restore or retrofit traditional or historic buildings. For example, hempcrete can replace or repair infill panels in timber frame buildings, be used to add insulation to solid walls in older buildings with poor insulation, or it can be applied to unevenly shaped walls to improve their appearance.
Hempcrete provides a wide range of benefits — commercially, structurally, and environmentally.
Benefits of Using Hempcrete
Hempcrete has numerous advantages as a building material. Hempcrete lacks the brittleness of regular concrete, removing the need for expansion joints typically required for absorbing vibration and temperature-induced expansion and contraction in structures. Easier to work with, hempcrete is also much more lightweight.
Unlike wood, hempcrete is naturally fire-resistant and pest-resistant. For example, it is virtually impossible for a hempcrete building to become infested with termites.
The material is also highly useful for structures in earthquake-prone areas, as hempcrete’s low density renders it resistant to cracking under movement.
Walls made from hempcrete are very breathable and allow moisture to pass through, which makes hempcrete highly resistant to mold. Moreover, it has low thermal conductivity and wind-resistant properties, making hempcrete an ideal insulator. Buildings made from hempcrete easily stay cool in the summer and warm in the winter — resulting in a perfect material for nearly any climate and leading to substantial energy savings.
“In many climates, a 12-foot hempcrete wall will facilitate approximately 60-degrees indoor temperatures year-around without heating or cooling systems,” said Joyce Beckerman, vice president of the Hemp Industries Association, in an interview. “The overall environmental footprint is dramatically lower than traditional construction.”
Environmentally, hempcrete can’t be beaten as an eco-friendly building material. Hempcrete is carbon negative, as the crop sucks up CO2 as it grows. Hemp can be produced very quickly without the need for pesticides or fertilizer, making it rapidly renewable. For those aiming to achieve a low carbon footprint, building with hempcrete is an optimal choice.
Drawbacks to Hempcrete
While the benefits to using hempcrete are numerous, there are some hurdles this material has to overcome — namely, the cannabis plant still has a negative stigma surrounding it and it is highly regulated or downright illegal to grow in many countries.
This recently changed in the United States, however, with the passing of the Hemp Farming Act of 2018, part of the 2018 Farm Bill. Thanks to this bill, hemp has been legalized federally, changing from a controlled substance to an agricultural commodity.
Despite this massive progress, American hemp businesses still face challenges in traditional marketing and sales approaches, as many online advertising platforms and financial institutions still do not distinguish between hemp and marijuana — thus banning all hemp-related companies from advertising on their platforms.
Where is Hempcrete Being Used Today?
Hemp-based structures date back to Roman times, though the first modern-day hempcrete building was constructed in 1986 in France. Today, hemp-based structures can be found all over the globe.
As hemp cultivation is legal across Europe, the continent has hundreds of buildings utilizing hempcrete. France, in particular, leads the way, as they are the largest hemp producer in Europe.
In the US, there are currently over 50 homes made from hempcrete, the first being built in North Carolina in 2010. Hempitecture, a Washington-based company, has been retrofitting homes using the material. In Colorado, there is Left Hand Hemp, located in Denver, who builds hemp structures and helps teach others through seminars about hempcrete. We can expect to see a lot more buildings utilizing hempcrete in the coming years in the US, now that hemp has been legalized federally.
Other countries catching onto the hempcrete trend include Israel, Nepal, Australia, New Zealand, Canada, and the UK.
It’s likely many more countries will begin to follow suit in Europe’s and the US’s footsteps of allowing cultivation of hemp soon. As hemp’s negative stigmas continue to be eradicated and its numerous benefits come to light, the use of hempcrete could skyrocket around the world. Seeing that it is incredibly sustainable and cost-effective, this trend will continue to benefit businesses, families, and our planet itself.
The Idaho based J.R. Simplot Company has announced the successful production of the first ever CBD Potato.
aking,” said Carl Burbank, Head Scientist of Research at Simplot. “These potatoes are generally easy to grow, they’re quick to mature, and they taste great.”
