Essential Research, LLC – FDA Warning Letter, Jul 31, 2023

The FDA issued a Warning Letter to Amadeus Benitez and Arek Schmocker regarding their product, "Chocolate Rescue for Dogs," sold on www.chocolaterescuefordogs.com and social media. The FDA reviewed these platforms in July 2023 and determined the product is an unapproved new animal drug.

The product is deemed a drug under section 201(g)(1) of the FD&C Act due to claims indicating its intent to diagnose, cure, mitigate, treat, or prevent disease in animals, or affect their body structure/function. Claims like "quickly and efficiently encapsulates the toxins in chocolate," "at-home remedy for chocolate ingestion," and "end of chocolate toxicosis in dogs!" establish these intended uses.

"Chocolate Rescue for Dogs" is classified as a "new animal drug" under section 201(v) of the FD&C Act because it is not generally recognized as safe and effective. It lacks an approved new animal drug application, conditional approval, or index listing under sections 512, 571, or 572, rendering it unsafe (section 512(a)) and adulterated (section 501(a)(5)).

The FDA warns that marketing this unproven treatment could cause animal owners to delay appropriate veterinary care for a potentially life-threatening emergency. The company must respond within fifteen working days, outlining corrective actions, preventing recurrence, and