Many pet-lovers out there would do just about anything for their dogs, cats, or animals they care about. As a pet owner myself, I have been closely monitoring the legality of hemp-derived cannabidiol (“CBD”) products for animals. Unfortunately, pet foods and treats containing CBD are currently illegal according to the United States Food and Drug Administration (“FDA”); however, certain compliant CBD topical animal products are not subject to FDA control, and thus, are legal to sell in interstate commerce.
Federal Illegality of Pet Foods & Treats Containing CBD
Despite the rising popularity of pet foods and treats that contain CBD, these goods remain illegal pursuant to the FDA. Although the Agriculture Improvement Act of 2018, more commonly referred to as the 2018 Farm Bill, removed “hemp” (with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis), and cannabinoids derived from hemp, such as CBD, from the Controlled Substances Act’s (“CSA”) definition of “marihuana,” see 21 U.S.C. § 802; see also 7 U.S.C. § 1639o, the 2018 Farm Bill explicitly preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act (“FDCA”). The FDA maintains that it is illegal to introduce CBD and THC products subject to the FDCA, including foods (as well as any animal food or feed), beverages, and dietary supplements, because the substances were investigated and approved as active drug ingredients. See 21 U.S.C. § 331(ll). Thus, at this time, it is federally illegal to sell CBD-infused pet foods and treats in interstate commerce.
Substances that are generally recognized as safe (GRAS) by the FDA, such as hulled hemp seed, hemp seed protein powder, and hemp seed oil, which each contain only trace amounts of CBD or THC, can be lawfully added to various foods and beverages. However, according to the FDA, these GRAS substances can only be legally marketed and sold in human foods. The FDA asserts that “[i]f an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act.” 21 U.S.C. § 342(a)(2)(C)(i). Currently, the FDA maintains that there are no approved food additive petitions, and that it is unaware of any GRAS conclusions, for animal food containing hemp-derived substances. Therefore, even GRAS substances must not be included in any pet foods or treats at this time.
Risky State Legality of CBD-Inclusive Pet Foods & Treats
Throughout the nation, numerous product lines of pet foods and treats containing CBD are available for consumers to purchase. So how are some states able to sell such goods? Certain states, such as Florida, have enacted hemp/CBD regulations that purport to permit companies to manufacture and sell THC and/or CBD-infused pet foods and treats (with not more than 0.3% total delta-9 THC) in intrastate commerce, meaning sale is permissible only within state boundaries. As of the date this blog was written, the FDA has not challenged any such state regulations that are in contradiction with the FDA’s position. Therefore, companies located in such states, or selling compliant CBD/THC-infused pet foods into such states, often move forward relying on the states’ protections and guidance while possibly underplaying the risk of potential federal crackdowns. Nevertheless, states moving forward with favorable regulations are simply not able to override federal law and preempt the FDA’s prohibitions.
Indeed, the FDA has issued several warning letters to companies in violation of the FDCA for adding CBD or THC to foods (including animal foods) or beverages, marketing CBD or THC goods as dietary supplements, and/or making impermissible health claims in the marketing, advertisement, customer comment/review sections, and sale of CBD or THC products for humans and/or animals.
Legality of Non-medicated CBD Topical Animal Products
Now that the bad news regarding CBD-inclusive, edible pet products is out of the way, it is time to get to the good news. Non-medicated CBD cosmetic products intended for use as grooming aids for animals are legal goods that fall outside the purview of the FDA and are not subject to the FDCA. This is an interesting anomaly, as cosmetic goods are certainly subject to the FDCA.
The FDA has provided guidance on its website that the FDCA defines a cosmetic as pertaining only to the human body, see 21 U.S.C. 321(i), “[t]herefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control.” Thus, hemp-derived CBD topical animal products that are compliant with the 2018 Farm Bill are legal to sell in interstate commerce. However, it is important to be mindful that if such products make impermissible health claims, or are intended for therapeutic purposes or to diagnose, cure, mitigate, treat, or prevent disease, they will be subject to regulation as new animal drugs under the FDCA, which could result in the FDA issuing warning letters and/or imposing monetary sanctions.
Paul Stevenson is an associate attorney with Ritter Spencer Cheng PLLC who practices cannabis law and represents clients in all facets of the cannabis and hemp industries, including dispensaries, growers, processors, manufacturers, retailers, and more.