By the time this issue arrives in your hands, planting season will be but a recent memory, and the 2020 hemp growing season will be in full swing. This year is a significant one for hemp farmers and the industry as a whole.
The 2019 growing season—the first after the federal government legalized hemp farming in the U.S. under the 2018 Farm Bill—was rife with many challenges. Columnist Marguerite Bolt of Purdue University outlines five of the top challenges growers faced last year. Still, as Bolt wrote, “The more time we spend in the field looking for problems, the more likely we are to find them, but also to find solutions.” While she was referring to hemp pests and pathogens, this applies to many aspects of hemp growing.
As you’ll read in “The Test of Time”, in 2019, an acre of Sarah Kelley’s hemp crop tested hot—an estimated loss of $20,000 in biomass. In addition to other possible solutions, Kelley says, “We’re going to test a little bit earlier instead of trying to reach the full maturity level. That’s when you get a little bit leery of testing hot.”
This issue’s cover story, “The Future of Fiber,” shares similar stories with different solutions. “Like many other fiber farmers ..., the Bio-Regen Co-op is experimenting with genetics. After their seeds from China resulted in hot crops in 2018 and 2019, the farmers are now primarily testing out a Polish variety certified by the Association of Official Seed Certifying Agencies (AOSCA),” Hemp Grower Associate Editor Theresa Bennett writes.
As farmers learn with each acre planted, university research also grows by leaps and bounds. In June, HG premiered its first Hemp Virtual Event (as part of its Cannabis Conference virtual event series), featuring a session, “The Latest in Hemp Research,” where researchers detailed their current projects.
This growing season will not be perfect, as U.S. hemp growers continue to learn valuable lessons. The weight of upcoming legislative changes bears down on those in states not yet compliant with the U.S. Department of Agriculture’s interim final rule; for many of those states, current regulations have been comparatively a bit more lax. Testing challenges need to be worked out, as do end markets. (The cover story on fiber and the Hemp Watch department on animal feed highlight some promising end markets and the hurdles they face.)
Yet, despite the inevitable trials of this year’s growing season, with another year under its belt after the fall harvest, the federally legal hemp industry will grow better and stronger once again.
Illustrations by Britt Spencer
The Agriculture Improvement Act of 2018 (the 2018 Farm Bill) might have legalized hemp nationwide, but the law had an ulterior motive. One of Congress’ motivations was to help farmers across the United States cash in on the skyrocketing global demand for cannabidiol, or CBD—one of the naturally occurring chemical compounds that can be extracted from the tall, fibrous hemp crop.
Hemp is a variety of the Cannabis sativa L. plant that has been used for thousands of years to produce everything from clothing to building materials. While hemp can still be a viable cash crop for all these purposes, the real money-maker for many U.S. farmers today is CBD.
CBD is reported to offer many of the same natural health benefits as the tetrahydrocannabinol (THC) found in cannabis, just without the mind-altering effects. (In other words: THC gets you high; CBD doesn’t.) Because of this, products that contain CBD are popping up everywhere—in oils, lotions, bath salts, beverages, pet food and more. Restaurants are now even selling meals prepared with CBD.
But the law, while decidedly pro-CBD, does not make profiting from CBD an easy proposition. If the U.S. Department of Agriculture’s interim final rule implementing the 2018 Farm Bill goes into effect as drafted, farmers with hemp that contains more than 0.3% THC in state-administered tests must pay to destroy their crops in addition to losing the potential commercial value of the plants.
Unfortunately for the nascent U.S. hemp industry, failed tests are fast becoming the norm. From Florida to Washington state, farmers who had intended to grow hemp with high concentrations of CBD are actually inadvertently growing what the federal government classifies as illegal marijuana (plants containing more than 0.3% THC)—or, to the hemp industry, “hot hemp.”
In Hawaii, the Honolulu Star-Advertiser reported in August 2019 that 18 crops—more than half of the hemp crops cultivated for the state’s pilot program—were unusable due to high THC levels.
In the here and now, crops are testing hot—and the rush to grow CBD-rich hemp may be causing the problem.
Meanwhile, the Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) said about 12% of hemp field tests came back hot for the 2019 growing season. The percentage of hot hemp didn’t change from 2018 to 2019 even though the number of registered growers increased tenfold. The regional newspaper Isthmus also reported that two Wisconsin growers anticipated a complete loss of about $40,000 on a crop of 70 hemp plants that tested at 0.5% THC content.
