/>iThe trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict that pet-and-animal product sales are among the fastest-growing sectors in the CBD market with estimated sales reaching $125 million by 2022.
Below is our list of six things we think every pet parent (or pet product manufacturer) needs to know about CBD and other hemp-containing pet products as well as the challenges facing regulators, veterinarians and industry stakeholders.
1. The basics on CBD, hemp and the 2018 Farm Bill
Cannabis sativa Linnaeus (Cannabis) is a hardy plant species that comprise many cannabis cultivars and chemovars with wide-ranging concentrations of delta-9-tetrahydrocannabinol (THC; the psychoactive component of cannabis); cannabinoids such as cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN); as well as terpenes, omega-3 and omega-6 fatty acids. CBD is the main nonintoxicating phytocannabinoid, and unlike THC, CBD has a very low affinity for CB receptors of the endocannabinoid system and possesses the unique ability to counteract the intoxicating and adverse effects of cannabis, such as anxiety, tachycardia, hunger, and sedation in rats and humans.
Parts of the Cannabis plant have been controlled under the Controlled Substances Act (CSA) since 1970 [21 U.S.C 802(16)]. In December 2018, the Agriculture Improvement Act, also known as the 2018 Farm Bill, changed how certain types of cannabis are scheduled by removing hemp, defined as cannabis and derivatives of cannabis with extremely low concentrations of THC (less than 0.3% THC) from the list of controlled substances under the CSA. The 2018 Farm Bill did not change anything with respect to animal food. Hemp or any derivatives remain Unapproved Ingredients for use in animal food of any kind or any species.
2. Are any CBD and hemp-containing products legal for use in pet products?
CBD or any other hemp-containing products have not been approved by the FDA for use in animals as drugs or food/feed supplements, which are the only two legal options for marketing animal products in the US. There is no equivalent to dietary supplements in animals, because the Dietary Supplement and Health Education Act of 1994 does not apply to products meant for animal use. Because FDA has already approved CBD as a drug for humans, then the use of CBD in any product, whether for use in humans or animals, would make that product an Unapproved New Drug or Unapproved New Animal Drug. New animal drugs, as well as new animal food products, are subject to pre-market approval for specific species.
3. Who’s responsible for regulating CBD in pet products?
In testimony before the US Senate in July 2019, Dr. Amy Abernethy, Principal Deputy Commissioner at FDA, stated that the Agency recognizes the need for “regulatory clarity, particularly given the significant public interest in hemp products, and CBD in particular.” Abernethy also stated that any manufacturer selling “any CBD food or purported dietary supplement products in interstate commerce” does so in violation of the Food, Drug, and Cosmetic Act (FDCA). She acknowledged that “FDA is considering the possibility of new legal pathways for CBD products.”
In addition to the FDA’s Center for Veterinary Medicine (CVM), animal products are regulated by the Federal Trade Commission (FTC) for advertising, DEA for controlled substances, USDA for growth and cultivation of hemp, and individual state regulatory agencies including the State Departments of Agriculture and other state regulatory agencies (i.e., State Chemists Office).
4. Warning Letters Issued for CBD-containing Products
On November 22, 2019, FDA issued 15 Warning Letters for CBD-containing products, 13 of those included allegations related to pet products marketed as unapproved new animal drugs. And, in May 2019, an FDA Warning Letter was issued jointly with the FTC for a CBD product for dogs that was being marketed as an unapproved new animal drug with unsubstantiated advertising claims. In 2020, several more FDA Warning Letters were issued for CBD products illegally marketed for pets. FDA has not reviewed the manufacturing process of these unapproved CBD-containing drug products, so the manufacturing conditions of, or contaminant levels in, these products is unknown.
In the December 22, 2020 News Release of Warning Letters for CBD, Dr. Abernethy said, “We [FDA] remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.”
5. How are CBD and other hemp-containing pet products being marketed today?
At the 3rdInternational Cannabinoid Derived Pharmaceuticals (iCDP) Summit, a virtual event held in September 2020, Dr. Dominick Chiapperino, Director of Controlled Substance Staff (CSS) at FDA’s Center for Drug Evaluation and Research (CDER), acknowledged challenges facing regulators and industry stakeholders alike due to the rapidly changing legal frameworks at federal, state, and local levels. He added that significant data is still needed to inform policy regarding use of consumer cannabis products.
The National Animal Supplement Council (NASC) and the Association of American Feed Control Officers (AAFCO) are two non-profit organizations working transparently with their members, FDA and manufacturers of CBD and other hemp-containing animal products to promote self-regulation and implementation of good manufacturing practices and quality assurance principles in the industry.
6. What Pet Owners Should Know When Discussing Use of CBD Products with a Veterinarian
Practicing veterinarians face a barrage of questions from pet owners about the use of CBD animal products for conditions ranging from arthritis to anxiety. Because the FDA has not approved cannabis-derived products for animals, vets are unable to prescribe a CBD product for a pet.
When a veterinarian prescribes, administers or recommends a product, they are usually doing so with the intent to prevent, treat, diminish, or cure a disease or condition. According to the AVMA, “Products for animals for which therapeutic claims are made that have not been evaluated and approved by the FDA are unapproved animal drugs. Unapproved animal drugs are considered to be ‘unsafe’ under the FDCA, because they have not been shown to meet FDA standards for safety and efficacy for their intended use.” As there are currently no approved cannabis-derived drugs for animals, the use of these unapproved drugs can put pets at risk and possibly create legal risks for veterinarians who administer, prescribe, dispense or recommend them. Additionally, the marketing of unapproved treatments by veterinarians increases the likelihood that animal owners may choose to use unapproved products instead of approved therapies to treat serious illnesses in their pets, which could result in worsening of disease and increased animal suffering.
As a matter of a First Amendment right to free speech, vets should be able to talk to pet owners about CBD. Nonetheless, laws applicable to the practice of medicine that may impact speech, such as laws that might limit a vet’s ability to recommend CBD products, will generally pass constitutional muster. But, free speech is not the only issue. Owners could administer CBD to pets on their own, and vets need to know what the animals they treat are taking. The American Association of Veterinary Boards, however, has taken the position that vets should be able to discuss CBD with clients. But, vets who talk to their clients about CBD could face license seizure from their state veterinary boards. Only a few states have addressed the use of CBD in pets, most notably California and Michigan have specific laws that allow vets to discuss the use of CBD with their clients. This area of the law is changing quickly, so, before addressing CBD with their clients, vets should clearly understand state rules and the position taken by their state veterinary board.
Final Thoughts
The laws around CBD and hemp-containing products is changing fast, so stay abreast of what is going on in your state (for talking to vets). It remains to be seen if (or when) the FDA will approve CBD products for use in animals and what sort of labeling requirements will be applied to those products.
