Blanc du Blanc, Inc. – FDA Warning Letter, Jan 22, 2014

On August 28, 2014, the FDA issued a Warning Letter to Blanc du Blanc, Inc. regarding their tear stain remover product, Angels' Glow, which contains tylosin tartrate, a macrolide antibiotic. An FDA inspection from January 8-22, 2014, at the Miami facility, along with a review of product labeling and the company website, determined the product is an unapproved new animal drug.

The FDA classified Angels' Glow as a drug under section 201(g)(1) of the FD&C Act due to its intended use for disease mitigation, treatment, or prevention in animals, and/or to affect animal body structure/function. Labeling statements, such as claims of eliminating "Ptyrosporin (Red Yeast), a bacterial infection," and being "100% tear stain free," supported this classification. The product was also deemed a new animal drug under section 201(v) because it is not generally recognized as safe and effective.

Since Angels' Glow lacks an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572, it is considered unsafe (section 512(a)) and adulterated (section 501(a)(5)). Introducing an adulterated drug into interstate commerce is prohibited by section 301(