FDA WARNING_LETTER - Intermarket Industries Inc. dba Doc Ackerman Pet Products - January 07, 2025

The FDA issued a Warning Letter to Greg Mongrain concerning the marketing of "Doc Ackerman's - Epilepsy & Seizure Formula" for animals. The FDA reviewed the firm's Facebook account in October and November 2024, noting direct links to product sales on Amazon and Only Natural Pet Store.

The product is deemed a drug under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] due to its intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, and/or its intent to affect the structure or function of an animal's body. Claims observed on product labeling, Facebook, and third-party webpages, such as "Epilepsy & Seizure Formula… Remedies for Dogs and Cats," "anti convulsant & antispasmodic herb … specifically for Epilepsy," and "CAT AND DOG SEIZURE TREATMENT HOME REMEDY," indicate this intended use.

The product is classified as an unapproved new animal drug under section 201(v) of the FD&C Act [21 U.S.C. 321(v)], as it is not generally recognized as safe and effective by qualified experts. To be legally marketed, a new animal drug requires an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512,