Checking the pulse on products

There's not much more intimate than the personal care lotions and potions we use to slather and later, anoint and appoint our skin, hair and nails with.

The conundrum:

1/ Our skin is genius at absorbing what's applied to it - upwards of 60% that is (1, 2) - and is an über-efficient delivery system to the bloodstream (4).

2/ There's virtually no regulation for what ingredients can be used in personal care products (5, 6) and virtually zero requirements for products' safety before going to market (7, 8).

According to the FDA, "In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe." (9) Some might suppose this to be reassuring if all products were tested, or even a most of them. Can you guess how many of the products currently on the shelves are tested for safety? 11 percent (10, 11).

Here are a few numbers to pique your perspective:

BY THE NUMBERS: Personal Care + Cosmetic Products

12 : the number of personal care and cosmetic products the average woman uses daily (12)

168 : the average number of ingredients in the products women use on a daily basis (13)

6 : the number of personal care and grooming products the average man uses daily (14)

85 : the average number of ingredients in the products men use on a daily basis (15)

1 in 5 : the number of cosmetic/personal care products that contain chemicals linked to cancer (16)

11% : the percentage of ingredients used to formulate personal care products that have been tested and reviewed for safety by CIR (Cosmetic Ingredients Review) (17)

56% : the percentage of cosmetic/personal care products that contain penetration enhancers that deliver ingredients more deeply and efficiently into the skin (18)

12.2 million : the number of adults exposed to known or probable human carcinogens via personal care products (19)

1 in 13 : the number of women exposed to known or probable human carcinogens via personal care products (20)

1 in 23 : the number of men exposed to known or probable human carcinogens via personal care products (21)

1 in 24 : the number of women exposed to known or probable reproductive and developmental toxins linked to impaired fertility and harm to fetuses via personal care products* (22)

* not including phthalates, which may be used in "Fragrances"

12,500 : the number of separate chemicals used as "fragrance" (23)

95% : the number of personal care products that contain phthalates* (24)

* Phthalates are linked to biaccumulation in humans and wildlife (25), cancer (26, 27), developmental and reproductive toxicity (28, 29), endocrine disruption (30, 31), neurotoxicity and neurodevelopmental disorders (32), toxicity of the brain, kidneys, liver and lungs (33, 34, 35), birth defects (36), and are toxic in the environment (37)

99.5% : the percentage of Americans that have phthalates in their body tissue (38)

35% : the percentage of children's products labeled as "natural" that contain one or more synthetic preservative linked to allergies, hormone disruption and/or nervous system problems (39)

12,500 : the estimated number of ingredients used in cosmetic products (40)

4,755 : the number of ingredients the FDA has no record of (41)

400 : the number of products on the market that contain chemicals prohibited for use in cosmetics in other countries (42)

400 : the number of products on the market that contain chemicals that industry assessment deems unsafe when used as directed on product labels (CIR and International Fragrance Association) (43)

1 : the number of pages in the 112 page Federal Food, Drug, and Cosmetics ACT (FFDCA) devoted to cosmetics (44)

0 : the number of products required to be tested for safety before marketing under the Act (FFDCA) (45)

$35 billion : the amount spent on personal care and cosmetics in the U.S. annually (46)

SOURCE NOTES

(1) Ford, R.A., Hawkins, D.R., Mayo, B.C., Api, A.M. "The in vivo dermal absorption  and metabolism of [4-14C]coumarin by rats and human volunteers under simulated condition of use in fragrances." Food and Chemical Toxicology 2001;39(2):153

(2) Bronaugh, R.L., Collier, S.W., Macpherson, S.E., Kraeling, M.E.K. "Influence of Metabolism in Skin on Dosimetry after Topical Exposure." Environmental Health Perspectives 1994;102(Suppl II):71-74. www.ehponlie.org/members/1994/Suppl-II/bronaugh-full.html.

(3) Kao, J., Hall, J. "Skin absorption and cutaneous first pass metabolism of topical steroids: In vitro studies with mouse skin in organ culture." Journal of Pharmacology and Experimental Therapeutics 1987;241(2):482-487. http://jpet.aspetjournals.org/cgi/content/abstract/241/2/482.

(4) Anderson, I. New Scientist September 1996. www.triangularwave.com/f9.htm

(5) EWG (Environmental Working Group). "Cosmetic Safety Database".  www.cosmeticdatabase.com/

(7) U.S. Food and Drug Administration. "FDA Authority Over Cosmetics". www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074162.htm 

 (8) U.S. Food and Drug Administration. "Cosmetics, FDA Authority and Policy".  www.cfsan.fda.gov/~dms/cos-toc.html

(9) U.S. Food and Drug Administration. "FDA Authority over Cosmetics". http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074162.htm

(10) FDA (U.S. Food and Drug Administration). 2008a. 9-Digit Code Number Dictionary. Voluntary Cosmetic Registration Program. https://info1.cfsan.fda.gov/vcrp/report/?cmd=cas

(11) FDA (U.S. Food and Drug Administration). 2008b. Voluntary Cosmetic Registration Program.

(12) EWG (Environmental Working Group). Exposures Add Up - Survey Results. 2004. www.cosmeticdatabase.com/research/exposures.php.

(13) Ibid. www.cosmeticdatabase.com/research/exposures.php

(14) Ibid. www.cosmeticdatabase.com/research/exposures.php

(15) Ibid. www.cosmeticdatabase.com/research/exposures.php

(16) EWG (Environmental Working Group). Skin Deep Cosmetic Safety Database. 2008. www.cosmeticdatabase.com

(17) Camapign for Safe Cosmetics. FDA Regulations. www.safecosmetics.org/article.php?id=316

(18) EWG (Environmental Working Group). 2008b. Skin Deep Cosmetic Safety Database. www.cosmeticdatabase.com

(19) EWG (Environmental Working Group). Exposures Add Up - Survey Results. 2004. www.cosmeticdatabase.com/research/exposures.php.

