compliance

Is my handmade product a soap or a cosmetic?

Not sure if you make soaps or cosmetics? Our article discusses the differences from an FDA perspective.

The Food, Drug Administration (FDA) develops regulations based on the different laws set by the Food, Drug and Cosmetics Act (FD&A Act). This act helps to protect public health by ensuring that drugs and devices are safe for human and animal use.

If your product meets the conditions of FDA’s definition of soap, it is regulated by the Consumer Product Safety Commission (CPSC) and not FDA. While if your product is a cosmetic, it is regulated by the FDA. This is why it’s really important to know which of your products falls under the category of “soap” and which is a “cosmetic”.

Soaps

Traditional soap is made through the combination of fats and alkali. These fats can come from multiple sources including, animal and minerals. These fats are then degraded to fatty acid and mixed with alkali to form soap.

According to FDA, soap has to meet three conditions:

  • The product must be composed mainly of “alkali salts of fatty acids”.
  • The product’s cleaning action has to be resulted from these alkali salts. This means that if your product has synthetic detergents, it is not considered a soap.
  • The product needs to be labelled and marketed only for use as soap. If it has other purposes, it is a cosmetic.

Generally speaking, traditional soaps that fit with the definition above are regulated in entirety by CPSC.

There are no specific regulations enforced by the CPSC for the labelling of soap. Hazardous substance labelling may need to be applied for situations where a strong degreasing agent is included that could potentially cause eye irritations - this however is not a common scenario for most soap makers.

Cosmetics

Cosmetics are defined, by the FDA, as a product intended for “cleansing the human body, making a person more attractive, or changing a person’s appearance”. Some examples of cosmetics include:

  • makeup
  • lipsticks
  • nail polish
  • moisturisers
  • toothpastes
  • deodorants
  • perfumes
  • hair dyes.

If you have identified that your product is a cosmetic, it will be regulated by the FDA under the FD&A Act. According to FDA’s official website, “under this law, cosmetics must not be adulterated or misbranded”.

This means that cosmetics will need to be safe to use under a labelled or customary condition of use. Cosmetics that contain colour additives will also need to be approved. Their website further states that labels should not be deceptive, and manufacturers have a legal responsibility for the safety of their products.

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