FDA Issues Warning Letter to Parasiticide Company

The FDA has issued a formal warning letter to No More Fleas Please, Inc. regarding the company’s marketing of products sold under the Queen City Animals brand name. According to the letter—dated October 17 and addressed to Shaun E. Koch, president of No More Fleas Please—the North Carolina—based company is in direct violation of the Federal Food, Drug, and Cosmetic Act.

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Upon FDA review of the company’s website, the agency determined that the products are intended for use in the mitigation, treatment, or prevention of diseases in animals, rendering them drugs under the Federal Food, Drug, and Cosmetic Act. However, because the products are unapproved new animal drugs, marketing them as such violates the Federal Food, Drug, and Cosmetic Act. These include all dosage forms of the following Queen City Animals products: Liquid Vanilla Flavored Wormer (pyrantel pamoate), Praziquantel Tapeworm Dewormer Capsules, Nitenpyram Flea Killing Capsules, and Lufenuron Flea Controlling Capsules.

The letter pinpoints specific statements made on the No More Fleas Please website that show the intended uses of the nonapproved products, including:

• Queen City Animals Praziquantel Tapeworm Dewormer Capsules: “Praziquantel paralyzes the tapeworms forcing them to release themselves from the digestive tract thus allowing your pet to digest them with just one treatment. Repeat only if your pet becomes re-infested.”
• Queen City Animals Liquid Vanilla Flavored Wormer (Pyrantal Pamoate): “Queen City Animals liquid wormer (pyrantel pamoate 50 mg/mL) treats your pets against roundworms and hookworms.”
• Queen City Animals Lufenuron: “Queen City Animals Flea Controlling Capsules kill the larvae and fleas in the eggs before they hatch and infest your pet.”
• Queen City Animals Nitenpyram Flea Killing Capsules: “Once the nitenpyram enters your pet's system, it begins to kill fleas in as little as 30 minutes.”

The letter concludes by stating that it is Mr. Koch’s responsibility to ensure that all of the products sold by his company are in compliance with FDA regulations. The agency gave the company 15 business days to acknowledge receipt of the warning and indicate how No More Fleas Please intends to address the issue. Failure to correct the violations may result in enforcement action by the FDA without further notice, which could include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.