(20) Ibid. www.cosmeticdatabase.com/research/exposures.php.

(21) Ibid. www.cosmeticdatabase.com/research/exposures.php.

(22) Ibid. www.cosmeticdatabase.com/research/exposures.php.

(23) FDA (U.S. Food and Drug Administration). 2007. Compliance Program Guidance Manual. Program 7329.001. Chapter 29 - Colors and Cosmetics Technology. www.fda.gov/downloads/Cosmetics/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/UCM073356.pdf

(24) EWG (Environmental Working Group). 2008c. 12,798 Products Containing Fragrance. Skin Deep Cosmetic Safety Database. Accessed May 11 2008 at www.cosmeticdatabase.com/browse.php?containing=702512 

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(25) Official Journal of the American Academy of Pediatrics, " Pediatric Exposure and Potential Toxicity of Phthalate Plasticizers," Shea, K. and Committee on Environmental Health, 2003, Vol. 111, No. 6, p. 1467-1474 - http://pediatrics.aappublications.org/cgi/content/full/111/6/1467

(26) Teratogenesis, Carcinogenesis, and Mutagenesis, "Genotoxicity of di-butyl-phthalate and di-iso-butyl-phthalate in human lymphocytes and mucosal cells", Kleinsasser, N., et al., 2001, Vol.21, Issue 3, p. 189-196, Wiley-Liss Inc. - http://www3.interscience.wiley.com/cgi-bin/abstract/78505490/ABSTRACT

(27) Official Journal of the American Academy of Pediatrics, " Pediatric Exposure and Potential Toxicity of Phthalate Plasticizers," Shea, K. and Committee on Environmental Health, 2003, Vol. 111, No. 6, p. 1467-1474 - http://pediatrics.aappublications.org/cgi/content/full/111/6/1467

(28) Scientific American, "Ubiquitous Chemical Associated with Abnormal Human Reproductive Development", Graham, S., 5/27/05

(29) CIIT Centers for Health Research, " Effects of Di(n-butyl)phthalate on Reproductive Development," Foster, P., 2006

(30) NIEHS (National Institute of Environmental Health Services, "Endocrine Disruptors", 2006 - www.niehs.nih.gov/oc/factsheets/pdf/endocrine.pdf

(31) CERHR (Center for the Evaluation of Risks to Human Development), "NPT Brief on the Potential Human Reproductive and Developmental Effects of Di(2-ethylhexyl) Phthalate (DEHP)," U.S. Department of Health, national Toxicology Program, Draft May 2006 - http://cerhr.niehs.nih.gov/chemicals/dehp/DEHP%20Brief%20Draft1.pdf

(32) Institute of Public Health, Denmark & Department of Environmentla Health, Harvard School of Public Health, "Developmental neurotoxicity of industrial chemicals," Granjean,P., Landrigan, P., 2006 - www.kevinleitch.co.uk/wp/wp-content/uploads/2006/11/chemicallist.pdf

(33) National Toxicology Program, "Chemical Information Profile for Diethyl Phthalate," CAS No. 84-66-2, 2006 

(34) Health Care Without Harm, "Aggregate Exposures to Phthalates in Humans," DiGangi, J. PhD, et al., 2002. www.noharm.org/library/docs/Phthalate_Report.pdf

(35) American Journal of Industrial Medicine, "Health Risks posed by use of Di-2-ethylhexyl phthalate (DEHP)," Tickner, J., et al., 2001, Vol. 39(1), p. 100-111

(36) Toxicology & Applied Pharmacology, "Teratogenic phthalate esters and metabolites activate the nuclear receptors PPARs and induce differentiation of F9 cell," Lampen, A., et al., 2003, Vol. 188(1), p. 14-23

(37) Journal of Environmental Monitoring, "Survey of phthalate pollution in arable soils in China," Hu, X., et al., 2003, Vol. 5, p. 649-653. www.rsc.org/publishing/journals/EM/article.asp?doi=b304669a

(38) CDC (Centers for Disease Control and Prevention). 2005. Third National Exposure Report. www.cdc.gov/exposurereport/report.htm

(39) EWG (Environmental Working Group). EWG Research Shows 22 Percent of All Cosmetics May Be Contaminated With Cancer-Causing Impurity. 2007. www.ewg.org/node/21286

(40) (FDA 2007) (FDA (U.S. Food and Drug Administration). 2007. Compliance Program Guidance Manual. Program 7329.001. Chapter 29 - Colors and Cosmetics Technology. Available for download at http://www.cfsan.fda.gov/~comm/cp-toc.html

(41) EWG (Environmental Working Group). Statement of Jane Houlihan on Cosmetics Safety. 2008. www.ewg.org/node/26545

(42) EWG (Environmental Working Group). Cosmetics with Banned and Unsafe Ingredients. Letter from Richard Wiles of EWG to Andrew von Eschenbach of FDA. 2007. www.ewg.org/node/22610

(43) Ibid. www.ewg.org/node/22610

(44) Tolchin M. 1990. Who's Monitoring Cosmetics Safety? New York Times. April 14, 1990)

(45) FDA (U.S. Food and Drug Administration). FDA Authority Over Cosmetics. 2005. www.cfsan.fda.gov/~dms/cos-206.html

(46) FDA (U. S. Food and Drug Administration). 2000b. Cosmetics Compliance Program. Domestic Cosmetics Program. Chapter 29 - Cosmetics and Color Technology. July 31 2000. http://web.archive.org/web/20010619050559/http://www.cfsan.fda.gov/~comm/cp29001.html  

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