I have been doing a lot of reading of what you can and cannot put on a soap label. Since my soap is not "pure soap" and it falls under the cosmetic category, I know you have to be careful with terminology as far as making claims of not saying it cures any diseases, affects the body in any way, etc. I noticed terms such as moisturing, skin-loving, hydrating, etc. are okay go go with. For those more experienced soap-makers, does anyone have an opinion if you say your bar "removes excess oil." Saying this, not sure if this is implying anything that would raise a flag. Or, if your soap bar name is say "Turn Back Time", with this be considered an inuendo of sorts to imply it's anti-aging, which I know is a flag. Thanks folks!
Define what you mean by not being 'pure soap'?
Here is the FDA's (food and drug administration) regulatory definition of soap:
- What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
- What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label.
- 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.
A product is a 'cosmetic' is the purpose is to make one more attractive or change one's appearance ie makeup, moisturizers, hair dyes, perfumes and colognes, nail care, shave creams. If the product is intended to affect the way a person's body works (remove excess oil), or to treat or prevent a disease (anti-aging, eczema), it's a drug.
While the FDA does not require licensing for cosmetics and registration is voluntary, it does fall under the FD&C Act and you have the legal responsibility for the safety and labeling of your products.
To start with, labeling requirements are more stringent for 'cosmetics' than for 'true soap'. As an example my Ingredients label (NOT legally required for True Soap) says: "May contain fragrance and colorants". On the other hand for my Bath Salts my Ingredients label say: "Lavender 40/42 Essential Oil, Mica, Titanium Dioxide, Iron Oxide and Manganese Violet". Also, the rules for color additives are more restrictive...they must be approved by the FDA and be from batches certified by the FDA. It's not enough for color additives to be 'body safe'...if the product is going to be used on the face, you need to make sure that it is lip and eye safe.
You also need to includes 'use' instructions on your label. Everyone knows what 'soap' is for and how to use it so I don't need to put instructions on the label, but Bath Salts I have instructions: "Add 3 or more scoops to the bath tub whilst filling with warm water. Once the salt has dissolved, sit back and relax." I also have a 'WARNING
': "For external use only. Keep out of the reach of children.
And while you should be following GMP (good manufacturing practice) even if you are only make 'true soap', it's a completely different ball game once your products fall under the FDA. Looking at excerpts from FDA's Inspection Operations Manual
is the reason why I am still only making True Soap at this time. Mind you, the FDA doesn't have a list of tests required for any particular cosmetic product or ingredient so you are okay with not following Item 6, but you are still responsible for your ingredients and product. Many people assume that because they have used their product with no apparent problems or because the ingredients are 'natural', 'organic' or 'botanical', the product must be safe. That is an erroneous assumption to make. Hemlock, Nightshade and Snake Root are examples of all three and will kill you.
Now this doesn't mean that you shouldn't use a ingredient because someone, somewhere, might be allergic to it. As an example, I have a friend who is allergic to Cocoa and Shea Butters; it's 20% of my recipe. Sure, I could make a soap without it (I do for her), but she is just one out of a hundred or so folks who have used my soap without issue. I mean, should we stop using Penicillin simply because I'm allergic to it? This is why your Ingredients label is so important, so people who do have allergies can make an informed decision.