1. LEAD IN YOUR LIPSTICK:
A Journal appraisal

2. introduction Lead used as a coloring element in ceramic glazes
traditional base metal for water pipes
basically taken up by ingestion
uptake of food (65%)
water (20%)
air (15%)
significant level of lead in the blood is about 10 microgram/dL
At higher levels, ~25 micrograms/dL, there is 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
Although lead is an element found naturally on Earth, human activity such as mining, burning fossil fuels and manufacturing has caused its vast spread. It is used as a coloring element in ceramic glazes, and in wicks of candles. It is the traditional base metal for water pipes. Previously, lead was used in gasoline but this was recently phased out. Due to contamination of soil by lead paints and corroded pipes, food such as fruit, vegetables, meats, grains, seafood, soft drinks and wine may contain significant amounts of lead. Since pipes were originally made of lead, their corrosion can lead to contamination of drinking water especially when water is slightly acidic.
Lead is basically taken up by ingestion. It can enter the human body through uptake of food (65%), water (20%) and air (15%). Lead poisoning occurs when lead builds up in the body, often over a period of months or years. The significant level of lead is about 10 microgram/dL since at this level, damage starts to arise, especially in children. At higher levels, ~25 micrograms/dL, there is high possibility of damage to kidneys and nervous system in both children and adults. Very high lead levels may cause seizures, unconsciousness and possibly death.
Signs and symptoms usually don't appear until dangerous amounts have accumulated. Exposure to amounts of lead too low to cause symptoms in the short term may increase the risk of high blood pressure and future risk for mental decline. Symptoms may include:
Pain, numbness or tingling of the extremities
Muscular weakness
Headache
Abdominal pain
Memory loss
Mood disorders
Reduced sperm count, abnormal sperm
Miscarriage or premature birth in pregnant women
Fatigue

3. 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
The mission to identify other commercially available products with significant lead content started about 3 years ago. In August 2007, toy company Mattel recalled more than 18 million products after high lead content was found in their toys that were subcontracted in China. Furthermore, in October 2007, Campaign for Safe Cosmetics released a report which revealed trace amounts of lead among commercially-available lipstick brands. The group reported these brands as having lead levels exceeding USFDA’s upper limit for candy, 0.1ppm. This news alarmed many, particularly the media, as the companies involved are top cosmetic companies in the United States.

4. The research question
Is there a significant amount of lead among commercially available lipstick brands that can pose health risks?
This leads us to our research question:
Is there a significant amount of lead among commercially available lipstick brands that can pose health risks?

5. objectives
To identify the allowable levels of lead according to drug authorities such as FDA
To identify commercial brands of lipstick with significant lead content
To compare the relative lead content in lipsticks with lead
To determine if the use of the said products has already caused hazard to human health
The following are the objectives:
To identify the allowable levels of lead according to drug authorities such as FDA
To identify commercial brands of lipstick with significant lead content
To compare the relative lead content in lipsticks with lead
To determine if the use of the said products has already caused hazard to human health

6. Lead in Cosmetics
Summary of RRL

7. 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: PPM
FDA study in 2009
Lipsticks in the market: PPM
Lipsticks should not be compared to candies because they are not ingested.
Currently, the US Food and Drug Administration (FDA) has not set a limit for lead as a contaminant in cosmetics, particularly lipsticks. A private group (Campaign for Safe Cosmetics, 2007), however, has set out to evaluate the lead content of several lipsticks based on the acceptable FDA limit of lead in candy, which is 0.01 PPM. The results of their study show that one-third of lipsticks in the market have levels of lead exceeding those of the allowable limit for candy ( ppm). A new study by the FDA (Hepp, Mindak and Cheng, (2009) also showed that the levels in the CSC study were underestimated and that the levels of lead in some lipsticks range from 0.09ppm to 3.06ppm. Comparing the levels of lead in lipsticks is not practical, however, according to the FDA, as lipsticks are not meant for ingestion, unlike candies (Al-Saleh, Al-Enazi & Shinwari, 2009), and are only applied topically.

8. 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
While the FDA has no limit on lipsticks, it has however, imposed a specific limit for lead content as an impurity in the color additives used in lipsticks or cosmetics in general. Color additives that have a lead content of ppm, according to the article by Al-Saleh et al (2009), are safe and acceptable by FDA standards.
The Bureau of Food and Drugs in the Philippines, on the other hand, has issued a circular (No ) issuing a statement that the maximum allowable limit of lead in cosmetics is 20 ppm. This statement was made after the consolidation of data from other ASEAN member countries.

