How the 2018 Farm Bill Impacts CBD Products for Pets
Passage of the 2018 Farm Bill aims to clear the confusion regarding the legal status of hemp/cannabidiol (CBD) products, and opens the market to more manufacturers, retailers and consumers.
The 2018 Farm Bill that the U.S. Senate overwhelmingly voted in favor of in December is now law. This is big news, as prior to the bill’s passage, certain federal agencies lumped hemp-derived and marijuana-based cannabidiol (CBD) products into the same controlled-substances category.
CBD made from hemp contains less than 0.3 percent tetrahydrocannabinol, or THC, the psychoactive ingredient associated with marijuana, and is sold in most states and online. The passage of the Farm Bill makes CBD products more accessible than marijuana-derived CBD, which can only be sold where marijuana is legal.
Under the new laws, hemp will be managed by the Department of Agriculture as a crop rather than by the Justice Department as an illegal substance.
The passage of the Farm Bill has been lauded by manufacturers of hemp-based CBD pet products; however, the industry still faces challenges when it comes to the terminology used to market these products.
Companies use a number of terms for products in this category, including CBD, phytocannabinoid-rich (PCR) hemp, hemp extracts, hemp actives and more, but without consistent regulation or guidelines, this makes it very confusing for retailers and consumers alike, said Heidi Hill, co-founder of Holistic Hound in Berkeley, Calif.
“Many of the product claims are similar, so it can be very challenging to ascertain the difference between products, especially when some of the products contain CBD and some do not,” she said. “[Holistic Hound] has taken a more conservative approach and rebranded several months ago as PCR, as we felt it was a more accurate representation of the full-spectrum nature of our products, as they contain not only CBD, but also all of the different constituents of the hemp plant that work together synergistically.”
Currently, there are no rules in place for what hemp-derived products should be called, according to Steve Smith, co-founder and president of Pet Releaf in Englewood, Colo., which brands its products as using full-spectrum CBD oil or full-spectrum hemp extract.
“There is a lot of confusion in the pet world surrounding the labeling of CBD, with some companies claiming that the use of CBD on labels is illegal, which is inaccurate,” he said.
Much of the confusion stems from the patent surrounding a human CBD pharmaceutical produced by GW Pharma called Epidiolex, he added. The GW Pharma approval process and the final U.S. Food & Drug Administration (FDA) patent does not grant the company a protected trademark on CBD, Smith said.
Marketing rules are not black and white, said Julianna Carella, CEO and founder of Treatibles in Oakland, Calif. The company follows the lead of the National Animal Supplement Council (NASC), which works closely with the FDA and FDA-CVM (Center of Veterinary Medicine).
“The NASC informs its members, including Treatibles, that the FDA’s position is that CBD is not allowed as an ingredient in animal foods due to provisions of the Federal Food, Drug and Cosmetic Act (FFDCA),” Carella said. “This prohibits marketing these products or adding article(s) investigated or approved as a new drug. We recently made a conscious decision to minimize our risk by omitting questionable terms from our packaging and marketing. If our products are pulled from shelves by regulators who misunderstand or misinterpret the law, hundreds of thousands of animals who rely on our products to help them feel healthy and happy will suffer.”
CBD products can offer many benefits for pets, and the manner in which these products work is complex.
“The most common reasons people seek out these products are to reduce anxiety, inflammation and pain, but these products are also incredibly effective for immune and nervous system support, seizures, nausea, GI issues and more,” Hill said.
The benefits of full-spectrum hemp oil include maintaining normal emotional balance, instilling calm and vitality, promoting healthy joints and flexibility, and supporting the body’s normal inflammatory response, according to Carella, who added, “We continue to hear about other conditions being ameliorated by our products.”
Pet Releaf has seen great success with a myriad of health conditions, with pain and anxiety being the two most common issues pet owners ask about, Smith said.
CBD products work via the endocannabinoid system (ECS), which is a system of receptors located throughout mammals’ bodies, from the brain to the immune system to bone marrow, that are involved in coordination, memory, pain reduction, reproduction and more.
