Soap: the Chameleon

Posted in: Legislation & Regulation, Soap & Cosmetic Labeling

chameleon-smSoap is a chameleon – it can be many things depending on what you claim it can do. It is the CLAIM that determines what the product is, and that, in turn, determines what REGULATIONS/LAWS apply.

Soap can be a drug: if you make claims that it (or any of the ingredients in it) is intended to treat physical issues (eczema, redness, irritation, poison oak/ivy, etc), it becomes a drug. Larger companies can do that because they have the ability to meet the requirements of the laws and regulations covering the creation, approval and manufacture of drugs. Handcrafters can’t possibly meet those requirements.

Drug manufacturing requires registration and inspections, along with manufacturing facilities and practices that handcrafters can never meet. Would you want someone with a cat in the house, making the product in their kitchen, measuring by hand and interrupted by a phone call, to make you a life-dependent drug? Anti-biotics for your grand-kid? Dose specific drugs like blood thinners? Didn’t think so.

Anyway, that means handcrafters have to stay within the definition of a cosmetic — cosmetics are ONLY intended to cleanse, promote attractiveness or beautify. No treatments involved. They 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).

Cosmetic manufacturers don’t require registration or inspection because the products really don’t do anything (at least according to what you can say about it)1. The manufacturer is responsible for ensuring that the product is SAFE, but (unlike other countries) doesn’t have to prove it to the government in advance to a government agency or get it approved in advance of sale. A soap that claims to cleanse, or make more attractive (moisturize, make your skin glow, exfoliate, etc) is a cosmetic. You just have to follow the cosmetic labeling regulations.

Soap CAN be exempt from definition of a cosmetic and not even regulated by the FDA, IF (and ONLY if) it is:

  1. the alkali salt of fatty acids (made with lye and oils), AND
  2. marketed and sold only as “soap” (only claims to clean).

Either way, your label must have the identity of the product, the net weight, and the name and address (physical street address) of the manufacturer on the label. A cosmetic must also have the ingredients listed, and there are potentially warning labels required under certain circumstances.

The FDA is responsible for administering the laws & regulations applicable to cosmetics. When a soap is exempt from the definition of a cosmetic, the FTC is responsible for administering the labeling laws and the Consumer Product Safety Commission is responsible for overseeing product safety.




References   [ + ]

1. That’s true at the Federal level and in most states, but a few states DO require registration or licensing before a company may make cosmetics.

13 Comments on “Soap: the Chameleon”

  1. Dawn Mason

    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. Marie Gale

      Soap that is exempt from the definition of a cosmetic (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 SPECIFCALLY 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.

  2. Dawn Mason

    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? : )

  3. 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 … the NAME of the product (that’s the brand or designator to identify it as YOUR product), the IDENTITY of the product (what it is) and 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 the 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. (This “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.

  4. Lori

    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. Marie Gale

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

  5. Lynn

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

  6. Linda

    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

  7. Koreen

    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.

  8. Ken

    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. Marie Gale

      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.

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