Lipstick and Lead: Questions and Answers

The following is taken directly from the FDA website:

“The Food and Drug Administration (FDA) has received a number of inquiries regarding reports of lead contamination in lipstick. The following information is drawn from responses to those inquiries, along with information on our latest findings”.

What is FDA’s legal authority over cosmetic safety?

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) and other FDA-regulated products (with the exception of coal-tar hair dyes). To learn more on this subject, please refer to FDA Authority Over Cosmetics1.

Has FDA set limits for lead in cosmetics?

No, FDA has not set limits for contaminants, such as lead, in cosmetics. However, FDA does set specifications for impurities, such as lead, for color additives used in cosmetics. FDA approval of color additives is based on safety evaluations that consider the color additive’s intended use(s) and estimated consumer exposure resulting from those uses. FDA-approved color additives are listed in Title 21 of the U.S. Code of Federal Regulations (CFR). To learn more about FDA-approved color additives, please refer to Color Additives2.

What are FDA’s limits for lead in color additives?

FDA limits lead in color additives to maximum specified levels, typically no more than 20 parts per million (ppm) for color additives approved for use in cosmetics. Some color additives listed under regulations in 21 CFR Parts 74 and 82, such as D&C Red No. 6 and D&C Red No. 7, are required to be batch-certified by FDA before they may be used in cosmetics. Part of the FDA certification process for such color additives includes testing each batch of the color additive for lead. Other color additives listed under regulations in 21 CFR Part 73, such as mica, titanium dioxide, and iron oxides, are not required to be batch-certified by FDA, although cosmetic manufacturers are still responsible for ensuring that the color additives used in their products meet FDA’s specifications.

Has FDA been aware of concerns about lead in lipstick?

Yes, reports about lead in lipstick are not new. In the 1990s, reports of analytical results from a commercial testing laboratory suggested that traces of lead in lipstick might be of concern. Subsequent evaluation by FDA of that laboratory’s test results determined that the method used had not been validated for the analysis of lipsticks. More recently, in October 2007, the Campaign for Safe Cosmetics (CSC) reported finding lead in a selection of twenty-five lipsticks on the market. FDA was not able to determine if a method validated for the analysis of lipstick was used to generate the data in the CSC report. Because reports regarding lead in lipstick have surfaced periodically and because of the amount of time that had elapsed since FDA last examined data and other information on lipsticks in the marketplace, FDA decided that further follow-up was needed.

How has FDA followed up on the latest reports?

FDA scientists developed and validated a highly sensitive method for the analysis of total lead content in lipstick and applied the method to the same selection of lipsticks evaluated by the CSC. FDA found lead in all of the lipsticks tested, ranging from 0.09 ppm to 3.06 ppm with an average value of 1.07 ppm. FDA concludes that the lead levels found are within the range that would be expected from lipsticks formulated with permitted color additives and other ingredients that had been prepared under good manufacturing practice conditions.

An article on FDA’s testing method3Exit Disclaimer4 was published in the July/August 2009 issue of the peer-reviewed Journal of Cosmetic Science.1 The article includes results for lead in all the lipsticks we tested. FDA’s testing method is now available for use by any suitable analytical laboratory for the determination of total lead in lipstick.

Is there a safety concern about the lead found by FDA in lipsticks?

No. FDA has assessed the potential for harm to consumers from use of lipstick containing lead at the levels found in its testing. Lipstick, as a product intended for topical use, is only ingested incidentally and in very small quantities. FDA does not consider the lead levels that it found in the lipsticks to be a safety concern. FDA also notes that the lead levels that it found are lower than limits recommended by other public health authorities for lead in cosmetics, including lipstick. 2,3

It has been reported that levels of lead in certain lipsticks exceed those for candy. Is this a fair comparison?

No. The FDA-recommended upper limit for lead in candy is 0.1 ppm5. It is not scientifically valid to equate the risk to consumers presented by lead levels in candy, a product intended for ingestion, with that associated with lead levels in lipstick, a product intended for topical use and which is ingested in much smaller quantities than candy.

Does FDA intend to continue investigating lead in lipstick?

