A deep dive into the CBD category.
Participants:
• Jade Beutler, CEO, Emerald Health Bioceuticals, San Diego, CA, www.emeraldhealthbio.com
• Lester Burks, CMO, Buried Treasure Liquid Nutrients, Pikesville, TN, www.buriedtreasureln.com
• Laura Fuentes, Co-founder and CEO, Green Roads, Deerfield Beach, FL, www.greenroadsworld.com
• Cheryl Myers, Chief of Scientific Affairs and Education, EuroPharma, Green Bay, WI, www.europharmausa.com
• Marge Roman, Manager, Stay Healthy!, Las Vegas, NV, www.stayhealthylasvegas.com
On Dec. 20, 2018 the Farm Bill was signed into law. This made marketers of hemp and cannabidiol (CBD) products breathe a sigh of relief—partly because hemp was removed from the Controlled Substances Act, meaning that it will no longer be “an illegal substance under federal law.”
However, there’s no getting around the fact that, in May 2014, the British biotech company GW Pharmaceuticals was granted Investigational New Drug (IND) status from the FDA (U.S. Food and Drug Administration) for phase 2/3 clinical trial of Epidiolex, a “proprietary cannabinoid” composition, for the treatment of Dravet Syndrome.
And according to an FDA statement released the same day, “It’s unlawful under the FD&C (Food, Drug and Cosmetics) Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
According to the FDA, this is “because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements [and under] the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.”
The FDA has also said that it is “not aware of any evidence that would call into question its current conclusion that cannabidiol products are excluded from the dietary supplement definition under section 201 (ff)(3)(B)(ii) of the TD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue.”
VR: Given the FDA’s current stance on CBD, and the complications due to GW Pharmaceuticals CBD drug filings, was the Farm Bill more of a pyrrhic victory for the supplement industry on CBD, or is there light at the end of this murky path forward?
Burks: Notwithstanding [former] FDA Commissioner Gottlieb’s statement, I do not think that it was a pyrrhic victory. Full-spectrum hemp oil was sold as a dietary supplement until The Marihuana Tax Act of 1937 [was] enacted in 1937. The statute effectively outlawed hemp production. The Comprehensive Drug Abuse Prevention and Control Act of 1970 put hemp on the controlled substances list until December 2018, when the Farm Bill was put into law.
With the enactment of the Dietary Supplement Health and Education Act (DSHEA) of 1994, all dietary supplements sold prior to 1994 would be grandfathered in and did not need a new dietary ingredient (NDI) process to be considered a supplement. The passage of DSHEA ensured that hemp oil was grandfathered in as a dietary supplement but could not be sold because hemp was still a controlled substance at that time.
A search of the internet turns up several listings of hemp oil bottles that were being sold prior to 1994, although 57 years earlier.
The problem with GW Pharmaceuticals, and the drug Epidiolex, is the FDA rules preclude CBD being sold in a food or dietary supplement ‘if’ it was not safe for humans or was not sold prior to the FDA granting drug status, including IND status to GW Pharmaceuticals.
As I see it, clearly hemp oil was being sold prior to 1994, but is there any proof it contained cannabidiol, probably not, unless there happens to be a bottle that was produced and sold before the classification of hemp as a controlled substance that has not been opened, then it could be tested. Otherwise the question that will need to be answered, possibly in court, is if the hemp oil being sold prior to 1994 indeed had CBD present. Common sense tells us that it did, but common sense doesn’t always prevail.
Myers: It is important for supplement manufacturers to know and follow the current law with regards to labeling. It has never proven useful in the past to work at cross purposes to the FDA. It is my hope, going forward, that a mutually beneficial solution will be created, but, as of yet, we do not have that. Ethical companies need to work towards that solution.
Fuentes: Green Roads’ product is made from a single isolate extract from the plant. Most CBD products on the market are a more broad-spectrum extraction meaning it contains more of the plant’s compounds than a single-isolate structure. I think there is room in the market for both kinds of products.
Beutler: Despite the recent passage of the Farm Bill, what most retailers and consumers fail to understand is, the sale of CBD as a dietary supplem-ent or in food remains unequivocally illegal without a clear path established yet for legalization.
VR: What is the position of natural products industry groups on CBD, and are they helping manufacturers and marketers navigate through these uncertain seas?
Roman: The industry is learning, along with the retailers, that CBD labeling is all over the place. If I can’t decipher a label, I know my customers won’t be able to, either.
Beutler: I agree. The position of natural products industry groups on CBD is all over the board. Some are optimistic on the CBD space, however there is no consistency, which has added to the vagueness surrounding CBD.
