INTRODUCTION
Lead
• used as a coloring elements
• basically taken up by ingestion
• uptake of food (65%)
• water (20%)
• air (15%)
INTRODUCTION
• significant level of lead in the blood is about
10 microgram/dL
• ~25 micrograms/dL, high possibility of
damage to kidneys and the nervous system
• Symptoms may include :
• pain, numbness or tingling of the extremities, muscular
weakness, headache, abdominal pain, memory loss, miscarriage
or premature birth in pregnant women, and fatigue
IN THE NEWS: LEAD CONTAMINATION
• Started 3 years ago
• Mattel (toy company) recalled more than
18 million products after high lead content was found in
their products in (August 2007)
• In October 2007, Campaign for Safe Cosmetics released a
report which revealed trace amounts of lead among
commercially-available lipstick brands
• lead levels exceeding USFDA’s upper limit for candy, 0.1ppm
Is there a significant amount
of lead among
commercially available
lipstick brands that can
pose health risks?
OBJECTIVES
1. To identify the allowable levels of lead according to
drug authorities such as FDA
2. To identify commercial brands of lipstick with
significant lead content
3. To compare the relative lead content in lipsticks with
lead
4. To determine if the use of the said products has
already caused hazard to human health
ALLOWABLE LEVELS OF LEAD IN COSMETICS
Currently no lead content limit set by FDA
Campaign for Safe Cosmetics, 2007
 FDA limit of lead in candy: 0.01 PPM
 1/3 of lipsticks in the market: 0.03-0.65 PPM
FDA study in 2009
 Lipsticks in the market: 0.09-3.06 PPM
 Lipsticks should not be compared to candies because
they are not ingested.
ALLOWABLE LEVELS OF LEAD IN COSMETICS
FDA has set a lead content limit as an impurity in the
color additives used in cosmetics
 10-20 PPM: safe and acceptable
BFAD statement
 Maximal allowable lead limit in cosmetics: 20 PPM
 Based on consolidation of data from other ASEAN
countries
COMPARISON OF COMMERCIAL BRANDS OF
LIPSTICKS WITH SIGNIFICANT LEAD CONTENT
FDA study in 2009
20 lipsticks of varying brands
Highest: Cover Girl brand, 3.06 PPM
Lowest: Avon brand, 0.09 PPM
Average level: 1.07 PPM
PARENT COMPANY
LIPSTICK LINE
AND SHADEA
LOT NUMBERSB
PROCTER & GAMBLE
INCREDIFUL LIPCOLOR
964 MAXIMUM RED
7241S1
5188S1
REVLON
REVLON, INC.
COLORSTAY LIPCOLOR
345 RED VELVET
COMPOSITEE
07298
LEAD
(PB)C
(PPM)D
3.06
3.05
2.91F
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
BRAND NAME
COVER GIRL
L'OREAL
L'OREAL
CLINIQUE
ESTEE LAUDER COMPANIES INC.
CLINIQUE
ESTEE LAUDER COMPANIES INC.
ESTEE LAUDER
ESTEE LAUDER COMPANIES INC.
BURT'S BEES
CLOROX COMPANY
MAYBELLINE
L'OREAL
PEACEKEEPER
PEACEKEEPER
DIOR
LVMH
DIOR
LVMH
MAC
ESTEE LAUDER COMPANIES INC.
