PhilGeis
Forum Replies Created
-
FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (emphasis added) .
Not claiming eyelash growth does not change the fact of intent. FDA will not let you play stupid but will assume intent unless you convince otherwise. You’d have to justify why this expensive ingredient is in your product, and they’d likely insist you demonstrate it is not having a drug effect.
-
Phosphate regs. To control eutrophication of lakes etc., misguided regulations banned phosphates in household products last century.
e.g. https://www.card.iastate.edu/ag_policy_review/article/?a=39
-
What is the formula? Soap can be contaminated - but it is rarely seen.
More commonly seen is wrapper (mold) contamination that also soils soap bar surface. Wrappers of major soap brands typically includes a preservative. -
what is pH? Be aware - you can’t sell this in the US.
-
Not aware of a “safe use” or “use by” provision for household products, esp. re. micro contamination. Can you share the regulation?
Household product preservation targets manufacturing contamination, not in-use contamination by consumers that is a concern for cosmetics.
Whether appropriate and required for household product or not, use by, ex dates or the moronic PAO should not be used to excuse unstable products. Why do you think no consumers will not be using your product one year after manufacture? -
Liquid dish soap is typically alkaline in pH and benzoate alone even at favorable pH by itself is a poor preservative . These products are typically preserved.
Consider Benzyl or Methyl isothiazolinone -
Use by date - on what would you base that and can you say more about “manufacturer guidelines.”
In what country will you sell?
-
Chelators are not equal. Like preservatives, subordinating a functional ingredient to serve a secondary claim is not without risk. All you have to judge is a PET test too blunt to dissect that risk.
-
For preservation (booster) - WITH a preservative. Those are good preservative systems and EDTA enhances.
-
For preservation - yes.
-
Bacterial spores and spores of many fungi will not be killed. There isn’t a good answer for speed of kill for other/vegetative cells but you can’t count on complete kill.
-
These are really poor “boosters” - esp. vs Gram negatives and their esterases.
-
What standard are you using for PET? Don’t think either USP 51 nor EP has relevant day 7 for what I’d assume is your category. Doesn’t change the need here for better preservation that might be better served with a paraben.
Suggest you review what’s used in marketed products - esp. US where I think 501k filling is needed.
-
Gamma irradiation is the best method for clay. Dry heat 180C for 2-3 hours would theoretically do it - if you get penetration and the material is dry.
Please don’t use “nasties” - no need for the mommy blog BS.
-
zetein said:@PhilGeis Can the cationic surfactant in conditioner be relied on for anti-microbial? If yes, what should the concentration and pH be?
Nope tho some might have a small effect, none adequately preserve. Note Downy and others with enough cationic to work through the wash still need preservatives.
-
Claim is at best mislabeled - they could call it “blessed” with the same accuracy. More importantly, how is it assured? Is there a rip off org like EWG that extorts to condifrm?
Confident that brief UN description took years, millions of dollars and extensive travel by authors to produce.
EU, US and major nations generate their own policy and those are largely picked up by smaller nations if they bother, not UN’s. -
Sorbate is so weak and the others are 100% useless as “preservatives”. This is not hurdle - it’s total BS.
Maybe they found this passed USP 51 - hardly a recommendation. One needs to design a system that should work and confirm efficacy with 51. 51 by itself is not a valid test for efficacy.
-
Sorbate alone is not useful and 0.1% is stupid.
Plastic - polyethylene? flip top or screw off?
Heat - how high and is it packed out hot/warm? -
Personal protection equipment for you - eye shields etc.
-
Use PPE
-
Your biggest issue is with Gram negatives. Wish you could use isothiazolinones - failing that phenoxyethanol or benzyl alcohol at ~0.5%. Don’t see too much purpose in multiple organic acids - DHA has the most favorable pKa but I worry about stability. Think you also need a chelator - EDTA, phytate.
What kind of process and package? -
pH ?
-
UN bureaucracy sticks its fingers in everything.
-
Dilute soap - any heat in prep? If water is in control and small batches, prob not with effective cleaning and sanitization.
If preservative needed - try benzoisothiazolinone (e.g. Proxel) or Gylcoserve (DMDM Hydantoin).