Statement by the Personal Care Products Council In Response to FDA’s Draft Guidance on The Maximum Level for Lead in Cosmetic Lip Products and Externally Applied Cosmetics

Washington, D.C. – “The Personal Care Products Council is pleased that the U.S. Food and Drug Administration (FDA) has issued draft guidance, in response to our 2011 citizen petition, that establishes a maximum level of 10 parts per million (ppm) for lead in cosmetic lip products and externally applied cosmetics marketed in the United States.  As noted in the FDA guidance, this safety level is firmly grounded in sound science, and it aligns with the recommendation in industry’s petition.

“According to FDA, lipsticks and cosmetics that meet the 10ppm maximum lead level pose no health risk to consumers; and of the 685 cosmetic products tested by FDA, 99% of them fell at or below this level.  Moreover, 10ppm is also consistent with standards set by The International Cooperation on Cosmetics Regulation (ICCR), and regions such as Canada, Japan and the European Union.

“It is important to note that our industry’s long-standing commitment to consumer safety and quality products was the motivating factor behind our organization’s 2011 petition to FDA on this issue.  We appreciate that within this draft guidance the Agency acknowledges its regulatory oversight of our products.

“Consumers should be aware that lead is never used as an intentionally added ingredient in or as an additive to lipstick.  However, because lead is a naturally occurring metal, it is routinely detected in the air, water and soil. Consequently, it may be found at extremely low levels as a trace contaminant in the raw natural ingredients used to formulate cosmetics, just as it is in thousands of other products. We hope that this guidance will conclusively alleviate any public concerns about the safety of lipsticks.

“For more information on the science and safety of lip color products please visit: http://www.cosmeticsinfo.org/products/lip-color.”

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Statement by Beth Jonas, PhD, Chief Scientist Personal Care Products Council In Response to Formaldehyde in Hair-Straightening Products

Washington, D.C. – “Consumer and product safety are top priorities for the cosmetics and personal care products industry, with careful and thorough scientific research and development serving as the foundation for everything that we do.   

“The Personal Care Products Council (the Council) is a non-voting industry liaison member of the Cosmetic Ingredient Review (CIR) Expert Panel. CIR, an independent, non-profit body of scientific and medical experts that assesses the safety of ingredients used in cosmetics in the U.S., initiated a review at the request of the Food and Drug Administration (FDA), the Professional Beauty Association, and the Council.  In 2011, CIR issued a final conclusion on the safety of formaldehyde and methylene glycol as used in hair straightening products and found them to be unsafe under present conditions of use.

“The Expert Panel noted that the safety of methylene glycol and formaldehyde in hair straightening products depends on a number of factors, including the concentration of formaldehyde and methylene glycol, the amount of product applied, the temperature used during the application process, and the ventilation provided at the point of use.  They concluded that under present practices of use and concentration, formaldehyde and methylene glycol are unsafe in hair straightening products. The panel also concluded that formaldehyde and methylene glycol are safe for use as a preservative in cosmetics at minimal effective concentration levels and that do not exceed established limits.  The ingredients are also safe in nail hardening products in the present practices of use and concentration.

“The Council fully supports the Expert Panel’s findings.

“It’s important to note that FDA has clear authority to regulate the safety of these products under the Food, Drug & Cosmetic Act, which requires that every product and its individual ingredients be substantiated for safety before they are put on the market, and that those products’ labels be truthful and not misleading.  

“Workplace safety and workers’ rights practices of our business partners are very important to our member companies.  Like many companies today, cosmetics companies believe that their responsibility does not begin and end with their own operations, but extends to the entire product value chain.  Our contracts with business partners outline our expectations for ethical business practices. These often include provisions for labor rights, and health and safety. Violation of these provisions can result in cancellation of these partnerships.  

“We take great pride in the high quality employment opportunities offered by the cosmetics industry to nearly 3.6 million people in the U.S.  We remain fully committed to safe and ethical business practices and urge the same of our business partners.”

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Statement by Linda Loretz, PhD, Chief Toxicologist Personal Care Products Council In Response to the Environmental Working Group’s New Skin Deep Report

Washington, D.C. – “Consumer and product safety are top priorities for the cosmetics and personal care products industry, with careful and thorough scientific research and development serving as the foundation for everything we do.  Our products are among the safest product categories regulated by the Food and Drug Administration (FDA).

“The Environmental Working Group’s (EWG) report is speculative, misleading and does not use sound science to assess the safety of ingredients used in cosmetics and personal care products.  The group’s Skin Deep database assumes certain ingredients are hazardous, despite the fact that they have been found safe for use in cosmetics by expert bodies such as the Cosmetic Ingredient Review (CIR) Expert Panel (U.S.) and the Scientific Committee on Consumer Safety (SCCS) (EU).   Like its Skin Deep database, the group does not use sound scientific principles or peer reviewed data as the basis for its claims. The analysis in this report is fundamentally flawed, and the conclusions are not meaningful.

“Personal care products companies invest nearly $3 billion each year in scientific research and development.  Numerous scientific, peer-reviewed papers are published on evaluating ingredient safety and enhancing or developing new safety methods.  Companies take their responsibility for consumer and product safety very seriously.

“Furthermore, FDA has clear authority to regulate the safety of these products under the Food, Drug & Cosmetic Act, which requires that every product and its individual ingredients be substantiated for safety before they are put on the market, and that those products’ labels be truthful and not misleading.  

“Families who use cosmetics and personal care products, regardless of their background, can feel confident that they are protected by a combination of federal safety regulations and a strong commitment by manufacturers to utilize the best science and latest available research data to substantiate the safety of a cosmetic product before it is marketed.  Companies employ tens of thousands of scientific and medical experts who are devoted to studying the safety of human health in relation to products and the ingredients used in them.

“We encourage consumers to visit www.Cosmeticsinfo.org to get factual, scientific information on ingredients most commonly used in cosmetics and personal care products in the United States.”

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