How do you do labels?

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... some soaps are cosmetics per FDA regulations, so labeling for cosmetics applies in those situations.
I would only agree with that statement to the extent that cosmetic claims are actually made, whether on the label or in the product description.

If no cosmetic claims are made, nothing in the ingredients themselves turns CP soap into a cosmetic. So @TheGecko my answer to your question is no, the mere addition of pumice, pine tar, goat milk, etc., without any cosmetic claims being made about said ingredient, does not turn your CP soap into a cosmetic that requires cosmetic labeling.
 
Okay, you're going to have to explain to me how 'pine tar soap' is "cosmetic". And how someone can challenge your soap as being "cosmetic" if you make no "cosmetic" claims to start with? I'm just imagining someone claiming that my GMS cured their eczema and now all of a sudden, my GMS, which is pretty much just my regular soap made with goat milk instead of water...is now subject to the time, expense and much stricter regulations. What kind of BS is that?!?

From the minute I decided to go from making soap as a hobby for my family (and maybe a few close friends), to turning this in a business and selling to the public, I've been doing the research, following the rules/law/guidelines. I follow reasonably good manufacturing processes...from storing my ingredients, to making the soap, to curing, to storing my cured soaps. I follow the rules for labeling my soaps (even after a year, my soap weighs more than the label says). I make zero claims for my soap...it's just soap, it will get you clean...end of story. It won't make you beautiful or hot or rich or popular. I don't tout the 'benefits' of any of my ingredients since I can't prove that any of said 'benefits' survive the saponification process. I could say that my Regular Soap is 'vegan' because it doesn't contain any animals products, but I don't even do that.

Now I'm worried about my "mechanics" soap. Does adding pumice powder change it from a 'true' soap to a 'cosmetic'?


I am sorry, I should have said, Pine Tar Soap is a drug, not a cosmetic. My mistake. Okay, now you can get riled up!

According to the FDA, it is not ONLY what you as the maker intends, but ALSO what the buyer expects.

This has been discussed here many times in the past, and it goes back to what the general public's perception is for a particular ingredient. Pine tar has been used for over 2000 years for medicinal purposes, and at least in the US, there is an expectation that pine tar or any other type of coal tar in soap is going to, at the very least, soothe the skin, at the other end of the public perception of this ingredient, it will treat psoriasis, eczema, and any number of skin conditions.

Here is a link to a statement from the FDA after another member wrote and asked for clarification for another kind of soap (shaving soap), which is a cosmetic according to the US federal regulations about what makes a soap a cosmetic:

https://www.soapmakingforum.com/thr...tions-re-ingredients.49159/page-2#post-459051
But, take a look at this part, specifically:


• Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

• Ingredients that may cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.



That comes directly from the FDA, and is still on the FDA website today, in spite of all the changes that have occurred as it continually gets updated and breaks links all over the place. I later wrote to that very same FDA agent for clarification and nothing has changed; every thing S. Wright said in 2014 was re-iterated again in 2019 via email to me.

Regarding Pine Tar as an ingredient in soap:

Pine tar as a medicinal ingredient per public perception:
https://www.psoriasis.org/over-the-counter/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5434829/
(Yes, I know there are contradictions between those two links, but public perception is the key.)

Pine tar has actually been banned by the FDA for use in cosmetics back in 1990:
http://pinch.com/skin/docs/fda/FDA-OTC-ingredients-ban
Take a look at this
link, which indicates that coal tar (and if the National Psoriasis Foundation's statement is taken as fact, then pine tar is also medicinal.

So really, pine tar in soap actually makes the soap a drug, despite what the soap maker intends, which a whole other can of worms. Even here at SMF, many many posts can be found about how effective pine tar soap is for our own members and spouses of members. Can any of us honestly pretend that denying pine tar has a reputation of helping skin conditions is going to suffice if the FDA shows up on our doorstep?

Food for thought.
https://www.soapqueen.com/business/a-surprise-visit-from-the-fda/
Here is an FDA document listing OTC ingredients that may be a clue as to what additives may require more stringent labeling on our soaps in the US:
https://www.fda.gov/media/75750/download
Regarding adding pumice to soap, yes, if you use the word exfoliate or similar, or your buyer expects exfoliation, that makes that particular soap a cosmetic. I am not sure if the general population in the US expect pumice to exfoliate, as much as I know they believe pine tar soap soothes the skin or helps treat skin conditions. But, I expect it does, so IMO, yes, it is a cosmetic.

But as I said before, if your labeling meets cosmetic standards, your label should not be an issue.
 
But, take a look at this part, specifically:


• Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

• Ingredients that may cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.



That comes directly from the FDA, and is still on the FDA website today, in spite of all the changes that have occurred as it continually gets updated and breaks links all over the place. I later wrote to that very same FDA agent for clarification and nothing has changed; every thing S. Wright said in 2014 was re-iterated again in 2019 via email to me.

