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  5. All Things Bunnies, Inc. - 684415 - 05/16/2024
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WARNING LETTER

All Things Bunnies, Inc. MARCS-CMS 684415 —


Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs

Recipient:
Recipient Name
Michelle Jorgenson
Recipient Title
President/Owner
All Things Bunnies, Inc.

(b)(6)
United States

customerservice@allthingsbunnies.com
shelly@allthingsbunnies.com
Issuing Office:
Center for Veterinary Medicine

United States


WARNING LETTER

May 16, 2024

Re: 684415

Dear Michelle Jorgenson:

This letter concerns your firm’s marketing of an unapproved new animal drug, Toltrazuril 5% Suspension, for the management of coccidiosis 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, https://www.allthingsbunnies.com, from December 2023 through May 2024, and has determined that you offer this product for sale there.

Based on our review of your website, your 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 it 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. For the reasons described below, 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 that show the intended use of your product as a drug include, but are not limited to, the following:

From the product label for Toltrazuril 5% Suspension on your webpage at the URL https://www.allthingsbunnies.com/Toltrazuril-5-Suspension-for-Coccidiosis-p/med132.htm:
• “Toltrazuril 5%: Used in Treatment of Coccidiosis”

On the product page for Toltrazuril 5% Suspension on your webpage at the URL https://www.allthingsbunnies.com/Toltrazuril-5-Suspension-for-Coccidiosis-p/med132.htm:
• “The most effective, non-invasive treatment for Coccidiosis on the market in as few as 1-2 doses!”
• “Liquid Toltrazuril (Compare to Baycox) actually kills coccidia with one or two doses!”
• “This is a revolutionary product that is safer and more effective than Albon without being as harsh on the system.”
• “If your rabbit has a jelly like poop coming out of the anus, lethargy, or sudden weight loss, chances are very great that it has Coccidia! Coccidia can take some animals in less than 24-48 hours. Keep this product on hand so you won't loose [sic] your prize animals.”
• “Toltrazuril has activity against many different types of coccidia at all stages.”
• “How does it work? The active substances in this medicine interfere with the enzymes needed for coccidia to breathe. As a result, it is able to kill the parasites at all stages. Also effective against roundworms.”

From the chart titled “Recommended Uses and Dosages for Medications” on your webpage at the URL https://www.allthingsbunnies.com/Articles.asp?ID=259:
• “Illness: Coccidiosis; Medical Treatment: Toltrazuril 5% (used as a cure for active cases)”

Your 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

During our review of your website, we noted that you sell a number of other products which may also be drugs for use in animals. You should review each of these products and determine whether they are also new animal drugs which are not legally marketed.

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 cause 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 684415” 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

 
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