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Personal Care Products Council CEO & President Pamela G. Bailey Testifies on FDA Cosmetic Regulation Before U.S. House Committee on Energy and Commerce
Date:5/14/2008

Combination of FDA Authority and Industry Consumer Safety Initiatives Make

Cosmetics Safest Category Regulated by FDA

WASHINGTON, May 14 /PRNewswire-USNewswire/ -- Today, Pamela G. Bailey, CEO and president of the Personal Care Products Council, appeared before the Subcommittee on Health of the U.S. Committee on Energy and Commerce to discuss the Food and Drug Administration Globalization Act Legislation on Device and Cosmetic Safety. Based in Washington, D.C., the Personal Care Products Council, formerly the Cosmetic, Toiletry, and Fragrance Association, is the leading national trade association representing the global cosmetic and personal care products industry.

"Consumer safety has always been the number one priority of our cosmetics and personal care products companies, and our continued commitment to safety has made cosmetics and personal care products the safest category of products regulated by the U.S. Food and Drug Administration," Bailey told the committee.

Of the 11 billion personal care products that are sold annually, an average of less than 150 adverse reactions are reported-most of which are minor skin irritations. Topically-applied and not ingested, cosmetics have the least potential to impact human health of any FDA-regulated product category. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, it is crime to market an unsafe cosmetic product in the United States.

Cosmetics products imported into the U.S. are subject to the same laws and regulations as those produced in the U.S. They must be safe and contain no prohibited ingredients, and all labeling and packaging must be in compliance with U.S. regulations. All colors must be listed and pre-approved by FDA, and a number of color additives must be batch certified by FDA. If the product has an intended use that causes it to be considered an Over-the-Counter (OTC) drug, it must comply with the regulations for drugs, including establishment registration and drug listing.

"Product safety in a global marketplace is not only a matter of law for our members but also the primary commitment for each of them and for our trade association," said Pamela Bailey. "The Council is a science-based, safety-first organization with a decades-long track record of product safety initiatives that go beyond the requirements of the law."

For nearly 40 years, personal care product companies have invested millions of dollars through the Council in additional safety programs and initiatives to supplement FDA regulations. These initiatives include:

-- The FDA Company Registration Program (VCRP) through which FDA collects

information on manufacturers, packers, and distributors of cosmetic

products in commercial distribution in the U.S.;

-- The Cosmetic Ingredient Review (CIR) -- an independent expert panel of

scientists and physicians that evaluate safety data for the most

commonly-used cosmetic ingredients;

-- The Cosmetic Ingredient Dictionary that has been cited by the FDA as

the primary source of ingredient names for FDA regulations requiring

cosmetic ingredient labeling;

-- Technical Guidelines for the industry that provide information on

microbiological testing, quality assurance, and safety testing;

-- Consumer Commitment Code that requires signing member companies to go

beyond the requirements of the law by agreeing to open their scientific

data and information to FDA scrutiny, to report to FDA serious and

unexpected adverse consumer experiences with a cosmetic product, and to

register their manufacturing establishments and formulas with the FDA;

-- The Establishment of International Consumer Safety Standards through

the International Organization for Standardization (ISO) program;

-- ICCR, a Global Harmonization of Regulations process, is an official

dialogue of international cosmetics regulatory authorities joined by

the cosmetics industry trade associations;

-- The Import Safety Committee, created by the Council last year to

benchmark the industry's best practices and policy objectives with

respect to import safety with the goal of developing additional

industry guidelines;

-- Consumer Information Website, CosmeticsInfo.org, launched in 2007, the

site provides consumers with easy access to in-depth, scientifically-

based information about cosmetic and personal care products and

ingredients.

"We appreciate this opportunity to work with the Committee to continue to ensure the safety of consumers in America," Bailey said.

Based in Washington, D.C., the Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry. Founded in 1894, the Council's more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on everyday, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.


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SOURCE Personal Care Products Council
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