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  5. 1 Stop Chicken Health Shop - 689150 - 07/29/2024
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WARNING LETTER

1 Stop Chicken Health Shop MARCS-CMS 689150 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Recipient:
Recipient Name
Marissa Weaver
Recipient Title
Operator/Owner
1 Stop Chicken Health Shop

(b)(6)
Spring, TX 77380
United States

one_stop_chicken_health_shop@hotmail.com
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER

July 29, 2024

Re: 689150

Dear Marissa Weaver:

This letter concerns your firm’s marketing of unapproved new animal drugs in violation of the Federal Food Drug and Cosmetic Act (FD&C Act).

The United States Food and Drug Administration (FDA) reviewed your website (https://www.1stopchickenhealthshop.com/) and Facebook page in January, February and March 2024, where you take orders for Coccibuster Toltrazuril 5 gram packet, Endocox Powder, Toltrazuril 2.5 10mL Syringe, Tony’s Treasure Tablets, Enrofloxacin 30 mg tablets – 10 pack tablets (Baytril generic), Enrofloxacin 10mg Tabs, Enrofloxacin 10% (Baytril) Liquid 15 mL Bottles. Based on our review of your website, the claims establish that these products 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 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)]. 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. As indicated below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates 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 products include but are not limited to the following:

From your webpage titled “Coccoidosis [sic] Treatment” at the URL https://www.1stopchickenhealthshop.com/shop/coccoidosistreatment/8?page=1&limit=30&sort by=category order&sort order=asc:

􀁸 Coccibuster Toltrazuril 5 gram packet
    o “…Prevention and cure of Coccidiosis …prevents high mortality…”
􀁸 Endocox Powder
    o “Toltrazuril powder for Coccidiosis treatment.”
    o “…An aid in the control and treatment of coccidiosis in various species of birds including pigeons, cage birds, and backyard poultry…”
􀁸 Toltrazuril 2.5 10mL Syringe
    o “Toltrazuril 2.5% liquid gel in a 10ml syringe. For the treatment of coccidia in livestock.”

From your webpage titled “Chicken Antibiotics” at the URL https://www.1stopchickenhealthshop.com/shop/chickenantibiotics/6?page=1&limit=30&sort by=category order&sort order=asc:
􀁸 Tony’s Treasure Tablets
    o “For the treatment of such symptoms as poor performance, respiratory, canker, sinusitis, air sacculitis, enteritis, diarrhea and weight loss.”
    o “Antibiotic/Antiprotozoal/and Anticoccidial”
    o “…designed to treat a range of diseases in pigeons where exact diagnoses are not possible.”

􀁸 ENROFLOXACIN 30 MG TABLETS – 10 PACK TABLETS (BAYTRIL GENERIC)
    o “Enrofloxacin is an antibiotic ... showing high activity against both Gram-negative and Gram-positive bacteria.”

􀁸 Enrofloxacin 10mg Tabs
    o “For the treatment of bacterial infections of the respiratory system. Mycoplasma, Salmonella, E. Coli.”

􀁸 ENROFLAXIN 10% (BAYTRIL) LIQUID 15 ML BOTTLES
    o “nrofloxacin [sic] 10% is a generic form of Baytril and is a broad spectrum antibiotic that helps treat bacterial infections such as Paratyphoid, Mycoplasma, and Salmonella/E.coli.”
    o “Safe to use on pet birds such as finches, canaries, pigeons, backyard chickens, and even pet rats.”
    o “May help when other treatments containing a different active ingredient have not worked”

From your Facebook webpage titled “1 Stop Chicken Health Shop” at the URL https://www.facebook.com/photo.php?fbid=115354441348563&set=pb.100086220222341.-2207520000&type=3:
􀁸 Endocox Powder
    o “… aids in the control and treatment of coccidiosis in various species of birds…, and backyard chickens...”
    o “…contains Toltrazuril, … one of the industry's most effective anticoccidials…”
    o “Safely aids in the control and treatment of coccidiosis”

Your products are new animal drugs 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]. 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 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 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 689150” 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: texastopknotchsilkies@hotmail.com

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