All told, Vote Hemp estimates that only about 50% to 60% of the hemp planted in 2019 will be harvested because of “crop failure, non-compliant crops and other factors.”
Why is this happening?
For one thing, scientific research methods, seed-certification processes and regional farming know-how are all still developing. In time, a hot crop will likely be a statistical outlier as the industry figures out how to perfect the low THC/high CBD balance, experts tell Hemp Grower. But in the here and now, crops are testing hot—and the rush to grow CBD-rich hemp may be causing the problem.
“The biggest factor contributing to the issue of hot hemp is probably the genetics that growers are sourcing,” says Bob Pearce, Ph.D., a professor of agronomy at the University of Kentucky who helps lead the school’s hemp research program. “Cultivars that produce predominantly CBD also produce small amounts of THC, typically in a pretty consistent ratio for that cultivar. So, as CBD increases, so does THC. Then you throw in environmental stress and management on top of a marginally compliant cultivar, and you start to see problems with hot hemp.”
Hemp experts have offered their top three recommendations for growers looking to seize the CBD future while preventing their crops from running hot.
“A lot of growers are going to struggle to reach 10% or higher CBD and 0.3% THC if they continue with current strains and practices.” — Jeanine Davis, professor, Department of Horticultural Science, North Carolina State University
1. Choose Known Cultivars.
Hemp growers should select known cultivars that have consistently tested well below 0.3% THC in their local areas, Pearce says. In most cases, the reason hemp tests hot is because of bad genetics. Farmers in Kentucky, for instance, might be using seeds bred for West Coast soil and climate when what they really need are cultivars developed specifically for Kentucky.
However, choosing a proven low-THC cultivar has its drawbacks. Pearce says some cultivars that have tested below 0.3% THC also produce less CBD—roughly 2% to 5% by his estimates. Most growers are aiming for 10% CBD. Pearce acknowledges the trade-off but says it’s better to have a legal plant with less CBD than a destroyed crop.
The most important thing, he stresses, is to obtain seeds and plants from reputable sources so growers have “some assurance they are getting what was advertised.” One problem, though, Pearce warns, is that seed and plant certification programs for hemp are currently in their “infancy at best and non-existent at worst.”
While many states have approved lists of hemp seeds, these are far from sure bets—at least not yet. Leeann Duwe, a spokeswoman for the Wisconsin DATCP, says the state of Wisconsin precertifies hemp seeds through a lab analysis of the variety. The DATCP looks for the total THC or the ability to calculate the total THC. If the THC is below 0.3%, then the variety is approved. However, the state’s approval of a seed variety does not guarantee a plant will pass a preharvest test for THC levels, Duwe tells Hemp Grower.
In Canada, where the industrial hemp market is more established (since legalization under the Cannabis Act in 1998), the Industrial Hemp Licensing Unit of Health Canada publishes a list of approved cultivars for each growing season. (At press time, the 2020 list was not available, but the 2019 list can be found here: http://bit.ly/Canada-approved-cultivars.)
Jeanine Davis, Ph.D., associate professor in the Department of Horticultural Science at North Carolina State University, says she expects to see more self-testing take place over the next year as a result of the Farm Bill and hot tests. Farmers want to do what they can to make sure they avoid a hot test.
“A lot of growers are going to struggle to reach 10% or higher CBD and 0.3% THC if they continue with current strains and practices,” she says. “What I saw in the western part of North Carolina in 2018 and 2019 is growers selecting strains that would produce the highest CBD possible and that would test at 0.3% total THC for the official test. If THC went above 0.3% at harvest, they weren’t too concerned because ... they had buyers.” Even though they had buyers, however, possession of hemp that exceeds the 0.3% threshold at any point is considered illegal. (For more on CBD to THC ratios, read "Cornell University Breaks Ground on Hemp Research.")
The new proposed federal rules push the time for official testing at a lab registered by the Drug Enforcement Administration (DEA) 15 days prior to anticipated harvest time, which makes a big difference in THC levels. “So same rules, just new time frame for when the official testing needs to take place,” Davis says.
“With the publishing of the interim federal hemp rule, we will see a big change in the strains growers choose to grow,” Davis says. “Many of the strains produced now will not test out at 0.3%15 days before harvest.”
