October 15, 2014


 FDA warns makers of unapproved ‘tear stain’ products

​Posted Oct. 1, 2014

Federal authorities have told three companies to stop selling unapproved products intended to remove stains under the eyes of dogs and cats.

None of the affected products are approved as drugs, yet all are marketed to treat conditions associated with “tear stains,” and some contain the antimicrobial tylosin tartrate, according to warning letters issued Aug. 28 by the Food and Drug Administration. If the companies continue selling the products, the FDA could seize those products and seek injunctions.

Tylosin is not approved for any uses in dogs or cats, an agency announcement states. And products are considered to be drugs if they are intended to mitigate, treat, or prevent any disease in animals or to affect the structure or function of animals’ bodies.

The warnings apply to the Angels’ Glow, Angels’ Eyes, and Pets’ Spark product lines sold in the U.S., as well as Clean Eyes, Sparkle Eyes, Glow Groom, and Health Glow products made for export. The Angels’ Glow products are made by Blanc du Blanc, the Angels’ Eyes products are made by I’m a Little Teacup, and the rest are from Petaware, all of which are based in Florida.

In the warning letters, the FDA cites statements from the companies that their products kill bacteria, eliminate infections, or treat conditions that cause stains on fur. The letter to Petaware also notes that the company had misbranded its exported Pets’ Spark, Glow Groom, and Health Glow products that contain tylosin.

“In a signed affidavit made during the inspection, you stated that you do not list tylosin tartrate on the labels of the tear stain remover products you export so that they are not detained by customs in the country receiving them,” the letter states.

And Petaware’s other exported products, Clean Eyes and Sparkle Eyes, did not include ingredient lists containing common ingredient names.