While having nothing to do with my previous rants on the topic, the FDA has issued warning letters to the manufacturers of Angels’ Eyes and similar products that are vaguely disguised antibiotics sold for purely cosmetic reasons, and without a veterinary prescription. These products have been widely available to decrease tear staining (hardly a life-threatening problem) in dogs, fully at odds with any concepts of prudent antibiotic use.
Here’s some of the FDA letter text:
“We have determined that your tear stain remover products containing tylosin tartrate are intended for use in the mitigation, treatment, or prevention of disease in animals, and/or to affect the structure or function of the body of animals, which makes them drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)]. Statements on your labeling, including your website and product labels, that establish these intended uses of your products include, but are not limited to, the following:
• "The active ingredient in Angels’ Eyes®, Tylosin as Tartrate, will prevent your dog from contracting Ptyrosporin (Red Yeast) and bacterial infections which causes excess tearing and staining."
• "May help keep tear stains away by reducing oxidation released through tear ducts."
• "Angels’ Eyes® is the first product specifically developed for BOTH DOGS & CATS to help eliminate unsightly tear stains from the inside out!"
• "Only ANGELS’ EYES® helps give your pets tear stain free eyes and bright coats."
In addition, your tear stain remover products containing tylosin tartrate are new animal drugs, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. You are using Tylovet Soluble (tylosin tartrate) as an ingredient in the formulation of your product. Although Tylovet Soluble is an approved drug, your use of Tylovet Soluble in your product is not a use covered by its approved application, and your products are not the subject of 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 [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
We acknowledge the receipt of three written responses submitted after the inspection in December 2013. These responses discuss your facility’s compliance with the Current Good Manufacturing Practices for Finished Pharmaceuticals (Title 21 Code of Federal Regulations Part 211 ). However, your responses do not adequately address our concerns regarding the approval status of your products and your use of tylosin tartrate in those products, as discussed above.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products. “
Interestingly, there’s no mention of anything on the Angels’ Eyes website. It will be interesting to see what happens, but it’s great to see some attention paid to this completely illogical use of antibiotics. Hopefully the FDA follows through with this and doesn’t leave it at the warning letter stage.