Cosmetic Bill Introduced in US Senate

Two US senators introduced legislation Monday that would require the Food and Drug Administration to evaluate and report on some of the ingredients used in cosmetics and personal care products such as shampoo and skin cream. The Personal Care Products Safety Act,  would require the FDA to investigate at least five ingredients each year. The reviews would lead to the agency providing guidance about whether ingredients should continue to be used, and if so, at what concentration levels.

The measure is supported by The Personal Care Products Council, as well as industry companies Johnson & Johnson, Procter & Gamble, Revlon, Estée Lauder, Unilever and L'Oréal. The legislation also has the blessing of The Environmental Working Group, Society for Women's Health Research, National Alliance for Hispanic Health and HealthyWomen.

Democratic Senator Dianne Feinstein of California and Republican Senator Susan Collins of Maine, the bill's sponsors, said that federal regulations of the ingredients in cosmetics and personal-care products haven't been updated for 75 years.

“From shampoo to lotion, the use of personal care products is widespread, however, there are very few protections in place to ensure their safety,” Feinstein said in a statement.

The bill would require the FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use – the two chemicals mentioned above are among those to be reviewed in the first year. The review process set forth in the bill would provide companies with clear guidance about whether ingredients should continue to be used and if so, what the concentration levels should be and whether consumer warnings are needed. For example, a chemical may be deemed inappropriate for use in children’s products, or appropriate for professional application only.

The first set of chemicals for review includes:

• Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion;

• Lead acetate, which is used as a color additive in hair dye;

• Methylene glycol/formaldehyde, which is used in hair treatments;

• Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion; and

• Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.

The bill would provide streamlined federal standards so that the personal care products industry knows what to expect and companies can plan for the future with certainty, according to the Senators.

Furthermore, The Personal Care Products Safety Act would also:

• Provide the FDA the authority to order recalls of certain personal care products that threaten consumer safety.

• Provide the FDA the authority to require labeling of products that include ingredients not appropriate for children and those that should be professionally administered. Complete label information, including ingredients and product warnings, would also be required to be posted online since approximately 40% of personal care products are purchased over the internet.

• Require companies to provide contact information on their products for consumers and report serious adverse events to the FDA within 15 days, including death, hospitalization and disfigurement. Health effects that could have resulted in hospitalization without early intervention would also be required to be reported.

• Require manufacturers to register annually with the FDA and provide the agency with information on the ingredients used in their personal care products.

• Direct the FDA to issue regulations on Good Manufacturing Practices for personal care products.To fund these new oversight activities, the bill would authorize the FDA to collect user-fees from personal care products manufacturers similar to what is done for medications and medical devices.

In response to the proposed legislation, Lezlee Westine, president and CEO of The Personal Care Products Council noted that for more than five years, the Personal Care Products Council and its member companies have worked collaboratively with members of Congress seeking to reform federal regulatory oversight for cosmetics and personal care products.  

“We support the creation of a national standard that maintains the continued safety of our products while providing the US Food and Drug Administration (FDA) with additional regulatory authority over our industry,” said Westine. “While we believe our products are the safest category that FDA regulates, we also believe well-crafted, science-based reforms will enhance industry’s ability to innovate and further strengthen consumer confidence in the products they trust and use every day.  The current patchwork regulatory approach with varying state bills does not achieve this goal.”