PhilGeis
Forum Replies Created
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What is the cosmetic effect of these extracts? Do you have an in vitro assay?
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Here is the overall history of this and related monographs https://www.fda.gov/drugs/historical-status-otc-rulemakings/rulemaking-history-otc-topical-antimicrobial-drug-products#Consumer_Antiseptic.
The FR citation you offered addresses only one of these topical antimicrobial product monographs, specifically
This document covers only OTC
consumer antiseptic rubs that are
intended for use without water. This
document does not cover consumer
antiseptic washes (78 FR 76444, 81 FR
61106); healthcare antiseptics (80 FR
25166, 82 FR 60474); antiseptics
identified as ‘‘first aid antiseptics’’ in
the 1991 First Aid tentative final
monograph (TFM) (56 FR 33644); or
antiseptics used by the food industry.The FR offers a CDER contact person - Anita Kumar, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5445,
Silver Spring, MD 20993–0002, 301–
796–1032. You’ve best advised to contact Ms. Kumar. -
Not MIT - sensitization problems.
If phenoxy you’ll still need a counterpart to the “+” of Germall +.
Any more info on your growthj?
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Oneka is silly. I’m more familiar with PHMB but Biguanides are good for swimming pools, poor in cosmetics.
Phenoxy/EHG/chelator/Benzoate at that pH should be ok.
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As in MyMicrobiome and its imaginary “standards”? Largely meaningless - and nothing regarding the anticipated health beauty benefit claim that is also fictional.
https://www.mymicrobiome.info/en/tested-and-certified-microbiome-friendly-products
Looking at the claimed methods - either the MyMicrobome folks have made dramatic improvements in microbiology - or they’ll full of it.
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Please stop. The first isn’t natural and poor - the last two are fantasy.
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Can’t technical safety - but the EU directive doesn’t give any wriggle room.
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Can’t say why someone would use now but the term has been used in ref to EDTA around a century.
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You need to describe the product
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and water activity is not based on water % short of anhydrous. 4% has to be controlled.
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Should i assume this is a water in oil emulsion?
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Probably a better preservative capacity.
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Maybe it’s not a great problem - if only a little nontransparent at 5C that resolves when warmer. What will be the chances of consumers using/seeing it at 5C and will they be put off?
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ok
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You could look at similar marketed products but, to Perry’s point, you don’t know their risk assessment. If this is just for you - you can be arbitrary. If you plan to sell, (micro) safety is on you and a food grade preservative like parabens might give you a technically-defensible position.
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That’s the only water in your product. If you water quality is good, you will have a small weakness vs fungi.
Do you control its pH?
Assume you’ll not try to challenge test.
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No - the composition of the aqueous addition - 4 parts water to 3 parts glycerine?
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What is composition of aq. mixture?
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Not to be argumentative - but do you have that in depth understanding? Can you say what hormone do you have in mind and to what purpose. I’m certainly not much help in risk but think pharma can provide perspective..
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Thanks and good points. There is no lab test that replicates with validity in-use challenge - the paper merely observed the efficacy of preservative in context of package and offered in vitro challenge data that apparently identified that level of preservative efficacy. What isn’t shown is that all the preserved products would have passed USP 51.
I’m not aware of any in vitro test that considers preservation risk in context of package or, for formulas, manufacturing risk. That so many are happy with a “pass” in compendial tests is a major flaw in the industry - every recalled product passed a compendial test.
In-use risk is what keeps most of the big companies in classic systems. The EO’s, organic acids, esters, glycols, eyes of newt/toe of frog and “naturals”ecocerts in general do not give that level of assurance. You’ll see a few rare excursions from those guys - specific formulations carefully constructed to meet their criteria and satisfy marketing but nothing that can work financially or effectively across the lines.
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Thanks for your comments. Please recall the discussion was about consumer testing in effort to determine in-use protection of consumers as is the practice of industry scientists from larger companies . Brannan et al. was offered as an example of a protocol. The wide ranges of consumer practices, esp. in a global context are hard to replicate with validity in the lab.
Do I understand you’ve not conducted such a study on your system? I do suggest you consider such a protocol. In my experience, dilute soap esp. in shampoo context could be at risk.
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sorry - P&G - meant Procter & Gamble as in global Pantene, Head & Shoulder , Olay, Clairol, Old Spice, etc,
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Thanks Mike
The assurance is yours - here’s an example of how P&G condiucted consumer testing and caimed method and preservative validation. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987
This is not a question answered with preservative testing, GMP compliance or absence of consumer complaints. Consumer are unlikely to recognize contamination or attribute relevant infection to their cosmetics.
Yes - I managed P&G global microbiology for decades. These same practices I describe can be found at Estee, Unilever, Avon etc.