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  5. Toltrazuril Shop - 684422 - 05/16/2024
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WARNING LETTER

Toltrazuril Shop MARCS-CMS 684422 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Yvette Pittman
Recipient Title
CEO
Toltrazuril Shop

4960 HWY 90, Suite 214
Pace, FL 32571
United States

info@toltrazurilshop.com
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER

May 16, 2024

Re: 684422

Dear Yvette Pittman:

This letter concerns your firm’s marketing of various unapproved new animal drugs containing toltrazuril, for the management of diseases in animals (specifically, treatment and prevention of coccidiosis and equine protozoal myeloencephalitis) in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The specific products are “Toltrazuril Shop Liquid Solution” 2.5%, 5%, and 10% and “Toltrazuril Shop Powder” 5% and are hereinafter collectively referred to as “your toltrazuril products”. The United States Food and Drug Administration (FDA) has reviewed your websites https://toltrazurilshop.com/ and https://toltrazurilshop.net/ from December 2023 through May 2024 and has determined that you offer these products for sale there. We have also reviewed your social media webpages at
https://www.instagram.com/toltrazurilshop/ and https://twitter.com/ToltrazurilShop which direct consumers to your websites https://toltrazurilshop.com/ and https://toltrazurilshop.net/ to purchase your products.

Based on our review of your websites and social media webpages, your toltrazuril 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.

Your unapproved toltrazuril products compete with legally marketed, FDA-approved drugs that are indicated for the treatment and prevention of coccidiosis and equine protozoal myeloencephalitis (“EPM"). Your marketing of these unapproved drugs in violation of the FD&C Act presents a disincentive for others to go through the FDA application/indexing process, which reduces the availability of legally marketed animal drugs which, unlike your drugs, have demonstrated that they are safe, effective, properly manufactured to ensure quality, and accurately labeled.

We are also concerned that you market your toltrazuril products for food-producing animals. In addition to raising potential concerns regarding safety for the animals themselves, toltrazuril products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of toltrazuril products by those animals and on safe levels of any potential residues for the human consumer.

Examples of claims FDA observed on your websites and social media webpage that show the intended use of your toltrazuril products as drugs include, but are not limited to, the following:

On your website at the URL https://toltrazurilshop.com/:
• “When it comes to safeguarding the health of animals, particularly in the fight against protozoal infections, toltrazuril has established itself as a pivotal medication. This antiprotozoal agent is revered for its ability to effectively treat diseases such as coccidiosis in a variety of animals, including horses, and is even utilized in the management of the challenging condition of Equine Protozoal Myeloencephalitis (EPM).”
• “Primarily used in veterinary medicine, toltrazuril is an essential treatment option for various parasitic infections that affect canines.”
• “No More Coccidia”
• “Keep your 4-legged pets free from Coccidia and EPM!”

On one or more of the product pages for your toltrazuril products (2.5%, 5%, and 10%) on your webpages at the URLs
https://toltrazurilshop.com/products/toltrazuril-coccidiosis-horse-epm-treatment-2-5-dogs-goats-cats-cows-pigs-camels-alpacas?variant=47678543888683,
https://toltrazurilshop.com/products/toltrazuril-coccidiosis-horse-epm-treatment-5-dogs-goats-cats-cows-pigs-camels-alpacas, and
https://toltrazurilshop.com/products/toltrazuril-horse-epm-treatment-10-solution-dogs-goats-cats-cows-pigs-camels-alpacas:
• “Toltrazuril Shop ... Liquid Solution, is a potent coccidiostat used to prevent and treat Coccidia & EPM in Horses, Dogs, Alpacas, Camels, Cats, Cattle, Dogs, Goats, Pigs, Reptiles, Rabbits, Bunnies and Sheep.”
• “Toltrazuril Shop 10% Liquid Solution, is a potent coccidiostat used to prevent and treat EPM in Horses.”
• “Usage: Toltrazuril Shop ... Liquid Coccidiosis Treatment, administered to combat coccidia infections in various animals, disrupts the developmental stage of the worm, Coccidia, which are single-celled obligate intercellular protozoan parasites.”
• “Action: Toltrazuril Shop ... Liquid Coccidiosis Treatment targets coccidia by inhibiting its development.”
• “Benefits: Toltrazuril Shop's productivity leads to lowering death...”
• “Dosage: ...A recent study showed that a single dose of Toltrazuril Shop cured puppies of coccidiosis.”
• “Conclusion: Toltrazuril Shop ... Liquid Coccidiosis Treatment proves to be a vital solution in managing coccidia infections across a diverse range of animals, including Horses, Dogs, Alpacas, Camels, Cats, Cattle, Goats, Pigs, Reptiles, as well as Rabbits and Bunnies. By effectively disrupting the developmental stages of Coccidia, this treatment not only promotes healthier lives in these animals but also contributes significantly to sustained agricultural productivity and animal welfare. Whether it's ensuring the health of household pets like dogs and cats, or supporting the well being of livestock and exotic animals, Toltrazuril Shop offers a comprehensive approach to combating this prevalent parasitic disease.”

On the product label for your toltrazuril powder (5%) product on your webpage at the URL https://toltrazurilshop.com/products/toltrazuril-coccidiosis-horse-epm-treatment-5-dogs-goats-cats-cows-pigs-camels-alpacas?variant=47614469767467:
• “Treatment and Prevention for Coccidiosis & EPM”
• “Usage: Administered to combat coccoidal infections in various animals. Toltrazuril 5% Liquid Coccidiosis Treatment mixes up the worm’s developmental stage.”

