Litigation Arising From Minimally Invasive Cosmetic Procedures: A Review of the Literature.

BACKGROUND: Minimally invasive cosmetic procedures are on the rise. To meet this rising demand, increasing numbers of physicians and nonphysicians are performing these procedures. Understanding malpractice trends and reasons for litigation in cosmetic medicine is important to establish safeguards for patient care and minimize liability. OBJECTIVE: Perform a comprehensive review of the literature on litigation associated with minimally invasive cosmetic procedures and discuss strategies to avoid facing a lawsuit. MATERIALS AND METHODS: The authors searched PubMed databases using a variety of keywords to identify studies of lawsuits arising from minimally invasive cosmetic procedures through December 2020. RESULTS: A total of 12 studies of litigation meeting inclusion criteria were identified: botulinum toxin (1), soft tissue fillers (3), lasers (5), body contouring/liposuction (1), chemical peels/dermabrasion (1), and sclerotherapy (1). Principle factors associated with litigation included negligence, lack of informed consent, vicarious liability for action of delegates, lack of communication, poor cosmetic result, failure to inform of risks, inappropriate treatment or dose, and failure to recognize or treat injury. CONCLUSION: Understanding malpractice trends and reasons for litigation in minimally invasive cosmetic procedures can strengthen the patient-provider relationship, establish safeguards for patient care, and may minimize future risk of a lawsuit.

Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies.

The EU Directive 2010/63/EU   on the protection of animals used for scientific purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation advocate for a change in the way toxicity testing is conducted. Whilst the Cosmetic Products Regulation bans animal testing altogether, REACH aims for a progressive shift from in vivo testing towards quantitative in vitro and computational approaches. Several endpoints can already be addressed using non-animal approaches including skin corrosion and irritation, serious eye damage and irritation, skin sensitisation, and mutagenicity and genotoxicity. However, for systemic effects such as acute toxicity, repeated dose toxicity and reproductive and developmental toxicity, evaluation of chemicals under REACH still heavily relies on animal tests. Here we summarise current EU regulatory requirements for the human health assessment of chemicals under REACH and the Cosmetic Products Regulation, considering the more critical endpoints and identifying the main challenges in introducing alternative methods into regulatory testing practice. This supports a recent initiative taken by the International Cooperation on Alternative Test Methods (ICATM) to summarise current regulatory requirements specific for the assessment of chemicals and cosmetic products for several human health-related endpoints, with the aim of comparing different jurisdictions and coordinating the promotion and ultimately the implementation of non-animal approaches worldwide. Recent initiatives undertaken at European level to promote the 3Rs and the use of alternative methods in current regulatory practice are also discussed.

Decrease of contact allergy to hydroxyisohexyl 3-cyclohexene carboxaldehyde in Europe prior to its ban and diagnostic value.

BACKGROUND: Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) has been the most reported fragrance chemical for two decades and will be prohibited in cosmetic products from August 2021. OBJECTIVES: To describe the time trend of HICC contact allergy in European patients with dermatitis in 2009 to 2019, and the added value of testing HICC separately in the baseline series. METHODS: Data were reviewed for 124 472 patients with dermatitis who were patch tested with HICC 5% pet. in the baseline series in the European Surveillance System on Contact Allergy (ESSCA) network (2009 to 2018) and at the Herlev-Gentofte Hospital Department of Dermatology and Allergy (2009 to 2019). RESULTS: Contact allergy to HICC was found in 1.98% of 9865 patients in Gentofte and 1.62% of 114 607 patients in the ESSCA network. Overall, the prevalence decreased annually, with 0.156 percentage points (P = .001) in Gentofte and 0.051 percentage points (P = .0002) in ESSCA. The frequency of missed contact allergy to HICC when testing only with fragrance mix II (FMII) was 0.17% (17/9865) and 0.35% (405/114607) of the whole test population in the Gentofte and ESSCA populations, respectively. CONCLUSIONS: This is the first study to demonstrate a significant decline in HICC allergy in European patients with dermatitis, most likely attributed to the upcoming European ban.

The epidemic of contact allergy to methylisothiazolinone-An analysis of Danish consecutive patients patch tested between 2005 and 2019.

