The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the FDA under the authority of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act. Labeling is defined as all labels and other written, printed, or graphic matters upon any product or any of its containers or wrappers, or accompanying a product and a label is any display of written, printed, or graphic matter upon the immediate container of any product.
The FDA defines a cosmetic as a product excluding pure soap intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered as also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., “fluoride” toothpastes), sun tanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.
The label statements required by the regulation must appear on the inside as well as any outside container or wrapper. The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale must state the name of the product and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The ingredient statement and name and place of business of the firm marketing the product, directions on using the products and any applicable warning must be stated on an information panel of the label. All label statements required by regulation must be in the English language and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase
Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with these requirements or if the container is made or filled in a deceptive manner may be considered misbranded and may be subject to regulatory action.
Liberty Management Group helps in providing assistance for the Voluntary Cosmetic Registration Program (VCRP) and for making the cosmetic labels in compliance with FDA requirements by reviewing and modifying cosmetic labeling which includes the review of ingredients as well.
Written by: Sonia Suresh, Junior Officer (FDA Regulations)
Published on: March 22, 2021
USFDA LABELING GUIDE 