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Public Statements

Letter to FDA Commissioner, Dr. Andrew C. von Eschenbach

Letter

By:
Date:
Location: Washington, DC


Kerry: Don't Shut Consumers out of Product Safety Conference

Senator John Kerry (D-Mass.) wrote a letter to FDA Commissioner, Dr. Andrew C. von Eschenbach, requesting consumer and stakeholder participation in the International Cooperation on Cosmetics Regulations meeting in Brussels, which starts today. Currently, the meeting of international regulators excludes all consumers and members of the public.

Kerry cited the potential environmental and safety risks posed by cosmetic products. The average consumer comes into contact with at least 126 different chemicals on a daily basis from the use of cosmetic products, many of them completely untested. Kerry emphasized that consumers should be given access to information about those chemicals and their effects. According to the Campaign for Safe Cosmetics, nearly 90 percent of the 10,500 ingredients used in cosmetics have not been evaluated for safety by federal regulators.

Below is the text of Kerry's letter:

September 26, 2007

Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach:

We are writing to voice our concern with the exclusion of consumers and members of the public from the International Cooperation on Cosmetics Regulations (ICCR) meeting in Brussels, Belgium on September 27, 2007. The U.S. Food and Drug Administration's mission to protect public health by assuring the safety of cosmetics is critical, given that American adults use an average of nine personal care products ranging from shampoo and shaving cream to sunscreen and body lotion that expose them to an average of 126 different chemical ingredients on a daily basis. Equally critical is the ability of consumers to participate in discussions aimed at ensuring cosmetic products' safety. Thus, while we appreciate FDA's efforts to guarantee the safety of these products through participation in the ICCR, FDA must also take steps to ensure that consumers and the public can participate in the ICCR process.

The ICCR meeting serves as a forum for international cosmetics regulatory authorities from the U.S., Japan, European Union, and Canada to "identify ways to remove regulatory obstacles among the regions, while maintaining the highest level of global consumer protection." However, while this upcoming meeting will be open to industry representatives, such as the Cosmetic, Toiletry, and Fragrance Association (CTFA), consumer and public health organizations concerned about the safety of cosmetics will be excluded.

The importance of consumer participation at the ICCR meeting is demonstrated by government data and independent research showing that the current system of cosmetics safety oversight is woefully inadequate and not sufficiently protective of public health.

· Nearly 90 percent of the 10,500 ingredients FDA determines to be used in cosmetics still have not been evaluated for safety by the CIR, FDA, or any other publicly accountable institution.

· FDA's Office of Cosmetics and Colors has described major gaps in federal authority over cosmetic safety: "...a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA."

· The limited determinations that CIR has made regarding unsafe uses for hazardous ingredients remain unenforced; a 2004 study found hundreds of products on the market in the U.S. in violation of CIR safety recommendations, containing ingredients that may cause harm when used according to package directions.

In order to ensure a more complete system of public health protections, it is critical to include the views of the consumer and public health community in the ICCR meeting.

We therefore urge FDA to:

provide for interactive electronic teleconferencing, recording, transcription, and publicly available posting of the upcoming ICCR meeting and all future ICCR meetings, to enable access and participation for members of the public who are unable to attend in-person;
notify stakeholders of the availability of this information; and
guarantee that interested stakeholders will be invited via public notice for all ICCR meetings.

If the above provisions cannot be implemented before the upcoming ICCR meeting, we respectfully request a postponement of this meeting until adequate public representation and access can be made available for all stakeholders concerned with the safety of personal care products.

Sincerely,

John F. Kerry
Barbara Boxer

Cc: Murray M. Lumpkin, M.D. Deputy Commissioner, Office of International and Special Programs, U.S. Food and Drug Administration

Melinda K. Plaisier, Assistant Commissioner, Office of International Programs, U.S. Food and Drug Administration

Michelle C. Limoli, Pharm. D., Associate Director for the European Union, Office of International Programs, U.S. Food and Drug Administration

Matthew E. Eckel, J.D., Staff Director; Director for International Agreements and Disclosure, Harmonization and Trade, Office of International Programs, U.S. Food and Drug Administration

Linda M. Katz, M.D., Director, Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration

Stanley R. Milstein, Ph.D., Chemist, Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration

Matthew R. Holman, Ph.D., Lead Chemist, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Michael L. Koenig, Ph.D. Biologist, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug
Administration


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