The good news is that the hot hemp problem is spurring research and development in new cultivars. In one example, the Spanish company Hemp Trading and the Spanish university UPV claim they have developed the first entirely THC-free hemp variety with high cannabigerol (CBG), a cannabinoid that can be extracted from both cannabis and hemp plants for medical use. (CBG can be found early during a hemp plant’s growth and is later converted into different chemical structures. CBD and THC start as CBG.)
This is promising, to be sure, but there are multiple variables during the growing process that can impact THC levels—even if you choose the right seeds.
All told, Vote Hemp estimates that only about 50% to 60% of the hemp planted in 2019 will be harvested because of “crop failure, non-compliant crops and other factors.”
2. Pay Attention to the Soil.
Preventing hot hemp is not only about selecting the right plant and the botany of that plant; it’s also about the biology of the soil and the enzymes converting the CBG to CBD, says Michael Goodenough, a managing partner of D&G Agtek, the parent company of sweetheal.com, a hemp and CBD producer in Connecticut.
“When the cannabis plant has been grown naturally in healthy living soils without stress, the CBG converts to CBD,” Goodenough says. “Living soils...naturally convert the sand, silt, clay and organic matter into nutrients that the plant can control and uptake as it desires. By allowing the plant to control this process, we see increases in all the sought-after cannabinoids and terpenes, including the minor ones we have yet to fully understand. This also helps prevent the undesired production of THC, increases the plant’s own natural defenses, creates less work for the farmer and, in turn, makes it less risky to grow.”
Goodenough notes that hemp in the U.S. is often grown on land that used to grow other crops, and the soil may have been neglected for years, especially if the farm went bankrupt.
Through his work, Goodenough has helped develop remediation processes that he says could take hemp with high THC content and then convert it into other cannabinoids like CBD.
3. Harvest Early.
In addition to paying attention to the soil, Goodenough says growers should also rethink taking their plants to full term. Cannabinoids increase with time in the plant, which is why growers should consider employing an in-house testing protocol and be prepared to harvest before the THC levels exceed 0.3%, even though harvesting early results in lower CBD levels as well.
“One thing farmers need to start thinking about is the ideal harvest time to maximize what they’re growing for but also to minimize risk,” says Kyle Sosebee, J.D., a hemp and cannabis lawyer based in Massachusetts. “We know that THC spikes at the very end of the growing season along with a lot of the other cannabinoids. What we may end up seeing is farmers harvesting earlier than they otherwise would just so they have a bigger safety margin and avoid that end-of-the-season spike in THC.
"That may become part of the growing strategy for farmers: They’re going to short themselves on CBD, but it’s going to be better than a total crop loss if your entire crop goes hot.”
Paul Barbagallo is a Boston-based writer and a former senior editor for Bloomberg News and beat reporter for Bloomberg BNA.
How many times have we heard that a balanced diet is essential to our health? Plant nutrition isn’t much different. Hemp plants can thrive or struggle depending on how you design your fertilization programs. Plants require 17 essential elements for growth. They obtain hydrogen (H), oxygen (O), and carbon (C) from irrigation water or as a gas via the atmosphere. Growers must provide the remaining 14 elements to help hemp plants thrive.
These include the macroelements:
- nitrogen (N)
- calcium (Ca)
- phosphorus (P)
- magnesium (Mg) and
- potassium (K)
- sulfur (S).
And they also include the microelements:
- boron (B)
- manganese (Mn)
- chlorine (Cl)
- molybdenum (Mo)
- copper (Cu)
- nickel (Ni) and
- iron (Fe)
- zinc (Zn).
The quantity of macroelements and microelements required varies by type of plant, but they are all required by the plant for growth.
Cobalt (Co), selenium (Se), silicon (Si) and sodium (Na) are four beneficial elements that promote plant growth but are not considered necessary to complete the plant life cycle. With hemp production, many growers are providing Si to promote overall plant health.
Providing a complete fertilizer package that contains all the essential elements is important to maximize plant growth. When designing a fertility program, it is also important to keep in mind some key principles that ensure there is a nutritional balance. Just like with human health, where we must balance our intake of sugar, protein, grains, fruits and vegetables, too much of one item can lead to imbalances in the plant due to antagonistic effects. For example, if too much P is provided, it can hinder the uptake of other elements and lead to Fe, Mn and Zn deficiencies.
