WARNING LETTER
Flea Assassin, LLC
MARCS-CMS 574951 —
March 07, 2019
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Ronald L. Sherrard
Recipient Title
Director
Flea Assassin, LLC
9920 El Greco Cir
Bonita Springs
,
FL
34135
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
4040 North Central Epressway, Suite 300
Dallas
,
TX
75204-3128
United States
March 7, 2019
Case # 574951
WARNING LETTER
VIA UPS EXPRESS
Ronald L. Sherrard, Director
Flea Assassin, LLC.
9920 El Greco Cir
Bonita Springs, FL 34135
Dear Mr. Sherrard:
This letter concerns your firm’s marketing of veterinary products under the Flea Assassin, brand name for the “treatment” of disease in dogs and cats, including all dosage forms of: Flea Assassin Nitenpyram and Flea Assassin Lufenuron. The U.S. Food and Drug Administration (FDA) reviewed your website, www.fleaassassin.com, where you promote and sell these products. Based on this review, we 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 the violative intended uses of your products include, but are not limited to, the following:
Flea Assassin Nitenpyram Rapid Flea Killer
“Rapid Flea Killer treatment kills live adults fleas fast”
“Treats flea infestations on cats and dogs 2-25 lbs”
“Kills adult fleas fast in an effective and hassle-free manner”
“Treatment starts working within 30 minutes, and stays in your pet’s system for 24-48 hours”
Flea Assassin Lufenuron Flea Control and Prevention
“Helps prevent flea re infestation of your pet”
“Monthly Flea Control & Prevention”
“Flea Control and Prevention treatment does not kill live fleas but prevents and controls flea infestations on cats and dogs”
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], respectively. 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.
Your written notification should refer to the Warning Letter Number above - Case #574951. Please electronically submit your signed reply on your firm’s letterhead to CDR John W. Diehl, M.S., Director, Compliance Branch,
at john.diehl@fda.hhs.gov,
orapharm2_responses@fda.hhs.gov.
If you have questions regarding the contents of this letter, please contact Ms. Rebecca Asente, M.S., Compliance Officer, at (504) 846-6104 or
Rebecca.asente@fda.hhs.gov.
Sincerely,
/S/
Monica Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II
CC:
VIA UPS EXPRESS
Natalia A. Sherrard, Director
Flea Assassin, LLC.
9920 El Greco Cir
Bonita Springs, FL 34135
Content current as of:
03/19/2019
Regulated Product(s)
Animal & Veterinary
Drugs