Folks from around the country and the world tuned into the U.S. Food & Drug Administration (FDA) website as they held a public hearing on Friday, May 31. Manufacturers and suppliers asked the FDA to regulate CBD like food or dietary supplements, while the FDA seemed to want more evidence on the safety of CBD products before giving the greenlight.
Background On The Hearing
For the uninitiated, after President Trump signed the Farm Bill into law back in December 2018, Scott Gottlieb, now former director of the FDA, issued a statement the same day the Farm Bill passed, clarifying the FDA’s regulatory authority. In the statement, Gottlieb explained that Congress preserved the FDA’s authority to regulate products containing cannabis and its constituents under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In April 2019, around the same time he resigned from the FDA, Gottlieb issued another statement, acknowledging the quickly growing industry throughout the country and total lack of federal regulatory guidance. This time around, Gottlieb laid out a handful of steps that the FDA plans on taking to address regulations around hemp and cannabidiol (CBD). Those included scheduling the public hearing for May 31, where written and oral public comments were submitted by stakeholders, sharing “their experiences and challenges with these products [hemp and CBD products], including information and views related to product safety.”
That statement also announced the formation of an internal agency working group to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
Fast-forward to May 31, the day of the public hearing, and all eyes in the industry focused on what all these stakeholders had to say to the FDA about CBD. The day started off with about two hours of oral comments, each speaker had roughly two minutes to deliver their thoughts.
Industry stakeholders representing cannabis businesses sang much of the same tune, clamoring for wise regulations on safety, testing, banking and interstate commerce, among other standards. NCIA Policy Director Andrew Kline’s comments included running through five major positions of the industry trade organization representing CBD companies. Those included recommending the FDA act quickly in setting up regulations, stressing the massive economic impact of the industry, saying that CBD products are generally safe, clamoring for voluntary, consensus-based standards and informing consumers of any potential risks. “The bottom line is this – an overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal health and safety concerns,” Kline told the folks at the FDA. “Time is of the essence. Hemp-derived CBD products are in very high consumer demand and the industry is eagerly awaiting FDA’s regulatory framework for these products. We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market.”
Anna Williams, representing the American Association for Laboratory Accreditation (A2LA), stressed the importance of testing for contaminants and adulterants as well as advocating for national standards on lab testing, instead of the state-by-state network of different standards.
Patients & Public Safety
After industry stakeholders had their chance to speak, the FDA allowed a group of advocacy organizations representing patients time to speak. That included representatives for the Alzheimer’s Association and the American Epilepsy Society, both of which were hesitant to throw their full support behind CBD as medicine. Kevin Chapman with the American Epilepsy Society said he wants to see clear warning labels, testing standards, more clinical trials and more studies before the group is ready to form a position on using CBD as medicine. Keith Fargo with the Alzheimer’s Association supports clinical trials to study it more, but thinks CBD is risky for patients without serious evidence of efficacy. A representative from the Tuberous Sclerosis Alliance also echoed similar concerns. They want to see labeling of drug interactions on labels of CBD products.
After those comments, some organizations had the chance to speak followed by comments from retailers and distributors. Patrick Bird, owner of PMB BioTek Consulting, spoke on behalf of AOAC International, where he primarily discussed public safety. He said they want cannabis products to be regulated with food safety in mind, asking for FSMA to apply to hemp products. They want to adequately ensure product safety with things like mandating HACCP plans, recall readiness, saying hemp products should be treated just like food products.
Retailers & Distributors
Peter Matz, representing the Food Marketing Institute, the trade association for the supermarket industry, said that regulatory ambiguity is a serious issue that needs addressing. “There is mass confusion in the marketplace for the public, suppliers, retailers and state regulators,” says Matz. “Demand for CBD products in human and animal use is growing rapidly. ¼ of American have already tried it. We are fielding questions from companies seeking clarity regarding the current federal regulatory framework.” He added, what many others also mentioned, that the FDA needs to move swiftly to provide a pathway to regulation.
Next on the docket came presentations from state government entities, including state departments of agriculture, followed by healthcare professionals. The state regulators that spoke mentioned a lot about food safety, standards, testing regulations, GMPs and things like that to protect consumer safety. “Currently states are struggling with the lack of sound scientific research available in CBD and long-term health impacts,” said Pam Miles, representing the Virginia Department of Agriculture.
