WARNING LETTER
Samuel Rodriguez dba KiloKennelzz
MARCS-CMS 674082 —
December 20, 2023
Delivery Method:
Via Email
Product:
Animal & Veterinary
Recipient:
Recipient Name
Samuel Rodriguez
Samuel Rodriguez dba KiloKennelzz
(b)(6)
United States
(b)(6)
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
WARNING LETTER
December 20, 2023
Re: 674082
Dear Samuel Rodriguez:
This letter concerns your firm’s marketing of an unapproved new animal drug product, Green Monster also known as Green Juice, for the treatment of diseases in animals. The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https://kilokennelzz.com/ in October, November, and December 2023 and has determined that you offer this product for sale there.
Based on our review of your website at the internet address https://kilokennelzz.com/, your Green Monster product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because this product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. This product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.
Examples of claims FDA observed on your website and product labeling that show the intended use of your product include the following:
From your home website titled “Green Juice” at the URL https://kilokennelzz.com/products/green-juice:
“GREEN MONSTER HELP COMBAT:
o PARVO
o COCCIDIA
o GIARDIA
o DISTEMPER
o KENNEL COUGH
o PNEUMONIA
o PYOMETRA
o MASTITIS
o PRE BREEDING TREATMENT AS WELL”
“Each bottle contains 6ML [sic] and is enough for a single dog.”
“Administer medication via IM injection in dogs rear legs. Use .5ML [sic] on each rear leg for 6 days. ONLY REARS!”
This product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is 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.
To be legally marketed, a new animal drug must have 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]. This product is not approved or index listed by FDA, and therefore, the product is 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 introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 674082” in the subject line of your email.
Sincerely,
/S/
Neal Bataller, ME, DVM
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Cc:
(b)(6)
Content current as of:
01/16/2024
Regulated Product(s)
Animal & Veterinary