Statement by Lezlee Westine President and CEO of the Personal Care Products Council in Response to the Safe Cosmetics Act of 2010 Introduced Today in Congress by Representatives Jan Schakowsky (D-IL), Edward Markey (D-MA) and Tammy Baldwin (D-WI)

“We appreciate the interest of Representatives Schakowsky, Markey and Baldwin in cosmetic regulation, and we share their desire to ensure that existing FDA regulatory oversight is enhanced to take into account evolving science, the continued growth of our industry, and the need to modernize the regulatory structure. Toward that end, our industry has lobbied for the last several years to obtain additional funding for FDA’s Office of Cosmetics and Colors.  We also just last week proposed a number of new measures, including FDA ingredient reviews, that we believe would enhance FDA oversight and give the agency the information and flexibility it needs to continue to ensure consumer safety and safeguard public health.

“We are concerned that the Safe Cosmetics Act of 2010 as written is not based on credible and established scientific principles, would put an enormous if not impossible burden on FDA, and would create a mammoth new regulatory structure for cosmetics, parts of which would far exceed that of any other FDA-regulated product category including food or drugs.  The measures the bill would mandate are likely unachievable even with the addition of hundreds of additional FDA scientists and millions more in funding and would not make a meaningful contribution to product safety.

“We urge Congress to carefully consider our recently announced proposals to strengthen FDA cosmetics oversight, including FDA ingredient reviews, and encourage the passage of the FDA Globalization Act of 2009, sponsored by Rep. John Dingell, which also includes enhanced FDA regulations of cosmetics manufacturers. Our proposals and Rep. Dingell’s legislation constitute the strongest, most efficient, and viable approach to modernizing the FDA regulation of cosmetics, increasing transparency, and enhancing existing consumer safeguards as science and technology evolve.

“Our plan includes the following five elements:

(1) Enhanced FDA Registration. It requires that personal care products manufacturers that market their products in the United States comply with the following:

  • Register with FDA all facilities where those products are manufactured.
  • File with FDA product ingredient reports disclosing all of the ingredients used in those products; and
  • Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) New Process to Set Safety Levels for Trace Constituents. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products;

(3) New FDA Ingredient Review Process. Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable;

(4) New FDA Oversight of CIR Findings. FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct. If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products;

(5) FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide “Good Manufacturing Practices” requirements.

“Strong federal safety requirements already govern cosmetics and personal care products sold in the U.S.  The safety of cosmetic and personal care products in the U.S. is overseen by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires that all cosmetics be substantiated for safety before they are marketed, contain no prohibited ingredients, and that all labeling and packaging must be in compliance with U.S. regulations. Under the FD&C Act it is a crime to market an unsafe cosmetic product. Our proposed measures would further enhance the effectiveness of the FDA cosmetic regulatory structure.”

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Nation’s Cosmetics Industry Calls for Greater FDA Role in Oversight of Ingredients in Personal Care Products

Groundbreaking Initiative from Personal Care Products Council Would Establish an Additional Layer of Federal Oversight & Enhance Existing Consumer Safeguards

WASHINGTON, D.C. (July 15, 2010) – In a groundbreaking initiative intended to enhance existing protections for millions of American consumers, the nation’s cosmetics industry today announced plans to support legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the U.S. Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.

The proposal represents the culmination of more than three years of planning and research by the Personal Care Products Council (the Council), the cosmetics industry’s trade group, which has consistently advocated for more FDA funding to support additional regulatory oversight.  The Council detailed its proposal in a letter to key health policy leaders in Congress.  The proposal would enhance current FDA and industry safety initiatives.

The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of the public and stakeholder groups and to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel.  No such FDA processes currently exist.

“For decades, the industry has had an impeccable safety record under the existing requirements implemented by FDA under the Federal Food, Drug, and Cosmetic Act.  Our products remain among the safest in the marketplace,” said Lezlee Westine, the Council’s president and chief executive officer. “Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role.  In fact, for the last 30 years, we have aggressively implemented numerous safety initiatives and processes to strengthen industry safety practices. Our consumers deserve multiple layers of protection and transparency.”

Westine emphasized the proactive nature of today’s announcement, which is being made in the absence of any specific public health risk or legislative mandate involving personal care products, which remain safe to use.  Rather, the industry is responding to American consumers who are requesting and deserving more transparency from government and industry while ensuring their ability to keep pace with continued demand for innovative products.

“From Wall Street to the Gulf of Mexico, we have seen what can happen when there is a breakdown in the relationship between government and the private sector,” said Westine. “Our initiative recognizes the need to establish a more collaborative and constructive relationship with federal regulators.”

Toward that end, the Council’s five-point plan includes mandatory industry reporting and mandatory Good Manufacturing Practices, two provisions currently in HR 759, the Food and Drug Administration Globalization Act of 2009, introduced by Congressman John Dingell (D-MI), and three additional provisions that industry is seeking.  

The Council plan includes:

(1) Enhanced FDA Registration.  It requires that personal care products manufacturers who market their products in the United States comply with the following:

  • Register with FDA all facilities where those products are manufactured.
  • File with FDA product ingredient reports disclosing all of the ingredients used in those products; and
  • Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) New Process to Set Safety Levels for Trace Constituents.  When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products;

(3) New FDA Ingredient Review Process.  Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable;

(4) New FDA Oversight of CIR Findings.  FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct.   If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products;

(5) FDA-Issued Good Manufacturing Practices.  FDA would establish industry-wide “Good Manufacturing Practices” requirements.

The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve.   Today’s consumers have even higher expectations for the products they choose for themselves and the companies that provide them,” said Westine. “Our companies commend Rep. Dingell for his ongoing work to better protect consumers and increase transparency.  We look forward to working with the current and next Congress to ensure these changes are meaningful and attain the full force of federal law.”

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