Inspections, Compliance, Enforcement, and Criminal Investigations

Little City Dogs 10/7/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District                         
158-15 Liberty Avenue
Jamaica, NY 11433  

 

October 7, 2014
 
WARNING LETTER NYK-2015-1
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
 
Ms. Bien King
Little City Dogs
3444 White Plains Rd., #11A
Bronx, NY 10467
SalesDept@LittleCityDogs.com
 
Dear Ms. King:
 
This letter concerns your firms marketing of numerous veterinary products under the Little City Dogs brand name, including Tapeworm Wormer Capsules for Big Dogs, Tapeworm Wormer Capsules for Cats, Tapeworm Wormer Capsules for Dogs, Cat & Canine Cardio Care, Flea Killer Capsules for Cats and Small Dogs, Flea Killer Capsules for Dogs, Flea Control for Cats and Small Dogs, Flea Control for Dogs, and Vanilla Wormer for Dogs and Cats (collectively, Little City Dogs products). According to information on your website at the internet address www.littlecitydogs.com and other product labeling, these Little City Dogs products are drugs as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (“the Act”) [21 U.S.C. § 321(g)(1)], as they are intended for use in the mitigation, treatment, or prevention of disease in animals or to affect the structure or function of the body of animals. As discussed below, these products areunapproved new animal drugs and your marketing of them violates the Act. 
 
Statements on your website that establish these intended uses of your product include, but are not limited to, the following:
 
  • Little City Dogs Tapeworm Wormer Capsules for Big Dogs:
-   “Little City Dogs is the only place you can get TAPEWORM medication in a BEEF FLAVORED capsule.”
-   “Contains Praziquantel — the same active ingredient in Droncit® and Tradewinds®”
-    “When Praziquantel causes paralysis of the WORM's muscles they let go of your dog's intestinal wall – get digested – and pooped out after just one treatment!”
-   “Treat your dog for tapeworms:”
 
  • Little City Dogs Tapeworm Wormer Capsules for Cats:
 
-   “Praziquantel works by causing severe spasms and paralysis of the worms' muscles. So the little critters are dissolved by your cat's digestive system and passed out.”
 
  • Little City Dogs Tapeworm Wormer Capsules for Dogs:
 
-   “When Praziquantel causes paralysis of the WORM's muscles they let go of your dog's intestinal wall – get digested – and pooped out after just one treatment!”
-   Little City Dogs BEEF FLAVORED Tapeworm Wormer contains THE EXACT SAME active ingredient as the HIGHER PRICED national brands! THE SAME AS: Droncit®, Tradewinds® & D-Worm®
EXCEPT IT COSTS LESS!”
 
  • Little City Dogs Cat & Canine Cardio Care
 
-   “Little City Dogs CAT & CANINE CARDIO CARE is safe and effective .05% ivermectin heartworm wormer.”
-   “Now you can treat your pet every single month for HEARTWORM…”
-   “Little City Dogs CAT & CANINE CARDIO CARE is our NEWEST WEAPON in the battle of the worms!”
-   “KILLS LIFE THREATENING HEARTWORMS.”
 
  • Little City Dogs Flea Killer Capsules for Cats and Small Dogs
 
-   “Contains the same active ingredient in Capstar®”
-   It starts killing fleas in 30 minutes
-   “Nitenpyram is approved for use in dogs and cats over 4 weeks of age and over 2 pounds of body weight.”
 
  • Little City Dogs Flea Killer Capsules for Dogs
 
-   “Little City Dogs Flea Killer is our best NEW WEAPON in our FIGHT AGAINST FLEAS!”
-   “Contains the same active ingredient in Capstar®”
-   “It starts killing fleas in 30 minutes”
-   “Flea Killer reaches peak performance in 3 to 4 hours”
-   “Nitenpyram is approved for use in dogs and cats…”
 
  • Little City Dogs Flea Control for Cats and Small Dogs
 
-   “Little City Dogs Flea Control is our NEWEST WEAPON in our FIGHT AGAINST FLEAS!”
-   “FLEA CONTROL kills 100% of flea eggs & larvae.”
-   “FLEA CONTROL turns even the flea dirt (pre-digested blood) into a flea larvae killer and kills them too. A few months treatment with FLEA CONTROL eliminates the infestation. Continued treatment with FLEA CONTROL will keep it from coming back.”
-   “Kill Juvenile fleas with Little City Dogs FLEA CONTROL.”
-   “Contains 165 mg Lufenuron per capsule the same active ingredient in Program®”
 
  • Little City Dogs Flea Control for Dogs
 
-   “Little City Dogs Flea Control is our NEWEST WEAPON in our FIGHT AGAINST FLEAS!”
-   “FLEA CONTROL kills 100% of flea eggs & larvae.”
-   “FLEA CONTROL turns even the flea dirt (pre-digested blood) into a flea larvae killer and kills them too. A few months treatment with FLEA CONTROL eliminates the infestation. Continued treatment with FLEA CONTROL will keep it from coming back.”
-   “Kill Juvenile fleas with Little City Dogs FLEA CONTROL.”
-   “Contains 165 mg Lufenuron per capsule the same active ingredient in Program®”
 
  • Little City Dogs Vanilla Wormer for Dogs and Cats
 
-   “Active Ingredient: Pyrantel Pamoate, kills hookworms, roundworms.”
 
 
The above referenced products are only intended to be a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only intended to be a sampling of statements that demonstrate the intended uses of your products.
 
Because your products are intended to prevent, mitigate or treat disease in animals or to affect the structure or function of the body of animals, they are drugs within the meaning of section 201(g)(1) of the Act, [21 U.S.C. § 321 (g)(1)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the 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 Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and are adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. Introduction of adulterated drugs into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. 
 
This letter is not intended to be an all-inclusive review of your products and their promotion. 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. 
 
Your written response should be sent to LCDR Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Jackson at (718)662-5711 or kristen.jackson@fda.hhs.gov.
 
                                               
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
 
 
cc:        P.O. Box 513
            Bronx, NY 10467

 

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