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What qualifies as an incidental ingredient?
Say i buy a blend of various plant extracts that also contains maybe a polymer or propanediol or a preservative, etc. And then i use this blend in my formula at 0.1%, or even 0.01%. Could i then legally omit certain ingredients in that blend from my product’s LOI, and just keep the ones I like? When exactly does it become okay to omit something from your LOI based on it being an “incidental ingredient”?
I found the FDA’s guidelines about this in the regulations but it seems somewhat vague and open to interpretation.
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18 Replies
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@GeorgeBenson Even though there’s no amount specified in the FDA guidelines, there is some criteria to determine incidental ingredients, like processing aids (reaction catalysts, acidifiers/neutralizers, etc) or substances that at the levels present in the final product have no technical value (eg., the preservative from a botanical blend that is added at 0.1%, has no technical value in the final product because it’s greatly diluted).
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It is very simple … if the ingredients are listed in the INCI of the ingredient then you must list them in your formula. You, as an individual, do not have an option to determine if a component is incidental or not. The manufacturer of the ingredient will have determined what components are incidental by what is not included in the INCI
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@MarkBroussard
The language is clear and as read, does not appear to support your comment. Do you have case law or other relevant FDA perspective to share that establish the ingredient manufacturers’ labeling dictates finished product labels in this context?21 CFR 701.3
(1) Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient. -
As I understand it, you are required to disclose all of the component ingredients of the INCI of an ingredient. If not, then how does one who did not develop the multi-component ingredient have the expertise to determine what is or is not an incidential ingredient in multi-component ingredient if the manufacturer listed that ingredient in the INCI? Let me do some research.
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As far as I know, it’s at the discretion of the finished product guy to decide and defend.
Your thought would be a good one for those folks without technical insight,. -
MarkBroussard said:@PhilGeis:As I understand it, you are required to disclose all of the component ingredients of the INCI of an ingredient. If not, then how does one who did not develop the multi-component ingredient have the expertise to determine what is or is not an incidential ingredient in multi-component ingredient if the manufacturer listed that ingredient in the INCI? Let me do some research.
Under what loopholes do you think Luecidal products are working under? Guarantee they would not say…. Pure deception!
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Odd example of what we called “incidental” - Kathon CG has more Mg salt than isothiazolinone (~20% to 1.5%) and we (former employer) labeled only the antimicrobial.
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I have never personally applied for an INCI, but I have clients who have. So I am not certain when one applies for an INCI if it is just a paperwork exercise or if you need to present a compositional analysis of your ingredient as manufactured that is backed by appropriate analytical testing to validate the components.
In the case of someone who adulterates a product, you can simply apply for the INCI and then adulterate the product during manufacturing. Perhaps trace compounds are considered to be processing aids.
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MarkBroussard said:@Graillotion
I have never personally applied for an INCI, but I have clients who have. So I am not certain when one applies for an INCI if it is just a paperwork exercise or if you need to present a compositional analysis of your ingredient as manufactured that is backed by appropriate analytical testing to validate the components.
In the case of someone who adulterates a product, you can simply apply for the INCI and then adulterate the product during manufacturing. Perhaps trace compounds are considered to be processing aids.
What I meant to say….. is if you walked into their office and asked them how they justify their business model…. They would point to an FDA exclusion. I find it hard to imagine they have not at some point….had to defend their product/practice in court?
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I don’t know anything about how Leucidal is manufactured nor what its composition is. If there is a concern, the FDA could easily inspect their facilities and test the materials/products for composition.
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MarkBroussard said:@Graillotion
I don’t know anything about how Leucidal is manufactured nor what its composition is. If there is a concern, the FDA could easily inspect their facilities and test the materials/products for composition.
I’m just guessing that if they were to have to defend their product, say in a court, they would probably not use a defense of ‘a repeated tragic spill at the mfg facility’. I’m sure they will point at the FDA should the situation arise.
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This information is required for submission for INCI name and the INCI name is determined by a committee of experts:
The following info is required:
- Trade Name
- Suggested Nomenclature
- Chemical Structure
- Empirical Formula
- CAS Number
- EINECS/EC/ELINCS
- Chemical Synonyms
- Composition Statement
- Manufacturing Method
- Solvents or Diluents
Presumably, if a component was merely an incidental processing aid in minute quantities, it would not be included in the INCI name.
Amazing that a product manufacturer is allowed to exclude certain components in the INCI name of a multi-component ingredient from their product LOI at their determination that the excluded ingredient is an incidental. Why would “incidentals” be included in the INCI name to begin with?
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If we look at the philosophy of why ingredients are listed, they are for one main purpose- to alert consumers of ingredients to which they may be allergic.
if you use that as a guide you should be listing any extra added ingredient in a raw material.
ingredient lists should not be used as marketing tools.
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@Perry:
Take this INCI: Camellia Sinensis Leaf Extract (and) Helianthus Annuus (Sunflower) Seed Oil (and) Ascorbyl Palmitate (and) BHT
Apparently, even though BHT is on the INCI of this ingredient, meaning it is a component of the ingredient, if I understand correctly, I could claim that BHT does not perform a function in my finished product and not list BHT on my product LOI since I consider it to be an incidental.
If this is the labeling rule, then it provides the opportunity for even less transparency to consumers on exactly what compounds are in a product. Granted, the concentration of BHT in the end product would be negligible, it’s still in there.
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I would read that as you have to list BHT since you know it is put in the material.
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Getting back to @PhilGeis‘ point on the language in the labeling regulation:
21 CFR 701.3
(1) Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient.
In this case, there would not be enough BHT in the final product to have a functional effect as an antioxidant in the full product.It seems there is a disconnect between the ingredient components listed on the INCI and the labeling rule that seems to allow the end product manufacturer to declare a component in an INCI as an incidental in their product and not put it on the label.
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Not sure I’d label BHT - if not functional or significant to product safety.
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Things would be much simpler and much more transparent if the 1% rule were eliminated and you had to list all components of an INCI on your product label. But, I guess that won’t happen unless Sean Patrick Maloney is ever again elected to Congress.
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