How does FDA define Cosmetic?
A product used on the human body to clean, beautify, and improve the appearance without affecting the human body’s structure or functions is considered a Cosmetic.
Examples of cosmetic products – skin creams, lotions, perfumes, lipsticks, fingernail polishes,
How can cosmetics also be a drug?
Products that are cosmetics but are also intended to treat or prevent disease or affect the structure or functions of the human body are also considered drugs. They must comply with the law’s drug and cosmetic provisions.
For example, shampoo for cleansing purposes is cosmetic. However, if the same product is labeled as an anti-dandruff product, it becomes both an over-the-counter drug and cosmetic.
There is a significant difference between Cosmetic Labeling FDA requirements for cosmetics and FDA labeling requirements for OTC drugs. Human OTC drug labels must contain the drug facts information. Also, the regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. The FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations as codified at 21 CFR 210 and 211.
Overview of Cosmetic Labeling FDA requirements
- The product label should display the principal display and information panel.
- Panel size must be large enough to provide sufficient space for the label information.
- Style & Size of letters must be of a minimum required size that are easily readable.
- Background contrast must be such that the label statements are conspicuous and easily readable.
- The label statement must be visible.
- The principal display panel should display the name of the product (product identity ), Net quantity, or contents and warning required by the 21 CFR § 740.10 warning
- The information panel should display the Directions for use, ingredient information, other warnings, name and place of the business.
Apart from the above labeling requirements a cosmetic product must comply with FDA recommend ingredient nomenclature and other requirements. FDAbasics LLC can assist you to comply with Cosmetic Labeling FDA requirements. Please contact us for more information.