US FDA Cosmetic Regulations – Compliance Guide

The FDA classifies products as cosmetics based on their intended use. The purpose of a product can be evaluated in a number of ways – through the effects described in its marketing, what customers expect from it, and even through certain ingredients. The FDA 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.” Some examples of products that are defined as cosmetics are:

• Lipsticks, eye shadows, foundations and other make-up products.
• Face and body moisturizers.
• Hair dyes and perming solutions.
• Body scents and perfumes.
• Nail polish, cuticle creams, etc.

Drugs, in comparison, are products that are defined 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.” Sometimes, a product fits the criteria to be classed as both a drug and a cosmetic, based on its intended use and effects.

The FDA recognizes ‘medical devices’ and ‘dietary supplements’ as separate categories in their own right, while other products, such as soaps, are regulated by the Consumer Product Safety Commission.

Yes, Every cosmetic product sold in the U.S. must be listed with the FDA.

• The listing must include:
  • Product name.
  • Product ingredients (including fragrances and flavors).
  • Facility information where the product is manufactured.
• Updates must be made annually or when there are significant changes to the product.

Under the Modernization of Cosmetics Regulation Act (MoCRA), there are certain exemptions for small businesses with an average annual gross turnover of less than $1 million USD over the past three years. However, despite these exemptions, we strongly recommend listing your products to ensure transparency and compliance with FDA expectations.

The FDA does not specify the testing required for each beauty product or ingredient. However, as a manufacturer, it is your responsibility to ensure that your products are safe when used as indicated in the instructions.

Some manufacturers, particularly those who are new to the market, may believe that a product is safe because they have used it themselves without any adverse effects, or because the ingredients are all ‘natural’. This is not correct.

OTC drugs are those that can be sold without a prescription from a medical professional. In these cases, the FDA regulates the formulations and labelling of different classes of drug, rather than the individual products. The FDA develops ‘monographs’ with guidelines for their production, distribution and application. Once the monograph is developed, companies can produce and sell these drugs without FDA pre-approval, as long as they are manufactured according to the guidelines. Monographs are used to establish the safety, effectiveness and required labelling of all OTC products.

A ‘monograph’ is used to define the safe and appropriate manufacture and use of OTC drugs. It covers ingredients, doses, formulation, indications for use and how the product should be labelled. Companies can manufacture and sell these drugs without a specific product license, as long as they conform to what is stipulated in the monograph. Monographs are published in the government’s Code of Federal Regulations(CFR). The function of the FDA is to ensure that the obligations of the Federal Food, Drug and Cosmetic Act are fulfilled.

US agent is responsible of assisting foreign cosmetic manufacturer to register their establishment to the FDA and maintain communication between the manufacturers, distributors and the FDA for products inquiries and facilities inspections.