Inspections, Compliance, Enforcement, and Criminal Investigations
Blanc du Blanc, Inc. 8/28/14
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
Blanc du Blanc, Inc.
169 NE 44th Street
Miami, Florida 33137
Dear Ms. Ellern:
This letter concerns your firm's tear stain remover product, Angels' Glow, which contains 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.angelsglow.com/, accessed on June 5, 2014.
We have determined that your tear stain remover products containing tylosin tartrate, a macrolide antibiotic, 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 ingredients in Angels' Glow will eliminate any Ptyrosporin (Red Yeast), a bacterial infection which causes excess tearing and staining."
• "Your dog can be 100% tear stain free. Angels' Glow is the first and best product on the market that will eliminate unsightly tear stains from within."
• "Our active ingredient is a macrolide antibiotic considered as narrow-spectrum because it is active against only a few specific bacteria, therefore it will not develop imbalance or resistance in the animal's immune system."
• "Angel's Glow contains a dilution of Tylosin, a macrolide antibiotic, used to fight infections in dogs and cats. Tylosin is used in the treatment of disease in food producing animals, including beef cattle, swine, poultry, pigs, and all human feed [sic]. Since 1961, this treatment is approved by the FDA."
• "It is 100% safe for daily use and guaranteed to clear the tearing better than any other product on the market."
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. These 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 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