Invisible Orthodontics Market: Who Are At the Greatest Risk of BPA from Aligners and Mouthguards?

News – by Million Marker Research Institute

Why Product Testing Is Important & Reading Ingredients Isn't Enough

There are two sides to the story for product safety. Ingredients on labels only tell half the story. Product testing is the only way to tell the true, full story. 

News – by Lliam Green

Contaminants in Invisible Orthodontics: Hidden Dangers to Oral Health

Invisible orthodontics products, such as clear aligners, retainers, and mouthguards, are in direct contact with our mouths for extended periods. These devices can contain intended ingredients that may pose risks, but our pilot studies have uncovered that many oral care products are contaminated with harmful substances not listed on the label. The global clear aligners market was valued at $3.8 billion in 2023 and is expected to grow at a CAGR of 24% from 2022 to 2031 [1]. This rapidly increasing demand for invisible orthodontics highlights the urgent need for rigorous safety testing on the millions of products used daily, ensuring consumer protection and regulatory compliance in this industry. Why This Matters The oral cavity is highly sensitive to chemicals, and long-term contact with harmful substances can significantly impact our oral health and overall well-being. This is why it's so important to be cautious about the materials used in dental products like aligners, retainers, and mouthguards that we keep in our mouths for long periods. Our mouths are particularly good at absorbing substances, which means chemicals from these devices can easily enter our bodies. This risk is even higher because many people wear orthodontic products for several hours each day or throughout the night. It's also important to note that these products can release more chemicals through various activities: Chewing or gnawing on the devices Wearing them during sports activities Grinding teeth at night Exposure to acids and bacteria naturally present in our mouths All of these factors can cause the materials to break down over time, potentially releasing more chemicals into our mouths. This is why it's crucial to ensure that the orthodontic products we use are made from safe materials and free from harmful contaminants. By understanding these risks, we can make more informed choices about the dental products we use and push for greater transparency and safety standards in the orthodontics industry. We Found Harmful Chemicals In Aligners We have conducted non-targeted testing on two popular brands of invisible aligners and discovered levels of certain chemicals that are concerning. Both brands were found to contain high levels of 4,4'-Diphenylmethane diisocyanate (MDI), a chemical commonly used in the production of polyurethanes. Polyurethanes are materials often used in the manufacturing of retainers and aligners for their flexibility and durability. However, exposure to MDI can cause respiratory issues and skin irritation, and long-term exposure may lead to more severe health effects, including asthma [1][2]. Additionally, one of the retainers tested showed high levels of Diethyl phthalate (DEP), a plasticizer used to increase flexibility in plastics. DEP can be absorbed through the skin or ingested. Exposure to DEP has been associated with endocrine disruption, potentially affecting hormonal balance and reproductive health [3][4][5]. The other retainer contained high levels of Butylated hydroxytoluene (BHT), an antioxidant used to prevent the degradation of materials. While BHT is generally considered safe in small amounts, it has been linked to potential liver and kidney damage with prolonged exposure [6]. Since invisible orthodontics are in the mouth for extended periods, these risks are exponentially higher.  A Need for Transparency in the Invisible Orthodontics Industry While invisible orthodontics are essential for correcting dental misalignments and protecting teeth, some popular products may contain potentially harmful ingredients or contaminants. For instance, some clear aligners and retainers are made from various types of plastic, which can leach chemicals like bisphenol A (BPA) or phthalates.  These endocrine disruptors have been linked to numerous health issues [7][8]. Additionally, products may contain residual monomers or other chemicals used in the manufacturing process. Besides known ingredients, products can also become contaminated throughout various stages of production. This makes product testing crucial for ensuring the safety of invisible orthodontics. How Do Harmful Chemicals Contaminate Invisible Orthodontics? Many invisible orthodontics contain plastic materials. However, many brands are making concerted efforts to make safer products. Unfortunately, even safe products can become unknowingly contaminated with harmful chemicals from various sources.  Contamination can occur at various stages of producing invisible orthodontics: Raw material sourcing: Materials used in manufacturing may be contaminated before reaching the manufacturer. Manufacturing process: Equipment or packaging materials can introduce toxicants. Chemical reactions: Components in the product may react with one another or degrade over time, producing other chemicals. Storage and transportation: Improper conditions can lead to chemical changes or contamination. Many brands may be unaware of these issues, as thorough testing is not always required or performed consistently. The only way to truly ensure product safety is through comprehensive, independent testing. Non-Targeted Testing for Invisible Orthodontics Safety The potential presence of harmful chemicals and contaminants in invisible orthodontics underscores the critical need for comprehensive product testing. With the oral cavity being particularly vulnerable to toxic substances, ensuring the safety of these products is paramount. Transparency in product formulations and rigorous safety assessments are essential for consumers to make informed choices about the orthodontic devices they use. To address this gap, our research institute plans to expand its database of product testing initiatives to focus on invisible orthodontics. We aim to test a wide range of products, including clear aligners, retainers, and mouthguards, using non-targeted testing methods.   By employing advanced techniques like high-resolution mass spectrometry, we can detect a wide range of known and unknown chemical compounds, enabling the identification of unexpected contaminants that may have been introduced during manufacturing, storage, or transportation. Why Your Support Matters By investing in our product testing initiatives, you're helping to create a safer future for all orthodontic patients.  Your donation will: Fund state-of-the-art laboratory testing Aid our research into safer material alternatives Enable us to share our findings with consumers, manufacturers, and regulators Support our consumer-facing database of scored products Help us advocate for stricter safety standards in orthodontic products Together, we can ensure that the products meant to improve our oral health and appearance are truly safe and effective.   Resources [1] https://www.alliedmarketresearch.com/clear-aligners-market-A12343  [2] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1600-0536.2011.01995.x [3] https://www.sciencedirect.com/science/article/pii/S0160412018303404 [4] https://www.sciencedirect.com/science/article/pii/S0160412018316453 [5] https://onlinelibrary.wiley.com/doi/full/10.2164/jandrol.108.006403[6] https://link.springer.com/chapter/10.1007/978-3-0348-7432-8_47 [7] https://www.sciencedirect.com/science/article/abs/pii/S0890623813003456 [8] https://www.sciencedirect.com/science/article/pii/S0160412021005286 

