Stakeholders at FDA’s Nov. 30 public meeting addressed the issue of preservative use in cosmetics, with industry representatives coming to the defense of currently used preservative systems, which are essential to ensuring safe consumer use, they say.

Held in Washington, D.C., the meeting was designed as a “listening session” for FDA Office of Cosmetics and Colors administrators to gain perspective on cosmetic microbiological safety issues.

FDA is examining cosmetic microbiological safety because it “links directly to FDA’s public health mission,” OCC Director Linda Katz noted during the meeting.

Moreover, some of the agency’s data and related guidance on the subject are close to 10 years old.

“Science changes,” Katz explained. “We can constantly gain new information, a wealth of information that all of you provide to us. As we look at guidances ... this is probably the right time to go back and see what needs to be changed.”

FDA could also be looking to exercise its authority under current law and refresh its understanding of a potentially sensitive cosmetic safety area with legislation in the works that would overhaul cosmetics oversight. The Safe Cosmetics Act of 2011 was introduced over the summer, and rival legislation supported by the Personal Care Products Council has been expected since July Also see "Council Backs Rival FDA Cosmetics Legislation In Wake Of SCA" - HBW Insight, 18 July, 2011..

FDA has not yet issued specific guidance in the area of cosmetic microbiological safety. Katz noted that after digesting material presented at its meeting and reviewing submitted comments, FDA may determine that guidance is unnecessary.

The agency is accepting stakeholder comments through Jan. 30 ([A#02111107002]).

“We’re interested in data and information, analysis and perspective regarding microbiological risk assessment,” Patricia Hansen, senior advisor for science and policy in the OCC, said at the meeting.

Preservative Safety Data Is Light, EWG Says

Activist organization the Environmental Working Group welcomed the occasion to press for FDA guidance “on the best methods for protecting consumers from both microbial contamination and exposures to harmful chemical preservatives.”

EWG law fellow Etan Yeshua said that some cosmetic products on the market contain preservatives that are potentially hazardous, while “others alarmingly appear to contain no preservatives at all.”

“There’s a gap in industry knowledge – or at least use of cosmetic preservation best practices, for which we believe FDA guidance would be well suited,” he said.

Additionally, FDA could consider mandating product labeling with expiration dates and disclosure of all preservatives “including those like formaldehyde that are often released into the product,” Yeshua said.

According to a Dec. 1 email from an EWG spokeswoman, the group has “yet to see enough research on any preservative for it to be classified as [categorically] ‘safe.’” She acknowledged that there are preservatives with low hazard ratings in EWG’s Skin Deep database, but data is too limited for an unequivocal “safe” characterization.

She pointed to sodium benzoate as an example. It received a “hazard rating” of 1 (low hazard) in the organization’s database, but the ingredient is also tagged with a “limited data” caveat because according to the group, few studies have been conducted to assess its safety.

“There's simply not enough available, reliable science on the safety of many of the preservatives on the market,” she said.

Industry Emphasizes: Preservatives Protect Consumers

David Steinberg, an industry consultant and representative for the Cosmetic Preservative Council, countered, asserting that preservatives help prevent contamination of products and have been needlessly under attack even “though their safety record is constantly reviewed.”

The top 20 most-used preservatives, according to FDA’s Voluntary Cosmetic Reporting Program, are all being reviewed or have been reviewed and in some cases re-reviewed and found safe by the Cosmetic Ingredient Review Expert Panel, he said.

Jay Ansell, vice president of cosmetic programs for the Personal Care Products Council, also emphasized that “current industry practices ensure that cosmetics are safe.”

“We have a product preservation system to ensure quality at point of purchase, and so that those [microbes] introduced during use of product will not adversely affect safety of the product,” he said.

The exec pointed to the “very low” overall incident rate for cosmetic products. For eye-area cosmetics, for example, there were just 10 reports of adverse events between 2004 and 2011 for 2.7 billion units sold.

Needlessly restricting preservative use could make those numbers go up, speakers suggested.

“We have very few preservatives to use,” said Phil Geis, former Procter & Gamble Co. executive turned industry consultant. “If we get rid of them, we are putting consumers at risk.”

Geis took issue with the notion that parabens and formaldehyde-releasers pose risks to consumers. “Parabens and formaldehyde-releasers are safe, I believe the data are clear on that,” he said.

Nevertheless, some personal-care firms are reformulating products in response to pressure from activist groups.

Johnson & Johnson recently pledged to remove formaldehyde-releasing preservatives from its baby products, though it maintains the ingredients are safe Also see "J&J Plans Baby Shampoo Reformulation; CSC Claims “Victory”" - HBW Insight, 21 November, 2011..

Steinberg cautioned that limiting the preservatives industry can use could force manufacturers to use permitted preservatives at higher levels, increasing sensitization risks.

While not convinced that microbiological safety guidance is needed for the cosmetic industry, Ansell assured OCC reps that the Council is “committed to continuous improvement [and] will work with FDA to ensure world-class performance in industry.”

Preservative Use At Crux Of FDA Cosmetic Microbiological Safety Meeting

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