Cosmetics are defined by FD&C Act 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. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc.
Drugs, on the other hand, are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.
Some products meet the definition of both cosmetic and drugs. For example, a cleansing shampoo is a cosmetic as its intended use is to cleanse the hair. An antidandruff treatment is a drug as its intended use is to treat dandruff. As a result, an antidandruff shampoo would fall under both cosmetic as well as drug. Another example is that of a toothpaste with fluoride, anti-perspirant deodorants, moisturizer with sun protection claims.
A product’s intended use is determined based on either the claims made on the label, advertisements, company website, general perception about the product in consumers mind or by the ingredients present in the product.
The FDA requirements of cosmetics and drugs are different. Below is an outline of the key differences:
- FDA approval – FDA does not approve cosmetics except for color additives. On the other hand, every new drug needs an approval or conformity to FDA’s OTC monograph.
- GMP – FDA has no set regulations for cosmetic GMP. There are only guidelines that cosmetic companies need to refer to. But for drug companies, FDA has laid clear regulations that drug companies need to comply with.
- FDA registration – Cosmetic registrations are voluntary. Drug Registrations and listings are mandatory.
- Labels – Cosmetic labels need to comply with cosmetic labeling regulations while OTC Drug labels require compliance to OTC drug labeling regulations and combination drugs requires compliance to regulations specific to combination product labeling.
- NDC number: Drug products are required to have a labeller code while cosmetics are exempt from the requirement
Liberty Management Group Ltd provides assistance with FDA Registration for Drugs and Cosmetic Establishments, Label compliance, US Agent service and many more FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: July 31, 2019
My product is an essential oil, used in aromatherapy. Does it comes under cosmetics or drug?
How an aromatherapy product is regulated by FDA depends on the intended use of the product. For example, If the use is to cleanse, it is a cosmetic but if the use is to prevent or cure a condition, it is a drug.