Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants

Cornell, Erika; Kwa, Michael; Paller, Amy S.; Xu, Shuai

doi:10.1111/pde.13419

Cited by 11 publications

(12 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Meanwhile, the incidence of adverse cutaneous reactions to skin care products has also been increasing, particularly over the last 5 years. 1,2 Moreover, recent studies have indicated that even branded skin care products can cause severe adverse cutaneous reactions. 3 Although eczematous reactions account for 90% of these adverse reactions, 4 a link between skin care products and an increased risk of breast cancer has been observed.…”

Section: Introductionmentioning

confidence: 99%

Adverse cutaneous reactions to skin care products on the face vary with age, but not with sex

et al. 2018

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

Adverse cutaneous reactions to skin care products on the face vary with age, but not with sex

et al. 2018

View full text Add to dashboard Cite

show abstract

“…A previous analysis of the CAERS database also showed the highest percentage of serious AEs (ie, death, serious injury, hospitalization) reported by consumers was due to baby products . The majority of these adverse events were due to skin reactions and many events led to health care visits . The decreased barrier function, increased infection risk, and a rising concern of allergic contact dermatitis in the neonatal and pediatric population suggest the need for greater caution in this cohort…”

Section: Discussionmentioning

confidence: 93%

Overview of high‐risk Food and Drug Administration recalls for cosmetics and personal care products from 2002 to 2016

Janetos

Akintilo

2018

J of Cosmetic Dermatology

Self Cite

View full text Add to dashboard Cite

Summary Background There have been several recent controversies surrounding cosmetic products that have impacted health. Dermatologists are often the first to encounter these issues, and recalls are one metric of a safety profile of cosmetics and their impact on health. Objective To analyze all recalls of cosmetic and personal care products from 2002 to 2016. Methods This observational study describes all FDA cosmetic and personal care product recalls, acquired via a Freedom of Information Act request, from 2002 to 2016. The total number of Class I, Class II, and Class III recalls, number and origin of manufacturers, number of products affected, and main reason for recall were collected. Results A total of 14 Class I, 266 Class II, and 33 Class III recalls were recorded. Baby products comprised the largest product category accounting for 24% of all recalls (76/313). 76% of recalls were due to bacterial contamination (237/313), followed by unapproved components, labeling issues, and skin irritation. The 14 Class I recalls accounted for 1.9 million products in distribution. Conclusions Cosmetic recalls impacted millions of products and had the potential to cause serious harm. Dermatologists have the ability to strengthen public safety by reporting adverse events, encouraging recalls of harmful products, and lobbying through dermatology organizations for meaningful change to current cosmetic regulation.

show abstract

“…For these reasons, cosmetic/cosmeceutical effectiveness and safety must be controlled in vitro on cell cultures and in vivo on skin (healthy or affected by minor disorders or mild abnormalities) by methodologies scientifically and clinically correct [12,13]. In reality, although the frequency of cosmetic adverse serious events reported by EU and USA guidelines seems to be low [14,15], the cross allergy and human sensitization phenomena connected with the activity of preservatives, emulsifiers, flavoring, colors, and other chemicals used for cosmetic, food, household, and professional products are increasing worldwide with the risk of chronic diseases [16]. What is interesting to underline on the class of preservatives more often present in many consumer products is that on the one hand, the mass media daily war against the 4-hydroxy benzoic acid and its derivatives, known as parabens, also if they are commonly found in various vegetable foods such as onion, carrots, peaches, etc., and posing a negligible risk to endocrine systems [17,18], and on the other hand, the great use and consume of the thiazolinone derivatives, biologically dangerous chemicals (almost unknown to mass media and consumers), which have provoked many allergic phenomena worldwide [19][20][21].…”

Section: Cosmetic Productsmentioning

confidence: 99%

A New Carrier for Advanced Cosmeceuticals

Morganti

Coltelli

2019

Cosmetics

View full text Add to dashboard Cite

Cosmetic products are generally formulated as emulsions, ointments, solutions or powders containing active ingredients. According to EU legislation, a cosmetic product is “any substance or preparation intended to be placed in contact with the various external parts of the human body with a view exclusively or mainly to cleaning, perfuming them, changing their appearance, and/or correcting body odors and/or protecting them or keeping them in good conditions”. However, science advancement in both active carriers and ingredients has streamlined the process through which many cosmetic products by their delivery systems can induce modifications on the skin physiology. This is the reason why Reed and Kligman redefined these products as “cosmeceuticals”, which refers to the combination of cosmetics and pharmaceuticals. Until recently, the term of cosmeceuticals has not had legal significance. The so-called cosmeceuticals, in fact, may induce modifications on the skin physiology, modifying, for example, transepidermal water loss, keratinocytes cohesion and turnover, modulating the inflammatory cascade, and/or altering the surface microbiota by the activity of the preservatives content. For these reasons, they are claimed to have medical or drug-like benefits. Naturally, their effectiveness on minor skin disorders or mild skin abnormalities has to be shown by in vitro and in vivo studies. On the other hand, their formulations contain emulsifiers, preservatives, and other chemicals which, by their cumulative use, may provoke side effects, such as allergic and/or sensitization phenomena. Moreover, many ingredients and packaging for such products are not biodegradable. In this study, we would like to introduce an innovative category of cosmeceuticals made by biodegradable nonwoven tissues. These cosmeceutical tissues, produced through the use of natural fibers, may bind different active ingredients and therefore become effective as antibacterial, anti-inflammatory, sun-protective, whitening, or anti-aging products, depending on the ingredient(s) used. Differently from the usual cosmetics, they do not contain preservatives, emulsifiers, colors, and other chemicals. They can be applied as dried tissue on wet skin, remaining in loco for around 30 min, slowly releasing the active ingredients entrapped into the fibers. It is interesting to underline that the tissue, acting as a carrier, has its own effectiveness via chitin and lignin polymers with an antibacterial and anti-inflammatory activity. When hydrolyzed by the human microbiota enzymes, they give rise to ingredients used as cell nourishment or energy. This paper will review part of the scientific research results, supporting this new category of biodegradable cosmetic products known as facial mask sheets.

show abstract

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants

Abstract: Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health.

Cited by 11 publications

References 12 publications

Adverse cutaneous reactions to skin care products on the face vary with age, but not with sex

Adverse cutaneous reactions to skin care products on the face vary with age, but not with sex

Overview of high‐risk Food and Drug Administration recalls for cosmetics and personal care products from 2002 to 2016

A New Carrier for Advanced Cosmeceuticals

Contact Info

Product

Resources

About