Warnings on shaving soap labels

[JackofallShaves]

All,

I am planning on selling men's shaving soap this summer. I have been trying to make sense of the labelling requirements for shaving soaps. I will be labelling my shaving soaps as cosmetics.

My question to all the experienced soapers out there is as follows - Is it necessary to list the 740.10 warning on the principal display panel? The warning text is "Warning - The safety of this product has not been determined."

When I read through this https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#clgc it does seem like it is required. See below pic and excerpt.

It also suggests, that the warning is not needed if the safety of the product has been adequately substantiated. Do I need to get a toxicology test done on my product prior to selling? It seems like safety of the product can be adequately substantiated by relying on available data for similar products. As most shaving soaps have a similar formulation, is there a repository of safety data available publicly?

Excerpt from FDA Labelling regulations


Cosmetics With Unsubstantiated Safety

Warning--The safety of this product has not been determined.

21 CFR 740.10

A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:

Warning - The safety of this product has not been determined.

The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.

The safety of a cosmetic can adequately be substantiated by:

a. Reliance on available toxicological test data on its ingredients and on similar products, and

b. Performance of additional toxicological and other testing appropriate in the light of the existing data.

Pic from FDA labelling requirements suggesting that the 740.10 warning is needed on the PDP.

 

[Kari Howie]

It’s shaving Soap. Why wouldn’t you label as soap? Isn’t it a rinse-off product?

 

[DeeAnna]

Shave soap is not simply soap. There is only one legally permitted purpose for soap that's simply soap -- to cleanse the body. If that's all you claim, then you only have to meet the labeling standards for soap that's simply soap.

If you claim anything more than that, it's not just soap. It's either a cosmetic (beautification claims) or a drug (medicinal claims).

Shave soap is used as a cosmetic, as cosmetics are legally defined in the US. It has to be labeled as a cosmetic.

I can't advise about the 740.10 warning -- sorry.

 

[Kari Howie]

Holy Smokes! A cosmetic?! How did anyone come to that conclusion?

 

[DeeAnna]

We talk about this fairly often, but usually in the context of people who want to know how to promote their soap as having medicinal benefits yet still sell it as plain old soap.

Selling soap as a medicine (cures, prevents, treats XYZ skin problem) isn't any more acceptable than selling it as a cosmetic (moisturizes, smooths, or beautifies the skin). If you want to sell soap as soap, you can only promote its ability to cleanse the skin.

Marie Gale has some very good articles and a book about this subject. Google her name and check out her website.

Also see https://www.fda.gov/cosmetics/cosmetic-products/frequently-asked-questions-soap

 

[Kari Howie]

We talk about this fairly often, but usually in the context of people who want to know how to promote their soap as having medicinal benefits yet still sell it as plain old soap.

Selling soap as a medicine (cures, prevents, treats XYZ skin problem) isn't any more acceptable than selling it as a cosmetic (moisturizes, smooths, or beautifies the skin). If you want to sell soap as soap, you can only promote its ability to cleanse the skin.

Marie Gale has some very good articles and a book about this subject. Google her name and check out her website.

Also see https://www.fda.gov/cosmetics/cosmetic-products/frequently-asked-questions-soap

Very enlightening! Thanks!

 

[JackofallShaves]

Thanks for the discussion thus far. DOes anyone else have knowledge OR an opinion on the 740.10 warning statement on cosmetic labels?

 

[DeeAnna]

You may have already seen this, but just in case --
See item 9 -- https://www.fda.gov/cosmetics/resou...mall-businesses-homemade-cosmetics-fact-sheet
Also see -- https://www.cir-safety.org/ingredients

I am wondering why you think your shave soap falls in this category -- "its safety has not adequately been substantiated..." ? Does it contain ingredients that are radically different than other shave soaps already on the market?

If it does contain similar ingredients as other shave soaps, why cannot this similarity be used to establish its safety? You do not have to specifically test your product if you can establish it contains ingredients also found in other products that are already considered safe.