Nitrogen Form. Nitrogen in fertilizers primarily comes from three sources. Nitrate-nitrogen is the main form the commercial floriculture greenhouse industry uses for its plants. While the cost is higher, it’s the preferred form of N because it promotes compact plant growth. The same applies predominantly to hemp grown for cannabinoids; in the cannabis industry, the market currently lacks plant growth regulators registered for use on cannabis, so you can opt for nitrate as a source for N to help avoid excessive overgrowth, also known as plant stretch.
The other two forms of N contained in most fertilizers are ammoniacal nitrogen and urea. Many organic fertilizers have N in these forms. Farmers growing hemp for fiber and grain would use ammoniacal N because much more of it is used per acre and it is cheaper. In commercial floriculture greenhouse production, these two forms of nitrogen are strategically deployed but are only used to a limited extent. Many growers will use ammoniacal nitrogen and urea-based fertilizers during the first two weeks after plants have been transplanted into the final container to help establish the plants and encourage a flush of new growth. After that point, most growers rely upon a nitrate-nitrogen based fertilizer.
The key takeaway here is to supply most of your N from nitrate-nitrogen. Evaluate your fertilizer type by reading the fertilizer label to ensure the N form you are providing is on target.
Moderating P Applications. Phosphorous fertilization strategies have been studied extensively over the past five years. One of our graduate students, Josh Henry, worked on optimizing P fertilization rates for his master’s degree thesis. In essence, plants require a baseline level of P to grow adequately (Fig. 1). For a continuous fertilization program for plants grown in a soilless substrate, the target concentration is between 8 parts per million (ppm) and 15 ppm of P. Providing levels below that will result in less plant growth, while concentrations above that level provide little benefit while costing more money. Phosphorus is also the primary contributor to plant stretch. Too much P will lead to excessive internode elongation and tall plants. That’s why it’s important to limit excessive P applications.
Plant nutrition experts are currently debating whether the P rate needs to be amplified just before flowering in hemp grown for cannabinoids to improve quality. Research led by Manitoba crop nutrition specialist John Heard on a dual-purpose hemp crop grown for seed and fiber suggests that extra P is not required by flowering hemp (Fig. 2).
The researchers found that hemp plants front-end load P during the first half of the growing season as seen with the plant’s upward accumulation of P. At midseason, the total accumulation in the plant plateaus. This indicates that the plant uptakes limited additional P. Hemp relies upon those internal P reserves and translocates (moves) P if it is required in other parts of the plant. This suggests that adequate P levels should be provided to hemp grown for flower during the first half of the production cycle for the plant to accumulate an adequate reserve that can be translocated if needed later. Providing a P boost late in the growing season appears to not be needed. A scientifically based trial is needed to clear up this uncertainty with greenhouse-grown hemp.
While the target P level for greenhouse-grown hemp is not currently known, we would speculate based on the scientific data from other species that levels of 15 ppm to 20 ppm P supplied on a constant basis should be all that is required. At North Carolina State University, we have begun an experiment looking into optimal P rates supplied at a constant level throughout the hemp crop cycle and will be able to further refine those recommendations in the near future.
Ratio of K to Ca to Mg. Providing a proper K to Ca to Mg balance is important for hemp production. Too much of one element does not in itself result in toxicity symptoms. Instead, excessive levels of one element has an antagonism against the others. For instance, excessive K will result in either a Ca deficiency or an Mg deficiency being observed in a plant. Many instances of Mg deficiency observed in hemp may be due to excessive K being supplied and not due to the lack of available Mg to the plant. Figure 3 illustrates the trend that is observed in the leaf tissue concentration of a plant when K is excessive.
For hemp, K, Ca and Mg all appear to be needed in larger quantities compared to other greenhouse floriculture species. In general, the rule is to provide K, Ca and Mg in a 4:2:1 ratio to avoid antagonisms. For commercial poinsettia production, we recommend a similar ratio around 200 ppm K to 100 ppm Ca to 50 ppm Mg; this would be a good starting point for hemp (which, like poinsettias, is a short-day plant) until scientifically based research can determine optimal rates. Also, keep in mind that excessive sodium (Na), which can come from your fertilizer source or irrigation water, can also interfere in K, Ca and Mg uptake.