9. 20 lipsticks of varying brands Highest: Cover Girl brand, 3.06 PPM
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
In the study done by Hepp, Mindak and Cheng (2009), 20 lipsticks of varying brands were found to have lead levels ranging from ppm. Among the 20 lipsticks, it is Cover Girl who has the highest level of lead, with 3.06 ppm. Avon has the lowest level of lead, on the other hand, with 0.09 ppm. On the average, lipsticks included in this study had a lead level of 1.07 ppm. Below is a table of the different brands.

10. Lipstick Line and Shadea
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
Queen Collection Q580 Ruby Remix
7136
2.24
Body Shop
L'Oreal
Lip Colour 22 Garnet
C274EA
1.79
Continuous Color 435 Cherry Brandy
7228
1.76
Colour Riche 315 True Red
FD261
1.47
Super Lustrous 660 Bed of Roses
07208 1508 53
1.37
Maybelline
Moisture Extreme F315 Cocoa Plum
WD2891
1.21
Super Lustrous 725 Love That Red
07284 1508 59
1.04
Here is a table of the different brands.

11. Colour Riche 752 Classic Wine FD064 0.79 FD234 0.67 Clinique
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
Long Last F9 Paprika
A87
0.48
Estee Lauder
Pure Color 1A3 Maraschino
B55
0.43
Burt's Bees
Clorox Company
Lip Shimmer Merlotg
0.33
Maybelline
Moisture Extreme E215 Midnight Red
WD3041
0.23
PeaceKeeper
Paint Me Compassionateg h
0.17
Dior
LVMH
Replenishing Lipcolor 752 Red Premiere
7A01
0.15
Addict Ultra-Shine 750 Shiniest Sexiness
7D01
0.12
MAC
Matte Lipstick Viva Glam I
A67
0.10
Avon
Ultra Color Rich U250 Cherry Jubilee
0.09
Average
1.07

12. 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: PPM
There were 3 outliers in the data
Without outliers: PPM
Only 2 brands above the 20 PPM limit
All 5 lipsticks that exceeded the limit: from China
Lipsticks with shimmers: PPM
All exceeded the 0.1 PPM limit in candy
In the study by Al-Saleh, Al-Enazi & Shinwari (2009), 48 lipsticks from 26 brands were bought from a 2-riyals store and analyzed. Analysis of their raw data showed that the levels of lead in their lipstick samples ranged from 0.27 to 3760 PPM. Removal of three outliers, however, adjusted the range to 0.27–36.90 PPM, with only two brands exhibiting lead levels above 20 PPM or the FDA limit for lead as an impurity. These two brands were noted to have originated from China as well as the other three outliers that exhibited lead levels as high as 3760 ppm. Lipsticks with shimmers were also noted to have high levels of lead in them (0.33–3760 PPM). All lipsticks included in the study, however, also exceeded the 0.1 PPM US FDA permissible lead level in candy, which was the standard used by the CSC in their study.

13. 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
According to article by the Inter-organization Programme for the Sound Management of Chemicals (1998), the allowable blood levels of lead are limited to <20 µg/dl in the general population. In the United States, the allowable level for children is <10 µg/dl as this amount can already lead to a 2.5-point decrease in intelligence quotient of IQ.

14. 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
40-50
Nervous system: IQ/learning disruption, sensory system deficits 40
Heart and Blood Vessels: Hypertension
<7
Formation of blood cells: biochemical (enzyme changes)
3-30
The blood lead levels presented in this table can affect certain organs in adults.

15. 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 to the toxic effects of lead due to their behavior and stage of development
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
The article mentions, however, that there is no exposure level below which lead appears to be safe and that children are more susceptible to the toxic effects of lead due to their behavior and stage of development. As mentioned, blood lead level in children as low as less than 10 µg/dl can hamper blood cell formation and affect one’s IQ or cause some form of learning disruption. Similar to adults, however, higher levels may cause colic, encephalopathy, renal atrophy, and interstitial nephritis as well.

16. 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
According to the American Academy of Child and Adolescent Psychiatry (2006), almost all children in the United States have been exposed to lead, commonly from paint, water, or soil. The Center for Disease Control (CDC) states that about 6 percent of children aged 1-2 years old have toxic blood lead levels.

