Top Dog Pet Store LLC dba The Bulldog Cartel

WARNING LETTER Top Dog Pet Store LLC dba The Bulldog Cartel MARCS-CMS 689279 — July 31, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Name Anthony Michael Pavon Recipient Title Owner Top Dog Pet Store LLC dba The Bulldog Cartel 15904 Imperial Hwy La Mirada , CA 90638 United States Info@thetopdogpetstore.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER July 31, 2024 Re: 689279 Dear Anthony Michael Pavon: This letter concerns your firm’s marketing of unapproved new animal drugs, Green Magic and Bulldog Cartel Parvo Combat, for the treatment of diseases in animals in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https://thetopdogpetstore.com/ in May 2024 and has determined that you offer these products for sale there. Based on our review of your website, your products are drugs under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because they are 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. For the reasons described below, these products are unapproved new animal drugs and introducing or delivering these products 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, social media webpages and products labeling that show the intended use of your products include the following: From your home website titled “ Green Magic ” at the URL https://thetopdogpetstore.com/products/green-magic?_pos=1&_psq=green&_ss=e&_v=1.0: o “ GREEN MAGIC o KILLS PARVO o PRE-BREEDING TREATMENT o KENNEL COUGH o PNEUMONIA o MASTITIS o COCCIDIA o GIARDIA” From your home website titled “ Bulldog Cartel Parvo Combat 30ml (Meds) ” at the URL https://thetopdogpetstore.com/products/bulldog-cartel-parvo-combat?_pos=1&_psq=parv&_ss=e&_v=1.0: o “ HELP COMBAT PARVO o COCCIDIA o GIARDIA o DISTEMPER o KENNEL COUGH o PNEUMONIA o PYOMETRA o MASTITIS o PRE-BREEDING TREATMENT AS WELL” From your Instagram webpage titled “topdog_petstore” at the URL https://www.instagram.com/reel/CiqdpCmsKyZ/, post dated September 18, 2022: o “ GREEN MAGIC HELP COMBAT: o PARVO o COCCIDIA o GIARDIA o DISTEMPER o KENNEL COUGH o PNEUMONIA o PYOMETRA o MASTITIS o PRE-BREEDING TREATMENT” From your Instagram webpage titled “topdog_petstore GREEN MAGIC” at the URL https://www.instagram.com/reel/CiOdfxBJHQw/ on September 7, 2022: o …Hells [sic] combat with Parvo Gardia [sic] Coccidia Mastitis Kennel cough Pre breeding” These products are new animal drug under 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. 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]. These products are not approved or index listed by FDA, and 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)]. Also, this animal drug is misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because it has not been drug listed with FDA. The introduction or delivery for introduction into interstate commerce of an adulterated or misbranded 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 products. 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 products are 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 689279 ” 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 Content current as of: 08/13/2024 Regulated Product(s) Animal & Veterinary Drugs