Soap Making FDA Regulations – What you need to know

how to keep your soap following FDA regulations

Soap making FDA rules should be followed if you sell your soap in the US. Many of my students from Soap Making School have been asking me what they need to do to take their soap making craft to the next level and start selling. 

Since the majority of my students are based in the USA, I will start with a blog relating to the FDA (Food and Drug Administration) regulations for selling soap. 

I will be covering other countries and their regulations in other blog posts.

More and more people are wanting to leave their day jobs behind and create their own business. 

The first thing I tell my students when they are considering a business is to get really comfortable with their soap making skills and get familiar with crafting your own recipes.  Making custom soap puts you in a different category than a soap maker with a standard recipe that can’t be customized.

I teach you how to create your very own recipes and never have to depend on anyone’s recipe or soap software program.

This is something you learn to do in the Complete Package Course.  This course teaches you to make your own Cold Process, Hot Process and Natural Liquid Soap Recipes.

There are many steps to take when you’re starting out with your business and I will be covering many of the topics in other blog posts.

This particular post will be focusing on what you need to do and know when it comes to soap making FDA regulations and laws.

Natural Soap and Synthetic Detergent Soap Have Different Regulations

FDA states natural soap is created by combining fats or oils with an alkali such as sodium hydroxide and potassium hydroxide. The fats and oils can be from animal, vegetable, or mineral sources.

When the fats or oils are mixed with the alkali, it turns into soap through a chemical reaction called saponification. When the soap is made properly, there is no alkali (lye) in the finished soap.

FDA states that Synthetic Detergents are different than true soap.  Most body cleansers, beauty bars and liquid cleansing gels are actually synthetic detergents. These detergent cleansers are popular because they make lots of suds. Some of these detergents are marketed as “soap” even though they’re synthetic soap.

How Does FDA Define Soap?

There are 3 conditions that the FDA requires in order to be soap:

  1. It must be made mostly of “alkali salts of fatty acid”.  This is created when saponification is complete.  It’s the finished soap when the chemical reaction from the fats, oils and alkali (sodium hydroxide or potassium hydroxide) is completed.  The word soap came from that actual chemical reaction “saponification”.
  2.  The “alkali salts of fatty acids (finished soap) must be the only ingredient that creates the cleaning effect.  If your soap contains synthetic ingredients to increase the bubbles, it’s considered a cosmetic and not a soap.
  3.  To qualify as a soap, it must be labeled and marketed only as soap.  If it’s intended to moisturize or leave a scent on the body like a perfume, it’s a cosmetic.  If the soap is intended to treat a skin condition such as acne or eczema, or if the soap is meant as an antibacterial product, it’s a drug.

How is Your Soap, Cosmetic or Drug Regulated?

Now that you have the information you need, you’ll have to establish whether you’ve created a soap, cosmetic or drug and how to register it.

If your soap meets the FDA definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA.

If it’s a cosmetic, it’s regulated by FDA. Neither the product nor its ingredients need approval by FDA, except if you use any color additives.

It is your responsibility to make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled. You don’t need to register your company or file your product formulations with FDA. If it’s a drug, it’s regulated by FDA. It must comply with the regulations for certain categories of non-prescription drugs. You will need to register your company and list your products with FDA

Soap Making FDA regulations – What if it’s Real “Soap”?

If your soap meets the definition of “soap”, it’s exempt from the provisions of the FD&C Act.

In conclusion, soap making FDA regulations state, traditional soaps made primarily from fats and alkalis are regulated by the CPSC. However, many “soaps” on the market today are, in fact, not just soap. They are cleansers, detergents, or other types of products regulated as a cosmetic or a drug by the Food and Drug Administration (FDA).

The 3 conditions that classify your soap as actual “soap” include:

  1.  What it’s made of.
  2.  What ingredients cause its cleaning action?
  3.  How it’s intended to be used.

The CPSC regulates only real soaps (not cosmetics or drugs) that are made from oil, fats and alkalis and that are created for consumer use. CPSC does not have specific labeling requirements for soaps.

If your soap is specifically for children 12 and under, it must undergo lead testing and you must issue a children’s product certificate that’s available from the CPSC.

It’s really important to stay up to date with any changes to soap regulations.  Stay updated by checking both the FDA site and CPSC site.  This blog post covers information that is currently available.  Please use this as a starting point only. 

In the Soap Making School Courses, you learn to make only natural true soap.  We don’t cover synthetic additives or bases. 

Click here to check out the courses available.

This information is specific for the USA.  If you are from another country (for example I am in Canada) and are planning on marketing your soap in the USA you also need to be aware of the FDA and CPSC regulations. 

Stay tuned for more blog posts on information for Soap Making Regulations in other Countries.

Happy Soaping


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