The potato, developed under the once-secret project Chemically Balanced Dog “CBD,” could face legal roadblocks. Traces of THC, the psychoactive substance in Marijuana that produces a high, has been found in the potato.
This may be why it has been named the ‘Mary Jane’ potato.
“We’ve been working ‘round the clock here to get the THC levels below .3 percent,” Burbank said. “Which is the legal maximum allowed in Idaho.”
Under Idaho law any plant containing more than .3 percent THC is illegal.
“It’s taken a lot of persuading to get this project off the ground,” Burbank continued. “When we realized our potatoes were getting our test takers high, we decided to move our operations to Oregon.”
Simplot scientists have been commuting to an undisclosed location in Oregon to continue their research. Burbank has high hopes for the potato plant.
“…potatoes may be able to outproduce Marijuana…”
“Pound for pound, our potatoes may be able to outproduce Marijuana as the largest source of both CBD and THC. If we can get Idaho to legalize, then maybe we can bring our research back to the potato state.”
Simplot hasn’t been shy about the products potential applications. From CBD infused french-fries, mashed potatoes, and hashbrowns, the Mary Jane potato could be consumed with every meal.
Local Boise Chef Marla Pound said she was excited to incorporate the potato into her menu.
“I absolutely love the idea of the Mary Jane potato,” Pound said, during an interview on restaurant row in downtown Boise. “Image having your customers leave your restaurant relaxed and happy. You could give them terrible service, but they’d be so relaxed that the wouldn’t care. Image what that will do for your Yelp reviews?”
Although the Mary Jane potato originated in the potato state, Idaho may be one of the last places where it comes to market. Governor Brad Little and the State Legislature have repeatedly stated that Marijuana and any THC products will remain illegal, even for medicinal use.
“For now, our target market won’t be Idaho,” Burbank said. “But someday, we hope that’ll change.”
CBD products that make “unsubstantiated” health claims, in particular, may have fewer options when it comes to credit card processing. Let’s take a look at finding a CBD merchant account for your business.
How is CBD Different than Marijuana?
Cannabidiol, or CBD, doesn’t get the user high. That’s an important distinction for many of its proponents, who want to use CBD to relieve medical ailments, not as a recreational drug.
However, when it comes to credit card processing, most companies don’t distinguish between CBD and marijuana. Unfortunately, there’s nothing you can do to change their minds. If a processing company tells you it can’t support your CBD sales, it’s best to continue your search.
At the heart of this question is the Controlled Substances Act (CSA), the statute that established U.S. drug policies. Manufacturing, importing or distributing, possessing, and using certain substances is regulated under the CSA. The Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) are in charge of which substances are added to or removed from the various “schedules” in the CSA.
The CSA has five “schedules” for different substances, with Schedule I being the most restrictive, and Schedule V the least restrictive. Schedule I substances are claimed to have a high potential for abuse, no current accepted medical use, and a lack of accepted safety for use of the drug under medical supervision. It includes drugs like LSD, MDMA (ecstasy), heroin, and – confusingly to some – marijuana.
Schedule V substances, on the other hand, are said to have low potential for abuse, have a currently accepted medical use, and, if abused, may only lead to limited dependence. Cough suppressants with codeine and similar products fall under Schedule V.
While the DEA has added certain CBD-containing epilepsy drugs to Schedule V, marijuana remains a Schedule I substance.
CBD vs. Marijuana According to the DEA
However, as mentioned, CBD isn’t exactly the same thing as marijuana. In fact, it may not fall under the CSA at all. A DEA internal directive states: 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. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations.
In this paragraph, the DEA clearly indicates that products that don’t fall under the Controlled Substances Act’s definition of marijuana may be sold and distributed in the United States.
The DEA further states: The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.
This latter paragraph suggests that the presence of cannabinoids (CBD) by itself doesn’t determine if a product falls under the Controlled Substances Act. Rather, that determination is made by whether the product falls under the CSA’s definition for marijuana.
