Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a "safety standard") for cosmetics to the standard of a "reasonable certainty … [of] … safe."a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as "a preponderance of the evidence" or "beyond reasonable doubt." The standards of proof for these product categories are also ranked according to increasing threshold for achievement of "safe" status. Lastly, this manuscript suggests how the requirements for the high standard of a "reasonable certainty of safe" (or "reasonable certainty of no harm") might be met.

Cosmetic Contact Lenses in the United Kingdom: Assessment of Online Regulation and Quality of Consumer Health Information.

OBJECTIVES: To determine the compliance of online vendors to the UK Opticians Act 1989 Section 27 requirements and safety regulations for cosmetic contact lens (CCL) sales and the quality of online CCL health information. METHODS: The top 50 websites selling CCLs on each three search engines, namely Google, Yahoo, and Bing, were selected. Duplicates were removed, and the remaining websites were systematically analyzed in February 2023. UK legal authorization for CCL sales was assessed using the Opticians Act Section 27 and safety regulations determined by the presence of Conformité Européene (CE) marking. The quality and reliability of online information was graded using the DISCERN (16-80) and JAMA (0-4) scores by two independent reviewers. RESULTS: Forty-seven eligible websites were analyzed. Only six (12.7%) met the UK legal authorization for CCL sales. Forty-nine different brands of CCLs were sold on these websites, of which 13 (26.5%) had no CE marking. The mean DISCERN and JAMA benchmark scores were 26 ± 12.2 and 1.3 ± 0.6, respectively (intraclass correlation scores: 0.99 for both). CONCLUSIONS: A significant number of websites provide consumers with easy, unsafe, and unregulated access to CCLs. Most online stores do not meet the requirements set out in the Opticians Act for CCL sales in the United Kingdom. A significant number of CCLs lack CE marking, while the average quality of information on websites selling CCLs is poor. Together, these pose a risk to consumers purchasing CCLs from unregulated websites, and therefore, further stringent regulations on the online sales of these products are needed.

Quality of cosmetics with active caffeine in cream and gel galenic bases prepared by compounding pharmacies / Qualidade de cosméticos com cafeína ativa em bases galênicas em creme e gel preparadas por farmácias de manipulação

As there is a great scarcity of studies on the importance of good compounding practices in the preparation of cosmetics, this study aimed to evaluate the quality control of cosmetics with active ingredient caffeine for the treatment of cellulite prepared by magistrals pharmacies. Microbiological analyzes, pH determination, color measurement, quantification of the percentage of the active ingredient caffeine and viscosity in creams and gels with 5% of the active ingredient caffeine were performed. In the microbiological analysis, the presence of molds and yeasts was verified above the permitted level according to the Brazilian pharmacopoeia. The pH decreased over time, contributing to the formulations becoming more acidic. In the color parameters, it was found that pharmacy F4 showed a brownish color, both for the gel and for the cream. The percentage of caffeine was within specifications in all formulations and the viscosity remained unchanged during the shelf life of the samples. It is important that the compounding pharmacies demand more effectively the commitment of the team, as well as the analysis of the raw material according to the microbiological control regulations to translate into the quality of the products prepared by the pharmacies and favor the consumer in the effective objective that the product you want to achieve.

Como há uma grande escassez de estudos sobre a importância de boas práticas de manipulação na elaboração de cosméticos, o presente estudo teve como objetivo avaliar o controle de qualidade de cosméticos com princípio ativo cafeína para o tratamento de celulite, elaborados por farmácias de manipulação de Campo Mourão. Foram realizadas análises microbiológicas, determinação do pH, mensuração da coloração, quantificação da porcentagem do princípio ativo cafeína e viscosidade em cremes e geís com 5% do princípio ativo cafeína. Nas análises microbiológicas foi verificada a presença de bolores e leveduras acima do pemitido segundo a farmacopéia brasileira. O pH diminuiu ao longo do tempo, contribuindo para que as formulações ficassem mais ácidas. Nos parâmetros de cor averiguou-se que a farmácia F4 apresentou uma coloração amarronzada, tanto para o gel quanto para o creme. A porcentagem de cafeína estava dentro das especificações em todas as formulações e a viscosidade se manteve inalterada durante o prazo de validade das amostras. Com o propósito de um melhor preparo magistral é importante que as farmácias de manipulação exijam de forma mais eficaz o comprometimento da equipe, bem como a análise da matéria-prima segundo as regulamentações de controle microbiológico. Além disso, a implementação de normas mais rígidas e o melhor controle da matéria-prima e das formulações finais fazem com que a qualidade dos produtos manipulados pelas farmácias magistrais seja aumentada significativamente, favorecendo o consumidor na efetiva finalidade a que o produto objetiva atingir.