17. 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
As women predominantly use lipsticks, lead exposure during pregnancy is also a viable concern. Lead in the body are mainly stored in the bone and these stores may be mobilized due to hormonal effects in pregnancy. Lead also readily crosses the placental barrier and may affect the fetus. Thus childhood exposure of women may not manifest in them specifically but could affect their future children via prenatal exposure.

18. 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
Currently, however, the FDA has assessed that the lead available in the lipsticks they have tested are safe and should not be a cause for concern. Their statement is based on the premise that lipstick is for topical use only and that majority of them are below the recommended limit given by public health officials (Health Canada, 2009), which is 10ppm.

19. 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%
The same cannot be said for other cosmetics such as kohl, however. In a study by Al-Ashban, Aslam, and Shah (2002), it was found that the blood analyses of regular kohl users revealed a high lead concentration and relatively low hemoglobin levels. Kohl, in the study, was also estimated to have lead levels as high as 52.3%.

20. 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).
For blood lead levels, the control group had a mean value of 0.9µg/dl ± 0.43 while the Kohl users group had a mean of 17.65µg/dl ±2.29. As for the hemoglobin levels, the control group had a mean of 14.02g/dl ± 0.21 while the Kohl users group had a lower mean at 12.22g/dl ± The article by Al-Saleh et al (1999) also supports the findings made by Al-Ashban et al (2002), particularly for blood lead levels.

21. Discussion

22. 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 ) for a maximum allowable limit of lead in cosmetics to 20ppm
The USFDA currently has not set a limit for lead as a contaminant in cosmetics. However there are specifications set for impurities in color additives used in cosmetics. The limit of lead levels in color additives approved for use in cosmetics is set at 20 ppm. The Campaign for Safe Cosmetics, a non-profit coalition, set the limit to 0.1pm, adapted based on the permissible limit of lead in candies following the assumption that lipsticks can be ingested. However, there has been an argument that 0.1 ppm is not valid as a limit level for lipsticks since they are not intended for ingestion and consumption on a regular basis and that the amount taken by the body is small. FDA Philippines has set an allowable limit of lead in cosmetics to 20ppm.

23. Hepp, Mindak and Cheng (2009)
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 ppm
Covergirl: highest level (3.06ppm)
Avon: lowest level (0.09ppm)
Average lead level of all lipsticks: 1.07ppm
In a study done by Hepp, Mindak and Cheng (2009), 20 lipsticks of varying brands were found to have lead levels ranging from ppm. Among the 20 lipsticks, it is Cover Girl which has the highest level of lead, with 3.06 ppm. Avon has the lowest level of lead, on the other hand, with 0.09 ppm. On the average, lipsticks included in this study had a lead level of 1.07 ppm.

24. 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 ppm
Exclusion of three outliers dropped upper value from 3760 to
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
In a study conducted by Al-Saleh et.al., all of the 26 brands consisting of 72 lipstick samples from China, USA, France, Italy, Taiwan and Germany turned out to be positive for lead. Lead levels range from ppm. These levels however have 3 outliers. Exclusion of these three outliers would drop the upper value of the range from 3760 ppm to ppm, with only two values above the limit set by the USFDA. Since there are no valid reasons to exclude the outliers, ultimately, 4 brands are recognized as having levels beyond the 20 ppm limit. These lipstick samples were obtained from China.

25. 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
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
Although overexposure to lead in general causes many health problems, there have been no accounts of effects as a direct consequence of lipstick use. As discussed in the study by Al-Saleh et.al.,lead in lipsticks might not cause an immediate health problem. However, it can accumulate due to repeated application and may result in cumulative toxicity. This is also 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.
Currently, however, the FDA has assessed that the lead available in the lipsticks they have tested are safe and should not be a cause for concern. Their statement is based on the premise that lipstick is for topical use only and that majority of them are below the recommended limit given by public health officials.

26. References
CSC, the Campaign for Safe Cosmetics (2007). A Poison Kiss: The Problem of Lead in Lipsticks. Available from: < 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, Al-Saleh, I, Al-Enazi, S. and Shinwari, N. (2009). Assessment of lead in cosmetic products. Regulatory Toxicology and Pharmacology, 54, Bureau of Food and Drugs (2006). Bureau circular , Maximum allowable limits of heavy metals for cosmetic products. Retrieved from 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, Inter-organization Programme for the Sound Management of Chemicals (1999). Global opportunities for reducing the use of leaded gasoline. Available from: American Academy of Child and Adolescent Psychiatry (2006). Lead exposure in children affects brain and behavior. Retrieved from and_behavior.