Furthermore, you can document the safety of the product by looking at the toxicology and safety info in the material safety data sheets (MSDS or SDS) for each component of your shave soap. Sodium stearate. Potassium stearate. Glycerin. Water. Potassium oleate. And so on.

Maybe you'll think I'm stating the obvious, but I'll say it anyway cuz some people really don't know -- it's not the ingredients that go into the soap, the documentation should be on what comes out of the soap pot.

Here's one source of SDS -- https://chemicalsafety.com/sds-search/ -- but there are many others.

Chemical databases might also be helpful, if you have a science background. Here are two I use -- https://www.cdc.gov/niosh/npg/npgsyn-a.html and https://pubchem.ncbi.nlm.nih.gov/

If you use fragrance oils, check out the IFRA documentation available from some of the fragrance oil suppliers. Nature's Garden is a good one for this info.

 

[JackofallShaves]

@DeeAnna - thanks for your response, your insights have been extremely helpful!

My shaving soaps contain the usual ingredients - stearic acid, coconut oil, shea butter and castor oil. And as a result, relying on available safety data is exactly what I am trying to do.

I was browsing the CIR website and it contains an independent study of most plant based fatty acids/oils. For example, potassium cocoate and sodium cocoate are deemed safe. See below.

But as you can see , shea butter and stearic acid are listed just by themselves and not as their saponified versions. Shea butter is primarily a mixture of palmitic, stearic, oleic, linoleic and some other unsaponifiables. Shea butter unsaponifiables are listed as safe in the CIR document.

How can I prove that using shea butter is safe? Should I search for Sodium Stearate? Potassium Stearate? Sodium Oleate? Potassium Oleate? And so on, individually? Is there anything with the name Sodium Shea Butterate? I found the below safety info. on Sodium Cocoa butterate.

https://cosmeticsinfo.org/ingredient/sodium-cocoa-butterate

If yes, I am having a difficult time navigation Pubmed. For example, if i search for sodium stearate, the below shows up. What data on Pubmed should I use to conclude that this is safe for cosmetic use?

 

[DeeAnna]

"...Shea butter is primarily a mixture of palmitic, stearic, oleic, linoleic and some other unsaponifiables. Shea butter unsaponifiables are listed as safe in the CIR document...."

Okay, so what are you finding out about sodium palmitate, sodium stearate, sodium oleate, and sodium linolate?

"...I am having a difficult time navigation Pubmed..."

An image of the header of the Pubchem document isn't very useful. A link would be considerably more helpful. This is your quest, not mine, so make it easy on me, please, to get to the data you have questions about.

I kinda doubt Pubmed is going to outright tell you a chemical is safe for cosmetic use -- it's going to give you toxicological data or links to where you can find that data.

 

[JackofallShaves]

Sorry about including the image, I thought the image would be more useful plus I am total rookie at trying to make sense of Pubmed. I am a Computer Science major with a Physics minor, Chemistry has not been my forte.

Here are some links on Sodium Stearate, I am unable to make a conclusion based on #1, but page 49 in the PDF linked in #2 seems to provide conclusive info that Sodium Stearate, Potassium Stearate are safe.

1) https://pubchem.ncbi.nlm.nih.gov/source/hsdb/5759
2) See page 49 of this PDF - https://www.cir-safety.org/sites/default/files/Fatty Acids.pdf

One last potentially dumb question - if my recipe involves using Stearic Acid, Coconut Oil, Shea Butter and Castor Oil with a 60/40 KOH and NaOH lye combination will I end up mostly with the following in my soap?

From the Stearic Acid

Sodium Stearate
Potassium Stearate

From the Coconut Oil

Sodium Cocoate
Potassium Cocoate

From Shea Butter(the only reason I am breaking Shea butter into individual fatty acids is because I am unable to find any information on "Sodium Shea Butterate")

Sodium Stearate
Potassium Stearate
Sodium Palmitate
Potassium Palmitate
Sodium Oleate
Potassium Oleate
Sodium Linolate
Potassium Linolate

Some unsaponifiables(are these the Linolenic Acid and the Arachidic acid?)