Safety Assessment of Citrus Flower- and Leaf-Derived Ingredients as Used in Cosmetics.

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 33 Citrus flower- and leaf-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus flower- and leaf-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing.

The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30-31 March 2021, SCCS/1628/21.

The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The "SCCS Notes of Guidance" are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision.

Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients.

Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.

Safety Assessment of Citrus Plant- and Seed-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 30 Citrus plant- and seed-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus plant- and seed-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel reviewed the available data presented and concluded that 18 of these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. The data for the remaining 12 ingredients are insufficient to determine safety.

Safety Assessment of Citrus Fruit-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 80 Citrus fruit-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe for use in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

Safety Assessment of Citrus Peel-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 47 Citrus peel-derived ingredients, which are most frequently reported to function in cosmetics as skin conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanical ingredients, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that Citrus peel-derived ingredients are safe in the present practices of use and concentration in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

Consumers' lack of understanding of customized cosmetics made on the spot and implications for regulations and controls.

Customized cosmetics immediately made on the spot are now in the market. The present study surveyed 1084 consumers to obtain general insights into their perceptions and perspectives on this novel type of cosmetic. Over half of the total respondents (57.2%) answered they were likely to purchase customized cosmetics; however, a large proportion of consumers also thought microbiological (59.2%)/chemical safety (69.4%) of cosmetics were not good. This reflects consumer anxiety regarding safety issues concerning the customized cosmetics. Even customized cosmetics are regulated by the cosmetic act in each country (i.e., the Cosmetic Act in the Republic of Korea, the Federal Food, Drug, and Cosmetic Act in the USA, and EC Cosmetic Regulation 1123/2009 in Europe), there have been no specific regulations for customized cosmetics made on the spot worldwide so far. To dispel consumer concerns and establish a principled market for the new cosmetics in the field, proper management plans should be established based on consumer surveys. This study indicated that consumers thought it was important to manage the facility/equipment and safety of raw materials (19.7%, each). We believe this study provides a valuable resource for understanding consumers' perceptions and requirements on customized cosmetics, which contributes to establishing future regulations and guidelines.

Beyond dermal exposure: The respiratory tract as a target organ in hazard assessments of cosmetic ingredients.

Dermal contact is the main route of exposure for most cosmetics; however, inhalation exposure could be significant for some formulations (e.g., aerosols, powders). Current cosmetic regulations do not require specific tests addressing respiratory irritation and sensitisation, and despite the prohibition of animal testing for cosmetics, no alternative methods have been validated to assess these endpoints to date. Inhalation hazard is mainly determined based on existing human and animal evidence, read-across, and extrapolation of data from different target organs or tissues, such as the skin. However, because of mechanistic differences, effects on the skin cannot predict effects on the respiratory tract, which indicates a substantial need for the development of new approach methodologies addressing respiratory endpoints for inhalable chemicals in general. Cosmetics might present a particularly significant need for risk assessments of inhalation exposure to provide a more accurate toxicological evaluation and ensure consumer safety. This review describes the differences in the mechanisms of irritation and sensitisation between the skin and the respiratory tract, the progress that has already been made, and what still needs to be done to fill the gap in the inhalation risk assessment of cosmetic ingredients.

Hispanic/Latinos and Skincare: Disparities in Product Development, Marketing, and Toxicity.

“Hispanic” and “Latino” (also known as Mestizo) describe a diverse racial and ethnic group, with a range of cultures, languages, and biological ancestry. It includes individuals of Mexican, Central-to-South American, and Spanish-Caribbean (eg, Cuban, Puerto Rican, and Dominican) descent.1 Individuals of Hispanic/Latino race and ethnicity represent a heterogenous group of people with different skin tones and Fitzpatrick phototypes. Hispanic/Latinos are the fastest growing population in the United States (US) - projected to increase from 55 million in 2014 to 119 million in 2060, an increase of 115%.2 By 2060, more than one-quarter (29%) of the US is projected to be Hispanic/Latino.2.

Fatty Acid Composition of Cosmetic Argan Oil: Provenience and Authenticity Criteria.