This is a continuation of your quote above... Even essential oils can have a perceived therapeutic use... :oops: This is why I'm not selling soap. Too scared! All my family and friends that use my soap tell me I should sell and I'm always replying nope!

https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Both
How is a product's intended use established?

Intended use may be established in a number of ways. The following are some examples:

  • Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.
  • Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
  • Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.
This principle also holds true for "essential oils." For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug.
 
I am sorry, I should have said, Pine Tar Soap is a drug, not a cosmetic. My mistake. Okay, now you can get riled up!

Not riled up, just really confused and trying to do things right (and legal). I’m afraid I had never heard of Pine Tar Soap until Dr Squatch and thought it was just a FO like “Bay Rum”.

The purpose of the pumice powder is more ‘cleaning’ power. My BIL and his friends are all gear-heads...none of them like Lava or “orange” base cleaners that mechanics often use. But they all like my soap and had asked if I could do something to make it better for washing off grease and grime. My first test bars contained regular pumice and it was okay, but they wanted something that wasn’t quite as rough. Then I found pumice powder and they liked it much better.

I’ve done some research on ‘product liability’...it’s why I quit using walnut shells despite putting the ingredients in bold red letters. I knew I would win any lawsuit, but it would still cost me.
 
That was tongue-in-cheek, I should have added a smiley, but we don't have one that matches. And I couldn't find a free one online either.

I get it about the mechanics soap. The only reason I add pumice and borax to soap is for my brother the blacksmith. I designed it for him at his request for a better soap to get the stains off his hands and make it only for him. Although my husband and another friend also use it sometimes as well.

As long as you are marketing it only as a cleaning agent, and your customer only wants to get their hands really clean, IMO, it works. After all, what gets those grimey greasy stained hands clean is the friction of rubbing the hands together with the cleaning agent (in this case the soap which includes pumice) and then that gets rinsed off, leaving the hands clean. Exfoliation is not the goal of mechanics or a blacksmith. Their only goal is to get the dirt, grease, grime and any resulting tough stains off their hands. They don't walk around the store in search of 'exfoliating' products, at least not that I have heard. I did my research on blacksmith soap on the blacksmith forums and not once do I recall anyone talking about exfoliating as a goal. They just wanted the most effective product to get their hands clean faster. That's how I came up with adding Borax to my blacksmith soap; it's what was determined the most effective for some.

But as you said before, your goal is to do the labels correctly, and as long as they are, then I don't see any reason to be concerned.
 
I am sorry, I should have said, Pine Tar Soap is a drug, not a cosmetic. My mistake. Okay, now you can get riled up!

According to the FDA, it is not ONLY what you as the maker intends, but ALSO what the buyer expects.

This has been discussed here many times in the past, and it goes back to what the general public's perception is for a particular ingredient. Pine tar has been used for over 2000 years for medicinal purposes, and at least in the US, there is an expectation that pine tar or any other type of coal tar in soap is going to, at the very least, soothe the skin, at the other end of the public perception of this ingredient, it will treat psoriasis, eczema, and any number of skin conditions.

Here is a link to a statement from the FDA after another member wrote and asked for clarification for another kind of soap (shaving soap), which is a cosmetic according to the US federal regulations about what makes a soap a cosmetic:

https://www.soapmakingforum.com/thr...tions-re-ingredients.49159/page-2#post-459051
But, take a look at this part, specifically:


• Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

• Ingredients that may cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.



That comes directly from the FDA, and is still on the FDA website today, in spite of all the changes that have occurred as it continually gets updated and breaks links all over the place. I later wrote to that very same FDA agent for clarification and nothing has changed; every thing S. Wright said in 2014 was re-iterated again in 2019 via email to me.

Regarding Pine Tar as an ingredient in soap:

Pine tar as a medicinal ingredient per public perception:
https://www.psoriasis.org/over-the-counter/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5434829/
(Yes, I know there are contradictions between those two links, but public perception is the key.)

Pine tar has actually been banned by the FDA for use in cosmetics back in 1990:
http://pinch.com/skin/docs/fda/FDA-OTC-ingredients-ban
Take a look at this
link, which indicates that coal tar (and if the National Psoriasis Foundation's statement is taken as fact, then pine tar is also medicinal.

So really, pine tar in soap actually makes the soap a drug, despite what the soap maker intends, which a whole other can of worms. Even here at SMF, many many posts can be found about how effective pine tar soap is for our own members and spouses of members. Can any of us honestly pretend that denying pine tar has a reputation of helping skin conditions is going to suffice if the FDA shows up on our doorstep?

