Soap: Cosmetic or Not?

Soap is a chameleon; it can be a cosmetic or something else, depending on what it is made of, what it’s used for, and what you claim it can do. In many cases, it is the CLAIM that determines what the product is, and that in turn determines which REGULATIONS or LAWS apply.

Soap Can Be a Cosmetic

Cosmetics are products that are applied to the human body to cleanse, alter the appearance, beautify, or make more attractive. Soaps most often fall into this category, although soap can be exempt from the definition of a cosmetic IF:

  1. It is primarily the alkali salt of fatty acids (made with lye and oils), AND
  2. The cleansing action comes from the lye and oils (no added detergents), AND
  3. It is marketed and sold only as “soap” (only claims to clean).

Melt and pour soap base may or may not meet the exemption criteria depending on what its composition. See Melt & Pour Soap: Soap or Cosmetic? Soap made with synthetic detergents (“syndets”) does not meet the exemption criteria (regardless of the fact that they are called “soap”).

COSMETIC: Aveno Moisturizing Bar – Amazon.com

The claims you make for the soap determine if it is a cosmetic. “Moisturizing” and “exfoliating” are common cosmetic claims for soap. Cosmetics don’t alter the function or structure of the body, they don’t cure or prevent anything. They only make you clean and/or pretty(ier).

If you make cosmetic claims, it doesn’t matter what the soap is made of—it’s automatically a cosmetic.

COSMETIC: Moisture Rich Soap – BucklersRemedy.com

Cosmetic manufacturers that meet the definition of a small business don’t require federal registration. Some states DO require cosmetic manufacturers to register.

Cosmetics and cosmetic labeling are regulated by the FDA.

Soap Can Be a General Consumer Product

Soap can be a general consumer product (like toilet paper, tissues, or floor polish).

If it is applied to the human body but it meets the exemption from a cosmetic (above), then it’s a general consumer product.

GENERAL CONSUMER PRODUCT: Ivory Soap – Wikipedia.com

If it’s not applied to the human body (laundry soap, dish soap, dog shampoo), then it’s a general consumer product.

GENERAL CONSUMER PRODUCT: Fels-Naptha Soap – Amazon.com

General consumer products do have label requirements which are regulated by the Federal Trade Commission.

Soap Can Be a Drug

Drugs are products that heal, treat, mitigate or prevent disease, or that alter the function or structure of the body. for more details.

If you make claims that the soap (or any of the ingredients in it) is intended to treat physical issues it becomes a drug. Treating acne, reducing pore size, alleviating itchy skin—these are all intended uses that would cause the soap to be a drug. Most of the time when you see a soap that touts to treat acne (other than is anti-bacterial) it is an over-the-counter drug.

OVER-THE-COUNTER DRUG: Asepxia Soap – Amazon.com

All drugs must be pre-approved before they can be marketed, either by going through the New Drug Approval Process or by meeting the standards and requirements of an over-the-counter drug. All drugs must be manufactuered in an FDA inspected and registered drug manufacturing facility.

Drugs are regulated by the FDA and have specific label label requirements depending on the active ingredients and the claims made. It’s interesting that when I was looking for a picture to put here as an example, the MAJORITY of the “acne soap” images that come up at Google were not in compliance with the FDA regulations covering acne soap (and many probably weren’t made in a drug-approved manufacturing facility.)

Soap can be a Pesticide

Pesticides are products that repel or kill pests. A bug repellent is a pesticide.

If you make claims that your soap will repel bugs, then it becomes a pesticide.

INSECTICIDE Soap

Generally, all pesticides must go through a testing and approval process to ensure they are safe. There is an exemption for minimum risk pesticides but they may only use a limited number of pre-approved minimum-risk active ingredients (like citronella) that are on the pre-approved list.

Pesticides are regulated by the Environmental Protection Agency (EPA). Pesticides (even minimum risk pesticides) require additional label information. Note that none of the bug repellent soaps I found through a Google search were correctly labeled as pesticides in compliance with the EPA regulations (for minimum risk pesticides or otherwise).

In Summary

When you are making and selling soap, be aware of what you say about it, because what you SAY can determine what it IS … and that in turn determines which regulations apply.

Navigating the Rules and Regs book by Marie Gale

Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!

Comments

15 responses to “Soap: Cosmetic or Not?”

  1. Chantay Glanville

    IF I were to say that my soap provides a luxurious creamy lather to cleanse the skin…would that be considered a cosmetic claim? Since the words are used to describe the type of lather it provides, and the only actual claim is that it cleanses the skin?

    1. Marie Gale

      Describing the product (its color, texture, feel, etc.) doesn’t usually modify the intended use.

      If the intended use is to “cleanse” (as in a soap), then saying that it’s got good lather or is pink or smells like watermelon is only describing the PRODUCT not what it is USED for.