If you’re unsure where your product falls, consult an attorney or expert on the drug classifications.
Problems for CBD Sellers
As mentioned at the beginning of this article, one problem for CBD sellers involves “unsubstantiated” health claims. If your product makes a health claim that hasn’t been verified by the FDA, it will fall into the category of “pseudo-pharmaceuticals” where it isn’t an approved prescription drug but still claims to have benefits like prescription drugs.
Getting a CBD merchant account when your product makes health claims can be more difficult.
What are “unsubstantiated” health claims?
For the purposes of credit card processing, unsubstantiated health claims are claims that have not been evaluated by the FDA. Any suggestion that a product will positively impact health can be considered a health claim, even if the claim is as general as suggesting the product can decrease anxiety.
Some CBD companies suggest that their products help with ailments ranging from difficulty sleeping to inflammation. However, The Washington Post cautions that the scientific backing for CBD’s effectiveness is limited at this time. It does, however, suggest that there is preliminary evidence that CBD may help with seizures.
If my product doesn’t make health claims, can I get a regular merchant account?
Probably not. Unfortunately, CBD products by nature are likely to be considered “high risk” by credit card processors due to the uncertainty of legality and changing regulations. That makes it more difficult for a processor to ensure a business is complying with state and federal regulations.
Keep in mind that many of the “quick sign-up” style services, such as Square, Stripe, and PayPal, prohibit CBD. Your account may originally go through, but will later be shut down when the processing company conducts internal reviews and finds out that you’re selling CBD. Save yourself the trouble and don’t sign up with any merchant service provider that prohibits CBD sales.
In some cases, you may be able to obtain a high risk merchant account, but it will be at the processor’s discretion whether or not to accept your business. Offshore merchant service providers may also be willing to offer you a CBD merchant account, but remember that it will be more expensive than a domestic option.
While some CBD sellers in the past managed to sign up for payment processing through Shopify, the company has confirmed that products containing CBD cannot be sold through Shopify Payments. It suggests finding a third-party gateway isntead.
Shopify may actively shut down merchant accounts for businesses selling products that contain cannabidiols. Note that you can still use Shopify to host your ecommerce store, you just can’t use Shopify Payments to accept credit cards through that store.
Elavon Stops Accepting CBD
In early 2019, backend processor Elavon announced that it will no longer support merchant accounts for businesses selling CBD. Elavon (and its resellers) was a pioneer in CBD merchant accounts, and many businesses were caught offguard by the news.
Unfortunately, processing companies operating on Elavon’s platform will not be able to continue processing payments for CBD businesses. If that’s you, you’ll need to secure an alternate solution. Fortunately, there are still processing companies that can offer merchant accounts to CBD sellers.
On Thursday the ADAI released information on those applicants.
All are licensed to legally grow, cultivate, process, and research industrial hemp in 2019.
“We have had a significant interest in the Alabama Industrial Hemp Pilot Program from potential growers and processors since the availability of applications was announced in January,” Commissioner Rick Pate said.
“The approval of applications and execution of license agreements is complete, and we are in the next phase of the program. We are encouraged after our initial meetings with the approved growers and processors that the first year of the pilot program will provide opportunities for the agriculture industry in Alabama.”
Individuals and businesses must be licensed by the ADAI to grow or process industrial hemp in Alabama. Under laws passed by the Alabama Legislature and the United States Congress, it is unlawful to possess any raw or unprocessed hemp, hemp plants, or hemp seed without a license from the ADAI.
Gov. Kim Reynolds has signed a bill into law that allows Iowa farmers to legally grow industrial hemp.
The Iowa Hemp Act passed the Legislature with overwhelming support last month.
The bill Reynolds signed Monday allows licensed growers to cultivate the crop on up to 40 acres. First, however, the Iowa Department of Agriculture and Land Stewardship must develop a plan and submit it for approval of the U.S. Department of Agriculture.
