According to recent reporting, pet industry spending is expected to reach $96 billion by 2020 with CBD as one of its fastest growing sections. Following the enactment of the Agricultural Improvement Act of 2018 (“2018 Farm Bill”), there has been a huge interest in the use of hemp-derived cannabidiol (“Hemp-CBD”) for our furry friends. Yet, public demand for Hemp-CBD pet products may be pushing the market ahead regardless of legal requirements.
While there are many Hemp-CBD pet products on the U.S. market, this blog post provides a brief overview of the regulatory framework surrounding Hemp-CBD pet foods.
Hours following the passage of the 2018 Farm Bill, Scott Gottlieb issued a statement in which the then-FDA Commission clarified that the federal legalization of the crop did not strip the agency of its regulatory authority over products containing hemp and its derived compounds, including Hemp-CBD pet foods.
Pursuant to Sections 301(ll) and 201(ff)(3)(B) of the Food, Drug and Cosmetic Act (“FD&CA”), food cannot contain an ingredient also found in an approved drug. Because the FDA approved CBD as an active ingredient in Epidiolex, a drug used in the treatment of epilepsy, for which substantial clinical investigations have been instituted, the FDA posits that it is unlawful to use CBD as an active ingredient in human and pet foods.
There is an exception to this rule if the substance was “marketed as” a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. Consequently, the sale and marketing of Hemp-CBD pet foods currently violates FDA policies.
The FDA has limited its enforcement actions against Hemp-CBD products for pets by issuing warning letters to companies that have been making unsubstantiated, egregious claims about the therapeutic value of their products. Therefore, if a company decides to enter the Hemp-CBD pet market regardless of FDA policy, it should, at a minimum, refrain from making any health claims.
Although the FDA prohibits the sale and marketing of Hemp-CBD pet foods in interstate commerce, several states have enacted legislation that expressly legalized the sale of these products. Oregon, for example, authorizes the manufacture, distribution and sale of Hemp-CBD pet foods, which are limited to “dog and cat” foods containing no more than 0.3 percent total THC. In addition, Hemp-CBD pet foods manufactured, sold and marketed in the Beaver State must meet other testing requirements imposed by the Oregon Health Authority, including but not limited to microbiological contaminants.
Other states have not taken a position on the sale of these products, rendering these products illegal at worse and unregulated at best.
So similarly to Hemp-CBD human foods, Hemp-CBD pet foods cannot lawfully be sold throughout the United States. As such, manufacturers, distributors and retailers of Hemp-CBD pet foods should consult with regulatory attorneys to understand and mitigate the risk of enforcement action by the FDA as well as state and local enforcement groups that prohibit the sale of these products.
For more information on this issue, please contact our hemp regulatory team.Read More