Dialing in the Micros. Managing microelements can be a challenge in most fertilizer programs. The concentration difference from deficient to adequate to excessive rates is very narrow. Until you become comfortable mixing your own micronutrient fertilizer salts, it’s safer to rely upon premixed micronutrient packages or the micros provided in commercial fertilizer blends.
All in Balance. Providing all the essential elements is the key to optimizing plant growth. Equally important is balancing the proportion of elements provided to hemp so plants remain healthy.
Editor’s Note: A version of this article was originally published in the September 2019 edition of Cannabis Business Times (Hemp Grower’s sister publication) and has been reprinted with permission.
When it comes to humans, the U.S. Food and Drug Administration (FDA) regulates five broad categories of products: food, drugs, cosmetics, dietary supplements and medical devices (e.g., inhalers, patches). Cannabidiol (CBD) products exist in each of these categories.
Pills, capsules, tinctures and patches containing CBD seem to be everywhere. Savvy cosmetic brands offer everything from CBD-infused lotions and balms to mascara and cleansers. People waiting in check-out lines at some grocery stores can snag CBD-infused candies, honey sticks and peanut butter cookies. And of course, Epidiolex, a drug used to treat certain epileptic conditions, made history as the first FDA-approved pharmaceutical to be derived from Cannabis sativa L.
But there is a problem with CBD products in four out of the five categories mentioned: except for Epidiolex, they all are illegal.
This comes as a surprise to many companies that come to The Rodman Law Group seeking legal advice. Many people believe that because hemp is now legal in the U.S., all products derived from hemp are legal too. This is simply not the case. While the 2018 Farm Bill did remove hemp and its extracts from Schedule I of the Controlled Substances Act, it did not make CBD products legal.
Ever since GW Pharmaceuticals submitted a New Drug Application for Epidiolex, the statutory language of the Food Drug & Cosmetics Act (FD&C Act) has prohibited CBD’s inclusion in any other product. This is because CBD is the Active Pharmaceutical Ingredient (API) in Epidiolex, and substances that are drugs or APIs are not allowed in the other FDA-regulated categories.
To better understand the significance of this, consider Sildenafil, the API in Viagra. Why don’t we find Sildenafil in sodas, chocolate bars and lotions? Because Sildenafil is permitted in just two products: Viagra and Revatio.
No legitimate company would ever infuse its cookies with Sildenafil. To do so would lead to the FDA imposing heavy fines, shutting down the company and possibly bringing charges against its principals.
But many companies haven’t hesitated to take chances with CBD.
So far, the FDA’s head-in-the-sand approach to the consumer CBD industry (nothing is permitted, everything is illegal) has not led to widespread and dramatic enforcement measures, but that could change at any time. Just because the FDA has not effectively shut down the CBD marketplace does not mean it won’t—a point we are obligated to emphasize with all of our CBD clients.
Frankly, from a strictly legal standpoint, the best advice we can give somebody considering entering the CBD market, at least for supplements, cosmetics, medical devices and foods, is: don’t. (We want to note that despite our obligation to inform our clients of the letter of the law, which we know makes us sound fairly negative, we are huge proponents of the industry and use CBD ourselves.)
Once we establish the fundamental illegality of the sector with clients, we begin using the phrase “optics and defensibility” like a mantra. Given the discrepancy between law and enforcement in the CBD sector, we coined the phrase to describe the principles a CBD company must adhere to in order to survive and, eventually, thrive. “Optics” refers to how a company and its actions are viewed by the public and relevant regulators, and “defensibility” is a measure of how defendable its actions are from a legal standpoint. While this adage applies to our representation of our CBD clients in general, it is most vital when it comes to marketing and labeling.
Labeling CBD Products
To properly address marketing and labeling issues for CBD products, the first step is to determine what rules pertain to the products in question. Our position typically is that a product should be treated as what it most resembles: a food, supplement or cosmetic. A product with CBD cannot legally “be” any of those things, so the general analysis is, “What would the product be classified as if it didn’t contain CBD?” Then, we apply the appropriate rules for marketing and labeling depending on the product.
The competing school of thought on this is some form of: “These products aren’t foods, dietary supplements or cosmetics, so we don’t have to, nor could we, follow their rules.” On a rudimentary level, this makes a little sense.
