To sell soap and cosmetics, understanding the rules of making claims about our products is key. These rules and regulations, created by the FDA (Food and Drug Administration), are put in place for the safety of consumers. Soap and cosmetics should not make claims that could confuse the product with a drug. The FDA regulates and defines cosmetics, drugs and soap differently. It can be a little tricky to understand these definitions and what type of claims are appropriate for cosmetics, drugs and soap.
A cosmetic is a product that is used to beautify, or alter the appearance. A drug is a product intended to diagnose, treat or prevent a disease. A product is also considered a drug when it is intended to affect the function of the body.
It is possible for a product to be considered both a drug and a cosmetic. This happens when a product has two intended uses. The FDA uses dandruff shampoo as an example. Dandruff shampoo cleanses the hair like a cosmetic, but treats dandruff like a drug. Products that are considered both a drug and cosmetics must comply with requirements for both drugs and cosmetics.
You may be wondering ,”where does soap fit into all this?” Soap is defined in its own special category by the FDA. According to the FDA website, a product is defined as soap when:
- the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
- the product is labeled, sold, and represented solely as soap [21 CFR 701.20].
Depending on what our product claims to do, it could be considered a drug, cosmetic, soap, or a combination of these categories. Drugs are required to be approved by the FDA, while cosmetics and soap are not. So for example if we were to say that our soap or cleanser helps treat acne, it is no longer considered only soap. It’s now considered a drug as well and would require FDA approval. If we say that our soap is moisturizing and will treat acne, it is now considered both a cosmetic and a drug.
The FDA takes several things into consideration when establishing the intent of the product. The FDA looks at how the product is advertised. This includes advertising online and other promotional materials. The FDA also considers the consumer perception and the ingredients that are considered to be drugs by the public. This means it’s important to consider how our product is labeled, as well as how it’s described online and other promotional materials.
With this said, even us Tiny Bubbles Lovable Soaps, LLC as a Small Business, have to be up to date with FDA Regulations, the Consumer Product Safety Commission and we have to follow Good Manufacturing Practices, to ensure our Costumers that the products they purchase from us are manufactured following regulations.