“In the US, Nasodine will be promoted for ‘nasal hygiene’ without any therapeutic claims. Based on legal advice obtained by the Company, this allows Nasodine to be marketed without FDA approval. Since 2020, multiple PVP-I nasal sprays have been introduced in the US and continue to be marketed this way.”
Interesting they have gone for no claims and this means no FDA approval needed. Could Viraleze using UK packaging have done the same ❓
see
https://thesentiment.com.au/firebricks-nasal-hygiene-spray-launched-in-the-us-without-fda-approvals/
Could this happen to Viraleze with marketing approval, page-2
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