Food for thought.
https://www.soapqueen.com/business/a-surprise-visit-from-the-fda/
Here is an FDA document listing OTC ingredients that may be a clue as to what additives may require more stringent labeling on our soaps in the US:
https://www.fda.gov/media/75750/download
Regarding adding pumice to soap, yes, if you use the word exfoliate or similar, or your buyer expects exfoliation, that makes that particular soap a cosmetic. I am not sure if the general population in the US expect pumice to exfoliate, as much as I know they believe pine tar soap soothes the skin or helps treat skin conditions. But, I expect it does, so IMO, yes, it is a cosmetic.

But as I said before, if your labeling meets cosmetic standards, your label should not be an issue.
That list opens up a very big can of worms. On a quick scan, I found beeswax, caffeine, castor oil, citric acid, colloidal oatmeal, various sugars, iron oxide, many EOs, salt, sorbitol, and purified water. Context must come into play at some point.
 
That list opens up a very big can of worms. On a quick scan, I found beeswax, caffeine, castor oil, citric acid, colloidal oatmeal, various sugars, iron oxide, many EOs, salt, sorbitol, and purified water. Context must come into play at some point.

Context would be what it is being used for.

If you look at the columns 'monograph' and 'sub-category', that's the part I would look at to try and get an idea if a consumer might expect anything beneficial from the ingredient when added to soap. Personally I know better, as do most of us, in regards to the fact that soap is a wash-off product and there is little or no opportunity for any residual benefit of a minuscule amount of any ingredient in our soap. But does the general public know that? Well, we would expect them to if they were to give it much thought. But the evidence is that many don't. Otherwise, why would they buy soap that is supposed to lighten skin (papaya), soap that is supposed to relieve poison oak (jewelweed), etc? Maybe because they want them to, but also maybe because in some cases they do, or someone told them they do.

But back to the purpose of anything on that list when in soap vs when in a cosmetic or drug, which soap may or may
not be, in certain cases...

Take sorbitol, for example, in bath or hand soap it is not used as a digestive aide, laxative or demulcent (unless perhaps added to tooth soap, hmmm); it's used to support or provide bubbles. I don't think anyone is going to expect soap with sorbitol to do any of those medicinal things, particularly since it is not listed in soap as an Active Ingredient. The term 'Active Ingredient' is only used on labels for drugs, anyway, so unless a soap is being marketed as a drug, that phrase won't be on the label.

Another example, coal tars used as a hair-dye are given exception in cosmetics by the FDA based on the law that addresses coal tar hair dyes specifically (C.F.R. 21 § 740.18). And that is for dyeing the hair only, no other purpose of coal tar is exempted when it comes to its use in a FDA regulated product. When used for any other purpose, prior approval is required for drugs. Coal tar derivative dyes are either not on the list of FDA approved colorants for use in cosmetics, or they are hidden (to me) by virtue of some other nomenclature (but I don't think they are.)

Caffeine, however has made me wonder. Would a consumer expect coffee soap to stimulate them to be more alert when used for their morning shower? If I recall correctly, my husband wondered about that when I first started making coffee soap. Of course it didn't anymore than any morning shower would.


But many of those things on that list are used as color additives in soap, and as long as folks don't expect some cosmetic or medicinal effect from those ingredients, when labeling, I think (my opinion) using the term, 'Colorants:' followed by the names of the the colorants should suffice as compliance when it comes to color additives. Which as we know is not required for true soap, but as responsible soap makers we try to label appropriately.

Also useful as it pertains to color additives: Marie Gale's article Are Your Color Additives Legal? She is basically talking about cosmetics there, but at one point I briefly entertained the thought, maybe we could claim pine tar as a color additive in soap and not a medicinal ingredient, but I don't think that would fly, because it is generally used in amounts greater than 1%, which is way more than most of us use of any color additive anyway.

And another useful color additive reference: FDA Color Additives and Cosmetics Fact Sheet.

And then that whole thing of "Label Appeal"as it pertains to some particular ingredient? What do we mean by that anyway? Isn't that a vague way of thinking or saying, the customer might think this ingredient is special and will provide some benefit? I know, it's vague, but it does lean in the direction of customer expectations of intended purpose as an ingredient, which then lends weight to the FDA's statement that consumer perception is more important to classify a product than even our own intent? (Link again)

An interestingly, the FDA bases this intended use criteria on a Senate report from 1934, in which it was concluded that

The courts, in deciding whether a product is a "cosmetic", a "drug", or both a "drug" and a "cosmetic", have relied principally on the consumer's perception of the meaning of a label statement and less so on the interpretation of the meaning of a label statement by the labeler or a regulatory agency.
 
This is great information @earlene . Thank you for the time you spent to track it down and explain what it means. I don’t sell soap, but I’ve thought about. However, it’s easy to feel overwhelmed by how much there is to know and the potential liabilities. I think those issues might quickly take the fun out of it.
 