News – by Lliam Green

Non-Targeted vs. Targeted Product Testing: Why MMRI Uses Non-Targeted Testing

In today's complex consumer landscape, product testing plays a pivotal role in ensuring transparency and safety throughout the entire path to purchase. As consumers increasingly demand cleaner products, comprehensive testing methods become crucial in maintaining product integrity and building trust. While many organizations rely on targeted testing approaches, which offer some advantages in identifying known compounds, these methods fall short in detecting unexpected contaminants or novel substances. The Million Marker Research Institute (MMRI) sets itself apart by employing non-targeted testing, a more comprehensive approach that casts a wider analytical net. Let's delve into the nuances of both methodologies to understand why MMRI's approach is at the forefront of product safety and quality assurance. A Case for Product Testing The need for comprehensive product testing has never been more critical, as recent studies reveal alarming levels of potentially harmful chemicals in everyday consumer goods. MMRI has conducted pilot studies that align with broader scientific findings, uncovering the presence of unlabeled contaminants in many products, including those that are marketed as “clean,” “green,” “non-toxic,” and “eco-friendly.”  These findings don’t necessarily mean that companies are purposefully adding them to their products. In many instances, product manufacturers and brands are unaware these chemicals are in ingredients and products.  These contaminants, including phthalates, bisphenols, and other concerning chemicals, can enter products through various pathways: Processing methods Growing conditions for botanicals Cross-contamination from machinery Packaging materials The health risks associated with these chemicals are significant and well-documented. For instance, phthalates and bisphenols are known endocrine disruptors that can interfere with the body's hormonal systems. Exposure to these chemicals, particularly during critical developmental stages, has been linked to neurodevelopmental issues, reproductive problems, and metabolic disorders [1][2][3][4][5]. Furthermore, the impact of these chemicals may disproportionately affect certain populations. Research has shown that the use of personal care products is associated with higher levels of phthalates in children's urine, with the highest levels found in non-Hispanic Black participants[6][7][8]. This highlights the need for comprehensive testing across diverse product lines to ensure safety for all consumers. Targeted Testing: The Traditional Approach Targeted testing is a conventional analytical approach that focuses on identifying and quantifying specific, predetermined compounds within a product. This method employs analytical techniques such as gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) to detect known substances of interest. In targeted testing, scientists develop a list of compounds to look for based on regulatory requirements, known contaminants, or specific concerns. The analytical instruments are then calibrated to detect these particular substances, often using reference standards for accurate quantification. Advantages of Targeted Testing Targeted testing offers several benefits that have made it a staple in product quality control: High sensitivity for specific compounds: Targeted methods can achieve very low detection limits for known substances, often in the parts per billion (ppb) range. Efficiency in routine analysis: Once established, targeted methods can process large numbers of samples quickly, making them ideal for high-throughput screening. Clear regulatory compliance: Targeted testing directly addresses specific regulatory requirements, making it straightforward to demonstrate compliance with established standards. Cost-effectiveness for known risks: When the potential contaminants are well-understood, targeted testing can be a cost-effective way to ensure product safety. Limitations and Drawbacks of Targeted Testing Despite its widespread use, targeted testing has several significant limitations that MMRI is hoping to address: Limited scope of detection: Targeted methods can only identify compounds that are specifically included in the analysis. This creates a potential blind spot for unexpected or emerging contaminants. Inability to detect unknown substances: Novel compounds or unexpected contaminants will be missed entirely by targeted testing, potentially leaving significant risks undetected. False negatives: If a harmful compound is not on the target list, it will not be detected, leading to a false sense of security about product safety. Lack of comprehensive chemical profiling: Targeted testing provides a narrow view of a product's chemical composition, missing the broader picture that could be important for understanding overall safety and quality. Inflexibility: As new contaminants emerge or regulations change, targeted methods require significant time and resources to update and validate new protocols. Missed opportunities for discovery: By focusing only on known compounds, targeted testing misses the opportunity to identify potentially beneficial or harmful novel substances that could be present in