Cosmeticos

Summary of Regulatory Requirement of Cosmetics Marketed in the United States
Cosmetics marketed in the United States, whether manufactured here or imported from abroad, must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FPLA), and the regulations published under the authority of these laws.
The FD&C Act definescosmetics as articles 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. Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.
Cosmetics That Are Also Drugs
Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure orfunctions of the human body, are considered 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), suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.
The FD&C Act requires that drugmanufacturers 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.
Adulterated or Misbranded Cosmetics
The FD&C Act prohibits the distribution of cosmetics which are adulterated or misbranded. A cosmetic isconsidered adulterated if:
* It contains a substance which may make the product harmful to consumers under customary conditions of use.
* It contains a filthy, putrid, or decomposed substance.
* It is manufactured or held under insanitary conditions whereby it may have become contaminated with filth, or may have become harmful to consumers; or if it is not a hair dye and it contains anon-permitted color additive.
A cosmetic is misbranded if
* Its labeling is false or misleading.
* Its label does not include all required information.
* The required information is not adequately prominent and conspicuous.
* Its container is so made, formed, or filled as to be misleading.
Cosmetic Labeling
The cosmetics distributed in the United States must comply with thelabeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper. FP&L Act requirements only apply to the label of the outercontainer. Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with these requirements may be considered misbranded and may be subject to regulatory action.
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, identify by descriptive name orillustration the nature or use 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 declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type...