The USDA must still release its own regulations this fall, with hopes of allowing farmers to grow hemp next year.
Since the 2018 Farm Bill eased federal restrictions on hemp production, most states have either legalized production or are growing it under a 2014 law that allows limited commercial production or research plots.
Among those that haven’t is South Dakota, where the governor vetoed such a law last month.
Copyright 2019 The Associated Press. All rights reserved.
With the legalization of hemp in the United States last December, the industry has been exploding: Reports and Data estimates it’ll be worth $13.03 billion by 2026. While you’ve probably noticed hemp-derived CBD products everywhere, hemp also has major implications for sustainable clothing — and denim icon Levi Strauss & Co. has made significant progress in making this happen.
In March, Levi’s debuted a collaboration with the Outerknown label that includes a pair of jeans and jacket made from a 69%-cotton/31%-hemp blend that feels like pure cotton. Why’s that significant? Hemp, a cannabis plant with a negligible amount of the psychoactive chemical THC, uses significantly less water and chemicals than cotton. Unlike cotton, though, the material is difficult to work with. The cotton fibers in your shirt are derived from a puffy bud on top of a plant, while hemp fibers come from a tall, sturdy trunk.
“It’s a longer, stiffer, coarser fiber,” Levi’s head of global product innovation, Paul Dillinger, told Business Insider. “It doesn’t want to be turned into something soft. It wants to be turned into rope.” Levi’s has found a way to make hemp fibers soft and able to blend with cotton, but in a way that uses significantly less water than the process used to turn hemp plants into a rough material. “It’s great that it’s resonating with the consumer, but it’s more important that it’s helping to future-proof our supply chain,” he said.
Dillinger explained that this is a significant research project that will continue for years, rather than a project that only results in a couple of high-end, niche products. “Our intention is to take this to the core of the line, to blend it into the line, to make this a part of the Levi’s portfolio,” he said.
Dillinger said Levi’s is continuing to work on improving the quality of its cottonized-hemp, to the point where it can be nearly half of a cotton-blend for most apparel, as well as fully hemp for certain products. And in five years, he said, he expects “a 100% cottonized-hemp garment that is all hemp and feels all cotton.”
Dillinger said that the need for cotton alternatives became apparent when looking at the growth trajectory of cotton demand compared to access to fresh water required for its cultivation and processing. Since he was familiar with the nature of hemp, he did not expect to find a solution there… until Levi’s discovered cutting-edge research in Europe, where industrial hemp was already legal in many countries. Levi’s would not reveal its partners or details of its breakthroughs, except to say that it had a market-ready material after three years.
When Levi’s finds a way to make 100% cottonized-hemp clothing, “We’re going to go from a garment that goes from 3,781 L of fresh water, 2,655 of that in just the fiber cultivation,” Dillinger said, drawing from data collected by the Stockholm Environmental Institute. “We take out more than 2/3 of the total water impact to the garment. That’s saving a lot.”
Despite his optimism, Dillinger was quick to point out that he doesn’t want hype around the hemp industry to make it seem like Levi’s and its competitors are going to fully replace cotton or revolutionize the industry overnight. To do it properly, there remains many years of research and development. Plus, it’s likely hemp will be just one of several natural cotton alternatives.
The idea is that hemp clothing, whether in a cotton blend or by itself, isn’t going to be a fad. Dillinger said that while he can’t speak for the company on this point, he personally isn’t too concerned about the marketing of cottonized-hemp clothing, because the ideal down the line is that customers won’t even notice a difference.
“So often there’s the assumption that to purchase a sustainably-made product is going to involve a sacrifice, and that the choice is between something ethically made or something that’s cute,” he said. “You don’t have to sacrifice to buy sustainably.”
In the coming months, the Food and Drug Administration will weigh whether certain food and dietary supplements containing cannabis or cannabis derivatives can be sold without violating federal law. Cannabis’s potential to compromise food safety or harm animals is just one of the many issues the agency will consider.
