How does US FDA regulate “soaps”?

  11 May, 2021

How does US FDA
regulate “soaps”?

Soaps are generally used for cleansing the body, face, hands etc. and can be formulated in various forms like solid bars, liquids, or powders. Apart from being used as a cleansing product, some soaps have anti-bacterial and anti-fungal properties that are used to treat various skin conditions. Did you know that the US FDA classifies soaps into three major categories based on the ingredients present in the formulation and intended use of the product? Let us take a quick look at what they are.

Product Classification

The 3 major classes into which Soaps can be categorized are:

  • 1. Cosmetics
  • 2. Consumer Products
  • 3. Drugs

Cosmetics:   The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance". Any product labeled as “soap” that meets this definition and its ingredients do not fall into drugs or consumer products categories are considered as cosmetics. For example, a cleansing product with SLS/SLES or any similar ingredients can be considered as Cosmetics.

Consumer Products:   Any product that is labeled as "soap" and the bulk of the nonvolatile matter in the soap consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds are considered as Consumer Products. These products are not regulated by the US FDA but fall under the supervision of the Consumer Product Safety Commission (CPSC). For example, any product that contains ingredients like Potassium Palm Kernelate which is an alkali salt of fatty acid is considered a consumer product. The CPSC has its own set of guidelines on the labeling and packaging of soaps.

Drugs:   Any cleansing product that contains active pharmaceutical ingredients like anti-fungal agents, anti-septic properties and are used to heal any skin condition are considered as Drugs. The US FDA has developed monographs for active ingredients and their uses. If the ingredient present in the formulation is a new ingredient, then a New Drug Application (NDA) must be submitted to the FDA.

This must have given you an idea as to how classification of a product plays a crucial role in launching a product in the market as the further regulatory processes will depend on the category of product into which it falls into. Are you confused about the myriad technicalities involved in correctly classifying your product category? If you are planning to launch your product in the US market, Athreva’s team of cosmetic experts can assist you in analyzing ingredients in your formulation, determine the intended use of your cleansers that are labeled as “Soaps” and find out how they are regulated by the US FDA.

The author of this blog Dr. Sravya is one of our in-house cosmetic regulatory experts. With hands-on experience in consulting for cosmetic manufacturing companies worldwide, her sharp eye for detail speaks for itself. You can find her on Linkedin.