Arnold's Service Company, Inc. – FDA Warning Letter
On February 17, 2010, the FDA reviewed www.Arnoldservice.com and found the website offering unapproved products for sale, claiming to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. The products cited are: Guardian Air Purification System with PHI Technology; Vapco Killz-It Disinfectant Deodorant Swine Flu, H1N1 Bomb; and Vapco Killz-It Aerosol Disinfectant/Deodorant Broad-Spectrum Antimicrobial Agent.
These products are not approved, cleared, or authorized by the FDA for H1N1-related uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352. Examples of violative claims include "Stop Swine Flu, H1N1 viruses" and "99%+ inactivation of H1N1 Swine Flu virus!" for the Guardian Air system, and "completely kills Swine Flu" for Killz-It products.
The FDA emphasizes that the marketing of unapproved H1N1 products poses a significant public health threat, especially given the nationwide public health emergency declared for the 2009 H1N1 Flu Virus. The company must immediately cease marketing these products and within 48 hours, email FDAFLUTASKFORCECDRH@
- Product type
- Devices
ID · b5df78aa-78e1-47e4-b8d9-5e22e95dcff8
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