Burks: As a member of SENPA—an organization representing the independent natural products retailer—I can say SENPA endeavors to make available a wide range of information from every view point to its membership so they can make well-informed decisions on the CBD front.
Fuentes: These groups tend to be interested in focusing on broad-spectrum, not isolated structures, and following FDA guidelines for dietary supplements when it comes to labeling and claims.
Myers: The federal law is relatively straightforward. The FDA has said that their stance is that it is outside compliance to sell isolated CBD, or claim an amount of CBD in a blend, even if naturally occurring as part of a spectrum of phytocannabinoids in hemp oil. However, very many companies have chosen to proceed with highlighting CBD. It will be interesting to see what happens in the future with regards to FDA enforcement.
VR: Some years ago, single botanical compounds would become all the rage and then science would later correct the marketing, and point to other compounds as being more important—recall the whole hypericin versus hyperforin circus about St. John’s wort. In the last couple of decades, compound families have grown in importance. Today, for instance, we talk about tocopherols and tocotrienols, not just d-alpha-tocopherol. We talk about carotenoids, not just beta carotene. So, as an industry, are we coming to the realization that full-spectrum are better in many cases? Is this the case with hemp extracts, in too? If so, why? If not, why?
Burks: I truly believe whole is better than part in the vast majority of cases when it come to dietary substances. One of the big reasons isolates are popular at any given time is simple—money. A manufacturer can isolate a compound and maybe even patent the compound or process thereby excluding competition. With patented or proprietary isolates there is the potential for generating huge profits easily and with no regard to the rest of the support compounds because a whole herb or food cannot be patented and comparatively little money to be made.
This is also the case with hemp and CBD. There is a lot of hype about CBD now for just the reason stated above. Yes, CBD does have a profound effect on human health, in most cases for the better, but science is showing, as more studies are being done, that the full spectrum has a wider array of health benefits and, in most cases, little or no contraindications.
Roman: I choose to sell only full-spectrum CBD products. The companies I am drawn to have good labeling and sourcing information on where, and how, the hemp is grown and extracted.
Fuentes: Right now, there is a lot of research to be done. But studies are showing results from single-structure applications, as well as from more of the full plant. I think in the future we will find a place for both single structures and broad structures, like CBD or CBN extracts.
We’re seeing an advantage to producing broad-spectrum hemp extracts that contain many CBD forms, as well as terpenes, which are like the essential oils of the plant, although it may be that not all of the extracts would show up on the lab because of the dilution process.
Myers: I think the realization that full-spectrum phytocannabinoids from hemp are more valuable than isolated compounds is a natural evolution of our understanding of the plant and what it can do. It’s not surprising that very specific nutrients or compounds would get the most attention, after all, a lot of early research on cannabis did focus on CBD, so it makes sense to emphasize it.
However, there’s much more to hemp than just CBD. The best hemp oil provides a full entourage of compounds, because a complete spectrum works together more strongly than any one isolated compound can on its own. For instance, research has found that a variety of hemp compounds may be more beneficial than singling out a specific cannabinoid.
Beutler: Isolates versus whole herb products will become a moot point. I predict the FDA may allow whole hemp extracts with concentration limits—but not high concentrate isolates or concentrates. Better yet is the use of non-cannabis, cannabimimetics like the ones found in our condition specific Endo line.
VR: Talk about the growing interest in non-cannabis hemp products.
Myers: Given the explosion of research on the endocannabinoid system, and the extraordinary popularity of hemp, it is understandable that consumers are also interested in phytocannabinoids or in phytocannabinoid-like compounds from non-hemp sources. In this case, we have been fortunate to be ahead of the game with our AnxioCalm supplement.
AnxioCalm features a clinically studied, special concentrated extract of Echinacea angustifolia that is standardized for alkamide content that works in the endocannabinoid system and with cannabinoid receptors to reduce anxiety and stress, much like phytocannabinoids from hemp. However, the alkamides in AnxioCalm are not found in hemp.
Compared to other echinacea species, only the specific extract used in AnxioCalm had the best alkamide profile. Its initial testing showed that it matched chlordiazepoxide (Librium) for calming results, but with none of the side effects typically associated with the drug, which include drowsiness, nausea, fatigue and vomiting—just to name a few.
Many people are looking to hemp for anxiety and stress relief—and it can do very well for that. But we’ve heard from people around the country who have been using AnxioCalm and attest to its efficacy. It is the perfect supplement for anyone dealing with daily anxiety issues, or just the occasional stresses that crop up. And there is no stress about its source, for either retailers or customers.