On your webpage titled “How Does Toltrazuril Work In Animals?” at the URL https://toltrazurilshop.com/pages/how-does-toltrazuril-work-in-animals:
• “More specifically, toltrazuril is known to interfere with the metabolic pathways of these parasites. By disrupting the division of the protozoal cells, it prevents them from proliferating within the host animal. This mode of action is crucial because it strikes at the root of the infection, thereby reducing both the immediate and lingering effects of the disease.”
• “For those in the equine industry, the term ‘toltrazuril EPM’ has become a beacon of hope. EPM, caused by protozoa like Sarcocystis neurona, can lead to severe neurological symptoms in horses. Toltrazuril, available from specialized suppliers like toltrazurilshop.com, has become a part of the strategic arsenal used by veterinarians to combat this condition.”
• “The application of toltrazuril extends beyond EPM. ‘Toltrazuril for coccidia’ is a phrase often encountered by those treating farm animals and pets for coccidiosis, a disease marked by intestinal distress caused by coccidian parasites. Toltrazuril's ability to impede the damaging lifecycle of coccidia makes it a highly sought-after treatment.”
• “Whether it's tackling coccidia or addressing the more complex EPM in horses, toltrazuril provides a strong line of defense against these debilitating infections.”

On your webpage titled “Toltrazuril 5% Liquid for Horses | Information and How To | Toltrazuril Shop” at the URL https://toltrazurilshop.com/pages/toltrazuril-5-liquid-for-horses-information-and-how-to-toltrazuril-shop:
• “Toltrazuril 5% Liquid, a potent EPM (Equine Protozoal Myeloencephalitis) treatment, finds extensive use in veterinary medicine, benefiting various animals, including horses. This versatile solution plays a crucial role in managing EPM infections, significantly contributing to the enhancement of equine health.”
• “Action:
    o With remarkable precision and efficiency, Toltrazuril 5% Liquid targets the complex life cycle of the EPM-causing protozoa.”
• “Benefits:
    o 1. Enhanced Equine Health: Toltrazuril's effectiveness reduces mortality rates and promotes healthier horses.”
On your blog titled “Coccidia in Puppies: Exploring Toltrazuril Treatment at Home” at the URL https://toltrazurilshop.com/blogs/blog/coccidia-in-puppies-toltrazuril-treatment-at-home:
• “Toltrazuril is a potent anti-protozoal medication commonly used to treat coccidia infections in puppies and other animals. It belongs to the class of triazines and works by disrupting the lifecycle of coccidia parasites.”
• “Toltrazuril interferes with the development of coccidia by inhibiting their ability to reproduce and multiply within the host's intestines. This action effectively reduces the parasite load and helps alleviate clinical symptoms.”
• “Studies have shown that Toltrazuril is highly effective in eliminating coccidia infections in puppies, with a success rate of over 95%. It provides rapid relief from symptoms and helps restore gastrointestinal health.”

From your Instagram social media webpage at the URL https://www.instagram.com/toltrazurilshop/:
• On your March 3, 2024, post:
    o “Toltrazuril 5% Defy coccidia & EPM - A Multi-Species Guardian”
    o “Toltrazuril Shop 5% Liquid Solution, is a potent coccidiostat used to prevent and treat Coccidia & EPM in Horses, Dogs, Alpacas, Camels, Cats, Cattle, Dogs, Goats, Pigs, Reptiles, Rabbits, Bunnies and Sheep.”
• On your February 15, 2024, post:
    o “Coccidia & EPM? Trust Toltrazuril For Horse Health - Coccidiosis & Horse EPM Treatment 5%.... for effective and convenient treatment. Our 5% Coccidiosis & Horse EPM Treatment is formulated to combat these debilitating conditions effectively.”
• On your September 22, 2023, post:
    o “Toltrazuril is a trusted solution in farming because it effectively fights coccidiosis, a common disease in livestock.”
    o “Toltrazuril also stands out for its lower likelihood of parasites developing resistance, making it a sustainable long-term choice.”
• On your September 18, 2023, post:
    o “Veterinarian’s [sic] trust Toltrazuril for healthier livestock.
1. Proven efficacy: Toltrazuril has a well-documented track record in preventing and treating coccidiosis in livestock. Veterinarians rely on us because it consistently delivers results, reducing the risk of disease and improving animal health.”
• On your August 14, 2023, post:
    o A picture of a lady sitting with a dog (both appear to be laughing) and a caption that reads “And then they said Albon is just as good as Toltrazuril!”

From your Twitter social media webpage at the URL https://twitter.com/ToltrazurilShop:
• On your March 3, 2024, post:
    o “Toltrazuril 5% Defy coccidia & EPM - A Multi-Species Guardian”
• On your February 15, 2024, post:
    o “Coccidia & EPM? Trust Toltrazuril For Horse Health - Coccidiosis & Horse EPM Treatment 5%”
• On your September 22, 2023, post:
    o “Toltrazuril is a trusted solution in farming because it effectively fights coccidiosis, a common disease in livestock.”
• On your September 18, 2023, post:
    o “Veterinarian’s [sic] trust Toltrazuril for healthier livestock. Here is why: 1. Proven efficacy”
• On your August 14, 2023, post:
    o A picture of a lady sitting with a dog (both appear to be laughing) and a caption that reads “And then they said Albon is just as good as Toltrazuril!”

Your toltrazuril 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]. 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

During our review of your websites, 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 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 684422” 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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