As discussed in this earlier blogpost, the United States Food and Drug Administration (“FDA”) issued a set of warning letters to 15 cannabidiol (“CBD”) companies for violations of the Food, Drug, and Cosmetic Act (“FDCA”). Many of the warning letters referenced provisions of the FDCA regarding the unlawful sale of animal food and animal drug products that contain CBD. Section 201(v) of the FDCA defines “new animal drugs” as any product that is not generally recognized as safe for use under the conditions prescribed, recommended, or suggested in the labeling based on the conclusion of qualified experts capable of evaluating the safety and effectiveness of animal drugs. The FDCA prohibits interstate sales of food containing a non-FDA-approved drug or any drug for which substantial clinical investigations have been instituted and the existence of which have been made public.
In addition to the announcement of the CBD-related enforcement actions, the FDA also provided additional information in the FDA Consumer Update on CBD, noting the FDA’s interest in learning more about the safety associated with CBD use in pets and other animals, as well as the safety of resulting human food products from CBD-consuming animals. Additionally, the FDA Consumer Update mentioned the results of a study showing changes in male reproductivity in the male offspring of CBD-treated female mice. The study results showed a decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone. While FDA acknowledged the laboratory test results were not indicative of male reproductive toxicity in human patients, it was enough to raise concerns about the impact of CBD and CBD-containing products on male fertility.
The FDA is also concerned about the quality of CBD products due to a lack of processing controls and practices, leaving the potential for inaccurate claims regarding chemical content of cannabinoid compounds, and unsafe levels of contaminants like pesticides and heavy metals. The FDA stated the use of CBD products for pets and other animals is not something to ignore, as the unproven medical claims and quality concerns are equally applicable to CBD products marketed for use in animals. While the FDA suggests individuals discuss the appropriate treatment options with their veterinarian, it is unclear whether the FDA considered the fact that these same veterinarians could recommend CBD products created for pets depending on the level of familiarity and experience the veterinarian has with the CBD product market.
There are less than 60 PubMed research articles related to the effects of cannabinoids on dogs and almost all of the research focuses on the toxicity due to accidental ingestion, experimental administration, or ingestion of synthetic cannabinoids. One study in Colorado found that the frequency of marijuana toxicosis in dogs reported by 2 veterinary hospitals increased 4-fold over a 5-year period from 2005-2010, which correlated with an increase in the number of state cannabis licenses issued by the state of Colorado during that same time period. Some researchers believe the higher levels of cannabinoid receptors could make dogs more susceptible to cannabinoid toxicity compared to humans, and that could further explain why 2 dogs in the Colorado study died after consuming baked goods containing “concentrated medical grade THC-infused butter,” although the study’s results don’t provide much more information on the parameters of the study.
On a number of occasions, the FDA has indicated that the agency will continue to prioritize enforcement actions for violations that pose the greatest risk to consumer health and safety, particularly those claiming to prevent, diagnose, treat, mitigate and/or cure serious medical conditions (i.e. cancer, Alzheimer’s disease, diabetes, etc.). In light of the recent FDA concerns regarding the safety and risk associated with consumption of CBD products by pets and other animals, including animals bred for human consumption, it is important to emphasize that FDA enforcement actions will not be limited to human CBD product claims. Make no mistake, the FDA is certainly showing an increasing interest and concern regarding the proliferation of non-FDA-approved animal drugs and food products containing CBD due to the initial research findings showing risks to male reproductivity. I would not be surprised to see additional FDA enforcement actions targeting animal drug and food products in the coming months given that most animal products, whether containing CBD or not, are not produced in accordance with human grade standards. Considering the additional contamination risks posed by non-human-grade processing and production controls, and the existence of research showing the potential for cannabinoid toxicity in male reproductivity, the FDA will not ignore the booming CBD pet and animal market.
The takeaway? The FDA is only going to increase regulation of the CBD pet product market. It would be wise to either end 2019, or begin 2020, with a “fun,” comprehensive review of your existing CBD products for use in pets and other animals, including the product warning, labeling, and packaging information. Unless a Christmas miracle arrives in the form of FDA-promulgated regulations governing the production and distribution of cannabidiol products that are not FDA-approved (i.e. CBD products other than Sativex and Epidelox), it is highly likely that the FDA will continue to increase enforcement efforts in the coming weeks and months to mitigate the potential for adverse events related to cannabinoid toxicity effects.
As always, please contact Green Light Law Group at (503) 488-5424 or email@example.com if you have any questions.