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Is part of the FDA definition of a cosmetic, not (deep) penetration of the skin?
I have spent the day…researching skin penetration enhancement. A number of times, I came across statements to the effect (USA based), that if your product actually penetrated, you were quickly entering the realm of a ‘drug’.
Just curious…can anyone link me to this kind of statement on the FDA website? Mainly…I am looking for something to flash to the beginners I help…that all seem to think that skin is a sieve for all the scary ingredient soups they want to put together, and in reality, not likely to penetrate, without significant help. An FDA piece that helps them realize most of what they concoct legally, should only sit up on top….would be nice.
(I have NO intention of teaching them penetration enhancement….that was for me.)
For as interested as they are in making potions… they will put absolutely no effort into learning about skin. ????
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5 Replies
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What I am asking….in a nutshell is…. Is there any verbiage in the FDA’s description of a cosmetic….in relation to its ability, or lack thereof, to penetrate the skin?
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Think folks haven’t responded as this is something that many (and the FDA) would prob find problematic - waiting for the “so what” other shoe to drop. We/they know that lots of cosmetic ingredients penetrate skin, so “deeply” e.g. that they/their breakdown products are excreted in urine.
Is penetration here a stand alone claim - nothing further, even inference?
the definition addresses intent - what is intent of penetration - in label and ads AND in your internal correspondence.
“articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance“
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Yeah, I’ve not seen anything that specifically mentions penetration in terms of a definition of cosmetics. Just because something penetrates does not automatically make it a drug or problematic. The FDA does not really weigh in on the general concept of ingredient penetration. Cosmetics are just not allowed to have biological effects.
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Thank you for your response Dr Phil and Perry.
I was clearly aware of cosmetic products with significant penetrating prowess and design. Just wasn’t sure if they were dancing with the devil…or full within their rights. 🙂
Aloha.
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I’ll add that FDA regulation of cosmetics is about to change dramatically. Not just MoCRA but a whole new organization within the Agency will take on the category. It’ll take a couple of years before we know their attitude.
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