Cosmetic adverse events were down in fiscal 2013 from the year before, but FDA will continue efforts to boost awareness and voluntary reporting while potentially zeroing in on ingredients cited in AE reports, the agency’s cosmetics head indicated Feb. 20.

Speaking at the American Conference Institute’s Legal, Regulatory and Compliance Forum on Cosmetics in New York, Linda Katz, director of FDA’s Office of Cosmetics and Colors, said the agency received 281 reports of cosmetics-related adverse events between October 2012 and September 2013.

Of those, 177 required some degree of medical attention, she said.

Last year’s total represents roughly 100 fewer reports of adverse events associated with use of cosmetics compared with the October 2011-September 2012 period, when AE reports through the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) increased 35% versus the prior year to 381 Also see "Cosmetics Adverse Events Reported To FDA Increase 35% In FY 2012" - HBW Insight, 2 September, 2013..

Katz noted, as FDA has before, that the agency cannot be certain if such figures accurately reflect the adverse-event landscape rather than fluctuating levels of public awareness with regard to the agency’s reporting mechanisms.

“The [2013] number itself is low, but it’s hard to know how to interpret this because basically any voluntary system where people don’t have to report we expect low numbers,” Katz said. “We don’t know if the numbers are low because truly there aren’t any adverse events more than 281, or they’re low because people just don’t know what to do if they have an adverse event and how to report it.”

She noted in an email to “The Rose Sheet” that other variables can impact reporting numbers, including media coverage of safety issues and whether individuals who experience adverse events consult healthcare professionals.

From late 2007 to September 2010, cosmetics-related adverse events reported to the agency declined each year. They then jumped significantly in 2011 and again in 2012 after FDA began to push for increased consumer participation in CAERS and posted a consumer update on its website titled “Bad Reaction to Cosmetics? Tell FDA” Also see "With AE Reporting Push, FDA Emphasizes Importance Of Cosmetic Safety" - HBW Insight, 11 April, 2011..

Cosmetics-Related Adverse Events
Reporting Period	Total AE Reports
October 2012-September 2013	281
October 2011-September 2012	381
October 2010-September 2011	282
October 2009-September 2010	122
October 2008-September 2009	174
October 2007-September 2008	221

Katz said the agency will continue its efforts “to try to encourage our consumers, our stakeholders and healthcare professionals to report to us so that we’ll have a better assessment and idea of what’s out in the marketplace and what the problems may or may not be from the different ingredients in different products.”

FDA’s educational efforts to date have included outreach at events, webinars and information posted to its website.

She said in her email that last year the agency “did not take as active a role” as in 2012, so the decline in AE reports is “to be expected.”

Substances On FDA’s Radar

Katz also highlighted some of FDA/OCC’s foremost priorities in the area of cosmetics safety, including research into ingredients of concern.

According to the program director, the agency zeroes in on potentially “problematic” ingredients by combing through adverse-event reports, voluntary recall information and “other organizations’ data,” and will also give consideration to ingredients that are used most frequently in cosmetics.

She cited phthalates and peptide ingredients as cosmetic agents on FDA’s radar.

The agency’s safety mission has become more complicated as the cosmetics market has grown, Katz noted.

“Our challenge is that as the global market has gotten larger over the last five to seven years we have seen a greater expansion both of ingredients and labeling indications and the ramifications and information that we need to be aware of to make sure that the products that are being marketed are safe,” she said.

Trace metals and other contaminants, or “non-functional constituents,” in cosmetic products are also on FDA’s priority list, according to Katz.

Lead, mercury and 1,4-dioxane are among contaminants targeted for research and standards development, with a view toward adopting standards consistent with International Cooperation on Cosmetics Regulation recommendations to promote global harmonization, the director said.

The agency aims to publish research on priority trace elements in cosmetics in the “next year or so,” she indicated.

FDA has investigated lead in lipstick in-house and is working on guidance on the subject, Katz noted Also see "FDA To Issue Guidance On Nano Cosmetics, Lead In Lipstick" - HBW Insight, 9 September, 2013.. The agency has tested more than 400 lipsticks on the market – including items identified by the Campaign for Safe Cosmetics as containing potentially hazardous lead levels – and found lead concentrations to be within acceptable ranges for products formulated with permitted color additives, which typically are restricted to lead levels of no more than 20 parts per million, according to the agency’s website.

While FDA has publicly stated that lead concentrations in surveyed lipsticks do not pose a risk to consumers, industry has been pushing for adoption of a formal 10-ppm ceiling on lead in cosmetics to make manufacturers’ compliance official Also see "In Brief" - HBW Insight, 21 January, 2013..

At the seventh meeting of ICCR regulators in Tokyo in July 2013, members accepted a guidance document that incorporates that threshold for cosmetic lead content Also see "ICCR Addresses Lead Limit, Endocrine Disruptors At 7th Meeting" - HBW Insight, 29 July, 2013..

Katz noted that FDA is exploring ways to update its Bacteriological Analytical Manual, which “presents the agency’s preferred laboratory procedures for microbiological analyses of foods and cosmetics,” according to FDA’s website. The agency’s aim is to revise the document’s chapter on cosmetics “so that it’s in plain English, or plainer English, so that it will be clearer what the standard should be,” Katz said.

In addition to addressing “arcane” language, FDA intends to revisit the BAM cosmetic standards and whether they are “right for what the levels of microbial contamination should or should not be,” consulting ISO standards and harmonizing where possible to create a “universal” standard, according to the director.

FDA notes on its site that “cosmetic products are not expected to be aseptic; however, they must be completely free of high-virulence microbial pathogens, and the total number of aerobic microorganisms per gram must be low.”

The Personal Care Products Council revised its microbiology guideline for cleaning and sanitation in 2013, underscoring that “effective cleaning and sanitization programs are essential to ensure microbial quality” in personal-care and cosmetics products ([A#02140203001]).

Final Nanomaterials Guidance In Sight

Katz said FDA’s final guidance “Safety Approaches to Nanomaterials in Cosmetics” is moving toward publication. A draft version was issued in April 2012 ([A#02131028009]).

The guidance is timely as nanotechnology in the cosmetics sector “has become much more sophisticated” and “widespread,” according to the director, who expects the document to release in the coming months.

FDA announced the availability of an ICCR working-group report on cosmetic nanomaterials Feb. 24. The report holds that existing toxicological testing methods and risk-characterization approaches are adequate for assessing the safety of nanomaterials in cosmetic products, but notes that the unique properties and behavior of nano-sized particles warrant targeted evaluations to address the potential for increased bioavailability and other concerns (see related story, p. 8).

The working group’s stance closely mirrored that in FDA’s draft guidance. According to Katz, the agency is conducting its own research to better understand nanomaterial risks.

For example, she said, “we have done skin safety studies to look at skin penetration to see what does penetrate and if it does penetrate, do we need to be concerned about systemic safety. And if it does not penetrate, what will it do topically to the skin.”

2014 Legislation Is “Anybody’s Guess”

Katz touched briefly on the prospect of legislation in 2014 to update federal cosmetics oversight. A proposed framework under development by FDA and industry representatives stalled in late 2013 ([A#02131028009]).

“The bottom line is: What will happen this year is really anybody’s guess,” said Katz. “There is continued interest on the part of the agency to continue discussions, interest on the part of industry, interest on the part of consumer groups, so who knows?”

FDA Cosmetics Update: 2013 AE Reports Tallied, 2014 Research Targeted

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