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WARNING LETTER
•Uv Flu Technologies, Inc.

Uv Flu Technologies, Inc. – FDA Warning Letter

Record Details

The FDA issued a Warning Letter to UV Flu Technologies after reviewing their websites, www.uvflutechnology.com and www.uvflutech.com, on March 23, 2010. The FDA determined that the company was marketing products, specifically the Viraguard UV 400 Air Purifier, with claims to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 Flu Virus in people. These products are not approved, cleared, or authorized by the FDA for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), 21 U.S.C. §§ 331, 351, 352.

Examples of violative claims include "Proven to Kill Airborne Pathogens including H1N1" and "Independent lab testing confirms UV Flu Technologies delivers 99% effectiveness eliminating viruses, bacteria, mold and allergens including H1N1 Swine Flu." The letter also notes that the Viraguard UV 400 is misbranded under 21 U.S.C. § 352(a) due to false claims of FDA approval on www.uvflutechshop.com.

The FDA requested immediate cessation of marketing unapproved/unauthorized H1N1-related products and removal of all statements suggesting FDA approval. The company was required to email FDAFLUTASKFORCE

Company
Uv Flu Technologies, Inc.
Product type
Devices
Office
Center for Devices and Radiological Health
Person
  • Timothy A. Ulatowski (Director)
View Company Profile

ID · 6fc2b580-2a59-48ce-b6c5-7c1dab301489

Violation Codes5
21 U.S.C. 33121 U.S.C. 35121 U.S.C. 35221 U.S.C. 360bbb-321 U.S.C. 352(a)

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