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Labelling
There is a particular extract that I want to use, but this extract is fresh herb/menstruum ratio: 1.33 : 1. Now my question is in two folds:
#1. In formulating, when using the extract, assuming you need 2%, would it be herb - 2% x 1.33 AND alcohol 2% x 1? I mean to use 2% of the herb wpuld mean 2 x 57.08% of extract. Or it should remain as 2% of the whole extract?#2. In labeling, would you declare the herb in the extract as just that or would you separate them?I mean such as Cinnamon extract or Cinnamon, alcohol, etc. -
7 Replies
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@braveheart I have had the same dilemma for quite a while now. For example, I was using Material A - Stearic acid and Palmitic acid - where Stearic:Palmitic is 38:62. Do I separate these two in the label?
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Water, Alcohol Denat, Passiflora Edulis Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract
@braveheart This is the INCI supplied by the supplier and I would think of it as one ingredient after deciding it’s place in my formula depending on the dosage. Anything repetitive in the INCI listing would be clubbed with those being in the main formula e.g. water being clubbed with water of the main formula or if ethanol is there I would club ethanol together. Below 1% you can put it anywhere you want as we all know.As for the query by crisbaysuli I think the supplier must have given the INCI name and and it can be mentioned as per the ratio of the product. Though if you see we have cetostearyl alcohol where generally it is 30 cetyl and 70 stearyl alcohol. But we dont mention it like that, we just use the term cetostearyl alcohol. -
@milliachemist, Thanks.
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At our company we would figure out the % activity of each component ingredient and list them as required by the LOI rules. So anything under 1% in the total formula would be listed in any order. Above 1% was listed in the order of concentration.
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We here at Beaumont operate under a different scheme. Since we are a FDA-registered manufacturer of OTC drugs and of cosmetics, we come under more frequent scrutiny by the FDA.
So, every ingredient we use has a dossier. One of the critical pieces of information in that file is a signed, official statement from the manfacturer listing the INCI name. We are allowed to rely on our suppliers - we don’t have to do any of the work ourselves, so the INCI name has to be whatever the supplier says it is. If we got a listing from a manufacturer like @milliachemist posted, we would have to list each ingredient separately, and in % order.The ingredient manufacturer is legally obligated to give you enough information for you to prepare an accurate LOI (but only after you have actually purchased the ingredient), although they are allowed to make you sign a NDA before they release it. -
@Bobzchemist you bring up an interesting question. If you are using a product that contains a chemical that isn’t declared on the INCI designation from the supplier, are we supposed to include that in the LOI?
I see this all the time where a supplier will provide documentation stating that the INCI for the product is simply “Super molecule X”, but the MSDS for the material lists things like Water, glycerin, ethanol, etc. I know that you don’t have to list preservatives that are at negligible levels, but what about carriers?
Here’s a fun exercise:Let’s say you wanted to bottle up and sell 100% Epitex 66 (from Dow) as a cosmetic.Here is the supplier literature:Note that the MSDS lists Water at 45-50% and Pentanediol at 1-5%What does your LOI look like? -
That’s a great question, @laskedbetter.
Discrepancies between INCI names on Tech Data Sheets and the information in MSDS Section 3, “Composition/information on ingredients” are the reason I insist on a signed, official statement from the manufacturer listing the INCI name(s). It’s one thing for a company sales department to put a partial INCI name on a data sheet - it’s quite another to have to certify the accuracy of the INCI listing in an official document on corporate letterhead signed by the head of their technical or regulatory department.To answer your question, my LOI would very probably look much more like the MSDS than the TDS - but either way, I’d have a credible document that I could show to the FDA proving that I listed everything on my LOI that the supplying company said was in there.
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