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FDA regulations about sanitizer
In considering putting a hand-sanitizer on the market I saw that the FDA’s regulations have made an “exception” during the pandemic, but that to be in that category you can’t put essential oils or any fragrance materials in it.However I do want to include EO’s - so does anyone know whether I need to get an ID/FTIR test for each ingredient? I assume it falls under OTC regulations - are there are particular guidelines for labeling? I see that a lot of people are putting sanitizers with scent on the market right now, but I still want to be sure I am following the FDA rules. -
3 Replies
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You would have to follow the standard OTC rules if you want to deviate from the temporary compounding. So registration, manufacturing in FDA registered facility, testing, etc.
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Marit, all those folks are fooling themselves into thinking their products are legit, or they are just gaming the system while they can. EV told you right: read up on 21CFR, follow the monograph for SDA and register with FDA. You need only assay the ethanol to validate, and GC with flame ionization detector does that easily as does a density meter if you know how.
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Thank you for the input
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