BACKGROUND: In 2005, methylisothiazolinone (MI) was allowed as a stand-alone preservative in cosmetics. This resulted in an epidemic of allergic contact dermatitis to MI, mainly affecting women exposed to leave-on cosmetics. Consequently, a regulation of Annex V in the European Union in 2017 banned the use of MI in leave-on cosmetics and reduced the allowed concentration in rinse-off products. OBJECTIVE: To analyze the temporal trends in contact allergy to MI in Danish patients in relation to key events including European regulations over time. METHODS: A retrospective study of consecutive patients patch tested with methylisothiazolinone from 2005 to 2019. Demographics and clinical characteristics in terms of MOAHLFA (male, occupational, atopic dermatitis, hand dermatitis, leg dermatitis, facial dermatitis and age >40 years), sources of exposure, and clinical relevance were analyzed in relation to key historical events. RESULTS: Three hundred eighty of 12 494 patients (3.0%, 95CI: 2.7-3.4%) tested from 2005 to 2019 were sensitized to MI. An increasing trend in the prevalence of MI contact allergy from 2005 to 2019 (P < .01) was observed, although a decline in the absolute number of patch-test positive patients was seen from 2013 and onward. A reduction in leave-on cosmetics as a source of exposure was observed following the legislative ban in 2017, from 24.8% from in 2010 to 2013 to 6.2% in 2017 to 2019 (P < .01). CONCLUSION: The epidemic of MI contact allergy is declining in absolute terms, although the prevalence in the patch-tested population has not returned to its pre-epidemic levels. The legislative regulation of MI in 2017 has been effective in terms of leave-on cosmetics as a source of exposure in MI allergic patients. The process of post-marketing risk assessment of contact allergens in the European Union needs improvement.

Medicinal plants and their preparations in the European market: Why has the harmonization failed? The cases of St. John's wort, valerian, ginkgo, ginseng, and green tea.

BACKGROUND: Botanical ingredients based on plants, algae, fungi or lichens have become widely available on the European Union market offering numerous preparations with considerable differences in classification. They are under the categories of food supplements, herbal medicinal products, cosmetics or medical devices. PURPOSE: The aim of the present work is to highlight how the European regulations concerning the different categories of botanicals can lead to different commercial choices such as time/cost for product development, application for a marketing authorisation, permitted indication (medical or health claim), and as a consequence, the same botanical products are sold in European Union as herbal medicinal products, food supplements, cosmetics or medical devices. Five different widely used botanicals, namely St. John's wort, valerian, ginkgo, ginseng, and green tea were selected to better explain the failure of harmonization through European Union. METHODS: A search of PubMed, ScienceDirect, European Medicines Agency and European commission web sites for medical devices and cosmetics, and European Food Safety Authority websites were conducted and the available information on regulation of herbal medicinal products, food supplements, medical devices and cosmetics in the European Union was collected. In addition, a market survey of all the sold botanical products in Europe was analysed by consultation of the medicines, medical devices, cosmetic and food agencies websites of the European countries. RESULTS: The current European legislation needs implementation and follow up because in the different countries the legal positions of the botanical products varied and it is possible to find the same product classified in the different categories, namely registered medicinal product including prescription only medicine, traditional herbal medicinal product, well established herbal medicinal products or food supplement, or medical device, or homoeopathic/anthroposophical medical product, cosmetic. CONCLUSIONS: There is an urgent need of harmonization, together with the implementation of interoperable vigilance databases, to avoid borderline options.

Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds.