Take, for instance, the Supplement Facts panel found on the back of all supplements. According to the FD&C Act, only dietary supplements may use the words “Supplement Facts” on their labels. As a result, some have argued that CBD supplements should not contain the “Supplement Facts” panel. We find such reductionist interpretations to be irresponsible, if not downright dangerous, but explaining why requires some background.
The “nutraceutical” or dietary supplement industry exists because of a carve-out to the FD&C Act created by the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation created a hybrid category of products that exists somewhere between the traditional FDA regulatory verticals of food and drugs. As far as traditional FDA regulatory purview goes, the nutraceutical industry is the Wild West. Supplement companies often tend to push the envelope on what they can sell and what they can say about their products.
It is actually scary how little oversight the FDA has over nutraceuticals. Virtually all of its enforcement power is retroactive. In other words, when it comes to dietary supplements, most of the time, the FDA is required by law to wait until a product is on the market before it can conduct tests or bring enforcement actions against a company.
A supplement company’s actions need to be fairly egregious to get the FDA’s attention. That said, in the “regular” dietary supplement world, failure to include a “Supplement Facts” panel will draw the FDA’s ire quickly. Accordingly, our view is that since CBD companies’ entire business model is the manufacture and distribution of an illegal product, the best course of action is total compliance with all other relevant regulations. Even if the rest of the nutraceutical industry is the Wild West, CBD companies should play the role of upright, law-abiding citizens who won’t even jaywalk.
Ultimately, there is nothing anyone can do to preclude the FDA from going after a CBD company since their products are illegal, but there is no need to give FDA extra ammunition if it does so.
This brings us to optics, an area where many companies tend to struggle. Strict guidelines exist concerning what companies can say about food, dietary supplements and cosmetics. In short, only products defined as drugs may make “disease claims.”
The FDA defines disease as “damage to an organ, part, structure, or system of the body such that it does not function properly, or a state of health leading to such dysfunctioning; except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” For purposes of clarity, we have split our analysis into two sections: one for dietary supplements and food, and the other for cosmetics.
Broadly speaking, a company can make claims about dietary supplements and food that span three different categories:
- Structure/Function Claims (SFCs),
- Qualified Health Claims (QHCs) and
- Authorized Health Claims (AHCs).
SFCs describe the role of a nutrient or dietary ingredient intended to affect or maintain the normal structure or function of the human body. These are claims that describe general well-being from consumption of a nutrient or dietary ingredient, such as “calcium builds strong bones.” These claims are not pre-approved by the FDA, but the company making them must have proof that the claim is truthful and not misleading.
If the product is a dietary supplement, the company must submit the claim to the FDA no later than 30 days after marketing the supplement. If a dietary supplement label includes an SFC, it must state in a disclaimer on the product that the FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.
SFCs for dietary supplements may focus on nutritive effects, such as “high in fiber,” as well as non-nutritive effects, such as “promotes a sense of wellbeing,” while SFCs for conventional foods focus on effects derived from nutritive value. As such, the FDA does not require food manufacturers to notify the FDA about their SFCs, nor does it require food products that have SFCs on their labels to have disclaimers.
QHCs must be supported by scientific evidence, and in order to be made, they require a pre-market review by the FDA.
AHCs, as the FDA explains on its website, are “claims that have been reviewed by FDA and are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or a health-related condition.” These claims must be supported by scientific evidence. Since 1990, the FDA has permitted only 12 AHCs, which are listed on its website.
So what does this mean for CBD? AHCs are not relevant to CBD, and CBD companies cannot make QHCs because:
- Not enough viable medical studies have been conducted on the effects of CBD in food and supplements to satisfy the scientific evidence requirement for QHCs.
- Even if such studies did exist, the FDA’s stance that consumer CBD products are illegal precludes it from even considering such claims.
Therefore, no CBD company may make AHCs or QHCs, which leaves SFCs as the only claim type a CBD company could theoretically make. We say theoretically because a company would have to weigh disclosing the claim to the FDA to be in full compliance with SFC guidelines against the fact that doing so draws the FDA’s attention.
That being said, we see companies blowing right past AHCs, QHCs and SFCs and making outright disease claims on their products—something that no food or dietary supplement company can do, CBD or not.
Determining whether a claim is a disease claim can be relatively straightforward. Stating that a product cures cancer or alleviates insomnia are obviously disease claims. But other disease claims are not as clear. For example, many companies claim their products “reduce muscle soreness.” While this might not seem like a disease claim, it is.
