FDA is expected to release a report detailing its findings on lead in lipstick this fall, but it remains to be seen whether the agency will heed industry requests to set a maximum limit for the trace contaminant in cosmetic products.

FDA will use the data from its study, “as well as other information available to the agency to determine the need for recommending specifications for lead in lipstick and other cosmetics,” an FDA spokesman said in an email to “The Rose Sheet.”

Office of Cosmetics and Colors Director Linda Katz said in April that while the report wasn’t finished, the data collected on lead levels in marketed lipstick products looked to be comparable with earlier test results (Also see "FDA’s Lead-In-Lipstick Testing Completed, Cosmetics Director Says" - HBW Insight, 25 April, 2011.).

The preliminary results – published in 2009 – indicated lead levels in lipstick were not a safety concern (“Lead Levels In Lipstick Not A Concern, FDA Says; More Testing Planned,” “The Rose Sheet” Sept. 7, 2009).

The Council defends its recommended 10-ppm limit on lead in cosmetics as “protective of the most vulnerable populations using lip products,” and suggests that cosmetics with lead levels below 10 ppm “are both safe and achievable.”

FDA says its next report is being reviewed and will likely come out this fall. It will include results from an extended study of lead content in 400 lipsticks. Results will be published in a Q&A section regarding lipstick and lead on FDA’s website, the spokesman said.

Ceiling Proposed To Limit Exposure

In June, the Personal Care Products Council submitted a citizen petition to FDA asking that the agency issue guidance recommending a maximum lead level of 10 parts per million for lip products and externally applied cosmetics.

A naturally occurring trace element, lead is not considered dangerous in small amounts, according to the Council. The trade group notes that consumers are inevitably exposed to lead through food, water and air.

The Council defends its recommended 10-ppm limit on lead in cosmetics as “protective of the most vulnerable populations using lip products,” and suggests that cosmetics with lead levels below 10 ppm “are both safe and achievable.”

Industry referred to FDA’s own established Provisional Tolerable Total Intake levels for lead, or “total daily lead intake levels that provide a wide margin of protection against lead’s adverse effects,” in suggesting the 10 ppm maximum.

FDA Endorsement Would Validate Industry

In its call for action, the Council notes that FDA has “worked for decades” to ensure that consumers are safe from excessive levels of lead by setting limits for other FDA-regulated products.

The agency set a lead limit of 10 to 20 ppm for color additives in food, drugs, cosmetics and medical devices and issued guidance for maximum lead levels in “generally recognized as safe” food ingredients, the trade group says.

If FDA heeds the Council’s recommendation and puts its stamp on a 10 ppm lead limit in cosmetics, it would help legitimize the trade troup’s position that cosmetics with trace levels of lead are safe for consumer use.

The Campaign for Safe Cosmetics has taken the personal-care industry to task in the past for lead levels in products that were significantly below 10 ppm.

The coalition’s 2007 “Poison Kiss” report suggested that lipsticks containing lead in concentrations greater than 0.1 ppm are a threat to consumer health. The report created a stir in the media, incited public outcry and prompted Senators John Kerry, D-Mass., Barbara Boxer, D-Calif., and Dianne Feinstein, D-Calif., to request FDA action on the issue (Also see "Senators Request FDA Inquiry Into Lead Discovered In Lipstick Products" - HBW Insight, 3 December, 2007.).

International Harmonization Incentive

Industry’s push for maximum lead limits could also be fueled by discussions at the international level, as achieving harmonized regulations for trace contaminants is one of the goals of the International Cooperation on Cosmetics Regulation.

At its last meeting, the ICCR continued discussions toward a recommended ceiling on lead levels in cosmetic products (Also see "ICCR Accepts Four Regulatory Guidance Reports; NGOs Seek Bigger Role" - HBW Insight, 1 August, 2011.).

Documents detailing those discussions are still being reviewed by FDA and have not yet been made public. According to the FDA rep, they could be released this fall.

The Council’s proposed 10-ppm lead level is consistent with cosmetic regulations under consideration in Canada and is stricter than the 20-ppm limit in Germany, the trade group notes.

By Lauren Nardella

FDA Eyes Industry-Proposed Lead Limit, With Lipstick Report Slated For Fall

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