LEAD IN YOUR LIPSTICK:

1. LEAD IN YOUR LIPSTICK: A Journal appraisal

2. introduction Lead • used as a coloring elements • basically taken up by ingestion • uptake of food (65%) • water (20%) • air (15%)

3. 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

4. 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

5. The research question Is there a significant amount of lead among commercially available lipstick brands that can pose health risks?

6. 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

7. Review of related Literature Examining the sources

9. Lead in your lipstick Summary of RRL

10. 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.

11. 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

12. 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

15. 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

16. 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

18. 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

19. 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

20. 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

21. 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

22. 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%

23. 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).

24. Discussion

25. 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

26. 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

27. 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

28. 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

29. 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

30. conclusion The verdict

31. Conclusions: author’s perspective Awareness Groups 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 • High lead content • Based on 0.01 PPM for candies • Stricter regulations required • Cite various health risks and hazards

32. 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.

33. 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%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.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.