What exactly are the regulations re: ingredients

[LBussy]

Man I give up ... I spend all day reading Healthcare regs. Can't do the FDA/CPSC right now.

Seriously though folks - I'm not trying to be argumentative (although I do realize I am being that), I just have a sort of weird thing about references. So far those don't tell me that Shaving Soap is absolutely not considered a soap but they do tell me that soap is absolutely exempt devoid of other claims.

 

[IrishLass]

I hear ya, and I don't hold anything against you. Trying to make sense of regs is a frustrating excersise in futility sometimes (well, most times, actually). It's almost as if they purposely write them that way because they secretly get their jollies from us not being able to get there from here, so to speak.

IrishLass

 

[SunWolf]

Thank you for the information and all of the links. I am just now looking into rules and regulations to determine if it's even worth the headache of trying to meet the gov. requirements to sell my soap at some point.

 

[wetshavingproducts]

Well, it's not at all clear whether shaving soap per se is a cosmetic since the relevant part of the FDA's decision is:

"(2) The product is labeled, sold, and represented only as soap."

Shaving soap is still soap regardless of how it's used. Since it's not used to cleanse the human body, none of the exceptions to the soap definition apply. So, it's not specifically addressed in that FDA decision unless it is considered soap.

Any further clarification on that issue is going to require finding a decision.


[br]
But, what about mislabeled ingredients lists? Are there any regulations regarding accuracy of the ingredients list in what is actually considered soap? So let's say I make a tallow soap with 1% kokum, shea, & cocoa butter. Then for marketing appeal, I say:

Made with: Kokum, Shea, & Cocoa Butters. Or Ingredients: Kokum, Shea, Cocoa Butter, tallow, water, lye.

The first could be considered advertising, yet still looks like an ingredients list. The second is clearly more deceptive.

Is that regulated?

 

[LBussy]

This seems to be the appropriate part:

21CFR§701.1 Misbranding.
(a) Among representations in labeling of a cosmetic which render such cosmetic misbranded is a false or misleading representation with respect to another cosmetic or a food, drug, or device.

(b) The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.

Part 701 applies if it is a cosmetic. I guess what I would question is if you have declared a soap as a defacto cosmetic if you label it as such?

 

[new12soap]

I do not understand the confusion. The FDA clearly states that in order to be classified as a soap, the item must meet 3 very specific criteria. 1) it must be composed mainly of the alkali salts of a fatty acid, 2) the cleansing action must be caused only by those alkali salts of a fatty acid (no synthetic detergents allowed), and 3) its intended use. It must be labeled and marketed for use only as soap.

Shaving soap is not labeled as just soap, it is shaving soap.

Shaving soap is not used to simply clean your skin.

Shaving soap is labeled, marketed, and has a commonly accepted and intended usage for a purpose other than cleaning the skin.

Shaving soap is a cosmetic.

There have been a lot of discussions here and elsewhere about exactly how and why a shaving soap is NOT just a soap. You can't just take a good shower bar and rub some on your face and shave with it. Well, you could, but most shavers don't really want to. You really can't take a good soap recipe and throw a little clay in and have a great shaving soap. A shaving soap MUST be formulated a bit differently, despite being comprised mainly of the alkali salts of a fatty acid, in order to be good at doing what it is going to be used for; shaving. Not cleaning. If it was just soap then shaving soap would not need to exist. The fact that its intended use is for shaving makes it a cosmetic.

I would absolutely encourage anyone to research any question they have and get accurate information from the governing body rather than take the word of even well-meaning folks on an internet forum. It's great to share common interests and information, but that is no substitute for going to the source.

Back to the OP's question, yes you can say "made with skunk oil!" on the label, but the list of ingredients you posted would indeed be misleading. Although you are not required to list your ingredients on soap, you are required to follow the CPSC regs, and if you choose to list ingredients you must do it correctly.

But don't take my word for it

 

[The Efficacious Gentleman]

Hah! You all think you have tricky regulation? Pop over the pond to where the real fun is.

I think the point has been made - the FDA say that a soap is for cleansing. No matter what else they say about salty-fats and so on, if it is not for cleansing then it goes beyond soap. Shaving soap is not for cleansing.

I doubt many artisans (and for many of them I use that term rather lightly) actually follow this.

so to the op, look to the cosmetic labeling info linked above

 

[wetshavingproducts]

Sorry, but I'm just not taking the word of a bunch of people on the internet. Until someone points out the decision classifying shaving soap as a cosmetic, it's a gray area and not regulated at the moment. Especially since it's marketed as soap. Shaving soap is still soap. Until the maker claims it is has any other property other than soap, it's soap.

the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

I'm sure the FDA and the consumer populace hasn't cared enough to get a ruling on the issue though.

Back to the OP's question, yes you can say "made with skunk oil!" on the label, but the list of ingredients you posted would indeed be misleading. Although you are not required to list your ingredients on soap, you are required to follow the CPSC regs, and if you choose to list ingredients you must do it correctly.

That seems like common sense, but it's not written in the regs. Where is it written? Is there a decision somewhere?

LBussy's got the right idea, but unless the soap is a cosmetic, it doesn't apply. It's narrowly written.

 

[The Efficacious Gentleman]

"Moisturizing soap" is still soap. But you'd need to label it as a cosmetic because it is intended for uses other than cleaning. Shaving soap has also been shown, on links provided to the FDA information, to fall in to this category of 'more than just soap'.

