FDA WARNING_LETTER - samuel rodriguez - January 16, 2024

The FDA issued a Warning Letter to Samuel Rodriguez concerning the marketing of "Green Monster" (also known as "Green Juice") for treating animal diseases. The FDA reviewed the firm's website, kilokennelzz.com, in October, November, and December 2023.

The product is deemed a drug under section 201(g)(1) of the FD&C Act due to its intended use in diagnosing, curing, mitigating, treating, or preventing animal diseases, or affecting animal body structure/function. Claims observed on the website and product labeling, such as "PARVO," "COCCIDIA," "GIARDIA," "DISTEMPER," "KENNEL COUGH," "PNEUMONIA," "PYOMETRA," "MASTITIS," and "PRE BREEDING TREATMENT," demonstrate this intended use.

"Green Monster" is classified as an unapproved new animal drug under section 201(v) of the FD&C Act because it is not generally recognized as safe and effective by qualified experts. To be legally marketed, new animal drugs require an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act. Since this product lacks such approval or listing, it is considered unsafe under section 512(a) and adulterated under section 501