AVON
AVON
COLOUR RICHE
752 CLASSIC WINE
LONG LAST
FJ MERLOT
LONG LAST
F9 PAPRIKA
PURE COLOR
1A3 MARASCHINO
LIP SHIMMER
MERLOTG
MOISTURE EXTREME
E215 MIDNIGHT RED
PAINT ME COMPASSIONATEG
REPLENISHING LIPCOLOR
752 RED PREMIERE
ADDICT ULTRA-SHINE
750 SHINIEST SEXINESS
MATTE LIPSTICK
VIVA GLAM I
ULTRA COLOR RICH
U250 CHERRY JUBILEE
FD064
FD234
0.79
0.67
AA7
0.55
A87
0.48
B55
0.43
1840701
0.33
WD3041
0.23
H
0.17
7A01
0.15
7D01
0.12
A67
0.10
H
0.09
AVERAGE
1.07
COMPARISON OF COMMERCIAL BRANDS OF
LIPSTICKS WITH SIGNIFICANT LEAD CONTENT
Study by Al-Saleh et al, 2009
 48 lipsticks from 26 brands
 Lead content range: 0.27-3760 PPM
There were 3 outliers in the data
 Without outliers: 0.27-36.90 PPM
Only 2 brands above the 20 PPM limit
 All 5 lipsticks that exceeded the limit: from China
 Lipsticks with shimmers: 0.33-3760 PPM
 All exceeded the 0.1 PPM limit in candy
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
Inter-organization Programme for the Sound
Management of Chemicals, 1998
 Allowable blood levels of lead: <20 µg/dl
 Allowable levels for children: <10 µg/dl
This amount can already lead to a 2.5-point decrease
in intelligence quotient of IQ
Nervous system: overt clinical encephalopathy
100-120 µg/dl
Kidney: atrophy and interstitial nephritis
40-100
Gastrointestinal: colic
40-60
Formation of blood cells: anemia
50
Reporudctive system: hypospermia, testicular
atrophy
Nervous system: IQ/learning disruption, sensory
system deficits
40-50
Heart and Blood Vessels: Hypertension
<7
Formation of blood cells: biochemical (enzyme
changes)
3-30
40
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
Inter-organization Programme for the Sound Management of
Chemicals, 1998
 There is no exposure level below which lead appears to be
safe
 Children are more susceptible
 Blood lead levels as low as 10 µg/dl can hamper blood cell
formation and affect one’s IQ or cause some form of
learning disruption
 Higher levels may cause colic, encephalopathy, renal
atrophy, and interstitial nephritis
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
American Academy of Child and Adolescent Psychiatry,
2006
 Lead exposure to children: paint, water, soil
Center for Disease Control
 About 6 percent of children aged 1-2 years old have
toxic blood lead levels
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
Lead exposure during pregnancy
 Lead in the body are mainly stored in the bone
 These stores may be mobilized due to hormonal effects
in pregnancy
 Lead readily crosses the placental barrier and may
affect the fetus
 Pregnant women may not manifest symptoms but their
future children could be affected via prenatal exposure
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
Currently FDA assessment of lipsticks tested
 Lead content levels are safe, not a concern
 Based on the premise that lipstick is for topical use only
 Majority are below the recommended limit given by
public health officials, 10 PPM
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
Study by Al-Ashban et al, 2002
 Blood analyses of regular kohl users revealed a high
lead concentration and relatively low hemoglobin levels
 Kohl was also estimated to have lead levels as high as
52.3%
EFFECT OF COSMETICS WITH LEAD TO HUMAN
HEALTH
Study by Al-Ashban et al, 2002
 Blood lead levels
Control group mean value: 0.9µg/dl ± 0.43
Kohl users group mean value: 17.65µg/dl ±2.29
 Hemoglobin levels
Control group mean value: 14.02g/dl ± 0.21
Kohl users group mean value: 12.22g/dl ± 0.37
The study by Al-Saleh et al (1999) supports the findings
made by Al-Ashban et al (2002).
