What is Soap and How is it Regulated?

We know many products as soap. Shower gel is soap, the stuff we wash our dishes with is soap, and even the detergent we clean our clothes with is often referred to as soap. However, by definition soap is not any of these!

According to the FDA soap is defined as “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.” By this definition, hot process and cold process soaps made with oils, water, and lye are considered soap. Also, any MP base that does not contain detergents will also be considered soap because it receives it’s cleansing properties from the saponification process created by combining oils, water, and lye. Link

“Today there are very few true soaps on the market. Most body cleansers, both liquid and solid, are actually synthetic detergent products. Detergent cleansers are popular because they make suds easily in water and don’t form gummy deposits. Some of these detergent products are actually marketed as “soap” but are not true soap according to the regulatory definition of the word.” Link

Easy enough, right? Basically if it’s made from oils, water and lye, it’s soap. Well…Not necessarily!

For soap to be regulated as soap, it’s only intended purpose can be to clean the body. You can’t state that it makes you smell like flowers or moisturizes and you definitely can’t say it heals something! These are cosmetic and drug claims, respectively. To sell something as soap and have it be regulated as soap you can only market soap to clean the body. That’s it. This is the regulatory definition of true soap.

Put in layman’s terms, true soap must receive it’s cleansing properties solely from oils, water, and lye. Once a detergent is added, it is no longer true soap and is regulated by the FDA as a cosmetic. Also, to be regulated only as soap, proper labeling requirements must be followed:

“Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.” Link

Products considered true soap:

  1. Hot process soap
  2. Cold process soap
  3. Detergent-free melt and pour soap
  4. Liquid soap made via saponification

However, these products are only considered true soap IF it’s only intended purpose is to clean the body.

Now that we know what soap is and we know it’s not regulated by the FDA, we can look at the regulations set forth by the Consumer Product Safety Commission (CPSC), the agency that regulates true soap: www.cpsc.gov

The page that I found any information on was titled Regulations, Mandatory Standards, and Bans. Since soap does not have it’s own category, we will look at cleaning products. There are two applicable acts regarding cleaning products: (1) Federal Hazardous Substances Act (FHSA), and (2) Poison Prevention Packaging Act (PPPA). In this blog post, we are going to look at the FHSA. Specific information regarding the FSHA can be found at ECFR 1500.83(a)(11).

“Packages containing polishing or cleaning products which consist of a carrier of solid particulate or fibrous composition and which contain toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates in the concentrations described in §1500.14(a) (1) and (2) are exempt from the labeling requirements of §1500.14(b)(3)(ii) if such toluene, xylene, or petroleum distillate is fully absorbed by the solid, semisolid, or fibrous carrier and cannot be expressed therefrom with any reasonably foreseeable conditions of manipulation.”

Hmmmm… Ok, don’t put this stuff in your soap. It’s obvious that the “cleaning products” category might not be what we’re looking for. The problem is that I can’t find any other applicable category. Perhaps it is best to look for some more general safety regulation.

According to the CPSC, “The Federal Hazardous Substances Act (FHSA) requires precautionary labeling on the immediate container of hazardous household products to help consumers safely store and use those products and to give them information about immediate first aid steps to take if an accident happens. The Act also allows the Consumer Product Safety Commission to ban certain products that are so dangerous or the nature of the hazard is such that the labeling the act requires is not adequate to protect consumers.Link

Basically, the takeaway from this is any product regulated by the CPSC must not be hazardous to the consumer. Hazardous substance is defined as “(A) Any substance or mixture of substances which (i) is toxic, (ii) is corrosive, (iii) is an irritant, (iv) is a strong sensitizer, (v) is flammable or combustible, or (vi) generates pressure through decomposition, heat, or other means, if such substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.” Link

The term ‘‘toxic’’ shall apply to any substance (other than a radioactive substance) which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface.

The term ‘‘corrosive’’ means any substance which in contact with living tissue will cause destruction of tissue by chemical action; but shall not refer to action on inanimate surfaces.

The term ‘‘irritant’’ means any substance not corrosive within the meaning of subparagraph (i) which on immediate, prolonged, or repeated contact with normal living tissue will induce a local inflammatory reaction.

The term ‘‘strong sensitizer’’ means a substance which will cause on normal living tissue through an allergic or photodynamic process a hypersensitivity which becomes evident on reapplication of the same substance and which is designated as such by the Commission. Before designating any substance as a strong sensitizer, the Commission, upon consideration of the frequency of occurrence and severity of the reaction, shall find that the substance has a significant potential for causing hypersensitivity.

The terms ‘‘extremely flammable’’, ‘‘flammable’’, and ‘‘combustible’’ as applied to any substance, liquid, solid, or the content of a self-pressurized container shall be defined by regulations issued by the Commission. [16 C.F.R. 1500.3(b)(10), 1500.3(c)(6), 1500.43, 1500.43a] Link

In short, if you’re making and selling soap, you are responsible for ensuring it contains no ingredients that can harm the consumer through normal use. To do so would be in violation of the safety standards set forth by the CPSC. The soap cannot be:

  • Toxic
  • Corrosive
  • Irritating
  • A strong sensitizer
  • Combustible or flammable
  • Cause anyone in harm in the course of normal use

We now know what soap is and how it’s regulated. Although true soap is not regulated by the FDA, it is still regulated and it must be safe. This, in my personal opinion, should give caution to those who want to make soap and sell it immediately without fully testing recipes. If your soap is not fully saponified it could be lye heavy and could fall under the definitions of (1) corrosive, (2) irritant, and (3) strong sensitizer. This could also be the case if an essential/fragrance oil is used in a way that is not within the IFRA guidelines. For example, Oil of bergamot and products containing 2 percent or more of oil of bergamot are considered strong sensitizers! Link

In summary:

For regulatory purposes, soap is made of oils, lye, and water, and it’s only intended use can be to clean. It cannot be marketed as anything or than to clean the human body.

Soap is regulated by the CPSC and must not be toxic, corrosive, irritating, or a strong sensitizer and cannot reasonably cause harm within the course of normal use.

Something like shower gel may be called “soap,” but it’s not regulated as soap and it’s not true soap if it contains detergent products and is not made into soap via the process of saponification.