SINCE THE U.S. Congress passed the Agriculture Improvement Act of 2018 (the Farm Bill), there have been significant misunderstandings about how this legislation affects hemp, CBD and other cannabinoid products provided for the benefit of animals. Many believed then, and some still believe, that the Farm Bill provided a path forward for various hemp/cannabinoid products, when in fact the legislation only defined a path for growing hemp and for defining hemp as an agricultural commodity.
When a company turns a commodity such as hemp into an article of commerce that consumers purchase for consumption by animals, that commodity likely falls under the authority of the U.S. Food & Drug Administration (FDA), along with state regulatory agencies, depending on the intended use/benefit statements.
The FDA has been very consistent in its position on hemp, CBD and other cannabinoids in products marketed for humans and animals. Their position has been and remains:
- Although allowed in some states by statute, hemp is an unapproved ingredient for inclusion in animal food, treats or health products.
- CBD is not approved, and the FDA has expressed safety concerns, especially for negative effects on the liver.
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In June 2019, the National Animal Supplement Council (NASC) provided comments in an FDA public meeting, stating that based on the increased consumer demand for hemp/cannabinoid products, the NASC, which represents the majority of the “supplement” industry, would come back to the FDA Center for Veterinary Medicine with a viable and responsible path forward. We did exactly that, and the FDA again expressed concern over safety in long-term use of CBD.
Thus, NASC’s board of directors decided, on behalf of NASC members and in the best interests of the industry, to sponsor a safety study to meet the FDA’s request for a long-term safety assessment. The duration of the study that would meet the agency’s definition of “long-term” was 90 days.
NASC-Sponsored Safety Study of CBD in Healthy Dogs with Control Group
A total of 32 healthy Beagles were given:
- CBD (eight dogs)
- CBD + CBG (eight dogs)
- CBD + CBDA (eight dogs)
- None of the above as the control group (eight dogs)
Those given CBD or a CBD combo were given it at a level that would cover all products in the marketplace that we track in the NASC Adverse Event Reporting System (NAERS). Our target was only to evaluate risk of use of these substances and not to evaluate efficacy or benefits.
A quick note about “safety” in the context of our study. The study we completed was a tolerability study and is termed as such because we did not attempt to identify “lethal dose” levels for these compounds. We were not going to kill or harm dogs in an effort to demonstrate tolerable risk of use of the cannabinoids selected.
Broad-spectrum was selected because it would be comparable to other botanical extracts currently marketed in animal products. The study materials came from NASC-qualified suppliers KND Labs and Open Book Extracts.
The results of the study were extremely favorable. The NASC is currently limited in what we can disclose because the manuscript has been submitted to scientific journals for peer review. This statement comes from the study summary:
“The results of our study indicate that CBD, CBD + CBG and CBD + CBDA at the ratios and doses utilized were well tolerated when healthy male and female Beagles were dosed for 90 consecutive days. These clinically determined conclusions are also supported by data from NAERS, which is the most advanced system in the world for these types of products given to non-human-food-chain animals. Based on the data available, it would be the conclusion of the authors that the substances do not pose significant risk to dogs in long-term use.”
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Meaning and Takeaways for Retailers
On Jun. 25, the FDA held the public informational meeting “A New Way Forward for Cannabidiol and Other Hemp Products.” The basic messages were that the agency understands these products are in demand by consumers and that products for companion animals are being considered. The agency reiterated its safety concern.
However, I believe the FDA is genuinely receptive to considering a risk-based approach in allowing these products to be federally recognized and lawfully marketed.
They are looking to the U.S. Congress to further define the path forward through public policy.
The bottom line? We hope the NASC-sponsored clinical study, supported by post-market data from NAERS, will provide regulators with a high level of confidence that these substances do not pose undue risk to animals and should be allowed to be marketed. The total cost of the study was just under $500,000, and we hope retailers will consider that it was NASC members that helped to establish the potential positive path forward for all stakeholders, most importantly the animals who benefit from these products.