Most companies understand they cannot claim their products relieve pain because pain is either the result of damage to the body or the result of a systemic or acute dysfunction of the body. But when a product claims to “relieve muscle soreness,” it is fundamentally claiming to relieve pain. Another common violation of the prohibition on disease claims is the claim that a product “reduces inflammation.”
The FD&C Act defines cosmetics as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
The FDA does not specifically prohibit cosmetics that contain CBD. But since CBD has no established cleansing or beautification properties, it is obvious that the addition of CBD to cosmetics is intended to have some effect on the human body. This leads us to one of the most widespread misconceptions in the health and wellness industry as a whole and in the CBD industry in particular.
Unlike the nutraceutical category that exists somewhere between food and drugs, there is no “cosmeceutical” category between cosmetics and drugs. Accordingly, if a “cosmetic” product is intended to treat or prevent disease or otherwise affect the structure or functions of the human body, the FDA classifies it as a “topical drug.”
The irony here is that many CBD companies view topical products as less risky from an FDA enforcement standpoint because they are not ingestible. From a legal standpoint, however, even if CBD was allowed in food and dietary supplements, given the definition of cosmetics and topical drugs, every CBD topical on the market would theoretically have to go through the same process that Epidiolex went through (years of clinical testing likely costing more than $2.5 billion, the estimated cost of developing an approved prescription drug, according to a report published by the Tufts Center for the Study of Drug Development) and should only be available through prescription.
The takeaway here is that labeling rules for cosmetic products are even more restrictive than those for dietary supplements and food, as a disease claim on a cosmetic will cause the product to be considered a drug. Our advice to CBD cosmetic companies is to make no claims whatsoever about the CBD in products, follow the FDA’s cosmetic labeling requirements to the letter if possible, and focus instead on the properties of ingredients they can highlight, such as moisturizers.
Moving Beyond the Product
Our stress on optics and defensibility is just as high when it comes to advertisements, website copy, social media posts, newsletters and so on. Everything used to promote a company’s brand and products is subject to scrutiny from not only the FDA but also the Federal Trade Commission (FTC).
Indeed, in September, the FTC announced it had sent warning letters to three companies advertising CBD products as a medical treatment option for a range of various illnesses, stating that “it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.” In its statement, the FTC warned the industry that any claims regarding the use of CBD products that are not currently supported by “competent and reliable scientific evidence” are forbidden. Then, in late April, the FTC took legal action by filing a complaint in federal court against California-based marketer Whole Leaf Organics for making unsubstantiated claims involving its vitamin C, herbal extracts and CBD products.
Most companies are not so foolish or immoral as to state in marketing materials that their CBD tincture will cure diseases. (Although sadly, many are.) But many well-intentioned businesses run afoul of FDA and FTC regulations all the same.
Consumer testimonials, links to third-party “educational” websites and links to published scientific papers that show CBD had some sort of health benefit are all violations. Of even greater concern: the current interpretation of the regulations holds that if a company’s social media account “likes” a post that makes a claim about CBD, not only will the company be seen as endorsing the statements in the original post, but also the FDA and FTC will treat the post as though it were made by the company.
As such, we strongly recommend companies resist the urge to broadcast their beliefs about CBD on anything owned by, or related to, their company. Information concerning CBD is just a Google search away. Instead of needlessly putting the company at risk by repeating what is widely available elsewhere, we advise our clients to champion other ingredients in their products, highlight how they are ethically made/sourced or tell a story about the company.
We preach the policy of optics and defensibility no matter what type of CBD product a company might be selling. Food, drugs, cosmetics, dietary supplements and medical devices each have their own rules about marketing, labeling and what may be said about them. It’s best to stick to them.
Note: Nothing contained in this article creates an attorney-client relationship. The contents of this article do not, and are not intended to, constitute legal advice. The information, content, and opinions are the authors’ own and have been provided for general informational purposes only. Additionally, the CBD industry is ever-changing, so this article may not constitute the most up-to-date information. For questions about this article or about the legality of CBD or any other cannabinoid, contact us or your own attorney.
Dave Rodman is the founder and managing partner, and Nadav Aschner is a partner of The Rodman Law Group, a full-service law firm based in Denver.