Lentis/Antimicrobial Agents in Consumer Products

Introduction What are Antimicrobial Agents? Antimicrobial agents (AMAs) are chemicals designed to kill or inhibit the growth of microbes like bacteria, viruses, fungi, and parasites. Many natural substances like tea tree oilAugust 10, 2023 Tea Tree Oil https://www.mayoclinic.org/drugs-supplements-tea-tree-oil/art-20364246 live Mayo Clinic, eucalyptus oilElangovan Shakthi February 27, 2023 Antibacterial Properties of Eucalyptus globulus Essential Oil against MRSA: A Systematic Review https://pmc.ncbi.nlm.nih.gov/articles/PMC10044518/ Antibiotics 12 3 PubMed Central, and honeyMandal Manisha April 2011 Honey: Its Medicinal Property and Antibacterial Activity https://pmc.ncbi.nlm.nih.gov/articles/PMC3609166/#:~:text=The%20antimicrobial%20activity%20in%20most,hydrogen%20peroxide%20activity%20is%20blocked Asian Pacific Journal of Tropical Biomedicine 1 2 156-160 PubMed Central have antimicrobial properties, but most AMAs are synthetic chemicals. These include Synthetic organic compounds like triclosan, quaternary ammonium compounds, and N-halamines, and inorganic compounds like metallic nanoparticlesBibi Aqsa 26 September 2024 Synthetic vs. Natural Antimicrobial Agents for Safer Textiles: A Comparative Review https://pubs.rsc.org/en/content/articlehtml/2024/ra/d4ra04519j Royal Society of Chemistry 14 30688-30706. Consumer Products Use Cases AMAs are commonly found in household cleaners, hygiene products (e.g., soap, deodorants, and lotions), textiles, and many other consumer products. Their inclusion is often marketed as an effective means to reduce harmful bacteria, viruses, and germs, thereby improving cleanliness and health. Despite the attractive marketing, most independent research shows that “no data supports the efficacy or necessity of antimicrobial agents in consumer products, and a growing number of studies suggest increasing acquired bacterial resistance to them. (Tan, 2002).”Tan Litjen August 2002 Use of Antimicrobial Agents in Consumer Products https://jamanetwork.com/journals/jamadermatology/article-abstract/478930 Arch Dertmatol. 138 8 1082-1086 JAMA The FDA adds, “Using these products might give people a false sense of security."August 14, 2024 Skip the Antibacterial Soap; Use Plain Soap and Water https://www.fda.gov/consumers/consumer-updates/skip-antibacterial-soap-use-plain-soap-and-water December 10, 2024 FDA Potential Risks of Antimicrobial Agents Not only do antimicrobial-containing consumer products fail to deliver on their promises, they also contribute to ever growing public health issues. In the United States, 2.8 million antibiotic-resistant infections occur each year, resulting in over 35,000 deaths.2019 Antibiotic Resistance Threats in the United States 2019 https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf?CDC_AAref_Val=https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf live December 10, 2024 CDC This problem is expected to worsen over time.Habboush Hacob June 20, 2023 Antibiotic Resistance https://www.ncbi.nlm.nih.gov/books/NBK513277/ StatPearls Publishing Moreover, the broad spectrum nature of antimicrobials used in consumer products means they target both harmful and beneficial microbes. Antibacterial hand soap, for example, wipes out good bacteria on skin causing potential negative impacts to the immune system. Key Participants Regulatory Agencies The United States Food and Drug Administration (FDA) regulates AMAs in drugs, devices, and antiseptics intended for use on or in the body.September 28, 2023 Antimicrobial Resistance and Medical Devices https://www.fda.gov/medical-devices/products-and-medical-procedures/antimicrobial-resistance-and-medical-devices live FDA The United States Environmental Protection Agency (EPA) regulates AMAs for use on inanimate objects like textiles, toys, kitchen surfaces.August 29, 2024 Antimicrobial Pesticides https://www.epa.gov/pesticides/antimicrobial-pesticides#:~:text=EPA%20regulates%20pesticides%20under%20the,from%20those%20of%20other%20pesticides live EPA Together, these agencies evaluate the safety of various AMAs, deciding which AMAs can be used in products, and determining the requirements from their use. The FDA and EPA balance consumer interests and safety with producer interests in creating the AMA regulatory landscape. Public Health Organizations and Research Institutions Alongside academic researchers, institutions like the United States Center for Disease Control (CDC) and the World Health Organization (WHO) provide valuable insight into the effects and long term implications of AMA use.Levy Stuart June 2001 Antibacterial Household Products: Cause for Concert https://wwwnc.cdc.gov/eid/article/7/7/01-7705_article International Conference on Emerging Infectious Diseases 2000 7 7 CDCNovember 21, 2023 Antimicrobial Resistance https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance?gad_source=1&gclid=CjwKCAiA6t-6BhA3EiwAltRFGKPDUVB4pVKrlqIm59RHSViQRPi5eMUPFjpQFoIYMLytIpfLF9rwuBoCSVkQAvD_BwE