By labeling a soap with 'shaving' you are clearly showing it is not intended for cleaning, which you have already read on the FDA website causes it to be classed as a cosmetic automatically.

Eta - you did actually ask a load of people on the internet after all

 

[wetshavingproducts]

Now my curiosity is piqued. I'll be seeing what I can find about the definition of a cosmetic.

Eta - you did actually ask a load of people on the internet after all

Partially true. I asked a bunch of people for the regs, not for their interpretation of the regs. I would say I am more than capable of interpreting rules & regulations, and am probably a lot more qualified to do so than 98-99% of the US population.

 

[LBussy]

I do not understand the confusion. The FDA clearly states that in order to be classified as a soap, the item must meet 3 very specific criteria. 1) it must be composed mainly of the alkali salts of a fatty acid, 2) the cleansing action must be caused only by those alkali salts of a fatty acid (no synthetic detergents allowed), and 3) its intended use. It must be labeled and marketed for use only as soap.

It doesn't say cleansing action, it says "detergent properties" and I'd argue (really?!) that "detergent properties" would include creating lather. Nothing says cleansing, here is a direct cut and paste:

How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

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, and
the product is labeled, sold, and represented solely as soap [21 CFR 701.20].
Products that meet this definition of soap are regulated by the Consumer Product Safety Commission disclaimer icon (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC.

http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Soap

 

[The Efficacious Gentleman]

Also from that link, just a little bit further on from lee's section:
----
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product

consists of detergents, or
primarily of alkali salts of fatty acids, and
is intended not only for cleansing but also for other cosmetic uses,
it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin.
----------
So an example of a product that does not meet the definition of soap for the FDA purposes is a mix of alkali salts of fatty acids intended for a use beyond just cleansing. While they list some examples, it is not exhaustive as indicated by their phrasing.

Are we really saying that a shaving soap can honestly be said to only be intended for cleaning someone? If not, then it is not a soap according to the FDA information above.

That is not interpretation.

 

[LBussy]

Sure, just read the REST if the page.

What's wrong with just jumping to conclusions like everyone else?

 

[new12soap]

I was paraphrasing this page http://www.fda.gov/cosmetics/productsingredients/products/ucm115449.htm

I called the FDA, just for clarification, and the gentleman on the phone directed me back to that very page. He said this is what the FDA calls "the three prong test" for whether a soap is just a soap. If it meets all of those criteria then it is a soap and falls under consumer protection. If it fails to meet any of those three, then it is a cosmetic, even if it only cleanses.

 

[LBussy]

... in case it was not clear *I* was jumping to conclusions.

 

[wetshavingproducts]

The only part of the definition or test that is relevant to the discussion of shaving soap as we call it (other shaving soaps may not meet the first two) is the following:

How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label.

Unfortunately, the damn FDA uses the word soap to describe the word.... wait for it.... soap.... *sigh*

The following two sentences are an attempt at further clarification, but really don't clarify anything because they aren't part of the definition, but rather are examples given. So what we're left with is:

How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap.

I was going to try and explain the ramifications, but I am just going to leave it at that.

 

[new12soap]

From: "Wright, Shontell" <[email protected]>
Date: October 9, 2014, 11:14:43 AM EDT
To: (me)
Subject: RE: VCRP Question

Dear (me),

Shaving soaps are regulated as cosmetics.

The intended use of a shaving soap is aid the process of shaving similar to a shaving cream or foam. Shaving products are intended to smooth the face by lubricating the skin which allows a gentler shave.

For your information in the United States, products are regulated according to their intended use. FDA determines intended use by the way in which a product is marketed as a whole, not on a word or phrase taken out of context. Intended use may be established in a number of ways. Among them are--

• Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. As noted above, certain claims may cause a product to be considered a drug even if the product is marketed as if it were a cosmetic.

• 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.

Consider the following definitions to determine the regulatory status of a product according to the intended use:

• The term "cosmetic" means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.

• The term "drug" means 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.

Drugs and cosmetics are regulated differently. For example, drugs are subject to premarket approval by FDA and drug manufacturers are required to register their manufacturing facilities with FDA. Please direct questions about drugs to FDA's Center for Drug Evaluation and Research (CDER). You can contact CDER's Division of Drug Information, Small Business Assistance, directly at [email protected]. Or, you may contact CDER's Division of Drug Information with general drug-related inquiries at [email protected]. For more information on drug registration, see “Drug Registration and Listing System (DRLS & eDRLS)” at http://www.fda.gov/Drugs/GuidanceCo...mation/DrugRegistrationandListing/default.htm and “Electronic Drug Registration and Listing Instructions” at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm177328.htm.

If, after reviewing this information, you still have questions, please let me know. I will be glad to help.

Best regards,

Shontell Wright
VCRP Staff
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So there it is, spelled out directly from the FDA (Bolding added).

 

[LBussy]

Thanks for posting that, and finding someone to answer clearly.

It doesn't matter if it's right or wrong, we now have an opinion by an agent of the FDA so we can/should file that away and use it as an additional reference with the regulations.

 

[wetshavingproducts]

Thanks for posting that info direct from the agency. Something shaving soap makers need to know. I can think of at least one that isn't following the law...

 

[LBussy]

Well at least I know by giving things away I'm not required to do it (covered under "samples")

An interesting thing I saw looking through the lapels regs: If you are "mail order only" you can include a separate sheet with all of the information. If someone has a bunch of labels done, that's certainly a consideration till they run out of the "bad" ones.