Cosmetic products are the safest products regulated by the U.S. Food and Drug Administration (FDA), a fact that has been publicly recognized by a number of FDA Commissioners over the last several decades. To further strengthen industry safeguards for consumers, the Personal Care Products Council (the Council) has instituted a Consumer Commitment Code for the cosmetic industry. This incorporates and strengthens some practices already in place for most companies, such as the current reporting of manufacturing establishments; and it includes new practices such as a Safety Information Summary Program that makes information relevant to cosmetic product and ingredient safety readily available to the FDA upon request. The Council's Board of Directors unanimously supports the principles and practices embodied in this Code. It formally launched on January 1, 2007. The Council continues to educate its members on the practices embodied in the Code. The Council will also reach out to many related trade associations and other organizations to encourage broad recognition of the Code. We will continue to work closely with the Food and Drug Administration to provide as much information regarding cosmetic safety as we believe the agency needs to evaluate the safety of the products. In providing FDA with access to this information, we seek to provide consumers with the continued confidence that the proper steps are being taken by government and industry to support the continued safety of all cosmetic products, and to allow consumers to make informed choices when purchasing cosmetic products.
The following principles constitute the Consumer Commitment Code:
- A company should market cosmetic products only after ensuring that every ingredient and finished product has been substantiated for safety. The decision that an ingredient has been substantiated for safety may be based on a finding by the Cosmetic Ingredient Review Expert Panel that such ingredient is safe for the use intended by the company or on other appropriate data and information.
- When marketing a cosmetic product containing an ingredient that exceeds limits on concentration or product type established by the Cosmetic Ingredient Review Expert Panel, a company should possess information sufficient to substantiate the safety of the ingredient for its intended use in such product and be willing to make that information available for inspection by the Food and Drug Administration.
- When marketing a cosmetic product containing an ingredient for which the Cosmetic Ingredient Review Expert Panel has found insufficient data to determine safety, a company should possess information sufficient to substantiate the safety of the ingredient for its intended use in such product and be willing to make that information available for inspection by the Food and Drug Administration.
- A company should participate in the applicable parts of the FDA Voluntary Cosmetic Reporting Program set forth in 21 CFR Parts 710 and 720 for products marketed in the United States, and file timely reports regarding its manufacturing establishments and ingredient usage.
- Although adverse events that are both serious and unexpected are extremely rare for cosmetic products, a company should notify the Food and Drug Administration of any known serious and unexpected adverse event as a result of the use of any of its cosmetic products marketed and used in the United States. "Serious" and "Unexpected" are defined in accordance with FDA's definition for such experiences related to drugs in 21 CFR 314.80(a). Information related to other product experiences as described in the Council's Safety Information Summary Program should be maintained in the safety information summary described in Paragraph 6 below. Such information should be made available for inspection by FDA under the conditions specified in that program.
- A company should maintain a safety information summary of ingredient and product safety information and data regarding its cosmetic products marketed in the United States as specified in the Council's Safety Information Summary Program Guideline, and make any information in that safety information summary available for inspection by FDA under the conditions specified in that program.
* The Code should not be construed as a legal standard. All companies have an independent obligation to ascertain that their cosmetic products comply with all current laws and regulations.