FDA WARNING_LETTER - BullyKamp Products LLC - July 31, 2024

The FDA issued a Warning Letter to Rogelio Ivan Hernandez and Luis Javier Hernandez concerning their firm BullyKAMP's marketing of unapproved new animal drugs, including The Antidote (Parvo Killer), Steroid Shot 5ML, Increase Litter Shot, Clavamox 5ML, and Bulldog Sauce. An FDA review of their website (bullykamp.com) in May and June 2024 revealed these products are offered for sale. The FDA determined these products are "drugs" under section 201(g)(1) of the FD&C Act due to their intended use in animals for disease treatment, prevention, or affecting bodily function. The products are deemed misbranded under section 502(o) of the FD&C Act because they have not been drug listed with the FDA. Furthermore, they are classified as "new animal drugs" under section 201(v) as they are not generally recognized as safe and effective. Since they lack FDA approval or index listing, they are considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Consequently, introducing or delivering these unapproved and adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act. The firm is required to respond within fifteen working days, outlining corrective actions, prevention measures, and supporting documentation. Failure to comply may result in legal action, including seizure or injunction. The FDA also advised reviewing other products, such as FishBiotic capsules, for compliance.