Inspections, Compliance, Enforcement, and Criminal Investigations
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. Eliana Ellern
169 NE 44th Street
Miami, Florida 3 313 7
Dear Ms. Ellern:
This letter concerns your firm's powdered tear stain remover products, which are sprinkled on animal food, that contain tylosin tartrate, a macrolide antibiotic. The U.S. Food and Drug Administration (FDA) conducted an inspection on January 8-22, 2014, of your manufacturing facility located at 169 NE 44th Street, Miami, Florida 33137. 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://www.petsspark.coin/, accessed on June 5, 2014.
Unapproved New Animal Drugs
We have determined that some of your tear stain remover products including, but not limited to, your Pets' Spark Beef Liver, Chicken and Vegetarian flavors, Glow Groom, and Health Glow products 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 website and product labeling that establish these intended uses of your products include, but are not limited to, the following:
• "Pets' Spark is made with natural organic ingredients and is a powerful product that weakens bacteria until stains around the eyes are completely eliminated and unable to redevelop. By using our dog tear stain remover, you're able to treat the root cause of tear stains, thus killing dangerous bacteria at its source and removing eye stains in a long-lasting manner ... " (Pets' Spark)
• "It is a proven product that will work on the underlying cause to gradually stop the production of gooey discharge and tear stains." (Pets' Spark)
• "Supports healthy skin & coat. May also assist with bad breath." (Glow Groom, Health Glow)
In addition, these tear stain remover products that contain 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. To be legally marketed, new animal drugs require 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]. These products are not the subject an approved application or index listing. 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)].
Unapproved Food Additives
Your tear stain remover products that you offer for export, including, but not limited to, Sparkle Eyes and Clean Eyes are foods under section 201(f) of the Act [21 U.S.C. 321(f)] because they are articles used for food for animals. The tylosin tartrate used in these products is a food additive under section 201(s) of the Act [21 U.S. C. 321(s)] because it is a component of the food. Tylosin tartrate is not subject of a food additive regulation that prescribes the conditions under which the additive may be safely used. Therefore, these tear stain remover products containing tylosin tartrate are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)], because they contain a food additive that is unsafe within the meaning of section 409 [21 U.S.C. § 348] of the FD&C Act.
Exported Misbranded Drugs and Foods
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. You further stated that your customers are aware that the product contains tylosin tartrate. As a result, your Pets' Spark Vegetarian (blue label), Glow Groom, and Health Glow products that contain tylosin tartrate and are offered for export are misbranded drugs under section 502(e)(1)(A)(i) of the Act [21 U.S.C. § 352(e)(1)(A)(i)] and 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)], because they do not declare the established name of the drug, or the established name and quantity of the active ingredient. In addition, your tear stain remover products, including but not limited to Sparkle Eyes and Clean Eyes, that contain tylosin tartrate and are offered for export are misbranded foods under section 403(i) of the Act [21 U.S.C. § 343(i)], because the product is made of two or more ingredients and the label does not include the common or usual name of each ingredient.
We acknowledge the receipt of your written responses received March 5, 2014 and June 6, 2014. 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. 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