# Soap/cosmetic/drug Q's



## HeatherSage (Oct 12, 2008)

I just signed up today looking for someone to talk to !!! I have not yet met  another soap maker and am getting frazzled with all this reading about the FDA and etc.  


It is my understanding that for soap, I do have to list ingredients on my soap ( once or twice?) .  I would love to chat with a seasoned soap business owner help break in down for me in a more personal way, once I think I understand another paragraph confuses me.  Thanks to all!


----------



## Tabitha (Oct 12, 2008)

It is my understanding that if it is just soap, and you make no claim you do not have to list ingredients, but if you do list 1, you must list them all. EX) If your label says soap w/ goat's milk, you listed one ingredient so you must list them all.


----------



## Tabitha (Oct 12, 2008)

Here is where you will find most of the info you need about labels:



http://www.cfsan.fda.gov/~dms
Is It a Cosmetic, a Drug, or Both? 
(or Is It Soap?) 


http://www.cfsan.fda.gov/~dms/cos-lab1.html
Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States. 

Cosmetic Labeling Regulations as Published in Title 21, Code of Federal Regulations, Sections 701, 740 and Other Pertinent Sections. 

Cosmetic Labeling Guide.


----------



## Soapmaker Man (Oct 12, 2008)

Tabitha said:
			
		

> It is my understanding that if it is just soap, and you make no claim you do not have to list ingredients, but if you do list 1, you must list them all. EX) If your label says soap w/ goat's milk, you listed one ingredient so you must list them all.



Hi there, HeatherSage, and welcome to our friendly soap forum!  
Tab answered your question completely correct.  Also, you may not make any medical claims.  For example, you cannot say "cures dry skin"  or "prevents psoriasis" as these are medical conditions and fall under FDA guidelines.

Welcome to TSMF again.

Paul


----------



## BubbleBitch (Oct 12, 2008)

Thank you for sharing this! :twisted: 

I intend to label clearly, the ingredients of my soap and not make any claims as per medicinal values.

I was wondering though, I wish to approach some small stores in my country about carrying my soaps...nothing fancy, a couple mall kiosks and whatnot, do I have to certify my soap in anyway?

Like, if even after I make the soap, and use it myself, and I list the ingredients, suppose someone uses it and has a poor reaction to it health wise, what is my liability, how do I protect myself as a fledgling, novice businessperson?


----------



## Tabitha (Oct 12, 2008)

I do not know what the laws are like in your country but it would be wise to get insurance for your soapmaking. You could be taken to court & lose everything.


----------



## BubbleBitch (Oct 13, 2008)

I will look into this.


----------



## HeatherSage (Oct 13, 2008)

Thank you both so much.  I love making soap and thats the easiest part !   I just havn't found any examples of handmade soaps in any stores that i went into ( i am a visual learner)  the internet has given me a lot of help but its easy to list ingredients on the net, trying to find the most reasonable way to list in my shop.


----------



## Tabitha (Oct 13, 2008)

I would go over to etsy.com & see how some of those soap shops list their items.


----------



## Healinya (Oct 13, 2008)

I'm curious - you can't say it 'cures dry skin' or 'helps with psoriasis'. But am I correct in thinking that you can mention 'many of my customers say that it is a miracle solution to their dry skin and psoriasis' (or something of that nature)?

From a few different jobs I had, I remember always having to put the phrase 'what I would if I were you, is....." rather than telling them what to do, to avoid a lawsuit.


----------



## HeatherSage (Oct 13, 2008)

Tabitha said:
			
		

> I would go over to etsy.com & see how some of those soap shops list their items.




Great place, thank you.  I am getting closer and closer !


----------



## mandolyn (Oct 17, 2008)

Healinya said:
			
		

> I'm curious - you can't say it 'cures dry skin' or 'helps with psoriasis'. But am I correct in thinking that you can mention 'many of my customers say that it is a miracle solution to their dry skin and psoriasis' (or something of that nature)?



You're still "implying" that it does such-and-such, & that implication moves it into an arena other than just plain soap that gets you clean.


----------



## beachgurl (Oct 18, 2008)

It took me awhile to understand and here's how I think of it:

My soap cleans your stinky behind ... doesn't fall under FDA guidelines, but is instead regulated by the Consumer Product Safety Commission and you do not need to list your ingredients except in cases like stated above. 

My soap is moisturizing ... now you're going into the realm of cosmetics which IS regulated by the FDA and as a result, you have to name your ingredients.

My soap cures psoriasis (sp??) ... now you're moving into the realm of drugs and it is subject to FDA testing and drug labeling requirements (look at the back of a bottle of Noxema or something ... the whole active ingredients thing).  This is a really quick way to get into some serious trouble if you don't have the capital resources to adequately test according to FDA guidelines.


----------



## ironbrewer (Jan 12, 2010)

beachgurl said:
			
		

> My soap is moisturizing ... now you're going into the realm of cosmetics which IS regulated by the FDA and as a result, you have to name your ingredients.



I've been wondering about this, so I dredged up this old thread. Can you in fact say that your soap is moisturizing and only have to list the ingredients. I'm planning on making shaving cream and soaps. It would be great to say it makes great lather and is moisturizing without having to get into the FDA drugs stuff. I couldn't figure this out reading the guidelines. I don't want to say it cures any conditions.


----------



## dagmar88 (Jan 12, 2010)

First of all, soap isn't moisturizing; it's cleansing. It's just that, depending on how you formulate your soap, some soaps are less drying.

Please read the article, "is it a cosmetic, a drug or both (or is it soap?) at 
www.fda.gov/cosmetics/guidancecomplianc ... 074201.htm to be well informed.


----------



## ironbrewer (Jan 12, 2010)

dagmar88 said:
			
		

> First of all, soap isn't moisturizing; it's cleansing. It's just that, depending on how you formulate your soap, some soaps are less drying.
> 
> Please read the article, "is it a cosmetic, a drug or both (or is it soap?) at
> www.fda.gov/cosmetics/guidancecomplianc ... 074201.htm to be well informed.



I've actually read that exact article a few time, and was still unsure about it. There are quite a few soaps especially shaving soaps that claim to be moisturizing. Maybe they cleanse and then add back moisture from superfatting?? I'm sorry if I offended you with my question.


----------



## dagmar88 (Jan 12, 2010)

I'm not that easily offended   

to quote the FDA:
_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].

If a cleanser does not meet all of these criteria...
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, such as beautifying or moisturizing,
it is regulated as a cosmetic.*

How does the law define a cosmetic?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "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" [FD&C Act, sec. 201(i)]. Among the products included in this definition are *skin moisturizers*, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product._

So, it is up to the way you want to market yourself. As long as you just label your soap as 'soap'; you don't have to deal with cosmetic guidelines and regulations. 
There's nothing wrong with being well informed though...
When you label that same soap as moisturizing is becomes a cosmetic and when you market it as soothing or healing, it becomes a drug.

IMO, there are no moisturizing soaps. Soap cleans; it doesn't prevent or treat dry skin. Even generously superfatted soap still cleans.
There are quite a few people who caim just about anything. That doesn't make what they state more correct or less profitable


----------



## Tabitha (Jan 12, 2010)

As stated above, soap does not add moisture. 99% of all soaps are drying so when you run across one that does not dry you _think_ it's added moisture when all it did was leave the moistire on your skin it already had.


----------