live WHO They publicize the potential impacts of antimicrobial resistance and other health concerns, influencing regulatory decisions, public opinion, and public health recommendations. Product Producers Product producers often simplify the science and societal impact of AMAs, focusing more on emotional aspects of hygiene and health to boost sales. For instance, Dial promotes antibacterial soap that “eliminates 99.9% of bacteria” and delivers a “crisp uplifting clean that leaves you feeling fresh.”Bar Soap https://www.dialsoap.com/products/bar-soap.html live Dial Other producers also use misleading hooks and overlook the health risks of widespread AMA use. Product Consumers Product consumers represent the end users of products made with AMAs. Their decisions reflect a combination of health and safety values influenced by marketing, public health recommendations, and personal health assessments. Consumers represent a wide range of decision makers with varied understandings of AMA risks and their future implications. FDA Bans the Use of Triclosan History In the 1930s and 40s, it was discovered that certain classes of chlorinated aromatic hydrocarbons had potential as powerful biocidal agentsHalden Rolf U. 2014-04-01 On the Need and Speed of Regulating Triclosan and Triclocarban in the United States https://pubs.acs.org/doi/10.1021/es500495p Environmental Science & Technology 48 7 3603–3611 10.1021/es500495p 0013-936X PMC3974611 24588513. First patented in the mid 1960s by the company CibaFDA 2016 Decision and History https://www.beyondpesticides.org/resources/antibacterials/triclosan/fda-2016-decision-and-history#:~:text=The%20first%20patent%20for%20triclosan,to%20the%20chemical%20company%20Ciba.&text=By%201972%20triclosan,%20although%20initially,way%20into%20the%20consumer%20market. 2024-12-10 Beyond Pesticides en, triclosan became one of the most widespread and common antimicrobial agents in common use. Despite being originally intended as a disinfectant for hospital use, in 1972 the biocide was introduced to consumers and triclosan quickly became common in deodorants, plastics, toys, textiles, and liquid hand soaps. Its ubiquity in these products have led it to now be found in all recesses of our environment, including within the soil, rivers, lakes, and sedimentsMcNamara Patrick J. Levy Stuart B. 2016-12 Triclosan: an Instructive Tale https://journals.asm.org/doi/10.1128/AAC.02105-16 Antimicrobial Agents and Chemotherapy en 60 12 7015–7016 10.1128/AAC.02105-16 0066-4804 PMC5118979 27736758. In 2005, "Approximately 500 000−1 000 000 lb (227 000−454 000 kg) of TCC [were] used in the United States every year"Halden Rolf U. Paull Daniel H. 2005-03-01 Co-Occurrence of Triclocarban and Triclosan in U.S. Water Resources https://pubs.acs.org/doi/10.1021/es049071e Environmental Science & Technology 39 6 1420–1426 10.1021/es049071e 0013-936X. By 2014, the US triclosan market was worth $1.4 billion. Hazards While triclosan has hardly shown any potential benefits to human health, many hazards have been associated with it. It has teratogenic properties, harming the development of newborns and leading to deformities or stillbirth. It has also shown to cause decreases in fecundity due to its function as an endocrine disruptorWeatherly Lisa M. Gosse Julie A. 2017-11-17 Triclosan exposure, transformation, and human health effects https://www.tandfonline.com/doi/full/10.1080/10937404.2017.1399306 Journal of Toxicology and Environmental Health, Part B en 20 8 447–469 10.1080/10937404.2017.1399306 1093-7404. Studies show that triclosan is a carcinogen both in vitro and in living organisms, promoting the growth of liver tumors. It has been demonstrated to upset cardiovascular functions, leading to greater risks of asthma and allergy development. Triclosan also harms plant and animal life. "TCS and TCC are 100–1000 times more effective in inhibiting and killing algae, crustaceans and fish than they are in killing microbes". Bioaccumulation of TCS has also been observed in a few organisms. However, triclosan's most interesting and potentially terrifying hazard is how its use causes the development of antibiotic-resistant bacteria. Because of the chemical's "specific targeting" behavior in bacteria, bacteria that are able to develop resistance to triclosan also develop resistance to a number of medically relevant antibiotics. This phenomenon may increase the prevalence of certain "superbugs" that threaten a widespread pandemic. Opposition The FDA first acknowledged the lack of safety and beneficial effects of triclosan in a 1974 Tentative Final MonographHalden Rolf U. Lindeman Avery E. Aiello Allison E. Andrews David Arnold William A. Fair Patricia Fuoco Rebecca E. Geer Laura A. Johnson Paula I. Lohmann Rainer McNeill Kristopher Sacks Victoria P. Schettler Ted Weber Roland Zoeller R. Thomas 2017-06-23 The Florence Statement on Triclosan and Triclocarban https://ehp.niehs.nih.gov/doi/10.1289/EHP1788 