Initial Bill Receives Support of Beauty Industry

Phoenix, AZ (April 20, 2012) – The “Cosmetic Safety Amendments Act of 2012,” (H.R. 4395) was recently introduced by Representative Leonard Lance (R-NJ) and is an important step in advancing and modernizing the regulatory oversight of cosmetics and personal care products. While the legislative process is lengthy and changes to the bill are likely to occur, the Professional Beauty Association (PBA) is highly encouraged by the bill’s introduction. PBA believes H.R. 4395 takes a balanced approach with the needs of all interested parties and most importantly allows the U.S. Food & Drug Administration (FDA) a greater role in assessing the safety of personal care products.

“The Cosmetics Safety Amendments Act of 2012 provides the needed improvements to the current laws regarding cosmetics and personal care products, without placing an undue burden on business or compromising safety,” stated PBA’s Director of Government Affairs, Myra Irizarry. “Consumers, manufacturers, distributors and government can in fact work together and PBA, along with our industry partners, are supportive of H.R. 4395.”

As part of the Safe Cosmetics Alliance (SCA), PBA is joining with other leading trade groups including the Personal Care Products Council (PCPC), Independent Cosmetic Manufacturers and Distributors (ICMAD), Direct Selling Association (DSA), and the International Fragrance Association North America (IFRA) in support of H.R. 4395. The bill calls for increased reporting and transparency by the industry and expanded regulatory oversight without a detrimental effect to small and medium-sized business’ ability to compete globally. By establishing modernized and uniform national regulations and guidance, businesses have the confidence to innovate and expand, without having to worry about dealing with various and ever-changing regulations at the state level.

“Everyone agrees that we need to update the regulation of personal care products,” said Representative Lance. “This bill will continue to advance consumer safety and provide a regulatory framework that furthers growth and innovation for American cosmetics manufacturers and small businesses.”

The legislation aims to create formal processes for the FDA to review ingredients for safety, set safety levels for trace impurities, create national uniformity for cosmetics regulations, review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel, and establish industry-wide “Good Manufacturing Practices.” Furthermore, under the new legislation, the voluntary registration programs for facilities and products would become mandatory, as would the reporting of any serious and unexpected adverse events. PBA and industry partners believe H.R. 4395 is more realistic and fair in its approach, while protecting the interests of all parties, than previously introduced legislation.

“Transparency and safety is vital to protecting the trust consumers place in the products our members manufacture, distribute and use,” stated PBA’s Executive Director, Steve Sleeper. “H.R. 4395 promotes best practices and will further improve our industry while protecting consumers.”

The Professional Beauty Association’s purpose is to advance the professional beauty industry by providing its members with business tools, government advocacy, education, networking, events and more to ensure business and career success with integrity. PBA is the largest organization of salon professionals with members representing salons and spas, distributors, manufacturers and beauty professionals.

Support the “Cosmetic Safety Amendments Act of 2012,” H.R. 4395, Sponsored by Representative Leonard Lance (R-NJ)

• The Personal Care Products Council (PCPC) supports H.R. 4395 which will create a greater role for the Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.

• The “Cosmetic Safety Amendments Act of 2012” takes a number of key steps to modernize the FDA’s oversight while ensuring consumer safety, increasing transparency, and allowing American businesses to thrive and compete globally.

• The proposals in H.R. 4395 represent the culmination of years of research and policy discussions, and are a testament to Congressman Lance’s leadership. The cosmetics and personal care products industry support Congressman’s Lance’s bill and his intentions with this legislation.

• This legislation builds upon language first included in legislation introduced in Congress by Representative John Dingell (D-MI) known as the “FDA Globalization Act of 2008”. More recently, Congressman Frank Pallone (D-NJ) and Congressman Dingell introduced legislation with similar provisions to H.R. 4395.

• PCPC has developed collaborative working relationships with members from both sides of the aisle and looks forward to continuing to work over the coming months to generate broad bipartisan support to modernize the regulation of cosmetics.

How the “Cosmetic Safety Amendments Act of 2012” Benefits Consumers

Each of the following provisions will improve regulatory transparency and ensure the safety of consumer products, without straining taxpayer resources, or disadvantaging small and medium-sized businesses’ ability to compete.

• Enhanced FDA Registration: Makes the current voluntary reporting program with the FDA mandatory for all manufacturers. New mandatory reporting would apply for manufacturing facilities, product ingredients as defined by current guidelines, and unexpected adverse events.

• New FDA Ingredient Review Process: Upon request or of its own initiative, the FDA would be required to review the safety of any ingredient intended for use in a personal care product and establish safety levels for those ingredients.

• New Process to Establish Safety Levels for Trace Constituents: Upon request or of its own initiative, the FDA would review the safety and establish tolerance levels for substances that are detected at trace levels in cosmetics.

• New FDA Oversight of CIR Findings: The FDA would review current and future findings of the Cosmetic Ingredient Review (CIR) Expert Panel, an independent, non-profit, panel of scientists and physicians who review cosmetic ingredients for safety, and make determinations about those findings.

How the “Cosmetic Safety Amendments Act of 2012” Benefits American Businesses

The proposed bill will provide certainty and clarity for manufacturing businesses bringing new products to market. This bill effectively regulates cosmetic products and their manufacturers, without placing an undue burden on small retailers, independent sales representatives, or distributors.

• FDA-Issued Good Manufacturing Practices: The FDA would establish industry-wide “Good Manufacturing Practices” for cosmetic products (GMPs).

• National Uniformity:  The new regulatory authority of the FDA would be primary and paramount in the United States.  This would preempt duplicative state legislation for cosmetics and personal care products. A strong and predictable national regulatory framework will encourage and enable American companies to innovate, expand and generate increased tax revenue and jobs.

The Safe Cosmetics Alliance is comprised of leading beauty and personal care products and services industry trade organizations representing manufacturers, suppliers, distributors, retail owners, salon/spa owners, and licensed beauty professionals who support science-based legislative and regulatory policies that enhance consumer and product safety standards. To learn more, visit