FDA WARNING_LETTER - HDFrenchies LLC dba Bully Baum - November 12, 2024

The FDA issued a Warning Letter to Stephanie Schenk concerning the marketing of unapproved new animal drugs, specifically Bully Baum No Seize, Can-B-Gone - Cancer Oil Extract, and Brain & Neurological, sold via bullybaum.com. An FDA review from October to November 2024 determined these products are drugs under section 201(g)(1) of the FD&C Act due to their intended use for treating animal diseases and affecting animal body functions. The products are considered "new animal drugs" under section 201(v) as they are not generally recognized as safe and effective.

Crucially, these products lack FDA approval or index listing under sections 512, 571, and 572, rendering them unsafe (section 512(a)) and adulterated (section 501(a)(5)). Furthermore, the animal drugs are misbranded under section 502(o) because they are not manufactured in an FDA-registered facility and have not been drug listed as required by section 510. Introducing or delivering these unapproved, adulterated, and misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act. The FDA requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.