Cosmetic Industry

The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.

• What kind of products are cosmetics?

  The FD&C Act defines cosmetics by their intended use, 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".

• Is my product a drug or cosmetic or both?

  RegR Consultants can assist you to determine the product classification of your device as a drug or cosmetic or both. Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

• Can my product be both a cosmetic and drug?

  Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug

• Cosmetic Labeling and Ingredient Review

  Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. A cosmetic product must be labeled according to cosmetic labeling regulations. Noncompliance to the FDA cosmetic labeling requirements is one of the major reason for an FDA detention. RegR Consultants can perform a label review of your products to be in compliance with the FDA cosmetic labeling requirements.

• Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

  MoCRA establishes new requirements for the cosmetic industry. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.

• Certificate of US FDA Registration and Listings

  The firms registered with the FDA are often requested by their clients or customers or suppliers to verify their FDA registration. RegR Consultants will provide you with the certificate of registration and listings.