FDA Considering Whether to Recommend Lead Limit for Lipstick
On its "Lipstick and Lead: Questions and Answers" webpage, the Food and Drug Administration states that the agency is 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. The Campaign for Safe Cosmetics recently sent a letter to the FDA urging it to take this step as well as revise statements on its webpage on the safety of lead in lipsticks in light of an FDA study finding lead in 400 lipsticks in the U.S., as well as another recent study on the effects of lead exposure.
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(FDA regulates cosmetic safety under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires that cosmetics marketed in interstate commerce be safe when used as directed in the labeling or under customary conditions of use. Cosmetics are not subject to pre-market approval by FDA. However, pre-market approval is required for the color additives used in cosmetics (including those in lipsticks), with the exception of coal-tar hair dyes.)
FDA Finds Lead in Cosmetics, CDC Report Finds No Safe Lead Level for Kids
The Campaign states that a January 2012 Centers for Disease Control and Prevention (CDC) advisory committee report found there is no safe level of lead for children. The report also identifies imported cosmetics as a risk factor for lead exposure in pregnant and lactating women. The Campaign also states that a recent FDA study on lead in lipstick indicates that lead is also found in cosmetics manufactured in the U.S.
FDA Study Found 400 Lipsticks with Lead but Says Doesn't Pose Harm
FDA states it has received a number of inquiries from consumers concerned about the amount of lead present in lipstick. The FDA conducted a study (updated December 5, 2011) and lists the results of the lead content found in 400 different lipsticks on its website. However, FDA states that its study confirms that the amount of lead found in lipstick is very low and does not pose safety concerns when lipstick is used as intended.
(According to FDA, lipstick is intended for topical use, has limited absorption, and is ingested only in very small quantities. FDA assessed the potential for harm to consumers from use of lipstick containing lead at the levels found in its testing and found that they do not pose safety concerns and are within the limits recommended by other public health authorities for lead in cosmetics, including lipstick.)
FDA is Evaluating Whether to Recommended an Upper Lead Limit for Lipstick
The Campaign for Safe Cosmetics is urging FDA to set a maximum limit for lead in lipstick based on the lowest lead levels cosmetic manufacturers can feasibly achieve. U.S. Senators Barbara Boxer, John Kerry and Dianne Feinstein have also urged FDA to take action to reduce lead in lipstick.
FDA has not set limits for lead in cosmetics but has set specifications for lead in color additives used in cosmetics. When FDA updated its webpage on lead and lipstick with the results of its study in December 2011, FDA stated that, although it does not believe that the lead content found in its recent lipstick analyses poses a safety concern, the agency is 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.
(See ITT's Online Archives 11120651 for summary of FDA's FAQs on lipstick and lead.
See ITT's Online Archives 11082910 for summary of FDA's fact sheet on import alerts for products that either have or potentially could violate the FD&C Act.)
FDA Lipstick and Lead Questions and Answers webpage is available here.
Campaign letter to FDA (dated 02/07/12) is available here.