Beutler: Hemp foods will continue to gain in popularity based on the exceptional nutritional profile of hemp protein, hemp oil and terrific omega profile as well as abundance of fiber.
Roman: There is some demand for the non-cannabis products, usually because the customer works in a zero-tolerance job. Currently, CBD use is not allowed by police or fire employees.
VR: Related to this topic, briefly what is science telling us about the body’s endocannabinoid system and the vital part that CBD can play in improving the health of consumers?
Fuentes: The endocannabinoid system is found in almost every metabolic function in the body. This is telling us that our body’s own endocannabinoids are a vital part of our body’s homeostasis and natural balance. If we don’t produce enough endocannabinoids (those found in the body already), we need to supplement our bodies with phytocannabinoids (from the plant). When our bodies are not balanced, that’s when we start to have breakdowns in the system which lead to more serious conditions.
Beutler: CBD is just one instrument in the band, and in isolation falls flat on its own. Our approach at Emerald is to use herbal and botanical compounds that mimic (cannabimimetics) our body’s very own endocannabinoids. Our products do not contain CBD yet mimic and match CBD. Our formulas include six herbals and botanicals that when compared to CBD and THC in vitro, outperformed them both in comprehensively influencing endocannabinoid biomarkers. The body’s endocannabinoid system is not dependent on CBD, THC or cannabis—and interacts with many non-cannabis compounds. The ECS is promiscuous yet selective. Think of it like the dating app Tinder just for cannabinoids. Our formulas mimic our body’s endocannabinoids and therefore can hook up to ECS receptor sites, just like THC or CBD from cannabis. The ECS does not prefer cannabis—it is just looking to hook up with a compatible mate—we make that love connection.
Roman: Science is teaching us that the ECS is more complex and vital than we ever imagined.
VR: What the main factors driving consumer demand for CBD products, and have these drivers changed over the last couple of years?
Roman: Consumers look to CBD to help with many conditions, the most common of which is pain management. I would say symptoms of anxiety are a close second.
Fuentes: Consumers are still trying to figure out the difference between CBD and THC. We need to continue with education, but consumers are hungry for the product and eager to try CBD in the many forms being presented to them. Over time, consumers will lead the path to what forms and traits are most effective and desired.
Myers: If you are choosing to use a hemp product, make sure you are working with a knowledgeable retailer and ethical companies with a track record of quality. There are many new players in the hemp world with various levels of expertise and legitimacy. There have been supplements sold on the internet marketed as CBD that upon analysis, contained no CBD at all.
Beutler: Originally it was hype and media buzz that drove consumer demand. However, it’s now transitioned into greater awareness of the endocannabinoid system and how best to support this critical system for common health concerns like sleep, inflammation, anxiety, mood and cognition. CBD in isolation and at the recommended use being sold in most retail stores is probably not enough to provide meaningful relief. A more complete and comprehensive approach must be taken to objectively support the human endocannabinoid system to include, diet, lifestyle and comprehensive ECS formulations.
VR: What do retailers need to know when trying to decide about carrying CBD products in their stores? And what can they tell their customers who are confused about where to buy them and how to choose which products to buy?
Fuentes: I’d tell consumers and retailers to know what’s in the products they purchase, and to know whether it came from hemp or marijuana. You want to know about CBD levels, THC levels, heavy metals, microbes, pesticides and solvents. The labeling should have a recommended serving size as well. Legitimate products will aim to be compliant with FDA rules and therefore won’t make claims on the packaging.
Myers: If you are choosing to [sell] a hemp product, make sure you are working with […] ethical companies with a track record of quality. There are many new players in the hemp world with various levels of expertise and legitimacy. There have been supplements sold on the internet marketed as CBD that upon analysis, contained no CBD at all.
EuroPharma, maker of the Terry Naturally brand, has a commitment to product excellence, and this is reflected by the emphasis we place on quality and efficacy. We follow state and federal regulations carefully. We do not carry any supplements labeled for CBD. Instead, we offer a suite of full-spectrum hemp supplements, called Hemp Select under the Terry Naturally brand name.
Our hemp is non-GMO (genetically modified organism) and grown and cultivated with eco-friendly practices. It is also extracted using a gentle, supercritical CO2 process, so there are no worries about contamination or chemical residues. But most importantly, all of our Hemp Select supplements offer a full spectrum of phytocannabinoids for a stronger entourage effect than any one compound alone.
