LEAD IN YO

UR LIPSTIC

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A JOURNAL A

PPRAISAL

INTRODUCTIONLead• 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

THE RESEA

RCH QUESTION

Is there a significant amount of lead among commercially available lipstick brands that can pose health risks?

OBJECTIVES1. To identify the allowable levels of lead

according to drug authorities such as FDA2. To identify commercial brands of lipstick with

significant lead content3. To compare the relative lead content in

lipsticks with lead4. To determine if the use of the said products

has already caused hazard to human health

REVIEW OF RELA

TED

LITERATU

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EXAMINING TH

E SOURCES

LEAD IN YO

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SUMMARY OF R

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ALLOWABLE LEVELS OF LEAD IN COSMETICSCurrently no lead content limit set by FDACampaign for Safe Cosmetics, 2007FDA limit of lead in candy: 0.01 PPM1/3 of lipsticks in the market: 0.03-0.65 PPMFDA study in 2009Lipsticks in the market: 0.09-3.06 PPMLipsticks should not be compared to candies because they are not ingested.

ALLOWABLE LEVELS OF LEAD IN COSMETICSFDA has set a lead content limit as an

impurity in the color additives used in cosmetics

10-20 PPM: safe and acceptableBFAD statementMaximal 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 200920 lipsticks of varying brandsHighest: Cover Girl brand, 3.06 PPMLowest: Avon brand, 0.09 PPMAverage level: 1.07 PPM

BRAND NAME PARENT COMPANY LIPSTICK LINEAND SHADEA

LOT NUMBERSB

LEAD (PB)C

(PPM)D

COVER GIRL PROCTER & GAMBLE INCREDIFUL LIPCOLOR964 MAXIMUM RED

7241S1 3.065188S1 3.05

REVLON REVLON, INC. COLORSTAY LIPCOLOR345 RED VELVET

COMPOSITEE 2.91F

07298 2.38

COVER GIRL PROCTER & GAMBLE QUEEN COLLECTIONQ580 RUBY REMIX 7136 2.24

BODY SHOP L'OREAL LIP COLOUR22 GARNET C274EA 1.79

COVER GIRL PROCTER & GAMBLE CONTINUOUS COLOR435 CHERRY BRANDY 7228 1.76

L'OREAL L'OREAL COLOUR RICHE315 TRUE RED FD261 1.47

REVLON REVLON, INC. SUPER LUSTROUS660 BED OF ROSES 07208 1508 53 1.37

MAYBELLINE L'OREAL MOISTURE EXTREMEF315 COCOA PLUM WD2891 1.21

REVLON REVLON, INC. SUPER LUSTROUS725 LOVE THAT RED 07284 1508 59 1.04

L'OREAL L'OREAL COLOUR RICHE752 CLASSIC WINE

FD064 0.79

FD234 0.67

CLINIQUE ESTEE LAUDER COMPANIES INC.

LONG LASTFJ MERLOT AA7 0.55

CLINIQUE ESTEE LAUDER COMPANIES INC.

LONG LASTF9 PAPRIKA A87 0.48

ESTEE LAUDER ESTEE LAUDER COMPANIES INC.

PURE COLOR1A3 MARASCHINO B55 0.43

BURT'S BEES CLOROX COMPANY LIP SHIMMERMERLOTG 1840701 0.33

MAYBELLINE L'OREAL MOISTURE EXTREMEE215 MIDNIGHT RED WD3041 0.23

PEACEKEEPER PEACEKEEPER PAINT ME COMPASSIONATEG H 0.17

DIOR LVMH REPLENISHING LIPCOLOR752 RED PREMIERE 7A01 0.15

DIOR LVMH ADDICT ULTRA-SHINE750 SHINIEST SEXINESS 7D01 0.12

MAC ESTEE LAUDER COMPANIES INC.

MATTE LIPSTICKVIVA GLAM I A67 0.10

AVON AVON ULTRA COLOR RICHU250 CHERRY JUBILEE H 0.09

AVERAGE 1.07

COMPARISON OF COMMERCIAL BRANDS OF LIPSTICKS WITH SIGNIFICANT LEAD CONTENTStudy by Al-Saleh et al, 200948 lipsticks from 26 brandsLead content range: 0.27-3760 PPM

There were 3 outliers in the dataWithout outliers: 0.27-36.90 PPM

Only 2 brands above the 20 PPM limitAll 5 lipsticks that exceeded the limit: from ChinaLipsticks with shimmers: 0.33-3760 PPMAll exceeded the 0.1 PPM limit in candy

EFFECT OF COSMETICS WITH LEAD TO HUMAN HEALTHInter-organization Programme for the

Sound Management of Chemicals, 1998Allowable blood levels of lead: <20 µg/dlAllowable 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

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

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 susceptibleBlood 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 HEALTHAmerican Academy of Child and

Adolescent Psychiatry, 2006Lead exposure to children: paint, water, soilCenter for Disease ControlAbout 6 percent of children aged 1-2 years old have toxic blood lead levels

EFFECT OF COSMETICS WITH LEAD TO HUMAN HEALTHLead exposure during pregnancyLead in the body are mainly stored in the boneThese 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 HEALTHCurrently FDA assessment of lipsticks

testedLead content levels are safe, not a concernBased 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 HEALTHStudy by Al-Ashban et al, 2002Blood 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 HEALTHStudy by Al-Ashban et al, 2002Blood lead levels

Control group mean value: 0.9µg/dl ± 0.43Kohl users group mean value: 17.65µg/dl ±2.29

Hemoglobin levelsControl group mean value: 14.02g/dl ± 0.21Kohl 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).

DISCUSSION

OBJECTIVE 1: TO IDENTIFY THE ALLOWABLE LEVELS OF LEAD ACCORDING TO DRUG AUTHORITIES SUCH AS FDAUSFDA – 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 LEADHepp, 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 LEADAl 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

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

OBJECTIVE 4: TO DETERMINE IF THE USE OF THE SAID PRODUCTS HAS ALREADY CAUSED HAZARD TO HUMAN HEALTH

CONCLUSION

THE VERDICT

CONCLUSIONS: AUTHOR’S PERSPECTIVEAWARENESS GROUPS

• High lead content Based on 0.01 PPM for

candies• Stricter

regulations required

• Cite various health risks and hazards

COSMETIC INDUSTRY AND US FDA

• No industry standard 10-20 PPM for dye

contaminants Study showed various lead

content – within acceptable limits• 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.

REFERENCESCSC, 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%202006-012.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.htmAmerican 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.