OBJECTIVE 1: TO IDENTIFY THE ALLOWABLE LEVELS OF
LEAD ACCORDING TO DRUG AUTHORITIES SUCH AS FDA
USFDA – no limit for lead as a contaminant in cosmetics as of now
 Impurities in color additives in cosmetics – 20ppm
Campaign for Safe Cosmetics
 Set limit to 0.1ppm based on permissible limit of lead in candies
BFAD (FDA Philippines)
 Issued a circular (No. 2006-012) for a maximum allowable limit of
lead in cosmetics to 20ppm
OBJECTIVES 2 AND 3: TO IDENTIFY COMMERCIAL
BRANDS OF LIPSTICK WITH SIGNIFICANT LEAD
CONTENT; TO COMPARE THE RELATIVE LEAD CONTENT
IN LIPSTICKS WITH LEAD
Hepp, Mindak and Cheng (2009)
 20 lipsticks of varying brands found to have lead levels
0.09-3.06ppm
 Among tested:
Covergirl: highest level (3.06ppm)
Avon: lowest level (0.09ppm)
 Average lead level of all lipsticks: 1.07ppm
OBJECTIVES 2 AND 3: TO IDENTIFY COMMERCIAL
BRANDS OF LIPSTICK WITH SIGNIFICANT LEAD
CONTENT; TO COMPARE THE RELATIVE LEAD CONTENT
IN LIPSTICKS WITH LEAD
Al Saleh et al. (2009)
 72 lipstick samples turned positive for lead, with levels ranging
from 0.27-3760 ppm
 Exclusion of three outliers dropped upper value from 3760 to
36.90
 Since no valid reasons to exclude outliers, four brands are
recognized as having levels beyond 20ppm
 All samples with lead content exceeding 20ppm obtained from
China
OBJECTIVE 4: TO DETERMINE IF THE USE OF THE SAID
PRODUCTS HAS ALREADY CAUSED HAZARD TO HUMAN
HEALTH
Lead in lipsticks might not cause an immediate health
problem
 However, it can accumulate due to repeated application
and may result in cumulative toxicity
 Dependent on the frequency of application which varies
from one woman to another
 The consequences of these products can only be
properly verified by conducting population risk
assessment exposure study
OBJECTIVE 4: TO DETERMINE IF THE USE OF THE SAID
PRODUCTS HAS ALREADY CAUSED HAZARD TO HUMAN
HEALTH
FDA has assessed that the lead available in the lipsticks
they have tested are safe and should not be a cause
for concern
 lipstick is for topical use only and that majority of them
are below the recommended limit given by public health
officials
CONCLUSIONS: AUTHOR’S PERSPECTIVE
AWARENESS GROUPS
COSMETIC INDUSTRY
AND US FDA
• High lead content
• No industry standard
 Based on 0.01 PPM for
candies
• Stricter regulations
required
 10-20 PPM for dye
contaminants
 Study showed various lead
content – within acceptable
limits
• Cite various health
risks and hazards
• Lead content negligible
to health
• Stress
CONCLUSION: GROUP’S VIEW
• Lead-containing products can indeed significantly increase lead
within the human body
• Best interest of health:
 Lead exposure among cosmetic users be minimized
 good manufacturing practice and proper quality control;
 imposition of lower lead level thresholds, or
 maintaining the current standard tolerance by regulatory
agencies such as the FDA and BFAD;
 not allowing vulnerable populations access to such
products.
REFERENCES
CSC, the Campaign for Safe Cosmetics (2007). A Poison Kiss: The Problem of Lead in Lipsticks.
Available from: <http://www.safecosmetics.org/about/reports.cfm>
Hepp, N.M., Mindak, W.R., and Cheng, J. (2009). Determination of total lead in lipstick:
Development and validation of a microwave-assisted digestion, inductively coupled plasma–
mass spectrometric method. Journal of Cosmetic Science, 60, 405-414.
Al-Saleh, I, Al-Enazi, S. and Shinwari, N. (2009). Assessment of lead in cosmetic products.
Regulatory Toxicology and Pharmacology, 54, 105-133.
Bureau of Food and Drugs (2006). Bureau circular 2006-012, Maximum allowable limits of heavy
metals for cosmetic products. Retrieved from www.bfad.gov.ph/oldsite/BC/bc%202006012.pdf
Health Canada (2009), Draft Guidance on Heavy Metal Impurities in Cosmetics.
Al-Saleh I, Nester M, DeVol E, et al (1999). Determinants of blood lead levels in Saudi Arabian
schoolgirls. International Journal of Occupational Environmental Health 5,107-14.
Inter-organization Programme for the Sound Management of Chemicals (1999). Global
opportunities for reducing the use of leaded gasoline. Available from:
http://www.chem.unep.ch/pops/pdf/lead/toc.htm
American Academy of Child and Adolescent Psychiatry (2006). Lead exposure in children affects
brain and behavior. Retrieved from
http://www.aacap.org/cs/root/facts_for_families/lead_exposure_in_children_affects_brain_
and_behavior.