products. These limitations underscore the need for more comprehensive testing approaches, particularly in an era where product formulations are becoming increasingly complex and global supply chains introduce new potential sources of contamination. While targeted testing remains valuable for specific applications, its shortcomings highlight the importance of complementary methods like non-targeted testing to ensure comprehensive product safety and quality. Non-Targeted Testing: The Comprehensive Approach Non-targeted testing (NTT), also known as non-targeted analysis (NTA), is an analytical approach that aims to identify and characterize all chemical components present in a sample without prior knowledge of its composition. Unlike targeted analysis, which focuses on detecting specific known chemicals, NTT seeks to provide a more complete picture of a sample's makeup. At MMRI, our NTT methodology process begins with meticulous sample preparation, ensuring that the samples are properly extracted and purified for analysis. We then utilize state-of-the-art high-resolution mass spectrometry coupled with advanced chromatography techniques, which allows for precise separation and detection of a wide range of compounds.  During analysis, we acquire data on all detectable compounds, capturing a broad spectrum of chemical information. This extensive dataset then undergoes advanced processing and statistical analysis, employing sophisticated algorithms and machine learning techniques to identify patterns and significant features.  Finally, we engage in thorough compound identification and characterization, utilizing extensive spectral libraries and in silico fragmentation tools to tentatively identify detected compounds, followed by targeted analysis methods for confirmation of critical findings. Advantages of Non-Targeted Testing Broader Scope of Detection: The primary benefit of NTT is its ability to provide a comprehensive view of a sample's composition. This approach allows for the detection of a wide range of compounds, both known and unknown, giving researchers a more holistic understanding of the sample. Ability to Identify Unknown Contaminants: NTT excels at discovering unexpected or previously unidentified compounds in samples. This capability is particularly valuable in fields such as food safety, environmental monitoring, and quality control, where the presence of unknown contaminants can have significant implications. Potential for Discovering New Compounds: By casting a wider net in terms of chemical detection, NTT opens up possibilities for identifying novel compounds or biomarkers. This aspect of NTT can be especially useful in research areas like metabolomics, where the discovery of new molecules can lead to important scientific breakthroughs. How MMRI Plans to Leverage Non-Targeted Testing for Safer Products Using NNT allows MMRI to help educate consumers about products so that they can make informed decisions about their purchases. We communicate these findings through a customer-facing portal that displays product safety scores determined by our product testing initiatives.  Our proprietary scoring system is designed to analyze the vast array of compounds detected through non-targeted testing, assigning weighted values based on factors such as toxicity, prevalence, and potential health impacts. This sophisticated algorithm will consider not only the presence of known harmful substances but also the potential synergistic effects of multiple compounds, providing a more nuanced understanding of overall product safety. By leveraging this comprehensive analysis, MMRI aims to identify truly "Pure" products. These are identified as products with minimal or no harmful ingredients and contaminants. We will then trace these products back to their suppliers, creating a database of responsible manufacturers and sourcing practices. This valuable information will serve as a bridge between contaminated brands and clean suppliers, facilitating connections that can lead to safer product formulations. Our ultimate goal is to foster seamless transparency throughout the entire product lifecycle. By providing brands with clear pathways to improve their products, we hope to incentivize the use of safer ingredients and manufacturing processes across industries. This approach not only benefits consumers by increasing access to safer products but also helps brands build trust and loyalty with their customer base. Furthermore, MMRI's system will allow for continuous monitoring and improvement. As new potential hazards are identified through our non-targeted testing, our scoring system will be updated to reflect the latest scientific understanding. This dynamic approach ensures that our safety assessments remain at the forefront of product safety science.   Resources [1] https://link.springer.com/article/10.1007/s12020-016-1158-4  [2] https://www.sciencedirect.com/science/article/abs/pii/S0890623822000260  [3] https://www.sciencedirect.com/science/article/abs/pii/S089062381730182X  [4] https://ehp.niehs.nih.gov/doi/full/10.1289/ehp.1307728  [5] https://www.mdpi.com/1660-4601/18/7/3585  [6] https://pubmed.ncbi.nlm.nih.gov/20056562/ [7] https://pmc.ncbi.nlm.nih.gov/articles/PMC1241863/  [8] https://pubmed.ncbi.nlm.nih.gov/34046860/ 