In this work, fatty-acid profiles, including trans fatty acids, in combination with chemometric tools, were applied as a determinant of purity (i.e., adulteration) and provenance (i.e., geographical origin) of cosmetic grade argan oil collected from different regions of Morocco in 2017. The fatty acid profiles obtained by gas chromatography (GC) showed that oleic acid (C18:1) is the most abundant fatty acid, followed by linoleic acid (C18:2) and palmitic acid (C16:0). The content of trans-oleic and trans-linoleic isomers was between 0.02% and 0.03%, while trans-linolenic isomers were between 0.06% and 0.09%. Discriminant analysis (DA) and orthogonal projection to latent structure-discriminant analysis (OPLS-DA) were performed to discriminate between argan oils from Essaouira, Taroudant, Tiznit, Chtouka-Aït Baha and Sidi Ifni. The correct classification rate was highest for argan oil from the Chtouka-Aït Baha province (90.0%) and the lowest for oils from the Sidi Ifni province (14.3%), with an overall correct classification rate of 51.6%. Pairwise comparison using OPLS-DA could predictably differentiate (≥0.92) between the geographical regions with the levels of stearic (C18:0) and arachidic (C20:0) fatty acids accounting for most of the variance. This study shows the feasibility of implementing authenticity criteria for argan oils by including limit values for trans-fatty acids and the ability to discern provenance using fatty acid profiling.

[Impact of the use of rings and nail polish on hand hygiene quality in healthcare workers]. / Impacto del uso de anillos y uñas esmaltadas en la calidad de la higiene de manos en el personal de salud.

BACKGROUND: Health-care-associated infections are a frequent problem in hospital environments. Hand hygiene is the most effective measure to prevent outbreaks. The use of certain accessories could decrease its effectiveness, facilitating horizontal transmission of pathogens. OBJECTIVE: Analyze the evidence that assess the impact of the use of rings and nail polish on hand hygiene quality in healthcare workers. METHODS: Non-systematic search in PUBMED/MEDLINE database (1978-2018) of studies in which the quality of hand hygiene or surgical washing is measured, using quantitative cultures or fluorescent stains. RESULTS: Wearing rings: 13 studies met the inclusion criteria. Seven were carried out in general wards. In all of them the use of rings was associated with lower quality of hand hygiene (the majority of low quality). Contrarily, in 3 of 4 primary studies carried out in the operating rooms (of low quality), their use did not affect the quality of surgical washing. Similarly, two systematic reviews obtained similar conclusions. Nail polish: 7 of 54 studies met the inclusion criteria. In four of them there were discordant results (the majority of low quality). One RCT showed a reduction in the quality of surgical washing only when the nail polish was damaged. Gel nail polish was associated with lower quality in two experimental studies. CONCLUSIONS: There is insufficient evidence to associate the use of these accessories with the reduction in the quality of hand hygiene. Its safety was not proven neither. Based on the available evidence (the majority of low quality), a negative impact of the use of rings in clinical units and also of damaged nail polish in operating rooms was observed. Better quality studies are required to address these relevant issues.

Risk communication for labeling all ingredients in consumer products.

The labeling of all ingredients contained in consumer products has been requested by consumers concerned regarding their safety. Consequently, regulatory agencies have set guidelines for industries on how to provide safety information regarding the ingredients in their products. However, discordant opinions were raised from stakeholders, resulting in the formation of a risk communication forum among industries, regulatory agencies, consumer groups, and academia. There are several methods that might be utilized to provide ingredient information to consumers: (1) listing all ingredients on the label of products, (2) providing major ingredients on the label of products, (3) presenting all ingredients on the websites of each manufacturer, and (4) listing major ingredients on the label of products and the remainder of ingredients (not on the label) on the websites. Each method might have its own advantages and disadvantages with respect to providing the information regarding the names of the ingredients used in consumer products to the consumers. A continuous risk communication forum might be an effective tool to facilitate an improved understanding of chemical information, toxicological science, regulatory guidelines, labeling methods, and consumers' concern. This study suggests that risk communication efforts may be helpful and a good opportunity for stakeholders to exchange opinions and reach a harmonious conclusion on labeling of consumer products ingredients.

Hygienic and cosmetic care habits in polish women during COVID-19 pandemic.

BACKGROUND: COVID-19 pandemic influences a lot of aspects of human life. Particularly, hygienic habits are affected. OBJECTIVES: Changes in washing and cosmetic standards during the pandemic toward the past are in the focus of our interest. MATERIAL AND METHODS: The questionnaire study was conducted anonymously in 140 women. The examination concerned pre- and during-pandemic routine hygiene activities such as hands washing, hair washing, bathing, the use of disinfectants, and use of specific type of cosmetics. RESULTS AND DISCUSSION: Compared were data before and during pandemic. Responders declared increased handwashing and taking shower after coming back home and after using local city transportation. We found also that increased use of disinfectants during COVID-19 pandemic. In contrary to that, number of people washing their hair decreased slightly. Work documents that profile of used cosmetics was changed; increasing hand cream use and decreasing in makeup cosmetics. Nearly, half of the respondents declare that they will maintain new habits also after the pandemic has ended.

