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  5. Linessa Farms, LLC - 684424 - 05/16/2024
  1. Warning Letters

WARNING LETTER

Linessa Farms, LLC MARCS-CMS 684424 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Timothy John Ventrello
Recipient Title
CEO
Linessa Farms, LLC

(b)(6)
United States

customerservice@linessafarms.com
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER

May 16, 2024

Ref: 684424

Dear Timothy John Ventrello:

This letter concerns your firm’s marketing of unapproved new animal drugs, Blackout Five Pure Toltrazuril Powder and Blackout Five 5% Toltrazuril Solution, for the treatment 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://linessafarms.com/, from December 2023 through May 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. 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 product labeling that show the intended use of your products include the following:

From your webpage titled, “Blackout Five Pure Toltrazuril Powder” at the URL https://linessafarms.com/product/blackout-five-pure-toltrazuril-powder/?attribute_amount=10+Gram:
• “…Blackout Five Pure Toltrazuril Powder… to help treat and prevent coccidia in many animals…”

From your webpage titled “Blackout Five 5% Toltrazuril Solution” at the URL https://linessafarms.com/product/blackout-five-5-toltrazuril-solution-400ml/?attribute_size=200ml:
• “…can be easily administered via oral drench and can be stored at room temperature…”
• “…to help treat and prevent coccidia in many animals…”

From your webpage titled “Coccidia Prevention Medications - Linessa Farms, LLC” at the URL https://linessafarms.com/coccidia-prevention-medications/:
• “Toltrazuril is a coccidiostat used in sheep and goats to prevent coccidiosis.”
• Image: “Blackout Five […] XXXXX […] Leading Toltrazuril Medication”

From your webpage titled “10 Pound Pack Bovatec 3 – Linessa Farms, LLC” at the URL https://linessafarms.com/product/10-pound-pack-bovatec-3/:
• “…For coccidiosis treatment, try Foundation Feed’s Blackout Five 5% Toltrazuril.”

On your social media webpage at the URL https://www.facebook.com/LinessaFarmsLLC/photos/pb.100064833035387.-2207520000/1530545100703262/?type=3:
• On your January 13, 2023, Facebook post: “…Don’t let coccidia hurt your gains this season! Read more about toltrazuril and Blackout Five 5% toltrazuril suspension!…”

Your products above 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, they 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. 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 684424” 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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