Pet Product Manufacturers Receive FDA Warning for Selling Illegal Drugs

The US Federal Drug Administration sent out two Warning Letters to pet product companies selling Toltrazuril, an antiprotozoal drug used to treat and prevent coccidiosis, equine protozoal myeloencephalitis (EPM) in animals.

Toltrazuril Shop and Linessa Farms LLC both received letters dated May 16, 2024 stating they are in violation of the Federal Food Drug and Cosmetic Act for selling the drug.

Toltrazuril Shop sells a Toltrazuril 5% Liquid Solution, which the website states, is a potent coccidiostat used to prevent and treat Coccidia & EPM in Horses, Dogs, Alpacas, Camels, Cats, Cattle, Dogs, Goats, Pigs, Reptiles, Rabbits, Bunnies and Sheep.

Linessa Farms, a small farm in rural Indiana, specializes in raising lamb and goat for commercial and show markets throughout the US, according to the farm's website. Currently, Toltrazuril is not available on its website.

FDA researched both company's websites and social platforms from December 2023 to May 2024.

FDA has not approved use of Toltrazuril in use for cats and dogs as well as chickens and other farm animals. However, toltrazuril is used regularly for the metaphylactic control of porcine neonatal cystoisosporosis on affected farms in Europe, Latin America, Canada, and Asian countries.

Ponazuril, an active metabolite of toltrazuril, is FDA-approved and used in the treatment coccidia and EPM.

In each letter, FDA writes that "For the reasons described below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce is prohibited."

The Letter to Toltrazuril Shop states:

"Based on our review of your websites and social media webpages, your toltrazuril products are drugs under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. For the reasons described below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]."

The letter goes on to say that the products compete with legally marketed, FDA-approved drugs for the treatment and prevention of coccidiosis and EPM. The company's marketing of these unapproved drugs is in violation of the FD&C Act and presents a disincentive for others to go through the FDA application/indexing process, which reduces the availability of legally marketed animal drugs which are proved safe for use.

In addition, toltrazuril products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of toltrazuril products by those animals and on safe levels of any potential residues for the human consumer.

The letter to Linessa Farms was simpler:

"Your products are new animal drugs under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because they 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. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. These products are not approved or index listed by FDA, and therefore, they are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]."

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drugs and biological products. For 2023 and 2024, Toltrazuril was not on the list.

A quick web search reveals that there are many other companies in violation of selling this unapproved drug in the US — including Amazon (the company is located in China). Most companies are pet-related websites including for dogs, bunnies, horses, and veterinarian pharmacies.