| FDA Labeling Requirements
Submitted by: Anne
Tues, Feb 01, 2000
Just talked to the FDA about labeling and the controversy over how you list ingredients (eg, all raw materials vs saponified names of oils). Per Richard Jewel, a 'compliance person' of the Cosmetics & Colorings Divison, in all the various 'sections and subsections' of the regs, there is leeway for doing it either way.
In the 'general provisions', 'ingredient' is defined as 'any single chemical entity or mixture that is used as a component in the manufacture of a cosmetic product', and the term 'manufacture' as 'the making of any cosmetic product by chemical, physical, biological or other procedures...'. In other words, the FDA fully anticipates that manufacturing processes may be chemical & that ingredients may change into something other than what they were at the beginning. So, it's perfectly proper to list sodium hydroxide, water & various oils, such as palm oil.
Since many cosmetic soap firms buy premade base from others to remill, though, they might use 'sodium palmate',etc, because they're buying soap premade, and, to them, that is an ingredient. That's the major reason these saponified names are listed in INCI, the guide to ingredient names for cosmetic makers. However, there is another subsection that says you don't necessarily have to list something that gets used up in the manufacturing process - in our case, sodium hydroxide. This would imply it's also okay to list what's left in the soap, instead of what went in. Only difficulty here is that there will also be, at the end of the process, a certain amount of oils left (if you're superfatting), plus glycerin, and it's hard to determine the predominance of those.
But anyway, the official word from the FDA is that either methodology - either listing raw materials - separate oils, sodium hydroxide, etc, OR end result - saponified names ('sodium palmate') is okay with them - neither is wrong. Pass this along to anyone you think might be interested, or any site that declares that there's only 'one way'.
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