Ocubright Tear Stain Remover, Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

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, www.ocubright.com, and product labels, that establish these intended uses of your products include, but are not limited to, the following:

• “Epiphora often results in a discoloration caused by overflowing tears in certain dog and cat breeds***While some veterinarians recommend an operation to open the tear ducts, others feel the operation is unnecessary and also doesn’t guarantee that the problem won’t reoccur.***Once you’re able to observe the problem and rule out other causes of tearing that may be treatable, like allergic conjunctivitis, OcuBright is a safe and effective solution.”

Potential Health Risks

• “In just a few weeks tear stains disappear completely, without adverse side effects.”

Regulatory Context

This letter concerns your firm's tear stain remover products, including but not limited to OcuBright Tear Stain Remover RS200 Regular Strength, 30 count; OcuBright Tear Stain Remover RSS200 Regular Strength Super Saver, 60 count; OcuBright Tear Stain Remover ES300 Extra Strength, 30 count; and OcuBright Tear Stain Remover ESS300 Extra Strength Super Saver, 60 count that contain tylosin tartrate, a macrolide antibiotic. The U.S. Food and Drug Administration (FDA) conducted an inspection from February 24 to March 3, 2017 of your manufacturing facility located at 3500 Mystic Pointe Drive, Suite 3600, Aventura, FL 33180.  In addition, FDA's Center for Veterinary Medicine reviewed product labeling obtained during the inspection of your facility and your website at the internet address www.ocubr

• “Tear staining is a common, unsightly finding in many light-coated dogs.***Tylosin, a macrolide antibiotic, has been used in several oral preparations to help reduce or eliminate this discoloration. This medication is thought to bind/neutralize naturally occurring, organic compounds found in tears called porphyrins. While the exact mechanism of action remains unknown, it does appear to successfully reduce or eliminate tear staining, often within 6-8 weeks.”

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 tylosin tartrate as an ingredient in the formulation of your product. Although tylosin tartrate is an approved drug, your use of tylosin tartrate 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