We offer Hemp Select in a variety of dosage levels and forms, including liquid, soft gel and blended with our clinically studied curcumin. This provides retailers and customer alike with the best hemp to suit their needs.
Roman: Our most popular delivery form is liquid extract; capsules and topical products are close behind.
VR: For manufacturers and suppliers, in a few paragraphs let retailers know what sets your products or extracts apart in a crowded field.
Roman: Transparency is my deciding factor. I also look for third-party testing and clear labeling. I’m pleased that a number of long-standing companies in the natural products industry are in the CBD arena.
Beutler: Well, our secret sauce is our proprietary PhytoCann Complex, an evidence-based six-herb, non-cannabis botanical blend that acts synergistically to exert a more powerful, and broader effect on the human endocannabinoid system than any single cannabis derivative (like CBD and THC), full-spectrum cannabis extract or cannabis itself.
PhytoCann forms the backbone of our flagship line of condition-specific products, each of which is formulated to address one of the nation’s leading five health complaints with the addition of therapeutic doses of proven targeted ingredients.
These include Endo Sleep (with passionflower and GABA), Endo Calm (with ashwagandha and GABA), Endo Inflame (with boswellia and curcumin), Endo Bliss (with saffron) and Endo Brain (with huperzine and bacopa).
And unlike CBD, our multi-award-winning products are fully legal in all states, DSHEA compliant, 100 percent drug-test safe, backed by a money-back guarantee for efficacy, and conveniently available nationwide over the counter at reputable chains like Whole Foods Market and online at Amazon.com.
Fuentes: Green Roads products are special in this crowded field because we pride ourselves on quality and transparency. You get authentic CBD in the form of products formulated by a licensed pharmacist. You get transparency about everything in each product, and how much of each ingredient is in there.
Burks: Life Line Foods LLC/Buried Treasure is a family-owned company that has been manufacturing exclusively for the natural products industry since 1969 (50 years this year). There are several things that set us apart.
Buried Treasure processes complete hemp using non-GMO organic pure-grain alcohol. Many other hemp oil processors say that using CO2 extraction is the only way to go. CO2 extraction has its drawbacks. It requires additional processing steps, which harm essential and important nutrients. Non-GMO organic pure-grain alcohol extraction is simple. First it is done by lowering the temperature of the raw plant material to -5 degrees Fahrenheit. At this temperature, more of the active compounds are preserved, and the unwanted waxes can be filtered out. The remaining oil is then slowly heated to a moderate temperature, to evaporate any alcohol that might remain. This results in a final product having a gorgeous light green color, containing terpenes, cannabinoids, omegas and even chlorophyll, all of which give Buried Treasure’s Complete Hemp a smooth flavor profile.
Buried Treasure is committed to full-plant extracts over isolates. The extensive scientific research has proven the synergistic effect on the receptors of the endocannabinoid system and the many health benefits of full-spectrum hemp oil.
Buried Treasure believes quality is not something that is done at the end of the process. It is integrated into every step, beginning with seed selection, then seedling propagation, mature plant cultivation, hand-harvesting and delicate care in oil extraction, until the moment product is placed in the bottle.
VR: What predictions do you have for the CBD-and-hemp products category?
Beutler: CBD as we know it, and as the primary descriptor on the front of product packaging will go away at some point when regulation comes down. There is a much bigger story here than just a single isolate ingredient like CBD. The endocannabinoid system (ECS) is a lifestyle choice and decision, just like paleo, keto or vegan. Many dietary, lifestyle and natural compounds impact the ECS in a positive way. The ECS category will continue to evolve and thrive. CBD has helped to raise awareness of the ECS as a whole and for this we should be grateful. I expect we’ll see the category of endocannabinoid health expand and grow quickly in the next five years and will be on par with the omega-3 category.
Myers: For the time being, it seems that the popularity and interest in hemp is unstoppable. There are pros and cons to that. On the positive side, hemp products have attracted customers to health food retailers that may have never before entered a store. It has opened many minds to the possibility of effective natural interventions. It is also a very effective natural medicine. The negative side is the number of inexperienced or even unethical businesses that have sprung up to monetize the interest in hemp and CBD without providing safe, efficacious, and legally labeled products. This puts the public and retailers at risk. Health food stores and customers need to be cautious and continually focus on educating themselves about this fast-moving category.
Burks: In the natural product industry, I believe CBD will give way to more full-spectrum products, not only because of the health benefits of full-spectrum but also because of FDA regulation, patents and products from the pharmaceutical industry.
Roman: The prediction is growth! VR
