Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
August 28, 2014
Ms. Lynda Winkowski
I'm a Little Teacup
5271 NW 108th Avenue
Sunrise, Florida 33351
Dear Ms. Winkowski:
This letter concerns your firm's tear stain remover products, including but not limited to Angels' Eyes Beef Formula, Chicken Formula and Sweet Potato Formula, that contain tylosin tartrate, a macrolide antibiotic. The U.S. Food and Drug Administration (FDA) conducted an inspection on December 3 - 19, 2013, of your manufacturing facility located at 5271 NW 108th Ave., Sunrise, Florida 33351. 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 http://angelseyesonline.com, accessed on June 5, 2014.
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 tearstains 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.
This letter is not intended to be an all-inclusive review of your products. CVM noted that your company offers for sale additional tear stain remover products that do not contain tylosin, but have similar label and labeling claims that demonstrate their intended use as a drug. FDA may take enforcement action against these 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.
Please direct your response to Andrea Norwood, Compliance Officer, U.S. Food and Drug Administration at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Andrea Norwood at 407-475-4724.
Elizabeth W. Ormond
Acting Director, Florida District