Sep
3
2014

The FDA sent warning letters to three makers of tear stain remover products that the agency says are misusing the antibiotic tylosin tartrate.

The makers and their products named in this round of warning letters are:

According to the FDA, the companies have all included tylosin tartrate in their product formulations without taking the proper steps to seek regulatory approval. The companies also made claims on their websites and product labeling about potential health benefits of their products, such as how they can prevent excess tearing and staining, as well as contribute to brighter coats, the FDA said.

"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 FDA wrote in the warning letters. 

The agency also informed the companies that the specified products have been deemed unsafe and adulterated because tylosin tartrate "is not approved for use in dogs or cats, nor for the treatment of conditions associated with tear stains."

The FDA directed the companies to remove the specified products from the market, or else risk seizure of the products and/or injunction against the manufacturers and distributors.

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