Mineral oils and waxes are mixtures of predominantly saturated hydrocarbons consisting of straight-chain, branched and ring structures with carbon chain lengths greater than C14. They have been used for many decades in skin and lip care cosmetic products due to their excellent skin tolerance as well as their high protecting and cleansing performance and broad viscosity options. In contrast to vegetable oils, mineral oils are non-allergenic since they are highly stable and not susceptible to oxidation or rancidity. They have a long history of safe use which is confirmed by clinical and epidemiological data. In Europe, mineral oils are only permitted in cosmetics if compliant with purity specifications on polycyclic aromatic hydrocarbons and safety requirements laid down in the European pharmacopoeia and the EU cosmetics regulation EC/1223/2009. The high quality of these mineral oils is assured by robust quality assurance and a refining/purification process designed to exclude substances with carcinogenic potential and to minimize the presence of mineral oil aromatic hydrocarbons. Given their highly lipophilic properties, mineral oils do not penetrate human skin and, thus, are not systemically bioavailable in the body. Moreover, no significant changes in the skin and no effects on any internal organ system have been reported and attributed to the topical application of refined mineral oils. Regarding potential oral exposure from cosmetic lip care products, Cosmetics Europe, the European trade association for the cosmetics and personal care industry, has advised cosmetic manufacturers to only use mineral oil fractions for which recognized food acceptable daily intake (ADI) values apply. The estimated dose of mineral oils ingested via lip care products contributes to <10% of the ADI value and should therefore be considered of no toxicological concern.

Time for a makeover-cosmetics regulation in the United States.

INTRODUCTION: Cosmetics and personal care products are ubiquitous. Consumer pressure arising from recent episodes of products found to be unsafe has led to new policy proposals to modernize cosmetics regulation in the United States. METHODS: We reviewed contemporary cosmetics regulation and collected major past and current policy proposals relating to cosmetics regulation with a focus on public health controversies. RESULTS: Under a structure originally established in 1938 that places regulation of cosmetics under the Food and Drug Administration (FDA), cosmetics manufacturers in the United States are not required to register their products or forward consumer complaints to the FDA, leading to broad under-reporting of adverse events. The FDA has limited authority to mandate product recalls. The existing FDA database system that collects adverse events related to cosmetics has limited public health utility. Current proposals for new cosmetics regulations seek to establish better systems for data collection and mandatory manufacturer registrations funded by cosmetic manufacturers. Additional policy changes could include a premarket review process for cosmeceuticals (cosmetics that make drug-like claims) and more advanced real-world data safety monitoring tools. CONCLUSIONS: With continued consumer concern and several recent cosmetic-related public health controversies, the FDA should be given more resources and broader authority to protect consumer safety.

[Mandatory regulations and standards regarding cosmetic botanic ingredients in major countries and regions].

Cosmetics containing botanic ingredients have been used from thousands of years up to now in China. Because of the consumers' demand for health and beauty,the number of products about " botanic" have been growing rapidly in the cosmetics market,which has played an important role in upgrading the industry and enhancing the international competitiveness nowadays. Therefore,to strengthen the management about used botanic raw materials in cosmetics products and revise the application regulation of new raw materials has become an important work to ensure product quality,promote the healthy and stable development of cosmetic business. The article summarizes the related mandatory regulations and standards about botanic ingredients which used as activity function in major cosmetic business countries or regions. Furthermore,the information of botanic ingredients commonly used in non-special cosmetics notification and special cosmetic registration system were described to expect the better application and development.

A systematic review of global legal regulations on the permissible level of heavy metals in cosmetics with particular emphasis on skin lightening products.

BACKGROUND: There is an urgent need to address the safety problems caused by the use of skin lightening cosmetics. Evidence suggests that some of them may contain heavy metals. OBJECTIVES: We conducted a systematic review of global legal regulations regarding the permissible level of mercury, lead, arsenic, and cadmium in cosmetic products, with particular emphasis on skin lightening preparations. METHODS: The systematic search of documents was a two-stage process. First, official websites of 17 regional organizations and subsequently regulations for countries with a population over 100 million were searched. RESULTS: Fifteen legislative acts, encompassing more than 67·2% of the global population were reviewed. Regulations were identified for 44/59 high income countries, 16/55 upper middle income countries, 9/45 lower income countries, 0/34 low income countries. The median adult literacy rate was 91·4% and 64·2% in countries with and without regulations, respectively. The use of mercury, lead, arsenic, and cadmium has been banned in 67, 67, 65, and 65 out of 69 countries, respectively. CONCLUSIONS: While regulations exist in most of the high income countries, in low income countries there is a lack of similar standards. In most countries for which these legal regulations have been identified, restrictions on the permissible level of heavy metals are strict. There is a need for enforcement of existing rules, and rigorous assessment of the effectiveness of these regulations.