PhilGeis
Forum Replies Created
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In science AI risks profound BS..
A post on Researchgate raised my suspicions so I read a university educator’s most recent a published article. Checked a couple of references that seemed kind sketchy. Neither existed (not in Google Scholar or in the journal he claimed for them). Went on to find most of the references were fictional, and one that existed was misquoted. AI check of its abstract at three sites - all concluded it was AI generated.
Haven’t decided what I’ll do about it - it’s not in my field. BUT do not take AI as accurate.
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483 from last January. You can see a little of the relevant 483. Looks like real poor GMP’s - not even documenting making. Bet they were dinged for not following making SOP’s. Bet they blew off the agency.
https://www.fda483s.com/fdadocs/a-p-deauville-llc-easton-united-states-of-america-5/
They’re talking the AP product https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=927db52f-90c8-4f4b-a61d-b84cc5a38fe7
Deauville has been in trouble before https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ap-deauville-llc-586306-11082019
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These are drug products (antiperspirants) so FDA has more power of recall than for cosmetics. I’ll look for FDA’s documentation and get back to you.
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To what purpose? Micro testing, product stability?
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Can you tell us your formula, packaging, water source and pH.
As Jennifer said, you might preserve around phenoxyethanol. Not enough by itself and “microbiome friendly” is a BS claim.
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Again on the negative side - there are hundreds of publications - usually from academics - that would have some of the silliest preservative systems useful.
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Are these pure powder form or solution?
Of these hexyl resorcinol is most vulnerable.
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fda.gov
How to Report a Cosmetic Product Related Complaint
Bad reaction to a cosmetic? Please tell FDA!
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Check for micro contamination. Even if clean, your product is very poorly preserved.
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Prob need something for Fungi/Gram positives and EDTA if it works.
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Hopefully a pump or some other protective package.
Risk in making is process water and hygiene quality - somewhat mitigated by heat of process. Adding a preservative (as aq. solution) in cool down will likely not help.
W-in-O emulsions are fairly resistant to contamination in use. Primary risk would be water added in use and you can’t protect vs. that. 221 is weak but does target mold.
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describe packaging.
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What preservative(s) in what context (liquid, powder?). Consider adding to water phase.
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<b style=”font-family: inherit; font-size: inherit;”>Regulation (EC) No 648/2004, 1223/2009 addresses household and industrial “detergents” NOT cosmetics.
“Detergent” means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, moulded piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes.
- “Cleaning preparation”, intended for domestic all purposes cleaners and/or other cleaning of surfaces (e.g.: materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);
. “Washing” means the cleaning of laundry, fabrics, dishes and other hard surfaces.
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This is antiperspirant with excessive active - Aluminum chlorohydrate max is 25%. If irritation it’s probably this ingredient that you could eliminate - making it a simple deodorant. You’ll need a preservative..
No idea how you could defend “chemical free”.
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I asked ’em for data - let’s see what they say.
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Yes - Gram neg’s (esp.pseudomonads) can “eat” benzoate.
Walmart - yup. Walmart’s contract packer’s formula.
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Sorry - I can’t help.
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SLS and prob some other surfactants change the apparent pKa of Benzoic acid enough to preserve efficacy approaching 8. Used this in P&G shampoos.
Maybe these guys have found the same effect with polyamine. Wonder that it’s enough to function that well in finished product (even even at the recommended the 2-3% level).
https://www.sciencedirect.com/science/article/abs/pii/0001868689800028
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4 and with differing pKa’s
https://chemistry.stackexchange.com/questions/159581/acidity-and-structure-of-edta-at-different-ph
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It’s ok - was in soap biz for many years never used EDTA (may be Mike can comment) and of course you can/should use in emulsions e.g.https://incidecoder.com/products/olay-regenerist-micro-sculpting-cream.
Can destabilize some gels.
We used either, not both.
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The big guys invest in environmental assessments for product, package and each ingredient - that can include expensive testing. Considering the huge volumes and global coverage, this is a clear corporate responsibility. Looks like they’re trying to leverage that into a claim. Certainly more substance than clean beauty but feels strange claiming priority for a basic responsibility.
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Sorry! My error - was distracted with “Lotioncraft” and missed the PE. That should be a good system.
Still - have you checked for micro contamination? That is a reasonable source of rancid odor.
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These are separate and independent regulations
One regulates only household and industrial detergents products, NOT cosmetics . That is Regulation (EC) No 648/2004, 1223/2009 that only requires EDTA on ingredient labeling fs >0..2%.
EU Cosmetic Directive that regulates cosmetics NOT household and industrial detergents requires EDTA on ingredient label if added at any level.
If you question is why the difference? Who knows - there may be a record of consideration somewhere but the regulatory expectation is always that folks comply, not ask why.