FDA to continue evaluation of lead levels in lipsticks as pressure over safety concerns mounts

FDA will publish its survey evaluating lead levels in the cosmetic product in June this year, having completed its latest analysis on 400 lipsticks at the end of last year.

The Campaign For Safe Cosmetics has applied pressure to the agency after the study found lead in 400 lipsticks tested at widely varying levels of up to 7.19 parts per million (ppm); more than twice the levels reported in a previous FDA study.

The Campaign is urging the FDA to set a maximum limit for lead in lipstick based on the lowest lead levels cosmetic manufacturers can feasibly achieve, with US Senators Barbara Boxer, John Kerry and Dianne Feinstein also urging similar action.

Urging for action​

However, FDA states that although the results did range from 0.026ppm right up to 7.19ppm, overall there was not a giant increase in the average levels of lead found in lipsticks.

“The expanded survey found that the average lead concentration in the 400 lipsticks tested was 1.11 ppm, very close to the average of 1.07 ppm obtained in our initial survey,”​ said FDA.

“Lipstick, as a product intended for topical use with limited absorption, is ingested only in very small quantities. We do not consider the lead levels we found in the lipsticks to be a safety concern. The lead levels we found are within the limits recommended by other public health authorities for lead in cosmetics, including lipstick,”​ the statement added.

The Campaign For Safe Cosmetics has sent FDA a letter asking them to correct misleading statements on their website about the supposed safety of lead in lipstick, claiming the agency has studied only the levels of lead in lipstick, and has conducted no health studies or safety assessments.

"Lead builds up in the body over time and lead-containing lipstick applied several times a day, every day, can add up to significant exposure levels,"​ said Mark Mitchell, MD, MPH, policy advisor of the Connecticut Coalition for Environmental Justice and co-chair of the Environmental Health Task Force for the National Medical Association.

Expanded survey​

FDA conducted its expanded survey of lipsticks, covering a wide variety of shades, prices, and manufacturers on the US market, testing for total lead content.

The selection of lipsticks tested was based on the parent company’s market share, and also included some lipsticks from niche markets in an effort to ‘capture lipsticks with unusual characteristics’.

Frontier Global Sciences, a private laboratory based in Seattle, performed the analyses following a protocol consistent with FDA’s validated method, and was required to show continued reliability of the results using specific quality control procedures

“Although we do not believe that the lead content found in our recent lipstick analyses poses a safety concern, we are evaluating whether there may be a need to recommend an upper limit for lead in lipstick in order to further protect the health and welfare of consumers,”​ FDA concluded.