Thank you, Mobjack Bay. It's a pain the way the CFR reads. Searching it and finding clear-cut answers has always been a challenge. In my former life, toward the end of my nursing career, my job was to teach the staff how to comply with state, federal and accrediting agency regulations. It was a huge pain in the tush to try and decipher and reconcile them all to each other. Luckily, there are classes/seminars taught by the feds, the state agencies and even the accreditation agencies that taught any new major and minor changes in those regulations when they came out. If it hadn't been for those seminars, I'd have had a hard time figuring out the ins and outs of them all.

As a result of those years, I did gain a little skill in the process, although it is still just as hard to find information as it was back then. Maybe more so, because the FDA keep breaking links on their website and we have to keep searching of the same old stuff again and again and again, even when there aren't any changes to the regulations.
 
Ingredients: Olive Oil, Water, Coconut Oil, Palm Oil (RSPO), Sodium Hydroxide, Cocoa Butter, Shea Butter, Castor Oil, Sodium Lactate and Kaolin Clay. May contain Fragrance Oils and/or Colorants.
Just curious as to why sodium hydroxide isn't labelled as the first ingredient? Im new!

Also, ive heard Canva is good for label/sticker making, but i haven't used it yet, so i can't comment on it...

https://www.canva.com/en_gb/
 
. I know that in foods, the main ingredients are listed first. So i take it you don't need to put lye first on the list because it isn't in the final product?

Technically, nothing in my ingredient listing is in the final product because the saponification process has turned the fats and lye into soap.

I just saw that you are from Scotland, I’m in the US. I don’t know what the labeling standards are in your country, but in the US...whether it’s soap, shampoo, mayonnaise, coffee creamer, etc...ingredients are listed from the most amount to the least amount.
 
I know that in foods, the main ingredients are listed first. So i take it you don't need to put lye first on the list because it isn't in the final product?
What do you mean by “main” ingredients? All of the items listed before the lye on that label are “main” ingredients - the soap cannot be made without them.

And as Gecko noted, the ingredients are listed in the order of weight. Thus, the ingredients listed before the lye are there because they were used in a greater quantity (by weight) than the lye. This is the same way that food is labeled in the US.

Otherwise, if you aren’t going by weight, who would determine what is a “main” ingredient, and not a “main” ingredient, and what would be the basis for making that determination?

Again, all of the oils listed before lye were necessary for making soap when saponified by the lye. So are the oils listed after the lye. So all of them are “main” ingredients."
 
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What do you mean by “main” ingredients?
I assumed lye would be listed first, then the oils, because lye was the main ingredient that you start off with followed by water, and then oils.
And as Gecko noted, the ingredients are listed in the order of weight. Thus, the ingredients listed before the lye are there because they were used in a greater quantity (by weight) than the lye. This is the same way that food is labeled in the US.
This is what i didn't know, i didn't know it was done by weight.

I just saw that you are from Scotland, I’m in the US. I don’t know what the labeling standards are in your country, but in the US...whether it’s soap, shampoo, mayonnaise, coffee creamer, etc...ingredients are listed from the most amount to the least amount.
Ive just read online, the UK and the US are labelled the same. I don't know what i was thinking!
 
Sodium hydroxide isn’t in the soap anymore after curing, so it shouldn’t be mentioned as an ingredient. The inci names are the ingredients, like Olea Europaea for olive oil or cocos nucifera for coconut oil.
 
Sodium hydroxide isn’t in the soap anymore after curing, so it shouldn’t be mentioned as an ingredient. The inci names are the ingredients, like Olea Europaea for olive oil or cocos nucifera for coconut oil.
I see what you're saying, but i read that there's two ways of writing the ingredients and both are legal. You can either write olive oil, coconut oil, sodium hydroxide, etc. Or you write sodium olivate, sodium cocoate, glycerin, etc, without a mention of sodium hydroxide. Is that right? Just making sure.
 
I see what you're saying, but i read that there's two ways of writing the ingredients and both are legal. You can either write olive oil, coconut oil, sodium hydroxide, etc. Or you write sodium olivate, sodium cocoate, glycerin, etc, without a mention of sodium hydroxide. Is that right? Just making sure.
@AnnickAimee In the US, we have the option to list what goes into the pot, what comes out of the pot, or to list no ingredients at all if we are selling it as plain soap with no claims.

The problem with trying to list what comes out of the pot is that without expensive testing, one cannot say with accuracy exactly what is in the soap. For instance, which of the oils used (and how much of it) was left unsaponified as your superfat? How much glycerine was created during saponification? To accurately list what comes out of the pot, you would need to know the answers to both of those questions.

Perhaps in countries where testing is required before selling, one could state with more accuracy exactly what is in the finished soap. Such testing is not required in the US, and that is why most US soapmakers list what goes into the pot -- because they can say with certainty what those ingredients are, and list them in descending order by weight. :)
 
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