One interesting aspect on their talks however was telling the FDA just how large their markets have gotten already and how they need guidance on how to regulate markets in their own states. Joseph Reardon, with the North Carolina Department of Agriculture, said they already have about 600 farmers growing hemp and thousands of processors working with the product in their state. “We urge the FDA to resolve the statutory issues improperly establish a legal pathway for CBD products to enter the market place,” Reardon commented. He also asked that the FDA extend the written comment period from July to August. “We are simply looking for a regulatory framework on the extraction, production and reconstitution of CBD or cannabinoid related products.”
Healthcare & Research
Healthcare providers, and physician testimony also echoed a lot of the same concerns, including the lack of research done, concerns about effects on at-risk populations and concerns about use as ingredients in dietary supplements and food. Some of the presentations also highlighted the room for nefarious activity in an unregulated marketplace. Some went as far as to mention cases where they found CBD vape juices with DXM in it (the active ingredient in cough syrup), CBD products found to contain THC, as well as synthetic cannabinoids responsible for drug overdose deaths. Some advocates in the hemp and CBD community have equated these arguments similar to reefer madness.
The major takeaway from this hearing is that everyone wants to see more data. Researchers and healthcare providers want to study the efficacy of CBD used in medicine, regulators want public safety information, patient advocates want to see data about effects on at-risk populations, trade organizations want data to back up label claims and the FDA wants to see just how safe CBD really is.
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1. What is CBD? What is CBD Oil?
Cannabidiol (CBD) is a naturally occurring constituent of industrial hemp/cannabis. Its formula is C21H30O2 and it has a molecular mass of 314.4636. It is the most abundant non-psychoactive cannabinoid found in cannabis, and is being scientifically investigated for various reasons.
CBD oil is a cannabis oil (whether derived from marijuana or industrial hemp, as the word cannabis is the latin genus name for both) that has significant amounts of cannabidiol (CBD) contained within it. Our CBD products and extracts are derived from industrial hemp, so they could be considered CBD-rich hemp oil, hemp derived CBD oil, CBD-rich cannabis oil, or plainly “hemp extracts” since they typically contain much more than just CBD. Again, cannabis doesn’t mean marijuana, but is the genus name, and general umbrella term which all forms of marijuana and hemp fall under. The form of cannabis we use for our CBD and hemp extracts is industrial hemp; we do not sell marijuana.
2. If a hemp extract is 40% cannabinoids, what’s the other 60%? What’s in your hemp extracts besides the naturally occurring cannabinoids?
Our Kentucky hemp extracts contain over 80 different phyto-cannabinoids such as cannabidiol (CBD), CBC, CBG, CBN, etc.. In addition to the cannabinoids naturally present in our agricultural hemp extracts, there are also many other types of natural molecules and phyto-chemical compounds such as amino acids, carbohydrates, vitamins (including B1, B2, B6, D), fatty acids (including omega 3 & 6), trace minerals (including iron, zinc, calcium, magnesium, potassium), beta-carotene, chlorophyll, flavanoids, ketones, nitrogenous compounds, alkanes, glycosides, pigments, water, and terpenes. The most common terpenes in our hemp extracts are Myrcene, Beta-caryophyllene, Terpinolene, Linalool, alpha-Pinene, beta-Pinene, Nerolidol og Phytol, trans-alpha-Bergamotene, Limonene/ beta-Phellandrene (Co-elution), and alpha-Humulene.
3. What’s the difference between Hemp and Marijuana?
Scientifically, industrial Hemp and Marijuana are the same plant, with a genus and species name of Cannabis Sativa. They have a drastically different genetic profile though. Industrial Hemp is always a strain of Cannabis sativa, while marijuana can be Cannabis sativa, Cannabis indica, or Cannabis ruderalis. The major difference is how industrial hemp has been bred compared to a marijuana form of Cannabis sativa. Typically speaking, industrial hemp is very fibrous, with long strong stalks, and barely has any flowering buds, while a marijuana strain of Cannabis sativa will be smaller, bushier, and full of flowering buds. However, newer industrial hemp varieties in the USA are being bred to have more flowers and higher yields of cannabinoids and terpenes, such as our Kentucky hemp we’re now using!
99% of the time marijuana has a high amount of THC and only a very low amount of CBD. Hemp, on the other hand, naturally has a very high amount of CBD in most instances, and only a trace amount of THC. Fortunately, the cannabinoid profile of hemp is ideal for people looking for benefits from cannabis without the ‘high.’ Hemp is used for making herbal supplements, food, fiber, rope, paper, bricks, oil, natural plastic, and so much more, whereas marijuana is usually used just recreationally, spiritually, and medicinally. The term cannabis oil can refer to either a marijuana or hemp derived oil, since marijuana and hemp are two different forms of cannabis.