Deep eutectic solvent-based magnetic colloidal gel assisted magnetic solid-phase extraction: A simple and rapid method for the determination of sex hormones in cosmetic skin care toners.

A simple rapid and efficient deep eutectic solvent-based magnetic colloidal gel (DES-MCG) assisted magnetic solid-phase extraction (MSPE) method followed by high performance liquid chromatography with a diode array detector (HPLC-DAD) was established for determination of four sex hormones (including ethinylestradiol, norgestrel, megestrol acetate and medroxyprogesterone acetate) in cosmetic skin care toners. The DES-MCG with the desirable advantages of high adsorbing ability was prepared by combining choline chloride/urea deep eutectic solvent and magnetic multiwalled carbon nanotubes (MMWCNTs). The synthesized DES-MCG was characterized using fourier transform infrared spectrometry (FTIR), scanning electron microscopy (SEM), transmission electron microscopy (TEM) and vibrating sample magnetometry (VSM). The cosmetic skin care toners were concentrated by a rotary evaporator and the obtained solutions were further purified by DES-MCG assisted magnetic solid-phase extraction. Response surface methodology (RSM) was applied for efficient optimization of the main variables in the extraction procedure. Under the optimized conditions, method detection limits and method quantitation limits were in the range of 1.2-6.6 ng mL-1 and 4.4-26.6 ng mL-1, respectively. The recoveries of the four sex hormones in different cosmetic skin care toners ranged from 80.1% to 118.8% and the precisions were no more than 0.35%. The developed method was successfully applied for the determination of sex hormones in cosmetic skin care toners.

Advanced quantitative proteomics to evaluate molecular effects of low-molecular-weight hyaluronic acid in human dermal fibroblasts.

Hyaluronic acid (HA) is physiologically synthesized by several human cells types but it is also a widespread ingredient of commercial products, from pharmaceuticals to cosmetics. Despite its extended use, the precise intra- and extra-cellular effects of HA at low-molecular-weight (LWM-HA) are currently unclear. At this regard, the aim of this study is to in-depth identify and quantify proteome's changes in normal human dermal fibroblasts after 24 h treatment with 0.125, 0.25 and 0.50 % LMW-HA (20-50 kDa) respectively, vs controls. To do this, a label-free quantitative proteomic approach based on high-resolution mass spectrometry was used. Overall, 2328 proteins were identified of which 39 significantly altered by 0.125 %, 149 by 0.25 % and 496 by 0.50 % LMW-HA. Protein networking studies indicated that the biological effects involve the enhancement of intracellular activity at all concentrations, as well as the extracellular matrix reorganization, proteoglycans and collagen biosynthesis. Moreover, the cell's wellness was confirmed, although mild inflammatory and immune responses were induced at the highest concentration. The more complete comprehension of intra- and extra-cellular effects of LMW-HA here provided by an advanced analytical approach and protein networking will be useful to further exploit its features and improve current formulations.

Accuracy of Product Ingredient Labeling: Comparing Drugstore Products With Online Databases and Online Retailers.

BACKGROUND: Patients with allergic contact dermatitis rely on ingredient lists published in databases and by online retailers to find safe skincare products. OBJECTIVE: The aim of this study was to determine the accuracy of product ingredient labeling by comparing drugstore product labels to ingredient lists published online. METHODS: Amazon was queried for best-selling items in several categories of skincare, generating a list of 93 products. These products were then found at a local Target and Walgreens and online on Contact Allergen Management Program, SkinSAFE, and Consumer Product Information Database. Drugstore product labels were compared with online ingredient lists and analyzed for discrepancies. RESULTS: There were 31 occurrences in which an allergen listed in the 2017 American Contact Dermatitis Society Core Allergen Series was omitted (present on the in-store label but missing from an online list.) Seven omissions occurred on Contact Allergen Management Program, 11 occurred on SkinSAFE, 5 occurred on Consumer Product Information Database, and 8 occurred on Amazon. CONCLUSIONS: Definitive treatment of allergic contact dermatitis is avoidance of allergens found on patch testing. These data suggest that patients may be at risk of inadvertent exposure to allergens from products, which are supposedly deemed safe according to online ingredient lists.