The Campaign for Safe Cosmetics’ Feb. 7 letter to FDA indicates that the activist group won’t be happy until the agency sets a formal limit for lead in lipstick, sharply reducing levels of the heavy metal in products used routinely by women of childbearing age.

Addressed to Linda Katz, director of the Office of Cosmetics and Colors, the letter responds to the division’s latest test results, posted on FDA’s website in December, which found lead levels ranging from 0.026 parts per million to 7.19 ppm in its screening of 400 lipsticks on the market Also see "FDA Issues Final Lead-In-Lipstick Report, Postpones Decision On Cosmetic Lead Limits" - HBW Insight, 12 December, 2011..

The agency maintained that those numbers were consistent with its initial round of testing, results from which were published in the July/August 2009 Journal of Cosmetic Science, and that such lead levels do not pose a health threat to consumers.

Pregnant women are particularly vulnerable, says the Campaign for Safe Cosmetics, pointing to a January report from a CDC advisory committee suggesting that there is no safe level of lead for children.

CSC disagrees. The group points out that FDA’s most recent testing revealed higher levels of lead than previously reported, even if the average lead concentration detected was roughly the same as in the first study.

Furthermore, CSC takes issue with statements on the agency’s website that seem to be based more on assumption or intuition than hard data.

In a section of its website titled “FDA’s Lipstick and Lead: Questions and Answers,” FDA states: “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.”

CSC says it has searched available scientific literature and “found no scientific studies – not one – to determine the amount of lipstick ingested into the body with the routine use of lipstick.”

It adds that “FDA has not, to our knowledge, conducted a formal safety assessment of lead in lipstick, nor has the agency publicly released any data or analysis to explain the agency’s position that there is no safety concern about lead in lipstick. Upon what assessment or reasoning did FDA base its opinion that lead in lipstick is safe?”

The agency also has assured consumers that the lead levels detected in its testing are lower than limits recommended by other public health authorities for lead in lipstick and other cosmetics, citing a draft guidance from Health Canada on heavy metal impurities in cosmetics and a judgment from the California Attorney General rejecting claims that lipsticks containing lead in trace concentrations violate the state’s Proposition 65 law.

CSC argues, however, that the different objectives of Health Canada’s guidance make its use as a standard of comparison inappropriate, and since California’s Prop 65 relates to products containing carcinogens, reproductive toxins and mutagens, its rulings are not relevant in assessing the danger of lead in lipstick, which research suggests is largely neurotoxic in nature, the group asserts.

In a Feb. 8 email to “The Rose Sheet,” CSC spokeswoman Stacy Malkan said FDA “simply has no science to back up claims of supposed safety of lead in lipstick.” CSC is asking FDA to correct “misleading” statements on its website.

Proposed Limits Differ Widely

The Personal Care Products Council has long held that lead, which is found naturally in air, water, and soil, is not hazardous to consumers at the trace levels in which it is present in cosmetics, or more specifically, in the raw materials from which cosmetics are made.

In June 2011, the trade association petitioned FDA to issue guidance recommending a maximum lead level of 10 ppm for lip products and externally applied cosmetics, which would help to legitimize its position that lead in miniscule amounts does not pose a risk to the public. A ceiling of 10 ppm would be consistent with limits the agency has set for color additives and with its daily Provisional Tolerable Total Intake Level for lead, the Council says Also see "FDA Eyes Industry-Proposed Lead Limit, With Lipstick Report Slated For Fall" - HBW Insight, 29 August, 2011..

CSC has a much smaller limit in mind. It notes that “FDA recommends a maximum allowable lead level of 0.1 ppm in candy not because that level is considered safe, but because FDA determined that level to be the lowest lead level candy manufacturers can feasibly achieve.” By the same logic, CSC says, FDA should set the ceiling for cosmetics based on the lowest lead levels that cosmetic manufacturers can feasibly achieve, which based on the agency’s latest testing would put the limit below 0.026 ppm.

FDA says it continues to review whether there is a need for an upper limit on lead in lipstick.

No Safe Lead Level For Children?

The Council has said that its 10-ppm limit for lead in cosmetics would be “protective of the most vulnerable populations using lip products.”

CSC has a different view, informed largely by a January report from an advisory committee to the U.S. Centers for Disease Control and Prevention suggesting that there is no safe level of lead for children.

In the report, titled “Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention,” the Advisory Committee on Childhood Lead Poisoning Prevention states: “Because no measureable level of blood lead is known to be without deleterious effects, and because once engendered, the effects appear to be irreversible in the absence of any other interventions, public health, environmental and housing policies should encourage prevention of all exposures to lead.”

According to the committee, lead exposure has been linked to impaired cognitive function, attention-related behaviors, reduced academic achievement and effects extending into the cardiovascular, immunological, and endocrine domains.

CSC’s concern is that millions of women of childbearing age are using lipstick daily, unaware that they may be “building up their blood lead levels each time they apply.”

In pregnant women, “lead easily crosses the placenta and enters the fetal brain where it can interfere with normal development,” the organization says, emphasizing that “we must protect women from lead exposure.”

L’Oreal Singled Out

Among all lipstick manufacturers named in FDA’s lead-in-lipstick report, L’Oreal is taking the greatest heat from CSC. The activist group has launched a campaign demanding that the France-based cosmetics giant – the “worst offender” in FDA’s study – “get the lead out.”

Likeminded individuals can “take action now” by clicking on a link that sends an email to L’Oreal CEO Jean-Paul Agon stating that “the company owes women a huge apology.”

In FDA’s testing, L’Oreal’s Maybelline Color Sensation and L’Oreal Colour Riche lipsticks took the two top spots for lead content, with 7.19 ppm and 7.0 ppm, respectively. The study included lipsticks purchased in retail stores between February and July of 2010.

Of the 10 highest lead-containing lipsticks, L’Oreal marketed five. In 2007 when FDA first surveyed the lipstick market on a smaller scale, L’Oreal had four lipsticks in the top 10.

“How many millions of women have applied and reapplied lead-laden L’Oreal lipsticks since we first asked the company to take action in 2007?” asks CSC.

“Clearly, L'Oreal needs to do a better job of keeping the lead out of its lipstick,” Malkan said.

In a Feb. 9 statement, L’Oreal maintains that all of its brands are in compliance with FDA regulations, the European Cosmetic Directive and other requirements for consumer safety in the more than 130 countries where L’Oreal is sold.

“L’Oreal maintains the highest standards for safety and consumers can use all of our products with complete confidence,” the company says. It points to FDA’s latest study – slated to be published in the May/June 2012 issue of the Journal of Cosmetic Science – as confirmation that “lipsticks pose no safety concerns for the millions of women who use them daily.”

Other lipsticks in FDA’s expanded survey’s top 10 include two shades of Shiseido Co.’s NARS Semi-Matte and two of Procter & Gamble Co.’sCover Girl lipsticks, Ruby Remix (Vibrant Hues) from the brand’s Queen Collection and Warm Brick (Continuous Color), both of which have been discontinued, according to P&G’s website.

(REQUEST IN FOR FDA COMMENT)

Campaign for Safe Cosmetics Wants Cap On Lipstick Lead, Proposes 0.026 PPM

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