How to Comply with Cosmetics Regulation in USA

How to Comply with Cosmetics Regulation in USA

In US, cosmetic products and ingredients, other than color additives, do not require FDA approval before they are placed on the US market. That does not mean cosmetic products are not regulated in the US. In this article, we will summarize how to comply with cosmetic regulations in USA.

Overview of Cosmetic Regulations in USA
The two most important cosmetic laws in the US are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). Under these laws, cosmetic products and ingredients do not need FDA pre-market approval, with the exception of color additives. However, the marketing of adulterated or misbranded cosmetics is prohibited. The adulterated products include cosmetic products bearing or containing any poisonous or deleterious substances that may pose harm to users under normal conditions of use and contaminated cosmetic products. The misbranded products included improperly labeled products and deceptively packaged products. Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety and labelling of their products.

Definition of 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" (FD&C Act, sec. 201(i)).  Examples include skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants (excluding soap). 

It is very important to know whether your products are regulated as cosmetics in the US or not. For example, in some countries, sunscreens are regulated as cosmetics. In the United States, they are regulated as drugs and must be approved by FDA as drugs. Hair restoration, skin protectant, pain relief, anti-aging effects, and treatment of acne, dandruff, eczema, or irritated skin are other examples of claims that would cause products to be regulated as drugs.

Some products meet the definitions of both cosmetics and drugs. 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. Other examples include toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. They must comply with the requirements for both cosmetics and drugs.

Requirements on Ingredients

FDA has regulations that specifically prohibit or restrict the use of certain hazards ingredients in cosmetics (example, Chloroform, mercury compounds, view list).

US FDA has also established a positive list system for color additives used in cosmetics. Color additives are permitted in cosmetics only if FDA has approved them for the intended use. In addition, some may be used only if they are from batches that FDA has tested and certified.

Other than banned/restricted ingredients and color additives, a cosmetic company may use any ingredient as long as it is safe under intended use conditions.

Labelling Requirements

Cosmetic labeling must be truthful and not misleading. A basic label must include the following information:An identity statement, indicating the nature and use of the product

· An accurate statement of net content.
· Name and place of business.
· Distributor statement: manufactured by xxx or distributed by xxxx.
· Material facts.
· Failure to reveal material facts is one form of misleading labeling and therefore makes
a product misbranded.
· Warning and caution statements.
· Ingredients.


Ingredients must be identified by their "common or usual names" in English in descending order of predominance on product labels in the United States. These common names sometimes are different from INCI names. For example, INCI names for botanical ingredients typically use Latin names.Since the U.S. regulations require the use of common or usual names. Latin terms may be included parenthetically following the common or usual name of an ingredient. Example: Aloe (Aloe Barbadensis) Extract.

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Voluntary Cosmetic Registration Program (VCRP)

Cosmetic manufacturers are not required to register their cosmetic establishments or file their product formulations with FDA, and no registration number is required to import cosmetics into the United States.

However, cosmetic firms are encouraged to participate in FDA's Voluntary Cosmetic Registration Program (VCRP) using the online registration system. Cosmetic manufacturers, distributors, and packers can file information on their products that are currently being marketed to consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP database.

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Animal Testing

The FD&C Act does not specifically require the use of animals in testing cosmetics for safety. Cosmetics that have been tested on animals are not banned in the US. Manufacturers are required to substantiate the safety of both ingredients and finished cosmetic products prior to marketing. They can make their own decision on whether to employ animal testing. 


How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated

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