Safe Cosmetics Act of 2010: New Bill Would Increase Cosmetics Regulations

Jul 22, 2010   
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The U.S. Food and Drug Administrations (FDA) current regulation of cosmetics is relatively lax compared to the way the Agency regulates drugs, biologics, medical devices, and other FDA-regulated industries.  However, that all may change if the Safe Cosmetics Act of 2010 becomes law. 

The bill (H.R. 5786), introduced this week, would alter the regulatory scheme of cosmetics in the U.S. to more closely reflect the way that FDA regulates the other industries under its purview.  The Safe Cosmetics Act of 2010 would maintain the current Food, Drug, and Cosmetic Act sections 601-603 concerning adulterated and misbranded cosmetics but would add a new subchapter that would include, among other provisions:

  • A requirement that domestic and foreign establishments that manufacture, package, or distribute cosmetics to register FDA annually; 
  • Establishments would be required to provide FDA with specific information about their products and provide FDA with a description of the establishments activities and gross receipts.  Manufacturers would have to supply FDA with contact information for each of its ingredient suppliers;
  • A requirement that FDA establish a “schedule of feesto provide for oversight and enforcement” of the new cosmetics regulation.  Such fees would only be assessed to companies with gross receipts or sales of more than $1 million;
  • The requirement that all cosmetics labels, both for retail sales and professional use, “bear a declaration of the name of each ingredient in such cosmetic in descending order of predominance;”
  • A requirement that cosmetics manufacturers and distributors submit to FDA all information about “the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels.”  The information to be submitted would include function and uses, tests of cosmetics, and exposure and fate information;
  • A prohibition on companies from manufacturing, importing, distributing, or marketing a cosmetic or cosmetic ingredient if the company has not provided FDA with the information required under the regulations.  Also, the bill contains a prohibition on companies from manufacturing, importing, distributing, or marketing if the companys product contains any non-permitted ingredients;
  • A mandate that adverse health effects associated with the use of a cosmetic be reported;
  • The requirement that responsible parties notify FDA if a marketed cosmetic is adulterated or misbranded is a way that the use of or exposure to the cosmetic (or any ingredient or component of the cosmetic) would likely cause serious health consequences or death.  FDA may request a voluntary recall of the affected products, issue a cease and desist order to stop the company from distributing, and/or require a recall or issue an emergency recall order;
  • A requirement that FDA issue regulations that includes lists of ingredients the FDA classifies as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics.  These regulations must be issued within two years of enactment of the Safe Cosmetics Act of 2010.
  • A requirement that FDA develop a “priority assessment list of not less than 300 ingredients” that cannot be included on the three lists mentioned above “because of a lack of authoritative information on the safety of the ingredient.”  FDA must determine the safety of these ingredients.
  • A requirement that FDA publish a list of “alternative testing methods” that do not involve using animals to test chemical substances; and
  • FDA authorization to require cosmetics containing “nano-scale” materials be labeled as such.

Currently, cosmetic establishments do not have to register with FDA.  Additionally, there is no regulation requiring that a cosmetic ingredient be approved by, or listed with, FDA prior to use.  The FDA, under 21 C.F.R. parts 710 and 720, has established the voluntary cosmetic registration program which allow firms to voluntarily register their facilities and list their products and ingredients.  FDA does regulate color additives more strictly with some requiring certification prior to use.  FDA regulations also prohibit or restrict certain ingredients for cosmetic use.  However, the provisions of the Safe Cosmetics Act of 2010 would greatly alter the current structure of the regulation and allow the FDA a much more invasive approach to the regulation of cosmetic firms. 

Rep. Jan Schakowsky (D-IL), with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced the bill just five days after the Personal Care Products Counsel (PCPC) announced that the organization had sent a letter to health policy leaders in Congress calling for changes in FDA regulations.  Many of the PCPC proposals are included in the Safe Cosmetics Act of 2010. 

The provisions of this new bill could significantly transform the way that the cosmetic industry does business.  Heightened scrutiny and regulation by the FDA would lead to greater cost for cosmetics manufacturers, distributors, and importers. 

For more information on FDA regulation of the cosmetic industry or how this new bill could affect your business, please contact us at