Cosmetics are defined 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”. Claims can be the defining difference to whether FDA will consider your product to be a cosmetic or a drug.
EAS can assist you in ensuring your cosmetic labels are in compliance with FDA regulations by reviewing your labels and crafting claims that help keep your product regulated as a cosmetic. We will review your ingredients for safety, and ensure that the correct ingredient name is used in your ingredient statement.
There are products that meet the definitions of both cosmetics and drugs when they have two intended uses, such as:
- Anti-dandruff shampoo which claims to reduce dandruff
- Deodorants making antiperspirant claims
- Makeup and moisturizers with sun protection claims
- Toothpaste containing fluoride
These products must comply with the requirements of both cosmetics and drugs. With our team of cosmetic label experts and OTC drug label experts, EAS can assist cosmetic companies with all their needs.