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  1. Warning Letters

WARNING LETTER

No More Fleas Please, Inc. MARCS-CMS 565319 —

Product:
Animal & Veterinary
Drugs
Animal Drugs
Recipient:
Recipient Name
Shaun E. Koch
Recipient Title
President
No More Fleas Please, Inc.
No More Fleas Please, Inc.

8712 Clavemorr Glenn Ct
Charlotte, NC 28226
United States

Issuing Office:
Dallas District Office

United States

October 17, 2018

CMS Case # 565319

WARNING LETTER

VIA UPS OVERNIGHT

Shaun E. Koch, President
No More Fleas Please, Inc.
8712 Clavemorr Glenn Ct
Charlotte, North Carolina 28226

Mr. Koch:

This letter concerns your firm’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 Queen City Animals products: Liquid Vanilla Flavored Wormer (Pyrantal Pamoate), Praziquantel Tapeworm Dewormer Capsules, Nitenpyram Flea Killing Capsules, and Lufenuron Flea Controlling Capsules. 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.

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 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 (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 Lufenuron
 
  • “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!”

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.”


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)]. 

This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products. 

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. 

Electronically mail your written response to John W. Diehl, Director, Compliance Branch, Office of Pharmaceutical Quality Operations, Division 2, at ORAPHARM2_RESPONSES@fda.hhs.gov and john.diehl@fda.hhs.gov. Please identify your response with CMS Case # 565319.

If you have questions regarding any issues in this letter, please contact Mr. Diehl at (214) 253-5288. 


Sincerely,
/S/
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

 
 
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