In April, the FDA laid out its plan to study the issue, which was prompted by growing interest in FDA-regulated products derived from Cannabis sativa L. and its components, including CBD.
“We’ve seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things,” said Scott Gottlieb, MD, then FDA commissioner, in a press release.
“We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products,” added Dr. Gottlieb, who stepped down April 5.
The FDA plan features a public hearing set for May 31 to gather stakeholder input. The agency will convene an internal working group to study the issue, taking into account statutory or regulatory changes necessary to legally market the products. The working group will also look at potential public health impacts resulting from the availability of such products.
In addition, the FDA is updating its webpage to answer frequently asked questions and help the public understand how the agency’s requirements apply to these cannabis and cannabis-based products. Moreover, the agency has issued several warning letters to companies marketing CBD products with unfounded claims of therapeutic benefits.
Although the 2018 Farm Bill removed hemp from the Controlled Substances Act, “Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds,” Dr. Gottlieb said.
“The only path that the (Federal Food, Drug, and Cosmetic) Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use.”
As part of the public hearing and related public comment period, the FDA is interested in data and information about the safety of cannabis and cannabis-derived compounds. For instance, the FDA asks, “Are there special human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g. species, breed, or class) that should be considered when assessing the safety of products containing cannabis and cannabis-derived compounds?”
Also, “What data are available about residues of cannabis-derived compounds in human foods (e.g., meat, milk, or eggs) that come from animals that consume cannabis or cannabis-derived compounds? Are there residue levels that should be tolerated in these foods?”
Here’s what you need to know about CBD:
What is CBD?
CBD, or Cannabidiol is one of the two most common compounds found in Cannabis plants, the other is THC or tetrahydrocannabinol. THC is the compound with intoxicating properties, but CBD is not psychoactive.
It’s used to treat things like anxiety and insomnia, and while there has been a ton of research already, there is still more work to be done. Many people are taking CBD because it helps them relax or get a good night’s sleep without giving them the “high” that THC produces.
The World Health Organization notes that CBD isn’t addictive and that “to date, there is no evidence of public health related problems associated with the use of pure CBD.”
Does it work?
More and more people are taking CBD as a supplement, and while some doctors suggest it has a place in treating things like pediatric epilepsy, chronic pain and anxiety, the FDA cautions consumers not to believe other over-hyped claims. The FDA has approved some seizure drugs containing CBD, but has also sent letters to companies warning them not to make outrageous claims about what CBD can do (there is no evidence that it can stop cancer cells or cure diabetes, for example).
“I think it’s really important to listen to these people and to learn what they’re saying,” Sara Jane Ward, a preclinical researcher who has studied CBD for more than a decade at Temple University’s School of Medicine tells the Philly Voice. “There is a lot of enthusiasm from the research community about the therapeutic potential of CBD for the treatment of diseases needing neuroprotection and anti-inflammatory effects and things like that.”
What the laws are
Congress legalized hemp late last year, but more legislation is needed to untangle CBD from marijuana. As long as the CBD was derived from hemp and not THC-containing marijuana, you can legally purchase it in many forms across the United States.
Can kids use CBD?
Many parents are interested in CBD to help kids with conditions ranging from cancer to Autism, but the FDA doesn’t want parents to administer CBD to kids, especially without speaking to a doctor first.
“With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult,” the agency notes on its website.
What about pregnant and breastfeeding moms and CBD?
CBD is safe for mothers to take, though doctors caution against taking it while you are pregnant or breastfeeding.
A recent study published in the journal Pediatrics shows that cannabinoids can be passed from a mother to her baby in the womb, as Consumer Reports notes.
Bottom line: CBD is something a lot of adults are exploring and finding helpful for managing anxiety, sleep and even boosting a yoga session. For adults, it could be a non-intoxicating alternative to a glass of wine, but pregnant women should proceed with caution and always talk to their medical care provider before taking any kind of supplement.