From Castor Oil

Sodium Castorate
Potassium Castorate

Thanks for all the help thus far!

 

[TheGecko]

Why are you labeling shaving soap as a cosmetic? It’s soap right? You can wash with it? It’s just made to lather more which makes it great to shave with.

 

[DeeAnna]

"...Why are you labeling shaving soap as a cosmetic?..."

@TheGecko -- did you read the entire thread? We already discussed this. See post 3-6.

edit --
@JackofallShaves -- Some of this "is it safe" question can be answered by inference. As in if it's used in similar products, you can infer it is safe in yours.

For example, per Pubmed, sodium stearate is used in cosmetics and deodorant sticks (https://pubchem.ncbi.nlm.nih.gov/source/hsdb/5759#section=Uses)

You don't have to understand all the gobbledygook to make good use of Pubmed for your particular purpose. Just read the plain language parts and apply some common sense.

A quick google search for "sodium stearate msds" results in a MSDS from Acme-Hardesty that says -- ADDITIONAL INFORMATION: No adverse effects are known when used appropriately. Keep in mind this is for mass quantities of the chemical in warehouses and factories. (http://www.acme-hardesty.com/wp-content/uploads/2014/03/Sodium-Stearate-NF-Powder-MSDS.pdf)​

I get the feeling you are wanting iron clad promises and explicit statements of safety, and I don't think you're going to get that for each and every ingredient in your soap.

While I applaud your desire to answer this question fully and completely, I also wonder if you are borderline over-thinking this. Document the info you find from reputable sources as your basis for safety and that should be plenty sufficient.

 

[shunt2011]

Why are you labeling shaving soap as a cosmetic? It’s soap right? You can wash with it? It’s just made to lather more which makes it great to shave with.

Shaving soap is a cosmetic. It's made to do more than just clean. As stated in previous post above.

 

[JackofallShaves]

Thank you @DeeAnna.

My wife often tells me that I am very black and white and that might be contributing to, as you perceive it "over thinking" and "wanting iron clad promises".

I would definitely like to err on the side of caution. There are too many artisan shaving soaps on Etsy and some in my local farmer's market as well, that do not comply with the FDA regulations for cosmetics. Intentionally or unintentionally, that is a decision that they have made and I would not like to be part of the same group.

Based on my research, and the links shared in this thread(a big thank you!), I think I am ok as I can conclusively substantiate safety of my products via inference from the results of the CIR study AND other resources like Pubmed. I have documented these in a separate folder on my hard drive. As a result, I do not need to have the 740.10 warning on the PDP.

 

[DeeAnna]

It's a wise idea to document your train of thought so you don't have to reinvent the wheel if you are someday asked to justify your choices. I'm glad you're putting the effort into researching the chemicals in your products so you can feel more confident about your decisions. Well done!

 

[TheGecko]

did you read the entire thread? We already discussed this. See post 3-6.

Yes I did, which is why I asked, because in all that, no one said why shaving soap, which is clearly soap as defined by the FDA (the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds) is considered a cosmetic when you consider that ‘soap’ could be considered a cosmetic based on the FDA’s description: "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance".

I can see how shaving can “alter” one’s appearance if you’re shaving off a beard or mustache, but are altering your appearance if you shave everything day? Are you altering your appearance by shaving your pits? Sorry to be a pain, just trying to find where that ‘line’ is.

 

[DeeAnna]

Plucking, shaving, waxing, depilatorizing (or whatever the word is) are all cosmetic procedures designed to make the body look different -- to alter its appearance. Makes no difference whether we're talking about armpits, beard, legs, nether regions, or elsewhere -- the body appears different with hair removed than with hair present. It makes no difference if you shave everyday or get permanent laser hair removal or shave once a year or whatever -- the procedure of hair removal is a cosmetic procedure intended to alter the appearance of the body from its natural state.

 

[justjacqui]

https://cosmeticsinfo.org/ is a great website to find general and safety information about most cosmetic ingredients.