Lipstick and Lead: Questions and Answers
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 Cosmetics.
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 Additives.
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 method 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 ppm.
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 Science[1]  .
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 |
- a
Lipsticks selected are the same brands and shades
analyzed by the Campaign for Safe Cosmetics (http://www.safecosmetics.org/your_health/poisonkiss.cfm
).
- b
Lot numbers embossed or printed on lipstick cases or end
labels.
- c
Results are for total lead content determined by FDA's
validated method [Reference 1].
- d
Reported in units of µg Pb/g in Reference 1.
- e
Combination of several lots.
- f
Result not used for determining average value of lead
content by FDA's validated method.
- g
No shade number on lipstick.
- h
No lot number on lipstick.
References:
1 Hepp, N. M., Mindak, W. R., and Cheng, J., "Determination
of Total Lead in Lipstick: 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 Cosmetics.
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
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