Yes. FDA does not believe that the lead content found in its recent lipstick analyses is a safety concern. However, the agency is planning to investigate a wider range of lipsticks than has been tested so far, including lipsticks similar to those recently assessed for lead content by another laboratory.4 If FDA determines that a safety concern for lead in lipstick exists, the agency will advise the industry and the public and will take appropriate action under the authority of the FD&C Act in protecting the health and welfare of consumers.

FDA Analyses of Lead in Lipsticks

The following results for lead content in a selection of lipsticks were obtained by scientists at the U.S. Food and Drug Administration (FDA) and reported in the Journal of Cosmetic Science6[1] Exit Disclaimer7. FDA purchased lipsticks from retail stores between October and December 2007.

Brand name Parent company Lipstick Line
and Shadea
Lot numbersb Lead (Pb)c
(ppm)d
Cover Girl Procter & Gamble Incrediful Lipcolor
964 Maximum Red
7241S1 3.06
5188S1 3.05
Revlon Revlon, Inc. ColorStay Lipcolor
345 Red Velvet
Compositee 2.91f
07298 2.38
Cover Girl Procter & Gamble Queen Collection
Q580 Ruby Remix
7136 2.24
Body Shop L’Oreal Lip Colour
22 Garnet
C274EA 1.79
Cover Girl Procter & Gamble Continuous Color
435 Cherry Brandy
7228 1.76
L’Oreal L’Oreal Colour Riche
315 True Red
FD261 1.47
Revlon Revlon, Inc. Super Lustrous
660 Bed of Roses
07208 1508 53 1.37
Maybelline L’Oreal Moisture Extreme
F315 Cocoa Plum
WD2891 1.21
Revlon Revlon, Inc. Super Lustrous
725 Love That Red
07284 1508 59 1.04
L’Oreal L’Oreal Colour Riche
752 Classic Wine
FD064 0.79
FD234 0.67
Clinique Estee Lauder Companies Inc. Long Last
FJ Merlot
AA7 0.55
Clinique Estee Lauder Companies Inc. Long Last
F9 Paprika
A87 0.48
Estee Lauder Estee Lauder Companies Inc. Pure Color
1A3 Maraschino
B55 0.43
Burt’s Bees Clorox Company Lip Shimmer
Merlotg
1840701 0.33
Maybelline L’Oreal Moisture Extreme
E215 Midnight Red
WD3041 0.23
PeaceKeeper PeaceKeeper Paint Me Compassionateg h 0.17
Dior LVMH Replenishing Lipcolor
752 Red Premiere
7A01 0.15
Dior LVMH Addict Ultra-Shine
750 Shiniest Sexiness
7D01 0.12
MAC Estee Lauder Companies Inc. Matte Lipstick
Viva Glam I
A67 0.10
Avon Avon Ultra Color Rich
U250 Cherry Jubilee
h 0.09
Average 1.07
  1. a Lipsticks selected are the same brands and shades analyzed by the Campaign for Safe Cosmetics (http://www.safecosmetics.org/your_health/poisonkiss.cfm8 Exit Disclaimer9).
  2. b Lot numbers embossed or printed on lipstick cases or end labels.
  3. c Results are for total lead content determined by FDA’s validated method [Reference 1].
  4. d Reported in units of µg Pb/g in Reference 1.
  5. e Combination of several lots.
  6. f Result not used for determining average value of lead content by FDA’s validated method.
  7. g No shade number on lipstick.
  8. h No lot number on lipstick.

References:

1 Hepp, N. M., Mindak, W. R., and Cheng, J., “Determination of Total Lead in Lipstick10: Development and Single Lab Validation of a Microwave-Assisted Digestion, Inductively Coupled Plasma–Mass Spectrometric Method,” Journal of Cosmetic Science, Vol. 60, No. 4, July/August, 2009.

2 Letter from Edmund G. Brown, Jr., Attorney General, State of California to J. L. Sean Slattery, David Lavine, and Laralei Paras regarding Proposition 65 claims concerning lead in lipstick, March 3, 2008.

3 Health Canada, Draft Guidance on Heavy Metal Impurities in Cosmetics11. exit icon12

4 Al-Saleh, I., Al-Enazi, S., and Shinwari, N., “Assessment of Lead in Cosmetic Products,” Regulatory Toxicology and Pharmacology, Vol. 54, pp. 105-113, 2009.

December 27, 2007; updated June 25, 2009, September 2, 2009, and November 3, 2009