I'm a Little Teacup – FDA Warning Letter, Dec 19, 2013

The FDA issued a Warning Letter to I'm a Little Teacup regarding its tear stain remover products, including Angels' Eyes Beef, Chicken, and Sweet Potato Formulas, which contain tylosin tartrate. An inspection was conducted from December 3-19, 2013, and product labeling, including the website, was reviewed.

The FDA determined these products are unapproved new animal drugs under sections 201(g)(1) and 201(v) of the FD&C Act, as they are intended for disease mitigation, treatment, or prevention in animals, or to affect animal body structure/function. Labeling claims, such as preventing "Ptyrosporin (Red Yeast) and bacterial infections" and "reducing oxidation," establish their drug intent. Although Tylovet Soluble (tylosin tartrate) is an approved drug, its use in these products is not covered by its approval. The products lack an approved new animal drug application, conditional approval, or index listing, rendering them unsafe per section 512(a) and adulterated per section 501(a)(5) of the FD&C Act.

The firm's responses regarding GMP compliance did not address the unapproved drug status. The FDA noted other tear stain removers with similar drug claims may also be in violation. The firm must respond within fifteen working days with corrective actions and documentation, or explain delays. Failure to correct