Environmental Health Perspectives 125 6 064501 10.1289/EHP1788 PMC5644973 28632490. Despite this early acknowledgement, the document was not published and no major actions against the chemical were yet taken. Since that time, a few cases were levied against the use of triclosan. In 1997 the EPA banned Hasbro Inc. from claiming the triclosan in its plastic toys had any beneficial effects. Nonprofit groups arose in response as well, with Beyond Pesticides submitting a petition in 2005 to ban all non-medical uses of triclosan. In 2010 the Natural Resources Defense Council filed a complaint against the FDA, finally spurring them on to take action, finalizing the monograph in 2013. Finally, in 2016, the FDA officially bans the use of triclosan and other antibacterial products in over-the-counter hand soapsCommissioner Office of the 2020-03-24 FDA issues final rule on safety and effectiveness of antibacterial soaps https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-antibacterial-soaps 2024-12-10 FDA en. However, many people believe this action was too narrow in scope, as it does not effectively remove the chemical from other products such as textiles, toothpaste, or plastics. In 2017 a conference of over 200 scientists and medical professionals gathered to draft the Florence Statement, a compilation of scientific research that exposed the harmful effects of triclosan and calls for its complete prohibition. Paraben Preservatives In Personal Care Products Parabens are synthetic preservatives used in cosmetics, personal care products, food, and medications.  They are extremely popular preservatives because they are particularly chemically stable, cheap to produce, relatively hypoallergenic, and are odorless and tastelessWei Fang Mortimer Monika Cheng Hefa Sang Nan Guo Liang-Hong 2021-07-15 Parabens as chemicals of emerging concern in the environment and humans: A review https://www.sciencedirect.com/science/article/abs/pii/S0048969721012171 Science of The Total Environment 778 146150 10.1016/j.scitotenv.2021.146150 0048-9697.  They have been used for this purpose since the 1920sCaioni Giulia Benedetti Elisabetta Perugini Monia Amorena Michele Merola Carmine 2023-04 Personal Care Products as a Contributing Factor to Antimicrobial Resistance: Current State and Novel Approach to Investigation https://www.mdpi.com/2079-6382/12/4/724 Antibiotics en 12 4 724 10.3390/antibiotics12040724 2079-6382 PMC10135053 37107085.  In consumer products, they are effective at preventing the growth of yeast, mold, and bacteria (gram-positive bacteria in particular), and are present in 80% of such productsBłędzka Dorota Gromadzińska Jolanta Wąsowicz Wojciech 2014-06-01 Parabens. From environmental studies to human health https://www.sciencedirect.com/science/article/abs/pii/S0160412014000579 Environment International 67 27–42 10.1016/j.envint.2014.02.007 0160-4120.  They are also used to prevent mold growth on many paper products such as newspapers, sanitary wipes, and food cartons.  They occur naturally in some foods, such as strawberries, blueberries, grapes, olives, yeast, and barleySasseville Denis Alfalah Maisa Lacroix Jean-Philip 2015-12 “Parabenoia” Debunked, or “Who’s Afraid of Parabens?” https://www.liebertpub.com/doi/abs/10.1097/DER.0000000000000147 Dermatitis 26 6 254–259 10.1097/DER.0000000000000147, and are produced by some microorganismsNowak Karolina Ratajczak–Wrona Wioletta Górska Maria Jabłońska Ewa 2018-10-15 Parabens and their effects on the endocrine system https://linkinghub.elsevier.com/retrieve/pii/S0303720718301060 Molecular and Cellular Endocrinology 474 238–251 10.1016/j.mce.2018.03.014 0303-7207. Health Concerns Parabens can be absorbed through the skin, and have been shown to accumulate in the human body to some degree.  When ingested orally (such as in foods) they are broken down and excreted through urine, but when applied topically, the breakdown occurs much more slowly, leading to accumulation in tissue.  Increased usage of personal care products is associated with higher concentrations of parabens in skin, blood, milk, and urineMatwiejczuk Natalia Galicka Anna Brzóska Małgorzata M. 2020 Review of the safety of application of cosmetic products containing parabens https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/jat.3917 Journal of Applied Toxicology en 40 1 176–210 10.1002/jat.3917 1099-1263. Many studies indicate that parabens possess estrogenic activity, which increases with increasing chain lengthOishi Shinshi 2001-02-01 Effects of butylparaben on the male reproductive system in rats https://journals.sagepub.com/doi/10.1191/0748233701th093oa Toxicology and Industrial Health en 17 1 31–39 10.1191/0748233701th093oa 0748-2337.  There is some evidence that tissue concentration of parabens is associated with estrogen-sensitive diseases, as it has been detected in high concentrations in breast tumors.  