Cosmetics and Soaps

This document provides useful information for producers of cosmetics.



New York State may require some producers of cosmetics to comply with the NYS Department of Environmental Conservation's Regulation, Part 233, Pharmaceutical and Cosmetic Manufacturing Processes. To learn more about or how to comply with this New York State regulation, contact the NYS Department of Environmental Conservation, Division of Air Resources, Bureau of Stationary Sources or visit their website. The NYS Environmental Facilities Corporation, Small Business Assistance Program, provides assistance to complete the application form as well as help applicants comply with and understand the permit requirements once it is issued.

Cosmetics marketed in the United States, whether manufactured here or imported from abroad, must comply with the provisions and regulations of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. The Federal Food, Drug, and Cosmetic Act defines cosmetics by their intended use, as articles that someone can rub, pour, sprinkle, or spray on, introduce into, or otherwise apply to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. These products include skin moisturizers, creams, lotions and powders; perfume products; finger/toenail polishes, removers and cuticle softeners; makeup (lipsticks, foundation, blush and eye makeup preparations); shaving creams; shampoos (except dandruff); permanent waves; hair colors; mouthwash and toothpastes (except with whiteners or fluoride); bath oils and bubble baths; and deodorants, as well as any material intended for use as a component of a cosmetic product.

Products are considered a drug if they intend to treat or prevent disease or otherwise affect the structure or function of the human body. Over-the-counter drugs are drugs purchased without a doctor's prescription. Examples of products that are over-the-counter drugs are fluoride or whitening toothpastes, hormone creams, sunscreen preparations, antiperspirants, acne medications and antidandruff shampoos. Drugs are subject to the U.S. Food and Drug Administration (FDA) approval. Generally, drugs must either receive pre-market approval by the FDA or conform to final regulations specifying conditions recognizing them as safe and effective, and not misbranded. The Food, Drug, and Cosmetic Act require drug manufacturers to register every year with the FDA and update their lists of all manufactured drugs twice annually.

Some products meet the definition of both cosmetic and drug. This may happen when a product has two intended uses. These types of products must comply with the requirements for both cosmetics and drugs. Before products are marketed with both a cosmetic and a drug classification, they must prove scientifically safe and effective for their therapeutic claims.

The Federal Food, Drug, and Cosmetic Act excludes soap from its definition of a cosmetic. Therefore, soap products are exempt from the FDA's jurisdiction. The FDA interprets the term ‘soap' as the bulk of the nonvolatile matter in the product that consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds. The product is labeled, sold, and represented solely as soap. In other words, soap products that consist primarily of an alkali salt or fatty acid and make no label claim other than cleansing of the human body are not considered a cosmetic. Not every product marketed as soap meets this FDA definition. Soap producers that use certain ingredients, such as lye, to produce soap should contact the U.S. Consumer Product Safety Commission. The U.S. Consumer Product Safety Commission oversees consumer product safety and specifically regulates certain products under the Federal Hazardous Act or the Poison Prevention Packaging Act. Contact the U.S. Consumer Product Safety Commission or visit their website for further information. If a soap label states a cosmetic or drug claim, then the product must also meet the FDA label criteria and cosmetic and drug requirements.

The Federal Food, Drug, and Cosmetic Act does not require cosmetics and their ingredients to undergo approval before they are sold to the public. The FDA only regulates these products after they are released into the marketplace. The Food, Drug, and Cosmetic Act prohibits the distribution of cosmetics that are adulterated or misbranded. A cosmetic is considered adulterated if it contains substances that make the product harmful to consumers under customary conditions of use; if it contains a filthy, putrid, or decomposed substance; or if it is manufactured or held under unsanitary conditions where it may have become contaminated.

Manufacturers may use any ingredient or raw material, except for color additives and certain prohibited substances, to market a product without a government review or approval. Color additives used in cosmetics require testing for safety and listed by the FDA for their intended uses. Regulations restrict or prohibit the use of the following ingredients in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicyanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.

The Cosmetic, Toiletries, and Fragrance Association publishes the International Cosmetic Ingredient Dictionary recognized by the FDA to provide a complete list of the most widely known cosmetic ingredients and their definitions and trade names. The dictionary is available for reference at many public libraries or at the Office of the Federal Register in Washington, DC or through the link below.

It is not required for cosmetic manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries with the FDA. To keep abreast of such information, the FDA maintains a voluntary data collection program. Voluntary registration and assignment of a registration number by the FDA does not indicate approval of a firm or product by the FDA. Cosmetic companies that wish to participate in the Voluntary Cosmetic Registration Program should contact the nearest FDA office or visit their website or the Office of Cosmetics and Colors. The program applies to cosmetics already on the market to consumers in the United States. It consists of two parts: the voluntary registration of cosmetic manufacturing establishments and the voluntary filing of cosmetic product ingredient statements (formulations). Participation helps the FDA inform manufactures about cosmetic ingredients that may be harmful and should be removed from product use.

Although the Food, Drug, and Cosmetic Act does not require manufacturers or marketers to test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests that are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears specific warning information.

A cosmetic is misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner. The Fair Packaging and Labeling Act requires cosmetics produced or distributed in the United States to list ingredients on every cosmetic product offered for sale to consumers intended for home use. Cosmetic samples and products used exclusively by beauticians in salons are not required to include the ingredient declaration. However, these products must state the distributor, list the content's quantity, and include all necessary warning statements. Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements required must appear on the inside as well as on any outside container or wrapper. The principal display panel must state the name of the product, identify by descriptive name or illustration the nature or use of the product, and bear an accurate statement of the net quantity or contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The information panel must state the name and place of the business of the firm marketing the product. The address must state the street address, city, state and zip code in English. The Cosmetic Labeling Manual is available through the link below.

The FDA can inspect cosmetic manufacturing facilities, collect samples for examination, and take action through the U.S Department of Justice to remove adulterated and misbranded cosmetics from the market. Domestic and foreign manufacturers must follow the same regulations. The United States may refuse entry of foreign products that appear adulterated or misbranded.

The FDA, Center for Food Safety and Applied Nutrition provides a Cosmetic Handbook that contains information on the FDA's requirements and policies for safe production and accurate labeling of cosmetics. The handbook has information for use in the production and distribution of cosmetic products and is available through the link below.

A trade association is a valuable source for information, services and advice for your business. The 3 associations linked at the bottom of this page are for reference purposes only and do not constitute an endorsement.

For additional information/Sponsor Agency:

Environmental Conservation, Department of

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