SILVER SPRING, Md. — Curaleaf, Inc. President Joseph Lusardi was issued an official warning letter July 22 by the US Food and Drug Administration (FDA) reprimanding the company for selling three versions of edible pet tinctures containing cannabidiol (CBD), as well as lotions, vaporizer pens, tinctures and pain-relief patches for humans, deeming the products as “unapproved new drugs.”
Donald D. Ashley, director of the FDA’s Office of Compliance for its Center for Drug Evaluation and Research, and Eric Nelson, Office of Compliance director for the agency’s Center for Veterinary Medicine (CVM), stated in the letter that the CBD-infused products were “in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.”
The use of products sold on Curaleaf’s website, “Bido CBD for Pets” in three flavors (pure, bacon and salmon), have been determined by the FDA to be used as a form of treatment or prevention of certain diseases, which constitutes them as drugs under section 201(g)(1)(B) of the FD&C Act, according to the agency.
The FDA stated this conclusion was reached after observing claims on Curaleaf’s website, including the treats’ effectiveness in aiding symptoms of anxiety, compulsive behavior, inflammation, seizures and neurological problems and other issues. The website also claims that the treats can be used in the place of veterinarian-prescribed anxiety medicine, “whereas CBD oil is natural and offers similar results without the use of chemicals.”
The agency stated the pet tinctures are “not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.”
Curaleaf was instructed to begin an investigation of its products, including those for humans, to correct the violations cited in the letter and avoid legal action.
This warning comes as the use of hemp and CBD in the pet industry has become more prevalent amid a vast gray area of regulatory controls on the ingredient.
On July 23, the FDA issued a statement reaffirming its mission to develop clear regulatory standards for consumer products made with CBD and hemp through an "agency-wide, integrated and collaborative approach."
"We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD," said Amy Abernethy, M.D., Ph.D., principal deputy commissioner of the agency.
“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD," Abernathy added.
Acting FDA Commissioner Ned Sharpless, M.D., said, “As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. Selling unapproved products with unsubstantiated therapeutic claims – such as claims that CBD products can treat serious diseases and conditions – can put patients and consumers at risk by leading them to put off important medical care."
For more regulatory news affecting the pet food market, visit our Regulatory page.