“Our bodies produce chemical compounds known as endogenous cannabinoids that interact with, and are triggered by, the phytocannabinoids in the cannabis plant to modulate and restore optimal balance throughout the body and brain, known as homeostasis,” Hill said.
When CBD, accompanied by the more than 100 other beneficial cannabinoids found in hemp, enters the body, the ECS is activated, Smith said.
“When this happens, the body begins two-way communication between the brain and other regulatory systems, which allows the body to self-heal,” he said. “A huge body of clinical research, including by the U.S. National Institutes of Health, has shown that full-spectrum hemp oil has potent anti-inflammatory properties and provides a significant boost to the immune system.”
Not a Pharmaceutical
The passage of the 2018 Farm Bill means that the FDA is going to pay much closer attention to companies making disease claims, manufacturers said.
Despite a large body of clinical research that has shown that full-spectrum CBD hemp oil is great for a multitude of diseases and conditions, companies cannot make these claims because hemp-derived CBD products are supplements, not FDA-approved pharmaceuticals, according to Smith.
Any company making claims involving a product regarding efficacy in diagnosing, preventing, treating or curing any disease or referencing any disease or chronic condition violates section 201(g)(1)(b) of the FFDCA and is subject to receiving a warning letter from the FDA, Carella said.
The administration already has issued strong warnings that it intends to crack down on such brands, Smith noted. Further, the U.S. Department of Agriculture (USDA) is preparing to enforce protection of agricultural crops in regard to hemp, first by issuing cease-and-desist orders to the many companies making false organic claims, he added.
The Farm Bill impacts animal supplements and treats by removing the U.S. Drug Enforcement Administration (DEA) from having authority over hemp cultivation or products that contain hemp, including plant parts and derivatives, as an ingredient, Carella said.
“Although that is a positive development, the Farm Bill will not make hemp or hemp derivatives (CBD) approved for use in animal feed/food,” she said. “That will need to be approved through AAFCO [Association of American Feed Control Officials]. Recently, the Hemp Feed Coalition applied to have hemp recognized as an approved food ingredient, but the consensus is that this will not take place until at least 2021.”
According to Bill Bookout, president of NASC, the FDA’s position is that CBD is not allowed as an ingredient in animal foods—biscuits, treats, snacks and the like are considered animal food—due to the provisions of the FFDCA and AAFCO.
Despite the existence of counterarguments, at present, some CBD products currently on the market, particularly those marketed as food, might, therefore, remain unlawful, according to Carella.
The FDA does not recognize CBD as a new dietary ingredient (NDI), and as the FDA only allows the listing of active ingredient levels it recognizes as dietary ingredients, the listing of CBD levels on packaging and other public platforms is nonregulatory compliant, according to Bill Reilly, founder of Burlington, Vt.-based HempVet, maker of eco-farmed, GMO-free, full-spectrum PCR hemp products.
“In other words, according to FDA regulations, listing CBD levels exposes sellers to a stop sale, product confiscation, warning letter and possible fine,” he said. “Clearly the FDA has been lax in the enforcement of the NDI rule as it concerns CBD, thus, opening the door for the growth of the CBD products category rather than the PCR, hemp or full-spectrum hemp products category.”
Know Your Source
Now that the Farm Bill has made hemp federally legal, more companies are expected to flood an already highly populated market, highlighting the need for strong manufacturer-retailer partnerships.
Knowing where the hemp is sourced and/or grown and whether those claims can be proven is particularly important for pet specialty retailers.
“Many products are sourced from foreign countries, and while this does not necessarily imply product inferiority, it’s critical to know if the cannabis is grown organically, as hemp plants are known to uptake much of any toxins, environmental contaminants and/or pesticides from the soil,” Hill said.
Further, the bill does not make all CBD products legal, Smith said.
“Imported hemp oil and imported CBD isolate are still considered Schedule 1 drugs in the DEA’s eyes,” he said. “The Farm Bill only legalized U.S.-based hemp grown under state U.S. Department of Agriculture’s (USDA) regulations.”
