FDA should take steps to ensure that the public can participate in an initiative to bring international cosmetics regulations closer to alignment, Senator John Kerry (D-Mass.) stated in a Sept. 26 letter to FDA Commissioner Andrew von Eschenbach.

Addressing the International Cooperation on Cosmetics Regulations-a project involving regulatory agencies from the U.S., Canada, the E.U. and Japan-Kerry held that public participation is a key element to the program's success.

"The [FDA's] mission to protect public health by assuring the safety of cosmetics is critical," Kerry said, noting that the average U.S. consumer is exposed to 126 chemicals from personal-care products every day. "Equally critical is the ability of consumers to participate in discussions aimed at ensuring cosmetics products' safety."

Kerry criticized the agency for excluding the public from the ICCR's first meeting in Brussels, Belgium Sept. 27. FDA should have postponed the meeting until adequate public representation was available, he added.

The focus of the first annual gathering of ICCR members was developing strategic guidance and policies for removing market barriers for cosmetics between participating countries (¹ Also see "CTFA Supports International Harmonization Project In Comments To CFSAN" - HBW Insight, 24 September, 2007., p. 3).

Although the Cosmetic, Toiletry and Fragrance Association was permitted to attend the meeting, FDA did not allow the participation of the public and consumer advocacy groups, including the Environmental Working Group, a move that Kerry suggested was unfair.

"In order to ensure a more complete system of public health protection, it is critical to include the view of the consumer and public health community," the senator maintained.

"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," he added.

Kerry urged the agency to "provide for interactive electronic teleconferencing, recording, transcription and publicly available posting of the upcoming ICCR meting and all future ICCR meetings to enable access and participation for members of the public who are unable to attend in person."

Furthermore, FDA should "notify stakeholders of the availability of this information" and guarantee that they will be invited via public notice to participate in all future meetings, Kerry concluded.

The EWG expressed similar sentiments in a letter to the commissioner dated Sept. 26, the same day it released findings from a study of ingredients in more than 23,000 products.

Specifically, EWG criticized what it suggested was deceptive means for excluding it and other advocacy groups from the Brussels meeting.

FDA informed the group on Aug. 30 that it could not attend due to meeting policies that provide only for industry/association regulatory dialogue. But in reviewing the terms of reference for the meeting, EWG identified "ample leeway" for public health and environmental groups to be part of the discussion.

"FDA's misrepresentation of the terms of reference and its attempt to exclude consumers and the public from participating in this public health discussion is unacceptable and runs contrary to principles of open government," EWG states.

The Campaign for Safe Cosmetics, a consumer advocacy conglomerate of organizations including EWG, added in a same-day statement that FDA's exclusion of advocacy groups from the meeting is an "outrage ... especially since they've set a place for the cosmetics industry at the table."

EWG maintains that exclusion of public watchdogs is "particularly troubling" given the findings from a study of ingredients in more than 23,000 products - released Sept. 26 as well - indicating that products sold in the U.S. "frequently violate industry safety standards and contain ingredients banned in other industrialized countries."

"Our findings raise fundamental concerns about closed-door industry regulator meetings that could further weaken international cosmetics policies," EWG states.

An update on a study published in 2004, EWG's most recent analysis found that nearly one of every 30 products marketed in the U.S. fails to "meet one or more industry or governmental cosmetics safety standards."

"We found nearly 400 products sold in the U.S. containing chemicals that are prohibited for use in cosmetics in other countries, and over 400 products containing ingredients that cosmetics industry safety panels have found unsafe when used as directed on product labels," EWG notes.

L'Oreal and Maybelline cosmetics, among others, were found to contain ingredients banned under new European cosmetics regs, and Rembrandt and Mentadent whitening products were found to contain ingredients banned in Japan.

Referencing its earlier 2004 review, EWG asserts that "three years later ... it appears that FDA has done little in the intervening time to improve product safety, and worse, is now working to exclude public health, consumer and product safety advocates from international cosmetics safety decisions."

"Given the findings of our analysis, improving product safety should be a far higher priority than removing regulatory obstacles, which are already lacking to the point that products illegal for sale in other countries or not assessed for safety are common on store shelves in the U.S.," EWG states.

In light of its findings, the advocacy group calls on FDA to "set a safety standard for cosmetics by clarifying the current regulatory requirement of 'adequate substantiation of safety'" in the Federal Food, Drug and Cosmetic Act and "include guidance on whether it will consider cosmetics safe if they contain ingredients banned in other countries or in violation of [Cosmetic Ingredient Review panel] recommendations."

The agency also should "ensure that all personal-care products on store shelves are safe for consumers" and "guarantee that meetings regarding cosmetics safety policy are open and accessible to the public."

In comments recently submitted to FDA, CTFA praised the agency's participation in the ICCR project and stressed its desire to work closely with regulators on the project.

- Eileen Francis (e.francis@elsevier.com)

Effort To Harmonize Cosmetics Regs Should Include Public Input – Sen. Kerry

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