Six Issues You Have to Know About CBD and Different Hemp-containing Pet Merchandise

The trend towards legalizing cannabis at the state level has resulted in an increase in cannabis products and an ever evolving market with many types of cannabis products for humans and their pets. Analysts predict that pet and animal product sales will be among the fastest growing sectors in the CBD market, with estimated sales of $ 125 million by 2022.

Below is our list of six things we think every pet owner (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 representatives.

1. The basics of CBD, hemp and the 2018 Farm Bill

Cannabis sativa Linnaeus (cannabis) is a hardy species of plant that includes many cannabis strains and chemovariums with extensive 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 primary non-intoxicating phytocannabinoid, and unlike THC, CBD has very low affinity for CB receptors in the endocannabinoid system and has the unique ability to counter the intoxicating and adverse effects of cannabis such as anxiety, palpitations, hunger, and sedation in rats and people.

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 the planning of certain types of cannabis by removing hemp, defined as cannabis and cannabis derivatives with extremely low THC concentrations (less than 0.3% THC), from the list of controlled substances under the CSA . In terms of animal feed, the 2018 Farm Bill did not change anything. Hemp or any derivatives remain unapproved ingredients for use in animal feed of any kind or species.

2. Are CBD and hemp products legal for use in pet products?

CBD or other hemp-containing products have not been approved by the FDA for use in animals as a drug or dietary supplement, which are the only two legal ways for animal products to be marketed in the United States. There is no equivalent to dietary supplements in animals as the Dietary Supplements and Health Education Act of 1994 does not apply to products intended for animal use. Since the FDA has already approved CBD as a medicinal product for humans, the use of CBD in any product, whether for human or animal use, would make that product an unapproved new drug or an unapproved new veterinary drug. New veterinary medicinal products and new animal foods must be approved for certain animal species before they can be placed on the market.

3. Who is responsible for regulating CBD in pet products?

In a testimony before the US Senate in July 2019, Dr. Amy Abernethy, FDA Deputy Commissioner, said the agency recognizes the need for “regulatory clarity, particularly given the significant public interest in hemp products and especially CBD”. Abernethy also stated that any manufacturer who sells “any CBD food or alleged dietary supplement in international trade” is doing so in violation of the Food, Drug, and Cosmetic Act (FDCA). She acknowledged that “the FDA is considering the possibility of new legal avenues 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 Hemp Growth and Cultivation, and individual state regulators, including the State Departments of Agriculture and other government regulators (ie, State Chemist Office).

4. Warnings for products containing CBD

On November 22, 2019, the FDA issued 15 warning letters for products containing CBD, 13 of which contained allegations related to pet products being marketed as unapproved new veterinary 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 veterinary drug with unfounded advertising claims. In 2020, several more FDA warning letters were issued for CBD products illegally marketed for pets. The FDA has not reviewed the manufacturing process for these unapproved CBD-containing drugs, so the manufacturing conditions or the pollutant content of these products are unknown.

In the press release dated December 22, 2020 with warning letters for CBD, Dr. Abernethy: “We [FDA] continue to focus on exploring potential avenues for lawful commercialization of CBD products while educating the public about these open questions about the safety of CBD. “

5. How are CBD and other hemp-containing pet products being marketed today?

At the 3rd International Cannabinoid Derived Pharmaceuticals (iCDP) Summit, a virtual event held in September 2020, Dr. Dominick Chiapperino, Director of Controlled Substance Staff (CSS) at the FDA’s Center for Drug Evaluation and Research (CDER), the challenges facing the regulatory authorities and, due to the rapidly changing legal framework at federal, state and local levels, representatives of the industry alike. He added that significant data is still needed to inform policy regarding the use of cannabis products for consumers.

The National Animal Supplement Council (NASC) and the Association of American Feed Control Officers (AAFCO) are two nonprofit organizations that work transparently with their members, the FDA, and manufacturers of CBD and other hemp-containing animal products to promote self-regulation and implementation good manufacturing practice and the principles of quality assurance in the industry.

6. What Pet Owners Should Know When Discussing CBD Product Use With a Veterinarian

Practicing veterinarians face a plethora of questions from pet owners about using CBD animal products for conditions ranging from arthritis to anxiety. Because the FDA has not approved any cannabis-derived products for animals, veterinarians cannot prescribe a CBD product to a pet.

When a veterinarian prescribes, administers, or recommends a product, they usually do so with the intent to prevent, treat, alleviate, or cure a disease or condition. According to AVMA, “Animal products with therapeutic claims that have not been evaluated and approved by the FDA are non-approved veterinary medicinal products. Unapproved veterinary drugs are considered “unsafe” by the FDCA because they have not been proven to meet FDA standards for safety and efficacy for their intended use. ”As there are currently no approved cannabis-derived drugs for animals, these cannot be approved for use Medicines put pets at risk and potentially pose legal risks to veterinarians who administer, prescribe, dispense, or recommend them. In addition, the marketing of unapproved treatments by veterinarians increases the likelihood that pet owners will use unapproved products in lieu of approved therapies to treat serious illnesses in their pets, which could exacerbate the disease and increase animal suffering.

For the purposes of the First Amendment right to freedom of expression, veterinarians should be able to speak to pet owners about CBD. Nonetheless, laws that apply to the practice of medicine that may affect language, such as laws that might limit a veterinarian’s ability to recommend CBD products, will generally meet constitutional requirements. But freedom of expression isn’t the only problem. Owners can self-administer CBD to their pets, and veterinarians need to know what the animals they are treating are consuming. However, the American Association of Veterinary Boards takes the position that veterinarians should be able to discuss CBD with customers. However, vets talking to their clients about CBD could face license confiscation from their state veterinary authorities. Few states have looked at the use of CBD in pets, and California and Michigan in particular have specific laws that allow veterinarians to speak to their customers about using CBD. This area of ​​law is changing rapidly, so before approaching their clients with CBD, veterinarians should have a clear understanding of state rules and the position of their state veterinary committee.

Final thoughts

The laws surrounding CBD and products containing hemp are changing fast, so stay tuned to what’s going on in your state (to speak to vets). It remains to be seen whether (or when) the FDA will approve CBD products for use in animals and what labeling requirements will apply to these products.