Retailers should also find out whether a company offers an “isolate” product, which contains only CBD, or a full-spectrum product, meaning it contains all the beneficial constituents of the whole plant, including other cannabinoids, terpenes, flavonoids and fatty acids, Hill said.
“We believe full-spectrum products to be superior to CBD isolate products in the breadth of benefit achieved when using all the constituent parts of the plant,” she said.
Ninety percent of CBD isolate is imported from China and Russia, according to Smith.
“In clinical studies, CBD isolates also show far less efficacy versus full-spectrum hemp oils, and CBD isolates have also shown serious contraindications with many commonly prescribed pharmaceuticals,” he said.
Testing and extraction methods rank high in the research process, too.
“Never accept anything less than third-party testing and readily available test results,” Hill said.
While there are benefits and drawbacks to CO2 and clean ethanol extraction methods, the end product is the most important consideration—whether it is clean and free of solvents, Hill said. Holistic Hound has used both methods in the past but now uses super-critical CO2, she added.
Smith, whose company extracts its full-spectrum hemp extract using only super-critical CO2 , explained that “most bulk CBD extracts are made using toxic solvent extraction, which requires the use of chemicals like butane, ethanol and even acetone to leach CBD and the other cannabinoids from the hemp plant.
“We use only pressurized air and extremely low temperatures to safely and effectively remove every cannabinoid from our hemp material,” he said. “No chemicals ever touch Pet Releaf hemp oil. Only sunlight, water and Horizon Dairy Farm organic cow manure—our only approved ‘fertilizer’—are used to grow the plants, and the extraction process is 100 percent solvent free.”
Other important considerations for retailers include whether a product features clear CBD levels and animal-appropriate dosing on the label, is compliant with quality standards and guidelines regarding claims and packaging, and if the manufacturer is recommended and carried by reputable distributors.
Companies should also be able to back all claims with certifications, Smith said.
“Pet parents don’t like being tricked, so retailers should ask for USDA certifications from anyone claiming organic or organic farming methods,” he said.
Retailers should research a company and its products for pets as they would for themselves, Reilly said.
“Experience counts,” he said. “Pet health support is a serious matter. Ask for details on the product developers’ educational background, degrees held, years of experience in product development and the pet heath profession, manufacturer reliability, source of ingredients, testing protocols and dosing guidelines.”
In addition, the company should provide training and sales materials to help retailers confidently understand and sell this category, Hill said.
“Holistic Hound constantly updates its training and sales materials with the most current information and research, and works alongside retailers to help train and educate their staff so they can pass on their knowledge to consumers,” she said.
Selling these products is still a Wild West scenario in the marketplace, and it is incumbent upon the retailer to spend the necessary time to research and understand these powerful products and choose the right partner for them, Hill added.
Pet Releaf has been preparing for the hundreds of companies that will be entering the cannabidiol (CBD) product space in chase of the “green rush,” as Steve Smith, co-founder and president of the Englewood, Colo.-based company, calls it.
“We have multiple new lines ready for launch, we are building out our new 20,000-square-foot state-of-the-art facility, and we have more than 17,000 acres of certified organic farmland under long-term contract to expand our PR-33 hemp plantings,” he said.
The company’s extraction partner is also completing a massive expansion in its CO2 extraction capabilities to accommodate the increase in its hemp biomass.
“Pet Releaf decided from day one that we would control our entire supply chain, from seed to sale, from plant to pet,” Smith said. “This control has allowed us to continue to scale to meet the exponential increase in demand we’ve experienced year over year.”
For the first part of 2019, Holistic Hound will add two products to its existing line of phytocannabinoid-rich (PCR) hemp and mushroom supplements, said Heidi Hill, co-founder of the Berkeley, Calif.-based company.
“We also are proud to be on track to receive our NASC certification, which will identify us as a company with products committed to quality, vigilance and continuous improvement to promote the well-being of companion animals,” Hill said.