07.15.15
The US Food and Drug Administration alerted Innovative Biodefense that its product claims for the Zylast antiseptic product line, including Zylast XP Antiseptic, Zylast XP Antiseptic Foaming Soap, and Zylast XP Antiseptic Lotion (collectively, the Zylast products) are unapproved drugs and in violation of the Federal Food, Drug and Cosmetic Act as currently formulated, labeled and promoted.
USFDA took exception to claims that the formulas were effective against a wide range of maladies including MRSA and Ebola. The Administration was particularly concerned about product claims made on the brand's website and Twitter accounts.
These claims included:
• "Zylast Eliminates: Norovirus (The Stomach Flu) 99.97% ... E. coli 99% ... MRSA & VRE 99% ... Cold & Flu Viruses 99%" (website); and:
• Zylast is more than 100 times as effective against the Norovirus as alcohol sanitizers ... " (Twitter).
USFDA took exception to claims that the formulas were effective against a wide range of maladies including MRSA and Ebola. The Administration was particularly concerned about product claims made on the brand's website and Twitter accounts.
These claims included:
• "Zylast Eliminates: Norovirus (The Stomach Flu) 99.97% ... E. coli 99% ... MRSA & VRE 99% ... Cold & Flu Viruses 99%" (website); and:
• Zylast is more than 100 times as effective against the Norovirus as alcohol sanitizers ... " (Twitter).