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	U.S. Food and Drug Administration 555 Winderley Place, Suite 200 Maitland, Florida 32751

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION

WARNING LETTER

FLA 17-10

May 16, 2017

Yoram Yogev, Owner/President
Ocubright Tear Stain Remover, Inc
3585 NE 207th St. Ste 617
Aventura, FL 33280

Dear Mr. Yogev,

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.ocubright.com, accessed on March 21, 2017.

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.”

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

• “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 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 receipt of your written correspondence dated March 24, 2017. Your response does not adequately address our concerns regarding the approval status of your products and your use of tylosin tartrate in those products, as discussed above. 

This letter is not intended to be an all-inclusive review of your products. FDA may take enforcement action against products at any time if they are found to be in violation of the FD&C Act. It is your responsibility to ensure that all of your products are in compliance with the FD&C Act and its implementing regulations.

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.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed.

Include copies of any available documentation demonstrating that corrections have been made.

Your firm’s response to this letter should be sent to: Florida District Office, ATTN: Andrea H. Norwood, 555 Winderley Place Suite 200, Maitland, FL 32751.  If you have any questions about the contents of this letter, please contact: Dr. Norwood, Compliance Officer, at 407-475-4724.

Sincerely,
/s/
Susan M. Turcovski
Director, Florida District