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  5. totaltoltrazuril.com - 684418 - 05/16/2024
  1. Warning Letters

WARNING LETTER

totaltoltrazuril.com MARCS-CMS 684418 —


Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs

Recipient:
totaltoltrazuril.com

United States

admin@totaltoltrazuril.com
Issuing Office:
Center for Veterinary Medicine

United States


WARNING LETTER

May 16, 2024

Re: 684418

This letter concerns your firm’s marketing of an unapproved new animal drug, Total Toltrazuril - Coccidiosis & Horse EPM Treatment, 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://totaltoltrazuril.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 at the internet address https://totaltoltrazuril.com/, 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 and product labeling that show the intended use of your product include the following:

From your home website at the URL https://totaltoltrazuril.com/:
• “THE SOLUTION IS TOTAL TOLTRAZURIL! GET THE SOLUTION! …GREAT FOR All your 4 legged companions…”
• “…Toltrazuril is the result of extensive research efforts to help treat EPM (equine protozoal myeloencephalitis) & Coccidiosis. Toltrazuril can be used `as both a preventative and a treatment for disease…”
• “…usually does not require follow-up treatment, even in advanced infections (after three to five days)…”
• “…the efficacy of the drug is independent from the severity of the infection…”
• “…Toltrazuril has a unique mode of action and there is no reason to be concerned with an adverse reaction or a drug-drug reaction. As Toltrazuril only has activity against protozoa, there is no effect on upset of intestinal flora and the formulation is very well tolerated…”
• “…It is recommended to repeat the treatment weekly for a couple of weeks. It is CRITICAL to clean the environment to rid it of coccidia…”
• “…Combats Coccidia Keep your animals safe from Coccidiosis!”
• “…Safe For Use No reported cases of this product ever harming or killing an animal”

From your webpage titled “Total Toltrazuril - Coccidiosis & Horse EPM Treatment” at the URL https://totaltoltrazuril.com/products/total-toltrazuril:
• “Total Toltrazuril – Coccidiosis & Horse EPM Treatment”
• “Total Toltrazuril is a preventative and treatment for both coccidiosis and equine protozoal myeloencephalitis (EPM)”

On your social media webpages at the URLs https://www.facebook.com/photo?fbid=650999707226061&set=pb.100069481117087.-2207520000, https://www.tiktok.com/t/ZT8xN9QR1/ and https://www.instagram.com/totaltoltrazuril/p/C0z17TfMiMm/:
• On your December 13, 2023, Facebook and Instagram posts: “…Total Toltrazuril effectively and safely combats Coccidia and eradicates EPM in your animals…”
• On your November 16, 2023, Facebook post: “…Toltrazuril is safe for a wide variety of animals, including horses, dogs, goats, sheep, chickens, cattle & more…”
• On your November 8, 2023, Facebook post: “…Toltrazuril is the result of extensive research efforts to help treat and prevent EPM and Coccidiosis in animals! …is easy to apply & is safe for your animals…”
• On your November 2, 2023, Facebook post: ”… Our solution acts as both a preventative and treatment against coccidiosis and EPM…”
• On your January 23, 2022, Facebook post: “…Having issues with Coccidia or EPM? We can help! DM for current coupon code! #toltrazuril #totaltoltrazuril #coccidiosis #epm…”
• On your November 8, 2021, Facebook post: “…adult chickens can also be infected with the disease and pass it on to other members of the flock through their droppings. Check our site for toltrazuril as a treatment and preventative…”
• On your October 29, 2021, TikTok post with an infographic that states “…EPM – COCCIDIA – COCCIDIOSIS Are these affecting your animals and CORID is not working? Try our Total Toltrazuril…”

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

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 684418” 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: info@totaltoltrazuril.com

 
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