Tuesday, December 11, 2007

FDA Labeling Guidelines for Soap

The Federal Food, Drug and Cosmetic Act of 1938 was signed by FDR amidst a burgeoning public outcry for consumer protection from quack cures and cosmetic products that caused harm rather than cure or enhance the user. The act was designed to protect the public from products that made unsubstantiated or fraudulent claims, or that caused harm due to inclusion of harmful ingredients. The act covered the broad scope of both what is consumed or ingested as food and those ingredients that are used to treat, cure or enhance cosmetically.

Though this new law made it illegal for manufacturers to include ingredients in products that could be harmful to an unsuspecting public yet it wasn't until it was amended to include - the Pesticide Amendment of 1954, the Food Additives Amendment of 1958, and the Color Additive Amendments of 1960 – that the law became specific in nature requiring manufacturers to use only ingredients (which included additives and color) in manufacturing that prior research revealed to be safe for public consumption.

However, it wasn’t until The Fair Packaging Act of 1967 that strict labeling guidelines became standard manufacturing practice which required manufacturers to own up to ingredients used in the manufacturing and processing of their products - and to this end to be accountable to a certain standard and disclosure to the public who bought their products. What this act did more than anything else was to usher in the era of ‘truth in labeling’ that held manufacturers responsible for ensuring that the products that they brought to the marketplace was safe for consumers by assuring that ingredients used in products were tested and deemed safe, that the manufacturing process did not expose product ingredients to contaminants and that required a listing of all ingredients along with company contact information on all items that was used for food, drug and cosmetic purposes.

Plain soap is not a Cosmetic or Drug

Manufacturers who create soaps are still held responsible for creating a safe product. Soap that makes no claims to do anything than its intended purpose, that is, as a cleansing agent is not a cosmetic under FDA guidelines and is not subject to the rigorous labeling guidelines of cosmetics. Instead it is regulated by the US Consumer Product Safety Commission, an independent federal regulatory agency which is charged with protecting the public against unreasonable risks of injuries and deaths associated with consumer products. The Federal Hazardous Products Acts gives jurisdiction to CPSC for regulating "...all noncosmetic, nondrug substances used in the home."

Soaps that are Cosmetics or Drugs

However, there are exceptions to this. Once a manufacturer uses verbiage which claims that the soap has a special use other than that which it is intended for - such as claiming that the soap has special moisturizing properties or that it treats or cures a certain skin condition, then the soap as per labeling is not just plain soap anymore but is now a cosmetic or even a drug and subject to the regulatory guidelines of cosmetics and drugs. In addition, what sets plain soap apart from cosmetic soaps is how they have to be labeled. A soap that claims it has special properties that will enhance or alter the molecular structure of the user has to be labeled with ingredients listed in International Nomenclature of Cosmetic Ingredients format. International Nomenclature of Cosmetic Ingredients AKA INCI, is a special naming convention which classifies ingredients used in cosmetic and body care manufacturing based on scientific, Latin or English names.

The Fair Packaging Act of 1967, sets specific guidelines for labeling products which states that all products should have the basic components listed below- Please note that if you are making regular soap which has no other claim than as a cleansing product then these guidelines apply to you:

This statement is taken from the Federal Trade Commission's Website

The FPLA requires each package of household "consumer commodities" that is included in the coverage of the FPLA to bear a label on which there is:

* a statement identifying the commodity, e.g., detergent, sponges, etc.;

* the name and place of business of the manufacturer, packer, or distributor;

* and the net quantity of contents in terms of weight, measure, or numerical count (measurement must be in both metric and inch/pound units)."

Links to Resources: http://www.cfsan.fda.gov/~dms/cos-lbl.html

Federal Trade Commission website with link to the Fair Packaging Act which directs how manufacturers should label consumer commodities: http://www.ftc.gov/os/statutes/fpla/outline.html

FDA Regulatory requirements for labeling of cosmetics marketed in the United States: http://www.cfsan.fda.gov/~dms/cos-lab1.html

US Food and Drug Administration

The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. http://www.cpsc.gov/

OSHUN Supply INCI listing of common names and INCI names of ingredients used in soap and cosmetic product manufacturing: http://www.oshun.ca/inci.html

Source: Permission to reprint by Winsome Tapper, Soapmaking Editor, http://www.bellaonline.com/site/soapmaking

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