In the USA the legal definition of “industrial hemp,” per Section 7606 of the Agricultural Appropriations Act of 2014, is “INDUSTRIAL HEMP — The term ‘‘industrial hemp’’ means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
4. Are hemp derived cannabinoids such as CBD as good as CBD from marijuana?
The short answer is yes. CBD is CBD, whether from marijuana or hemp. Most marijuana has a very low non-psychoactive cannabinoid profile (like CBD, CBC, CBG), so most of the time hemp would be much more preferable for anything besides THC. Marijuana is usually very high in THC (gives people the high) but usually very low in other non-psychoactive cannabinoids.
Nowadays in the USA, many farmers are growing industrial hemp flowers that are just as beautiful, odor-producing, and terpene rich as the best marijuana strains, such as our partnered farmers in Kentucky.
5. Why don’t you source your Hemp and CBD from within Colorado?
We feel that the hemp program in Kentucky is more well suited for our company in regards to growing hemp, and that because it’s 100% compliant with Section 7606 of the 2014 Farm Bill (and the 2016 Agricultural Appropriations Act), procuring it from there is perfectly legal at the federal level. Kentucky’s ecology is perfect for hemp just as it is for tobacco. The growing season is longer than in Colorado, and the soil is richer, so the quality of the hemp and the yields are better.
6. What’s the percentage of cannabinoids and CBD in your product?
Our raw extracts have varying percentages of cannabinoid and cannabidiol (CBD) content, the range being 10%-99%. Each product has a unique formulation and uses varying ratios of our extract types. Our CBD Isolate is over 99% pure CBD.
7. What is the best method of use?
For our dietary supplements we can only recommend them for internal consumption. Our CBD isolate is for research purposes only. If you don’t like the flavor of the oil supplements, you can mix with something sweet like apple sauce or honey to cut through the flavor.
8. What’s the ideal serving size for me, and how often should I take it?
There is no easy answer to this. Our starting recommended serving size is 15 drops but we generally recommend experimenting to see what feels best to you. Some prefer 5 drops, some prefer over 50 drops per day.
9. What is the safety of your hemp extracts? Are there negative side effects?
Hemp is considered by many to be generally safe. We’ve never seen or heard of any significant or negative side effects in our years in the industry. That said, we can’t rule them out. Please consult with your physician before using any dietary supplement including Hemp extract supplements.
10. Which of your CBD and hemp products should I get?
As a company who sells various dietary and food supplements, we can’t suggest any of our products for the prevention, treatment or cure of any disease or ailment.
When considering our different dietary hemp products, know that they all come in two strengths. Our Original Hemp blends (Classic Hemp Blend, Hemp Complete, Brainpower oil, & Signature Blend) all have 250+mg of cannabinoids per fluid ounce, and our concentrated blends have 1,500+mg per fluid ounce, six times the potency of our traditional oils. We’ve found that sometimes less is more, but nevertheless, some people like to take very large serving sizes of our hemp extracts.
The main difference between the four Original Blends is the additional herbal ingredients besides hemp. We suggest you research the separate components of each blend to determine which product may be most appealing to add to your dietary regimen. If you know it’s solely the hemp extract that you are looking for, with no additional ingredients, then Classic Hemp Blend or Classic Hemp 6x is what you’re looking for.
For dabbing and vaporizing or for research you can try our CBD Isolate.
THOSE WHO SUSPECT THEY MAY HAVE A DISEASE OR ARE SEEKING HELP FOR A DISEASE SHOULD CONSULT A QUALIFIED MEDICAL PROFESSIONAL.
11. Why do people use Hemp Extracts and CBD? What are the benefits and uses of CBD?
In accordance with federal regulations we cannot make health claims regarding our dietary supplement products. We can only recommend our products for general wellness.
12. Is a standard hemp seed oil the same as a high-CBD hemp extract?
Absolutely not. Standard hemp oil, which can be found very cheaply at a grocery store, is a much different product than our CO2 hemp extracts (not from seed). Standard hemp oil is produced by cold pressing the seeds, whereas our hemp extract is a supercritical CO2 extraction of the hemp plant itself, not the seeds. Hemp seed oil is considered to be a great nutritive food, but it doesn’t have the naturally occurring terpenes, cannabinoids and other components that our extracts do have.
