FDA Warning Letter: No More Fleas Please, Inc.

On October 17, 2018, the FDA issued a Warning Letter to No More Fleas Please, Inc. concerning the company’s marketing of veterinary products under the Queen City Animals brand name for the “treatment” of disease in dogs and cats, including all dosage forms of the following products: Queen City Animals Liquid Vanilla Flavored Wormer (Pyrantal Pamoate), Queen City Animals Praziquantel Tapeworm Dewormer Capsules, Queen City Animals Nitenpyram Flea Killing Capsules, and Queen City Animals Lufenuron Flea Controlling Capsules.

According to the Warning Letter, “The U.S. Food and Drug Administration (FDA) reviewed your website (www.nomorefleasplease.com), where you promote and sell these products, as well as your product labeling. Based on the information we obtained from the website and labeling, we have determined that your products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act.”

The Warning Letter continues, “Statements on your website and product labeling that show these intended uses of your products include, but are not limited to, the following:

  • Queen City Animals Liquid Vanilla Flavored Wormer (Pyrantal Pamoate)
    • ‘Queen City Animals liquid wormer (Pyrantal Pamoate 50 mg/ml) treats your pets against roundworms and hookworms.’
    • ‘It will kill these parasites, yet it is absolutely harmless to your pet.’
    • ‘The dose goes into the digestive tract and it paralyzes the worms, causing them to detach from the intestinal wall and be digested and eliminated.’
  • 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 Nitenpyram Flea Killing Capsules
    • ‘Nitenpyram is the active ingredient in Capstar®’
    • ‘Queen City Animals Flea Killing Capsules for cats and dogs 2 – 25 pounds contain 12 mg Nitenpyram to kill the adult fleas on your cat or small dog.’
    • ‘Once the Nitenpyam enters your pet’s system, it begins to kill fleas in as little as 30 minutes.’
    • ‘Our Flea Killing Capsules can be given as often as once per day.’
  • Queen City Animals Lufenuron Flea Controlling Capsules
    • ‘Queen City Animals Flea Controlling Capsules kills the larvae and fleas in the eggs before they hatch and infest your pet’
    • ‘Dosed properly, Lufenuron is harmless to your pet but deadly to flea eggs and larvae.’
    • ‘Used monthly, in conjunction with our Flea Killing Capsules, you will have a program in place that will keep your pet and home flea free.’
    • ‘With monthly treatments, your home will be transformed into a Flea Free Zone!'”

The Warning Letter goes on to say, “Because your products are intended to prevent, mitigate or treat diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these products are new animal drugs, as defined by 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. They are not the subject of 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]. Therefore, the products 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 letter concludes with a call for evidence of corrective action, including documentation, within 15 working days of the company’s receipt of the letter.

Click here to read the full FDA Warning Letter.