  2. Rereading this, am I to believe that I need to have list on my soap label. The label if ‘Soap’, net weight, my address and company only? I do not have to list ingredients, smce it is not a cosmetic? *sighs*. Why must they continue to change the rules? Thank you Marie for you time and effort you put into getting this information out there,

    1. IF the soap is:

      • the alkali salt of fatty acids (lye/oil) AND
      • is marketed and labeled only as “soap”

      THEN the soap is not a cosmetic and does not require the ingredient list.

      If it is a detergent-based product OR you say the soap does anything more than clean, then it IS a cosmetic, and DOES require the ingredient list.

      Either way, the package requires the identity (what it is), the net weight, and the business name and address.

  3. I just a made a Cucumber soap. I used a whole large cucumber. I only labeled it as Cucumber Soap. Of course I didn’t make any claims or statements on it. Only listed ingredients on the back label.

  4. Thank you for clarifying so much of the information on the FDA site! I understand the “true soap” definition for cold process soap labeling. How does all this relate to Melt and Pour glycerin bases for soap labeling? We alternate between the 2 major US Melt and Pour Soap manufacturing companies. Both manufactures sell the products as …melt and pour soap base… Some melt and pour products are made with lye and some are not. Can we call both types “soap”? Can we just say “vegetable glycerin soap base” followed by the colorant and fragrances for our standard label? We make no claims on our labels. Thank you!
    Linda

  5. Thank you for this wonderful information! I just waded through the FDA site, and this was refreshingly straightforward.

  6. I have an additional question about making/selling soap (true soap that makes no claims except that it cleanses, and is regulated by CPSC and not FDA): Can the soap contain essential oils/fragrance oils, natural colorants such as clays/botanicals, micas, other colorants (ultramarines, oxides), and still be considered just soap?? Assuming, of course, that there are no claims made (verbally, on the label, or in any marketing materials) regarding those additives?? I understand that you can not offer legal advice, but I would like to get your thoughts on this.

    Thank you!!

    1. So long as the soap still complies with the exempt definition where the bulk of the non-volatile matter is composed of the alkali salt of fatty acids. Color additives, clays, and botanicals are non-volatile matter, but normally aren’t sufficient to change the fact that the BULK (that is, the highest percentage) is still soap. Fragrance and essential oils are “volatile” (not “non-volatile”) so they don’t change the definition.

  7. Thanks for this info as I have heard many different variations of this law.
    Happy Soaping!

  8. Jody S Pratt

    I have a question. If I make Lavendar Soap with LavendaR EO- I can’t name it Lavendar Soap? Or is it ok to Says = Soap Scented with Lavender? I am real confused by not being able to use an ingredient in the Titel(how can you name saps otherwise)?

    1. Marie Gale

      There are three different things that can go on the label:

      1. the NAME of the product (that’s the brand or designator to identify it as YOUR product),
      2. the IDENTITY of the product (what it is) and
      3. MARKETING TEXT which tells the consumer more about the product so they want to buy it.

      The regulations are slightly different between the FDA (for soap as a cosmetic) and the FTC (soap exempt from cosmetic regulations) but the general intent is to avoid misleading the consumer by putting an ingredient in the name/identity to make it seem like the product contains all or mostly all of that ingredient. The “Shea Butter Cream” that has 1% shea butter, or (in the food department) “strawberry jam” that doesn’t contain any strawberries, only flavor.

      My recommendation is avoid an ingredient name in either the product name or identity to be on the safe side, and comply with both sets of regs. BUT, you could put marketing text on the label that says “scented with pure lavender essential oil” or “lavender scented” for example.

      Just make sure that those words are SEPARATE from (by spacing, font, color, etc.) both the name of the product and the identity.

      Note that the NAME is not required, so you don’t have to come up with something if you don’t want to. The identity is “soap” or “handmade soap” or “handcrafted soap.” Then your marketing text says whatever you want it to say.

  9. Thanks, Marie. I guess my question is, is the water that is added to the soap paste part of the “non volatile matter”. If it is, then the bulk of the non volatile matter would be water, and apparently the final product would not be able to be classified as soap? Am I over thinking this? : )

  10. Is ” true” liquid soap made with oils and lye and claiming only to cleanse covered by the CPSC? Do you know of any testing requirements?

    Thanks!

    1. Soap that is exempt from the definition of a cosmetic [that is where 1) “the bulk of the non-volatile portion is the alkali salt of fatty acids and 2) it is marketed and sold only as soap] is regulated by the FTC for labeling requirements and the CPSC for safety. Under the CPSC, soap is an “unregulated product” which means there aren’t any regulations SPECIFICALLY addressing soap safety. You are still responsible for ensuring it IS safe, for following hazardous substances rules (not really applicable to most soap), and reporting if there are any lawsuits about the safety of your products.

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