13. Do I need to move to Colorado to get your Hemp Extracts and CBD? Where do you ship?
No. We actually source our hemp from Kentucky, as it’s legal to ship across state lines. Many people are under the impression that the only way to acquire hemp extracts and CBD for themselves or a loved one is to move to Colorado or another cannabis-friendly state. Many major news outlets are misinformed and are unfortunately spreading the idea that you can only get CBD oil in the states where medical marijuana has been legalized. This is simply not the case though. Because our extracts comes from hemp instead of marijuana, we can and do ship to all fifty states, and no medical marijuana card is needed. There are some exceptions, like with Indiana, Missouri and South Dakota we can’t sell our concentrated products due to state legislation.
We also ship to Japan, Australia, the EU, Switzerland, and Brazil. For all EU orders contact our exclusive distributor there, Cannawell.
14. Is your Hemp Extract Oil similar to Rick Simpson Hemp Oil?
Not quite. Ours are from hemp and RSHO is usually using marijuana, a different form of cannabis than industrial hemp. Our industrial hemp extracts are more standardized and will usually have a much higher content of non-psychoactive cannabinoids like CBD than one produced through the Rick Simpson method. And oils produced through his method will usually have a much higher THC content, as it’s typically marijuana that is used for RSHO.†
Generally speaking, most marijuana producers and sellers (especially on the black market) don’t test for contaminants (metals, pesticides, bacteria, etc.). Rick Simpson Hemp Oil is actually more a method of extraction than it is a specific product. People use the Rick Simpson method with hundreds of different strains of marijuana, so the THC, CBD and other cannabinoid content of the final oil is always varying greatly, depending on the cannabis the consumers are acquiring. Usually what’s used for Rick Simpson oil is a strain with an inferior CBD content (and high THC), because that’s what the vast amount of marijuana is nowadays.
15. Where do you source your hemp and CBD from?
We have partners in Kentucky who grew a dedicated plot for us this year (2016) which is being used in our products now. We also currently source from Europe but we’ll be changing that soon.
16. What kind of testing/analysis is performed on your products?
We have an industry leading quality control system, and we have third party laboratories analyze all of our hemp extracts and our final products for cannabinoid potency, heavy metals, bacterial and microbial life, mycotoxins (fungus), and pesticides.
17. What is CO2 extraction? What’s the difference between subcritical and supercritical CO2 extractions?
CO2 extraction is an extraction process that uses pressurized carbon dioxide to extract phyto-chemicals (such as CBD, CBG, or terpenes, flavonoids, etc.) from a plant. CO2 at certain temperatures and pressures acts like a solvent, without the dangers of actually being one. It is the most expensive extraction method, and is widely considered the most effective and safest plant extraction method in the world.
Many hemp and CBD companies boast about their supercritical CO2 extractions, but that’s actually only one (and perhaps an inferior) method of using a CO2 extraction machine. There are also subcritical CO2 extractions, and ‘mid-critical’, a general range between subcritical and supercritical. Subcritical (low temp, low pressure) CO2 extractions take more time and produce smaller yields than super-critical, but they retain the essential oils, terpenes, and other sensitive chemicals within the plant. Supercritical, on the other hand, is a high pressure and high temperature process that damages most terpenes and heat sensitive chemicals, but can extract much larger molecules such as lipids (omega 3 and 6), chlorophyll, and waxes. A truly full-spectrum CO2 extract includes first performing a subcritical extraction, separating the extracted oil, and then extracting the same plant material using supercritical pressure, and then homogenizing both oil extracts into one. In the essential oil industry, an extract made using this specific process is referred to as a CO2 Total.
18. What is the endocannabinoid system (ECS)?
“The endocannabinoid system (ECS) is a group of endogenous cannabinoid receptors located in the mammalian brain and throughout the central and peripheral nervous systems, consisting of neuromodulatory lipids and their receptors.” Wikipedia
There are two main types of receptors in the ECS, CB1 and CB2. CB1 receptors are primarily located in the central nervous system and brains of mammals, and CB2 are generally found in the peripheral nervous system. There are two main cannabinoids mammals produce- 2AG and Anandamide (named after the Sanskrit term “ananda” which translates to “peace”).
For hundreds of millions of years every vertebrate on Earth has been equipped with this ECS, a crucial system in the body, and it has been known about in the scientific and medical communities since the 1980’s. However, it’s still not taught about in most medical schools.