{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T01:05:43Z","timestamp":1773277543938,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2018,3,25]],"date-time":"2018-03-25T00:00:00Z","timestamp":1521936000000},"content-version":"vor","delay-in-days":24,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100007059","name":"Northwestern University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007059","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background\/Objectives<\/jats:title><jats:p>Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer\u2010submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration\u2013designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in\u00a0situations in which a product adversely affects a child's health.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pde.13419","type":"journal-article","created":{"date-parts":[[2018,4,6]],"date-time":"2018-04-06T03:39:13Z","timestamp":1522985953000},"page":"225-229","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants"],"prefix":"10.1111","volume":"35","author":[{"given":"Erika","family":"Cornell","sequence":"first","affiliation":[{"name":"Feinberg School of Medicine Northwestern University Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Kwa","sequence":"additional","affiliation":[{"name":"Feinberg School of Medicine Northwestern University Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy S.","family":"Paller","sequence":"additional","affiliation":[{"name":"Department of Dermatology Feinberg School of Medicine Northwestern University Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3560-6945","authenticated-orcid":false,"given":"Shuai","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Dermatology Feinberg School of Medicine Northwestern University Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,3,25]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Commission Regulation (EU) No 1004\/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223\/2009 of the European Parliament and of the Council on cosmetic products. OJ L2014;282:5\u20108[online].http:\/\/data.europa.eu\/eli\/reg\/2014\/1004\/oj. Accessed June 9 2017."},{"key":"e_1_2_7_3_1","unstructured":"Cosmetics Safety Q&A: Parabens.U.S. Food & Drug Administration web site[online].https:\/\/www.fda.gov\/Cosmetics\/ResourcesForYou\/Consumers\/ucm397393.htm. Accessed June 4 2017."},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.111.6.1467"},{"key":"e_1_2_7_5_1","unstructured":"WEN by Chaz Dean cleansing conditioners: FDA statement\u2014investigation of adverse event reports[online].https:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm511890.htm. Accessed July 1 2017."},{"key":"e_1_2_7_6_1","unstructured":"SeveranceC.Wen lawsuit grows to 200 including parents on behalf of children. CBS DFW. November 11 2015 [online].http:\/\/dfw.cbslocal.com\/2015\/11\/11\/wen-lawsuit-grows-to-200-including-parents-on-behalf-of-children\/Accessed July 17 2017."},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2017.2762"},{"key":"e_1_2_7_8_1","first-page":"29","article-title":"Contact allergens in a pediatric population: association with atopic dermatitis and comparison with other North American referral centers","volume":"3","author":"Jacob SE","year":"2010","journal-title":"J Clin Aesthet Dermatol"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2017.3046"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2017.3045"},{"key":"e_1_2_7_11_1","unstructured":"Lesson 4 coding food food\u2010related cosmetic and vitamin products. U.S. Food & Drug Administration Web site [online].https:\/\/www.accessdata.fda.gov\/scripts\/ora\/pcb\/index.cfm?action=tutorial.LES4_IND_CODE02_50#53_glossary. 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The National Law Review. January 18 2017 [online].http:\/\/www.natlawreview.com\/article\/talcum-powder-ovarian-cancer-lawsuits-centralized-new-jersey. Accessed June 4 2017."},{"key":"e_1_2_7_21_1","unstructured":"Baby wipes causing itchy scaly rashes in some babies. NBC News. January 13 2014 [online].https:\/\/www.nbcnews.com\/health\/kids-health\/baby-wipes-causing-itchy-scaly-rashes-some-babies-n8211. Accessed October 22 2017."},{"key":"e_1_2_7_22_1","unstructured":"LapidosR.The plus factor: we're predicting a clean beauty revolution. August 8 2016 [online].https:\/\/www.wellandgood.com\/good-looks\/clean-beauty-revolution-personal-care-act\/slide\/5\/. 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