FDA REGISTRATION FOR COSMETIC

FDA’s legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of colour additives. However, FDA can pursue enforcement action against products on the markets that are not in compliance with the law or against firms or individuals who violate the law.

The Federal Food, Drug & Cosmetic Act (FD&C) defines cosmetics 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 polish, eye and facial make-up preparations, shampoo, permanent waves, hair colours, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product.

Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. In general, except for colour additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic product, provided that–

The ingredient and the finished cosmetic is considered safe under labelled or customary conditions of use,
The product is properly labelled, and
The use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.

Voluntary Cosmetic Registration Program (VCRP/CPIS)

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 U.S.

There are two parts to the VCRP, described in detail in the sections below. You may participate in both parts of the program or only one part. The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to products that are not for sale, such as hotel samples, free gifts, or cosmetic products you make in your home and give to your family/friends.

FDA uses the information to evaluate cosmetic products in the market. Because product filings and establishment registrations are not mandatory, voluntary submissions provide FDA with the best information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution.

Cosmetic manufacturing establishment registration with the U.S FDA

Cosmetic manufacturers or packers whose products are in commercial distribution in the United States should register their cosmetic establishments with the U.S FDA, using a separate Form for each cosmetic manufacturing location. Only cosmetic manufacturers and packers should register not cosmetic distributors. FDA assigns a registration number to each cosmetic establishment registered and sends you a receipt.

Cosmetic Product Ingredient Statements (CPIS) Filing with the U.S FDA

A cosmetic manufacturer, packer, or distributor should file a statement for each cosmetic product the firm has entered into commercial distribution in the U.S. With the distributor’s permission, a private labeller or packer also may file these forms.

Primary Solutions can assist in:

Voluntary Cosmetic Registration with the U.S FDA
Cosmetic Product Ingredient Statement Filing with the U.S FDA

Cosmetic Labelling

The cosmetics distributed in the United States must comply with the labelling regulations published by the FDA under the authority of the FD&C Act and the Fair Packaging and Label Act. Labelling means all labels and other written, printed or graphic matter on or accompanying a product.

Primary Solutions can assist in:

Reviewing and provide advice on cosmetic labelling incompliance with FDA requirements.
Reviewing the ingredients used in the cosmetic products

The FD&C Act defines cosmetics 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 polish, eye and facial make-up preparations, shampoos, permanent waves, hair colours, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product.

The United States has strict laws regarding ingredients and labelling of cosmetics, and some cosmetic products are in fact regulated in the U.S. as drugs. Primary Solution’s Label and Ingredients Review Service helps companies comply with U.S. FDA extensive labelling requirements by cross-referencing the details in the label against thousands of pages within the Code of Federal Regulations as well as the Federal Register, VCRP Cosmetic Ingredient Dictionary, Guidance Documents, the U.S. FDA Labelling Manual, and Warning Letters issued by U.S.