The United States of America
Legal framework
The cosmetics, personal care & toiletries industry in the United States is governed by the U.S. Food and Drug Administration (FDA).
FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for products marketed on a retail basis to consumers, and the Fair Packaging and Labeling Act (FPLA).
Other regulations and Federal Register documents include the Code of Federal Regulations, Title 21 - Cosmetic Products.
The FD&C Act is a set of laws, passed by the U.S. Congress in 1938 and amended several times, giving authority to the FDA to oversee the safety of food, drugs, and cosmetics.
It includes a provision that establishes a legal difference between a “cosmetic” and a “drug”, which is determined by a product's intended use and different laws and regulations apply to each type of product.
The FD&C Act defines cosmetics 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". (FD&C Act, sec. 201(i))
Drugs are defined, in part, 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". (FD&C Act, sec. 201(g) (1))
Drugs are usually available with a prescription. However, some drugs are available to consumers without a prescription; these are classified under the over-the-counter (OTC) drug products.
There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. OTC drugs generally show the following characteristics: their benefits outweigh their risks; the potential for misuse and abuse is low; consumer can use them for self-diagnosed conditions; they can be adequately labeled; health practitioners are not needed for the safe and effective use of the product.
The Fair Packaging and Labeling Act (FPLA), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all "consumer commodities" be labeled to disclose net contents, identity of commodity, and name and place of business of the product's manufacturer, packer, or distributor. The Act authorizes additional regulations where necessary to prevent consumer deception or to facilitate value comparisons.
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States. The Title 21 is the portion of the CFR that governs food and drugs within the United States. The 700 series includes the limited regulations on cosmetic products.
Regulatory procedures*
The U.S. Food and Drug Administration (FDA)'s legal authority over cosmetic products is different fromother products regulated by the agency, such as drugs, biologics, and medical devices. With the exception of color additives, cosmetic products and ingredients are not subject to FDA premarket approval authority. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.
In the United States, cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded.
Manufacturers are not required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA. However, companies are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA's Voluntary Cosmetic Registration Program.
The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States. The VCRP aims at consumer protection, while also helping cosmetic manufacturers and distributors make informed decisions.
BIORIUS can be appointed to enter cosmetic formulations and establishments into the VCRP on behalf of a cosmetic firm.
*Source : FDA.