FDA WARNING_LETTER - Linessa Farms, LLC - June 11, 2024

The FDA issued a Warning Letter to Timothy John Ventrello regarding the marketing of unapproved new animal drugs, Blackout Five Pure Toltrazuril Powder and Blackout Five 5% Toltrazuril Solution, for treating coccidiosis in animals. The FDA reviewed the firm's website, https://linessafarms.com/, from December 2023 through May 2024, and found these products offered for sale.

The products are deemed "drugs" under section 201(g)(1) of the FD&C Act due to their intended use in the diagnosis, cure, mitigation, treatment, or prevention of animal diseases, or affecting animal body structure/function. Examples of claims cited include "treat and prevent coccidia in many animals" and "Toltrazuril is a coccidiostat used in sheep and goats to prevent coccidiosis."

These products are classified as "new animal drugs" under section 201(v) of the FD&C Act because they are not generally recognized as safe and effective by experts. To be legally marketed, new animal drugs require an approved new animal drug application, conditional approval, or index listing under sections 512, 571, and 572 of the FD&C Act. Since these products lack such approval or listing, they are considered unsafe under section 512(a) and adulterated under section