The FDA’s warning letter to No More Fleas Please states that products sold under the Queen City Animals brand name violate the Federal Food, Drug, and Cosmetic Act.
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:
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.
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