However, despite parabens’ demonstrated estrogenic effects, there is no conclusive evidence that they result in harmful outcomes in humansLiszewski Walter Zaidi Abu Jaafar Fournier Elise Scheman Andrew 2022-11 Review of aluminum, paraben, and sulfate product disclaimers on personal care products https://linkinghub.elsevier.com/retrieve/pii/S0190962221019447 Journal of the American Academy of Dermatology 87 5 1081–1086 10.1016/j.jaad.2021.06.840 0190-9622.  Many of the studies into possible toxicity are in vitro or in animal models, use concentration exposures that may not be representative of typical exposure, and therefore have limited efficacy in determining the overall effect on the human body. There is also concern that when ingested, parabens could disrupt the natural gut microbiome, and encourage the development of resistant strains of bacteria in the digestive tract. Environmental Effects Parabens enter the environment in wastewater and indoor dust.  In indoor environments, the concentration of parabens in dust was correlated with an increase in abundance of genes related to antibiotic resistance in the bacteria making up the dust microbiome.  The presence of parabens in wastewater, surface waters, and sediments is thought to encourage the development of antibiotic resistance as well. In addition to concerns over resistant bacteria, disruption of aquatic microbiomes may have ecological consequences, with parabens and their metabolites detected in aquatic plant and animal tissuesVale Francisca Sousa Cátia A. Sousa Henrique Santos Lúcia Simões Manuel 2022-05-01 Parabens as emerging contaminants: Environmental persistence, current practices and treatment processes https://www.sciencedirect.com/science/article/pii/S0959652622008757 Journal of Cleaner Production 347 131244 10.1016/j.jclepro.2022.131244 0959-6526. Regulations and Recommendations In the EU, usage of parabens in cosmetic products is regulated by the EU Cosmetic Directive, which sets maximum concentration limits for longer-chain parabens and shorter-chain parabens at 0.4% and 0.8% respectively.  The FDA sets equivalent limits.  In the EU, some longer-chain parabens are banned in use of cosmetics altogether. In food products, parabens are generally regarded as safe at concentrations below 0.1% by the FDA. In the US, cosmetics and personal care products are largely unregulated.  Cosmetic products do not require any FDA approval before entering the market.  Testing the safety of such products is wholly the responsibility of the manufacturerMarch 3, 2005; updated August 3, 2013 FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.  The current FDA stance on parabens is that “At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human healthParabens in Cosmetics https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics.” Response to Health Concerns If the public shows concern over a particular ingredient, manufactures often begin marketing products as specifically not containing that ingredient (ex. “paraben-free” or “sulfate-free”) even if that ingredient hasn’t been shown to be unsafe.  This can lead to increased public distrust of these ingredients.  Appealing to customer distrust of synthetic ingredients is a lucrative strategy for manufacturers, with $1.6 billion of cosmetics marketed as natural sold in the US in 2019van der Schyff Veronica Suchánková Lenka Kademoglou Katerina Melymuk Lisa Klánová Jana 2022-06-01 Parabens and antimicrobial compounds in conventional and “green” personal care products https://www.sciencedirect.com/science/article/pii/S0045653522005124 Chemosphere 297 134019 10.1016/j.chemosphere.2022.134019 0045-6535.  However, due to lack of regulation of how cosmetic products are marketed in the US, Cosmetics that don’t label parabens as an ingredient, or are specifically labeled “paraben free” may still contain themMakkliang Fonthip Kanatharana Proespichaya Thavarungkul Panote Thammakhet-Buranachai Chongdee 2018-07-01 A miniaturized monolith-MWCNTs-COOH multi-stir-rod microextractor device for trace parabens determination in cosmetic and personal care products https://www.sciencedirect.com/science/article/abs/pii/S0039914018302649?via=ihub Talanta 184 429–436 10.1016/j.talanta.2018.03.024 0039-9140.  Additionally, products marketed as “green” or “natural” also frequently contain parabens. In response to concern over health effects of parabens, many personal care product manufacturers switched to alternative preservatives such as methylisothiazolinone and methylchloroisothiazolinone.  These compounds are more likely to cause allergic reactions, and their adoption has been associated with an increase in incidents of allergic contact dermatitis. Plant extracts and essential oils are also used to replace parabens as preservatives in products marketed as “natural.”  However, the essential oils used are effective against fewer microorganisms, and are much more likely to cause allergic reactions.  Many are only effective when used in combination with synthetic preservatives.