FDA WARNING_LETTER - Energetic Essences, LLC dba Pet Essences - November 12, 2024

The FDA issued a Warning Letter to Polly Fox concerning the firm's marketing of an unapproved new animal drug, "Seizures," for treating animal seizures. An FDA review of the petessences.com website in October-November 2024 identified the product as a drug under FD&C Act section 201(g)(1) due to claims indicating its use for diagnosis, cure, mitigation, treatment, prevention of disease, or affecting animal body structure/function. Specific claims included reducing seizure frequency/severity/duration, preventing seizures, managing them as they occur, and addressing physical symptoms like shaking and drooling.

The "Seizures" product is classified as a new animal drug under FD&C Act section 201(v) because it is not generally recognized as safe and effective by experts. Consequently, it lacks the required FDA approval, conditional approval, or index listing under sections 512, 571, and 572. This renders the product unsafe under section 512(a) and adulterated under section 501(a)(5). Introducing or delivering this unapproved and adulterated drug into interstate commerce is prohibited by 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.