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WARNING LETTER

July 31, 2024

Re: 689278

Dear Rogelio Ivan Hernandez and Luis Javier Hernandez:

This letter concerns your firm’s marketing of unapproved new animal drugs The Antidote (Parvo Killer), Steroid Shot 5ML, Increase Litter Shot, Clavamox 5ML, and Bulldog Sauce 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://bullykamp.com/ in May and June 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. Also, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA. 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 and products labeling that show the intended use of your products include the following:

From your home website titled “THE ANTIDOTE !!! **** (PARVO KILLER)” at the URL https://bullykamp.com/store/ols/products/the-antidote--parvo-killer:

• “… help combat the following symptoms:

    o PARVO
    o COCCIDIA
    o GIARDIA
    o DISTEMPER
    o KENNEL COUHG [sic]
    o PYOMETRA
    o MASTITIS
    o PRE-BREEDING TREATMENT

From your home website titled “Steroid Shot 5ML” at the URL https://bullykamp.com/store/ols/products/steroid-shot-5ml:

• “… used to treat mild inflammatory conditions and/or to suppress the inflammation associated with an allergic response.”

From your home website titled “Increase Litter Shot” at the URL https://bullykamp.com/store/ols/products/increase-litter-shot:

• “Increase Litter Shot…Process should start once you notice your female bleeding.”

From your home website titled “Clavamox 5ML” at the URL https://bullykamp.com/store/ols/products/clavamox-5ml:

• “MEDECINE [sic] / ANTIBIOTICS”

From your home website titled “BULLDOG SAUCE” at the URL https://bullykamp.com/store/ols/products/bulldog-sauce:

• “…. an effective treatment for most skin disorders and skin-related ailments. Use BULLDOG SAUCE to speed the healing of cuts, bruises, burns, swelling and hair loss.
• “… For: MANGE, HOT SPOTS, RASHES, RINGWORMS [sic], HAIR LOSS, EXCESSIVE ITCHING, BELLY RASHES, ETC...”

From your Facebook post titled “BullyKAMP Products” at the URL https://www.facebook.com/photo.php?fbid=821824236642611&set=pb.100064451271781.- 2207520000&type=3 dated April 20:

• “THE ANTIDOTE!!! **** (PARVO KILLER)”

From your Facebook post titled “BullyKAMP Products” at the URL https://www.facebook.com/photo.php?fbid=742630577895311&set=pb.100064451271781.- 2207520000&type=3 dated December 9, 2023.

• “… We got it. #parvokiller #bullykampproducts”

From your Facebook post titled “BullyKAMP Products” at the URL https://www.facebook.com/photo.php?fbid=713362597488776&set=pb.100064451271781.- 2207520000&type=3 dated October 17, 2023:

• “Get rid of PARVO… the Antidote”
• “… good to have on hand. Pups can turn bad at any moment. #parvo #killer #antidote #bullykampproducts”

From your Facebook post titled “BullyKAMP Products” at the URL https://www.facebook.com/photo.php?fbid=749197433905292&set=pb.100064451271781.- 2207520000&type=3 dated December 20, 2023:

• “Got skin issues? Well look no further. We got the cure.”

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)]. 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 products. For example, we noted that you offer for sale FishBiotic SMZ/TMP Capsules, FishBiotic Penicillin Capsules, FishBiotic Amoxicillin Capsules, and
FishBiotics Cephalexin capsules. You should review these and any other products you sell to determine if they comply with the FD&C Act. 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 689278” 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