News – by Lliam Green

Contaminants In Diaper Rash Cream: Hidden Dangers to Infant Health

Diaper creams are applied to the most sensitive areas of babies during the most vulnerable time of their lives. These products can contain intended ingredients, such as fragrances that contain phthalates, a class of chemicals linked to brain development and behavioral issues in children [1]. However, our pilot studies have uncovered that many personal care products are contaminated with harmful carcinogens and hormone disruptors that are not on the label. The diaper rash cream market was valued at $1.75 billion in 2023 and is projected to grow 5.4% annually through 2032 [2]. This ever-increasing demand for diaper rash creams highlights the urgent need for rigorous safety testing on the millions of products sold each year, ensuring consumer protection and regulatory compliance in this industry. Why This Matters Babies are particularly vulnerable to the harmful effects of chemicals. Repeated exposure to dangerous chemicals can have lasting effects on their mental, physical, and reproductive development [3]. It is especially important to limit exposure to harmful chemicals in products that sit on their skin for long periods of time, such as diaper rash creams. Baby skin is significantly thinner and more permeable than adult skin, especially in the diaper area, and are thus  at a greater risk of absorbing chemicals applied topically [4].  Directions on the label for Desitin Maximum Strength state: “Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.  This extended exposure, combined with the large surface area relative to body weight in infants, increases the risk of systemic absorption of toxic chemicals [5].  A Need for Transparency In the Diaper Cream Industry While diaper rash creams are often essential for protecting babies' sensitive skin, some popular products may contain potentially harmful ingredients. For instance, Desitin Maximum Strength, a top-selling diaper rash cream, includes fragrance, which can contain undisclosed phthalates.  This top-selling formula also contains petroleum and glycerin, both derived from crude oil and susceptible to contamination [6].  These petroleum-based ingredients may harbor impurities such as polycyclic aromatic hydrocarbons (PAHs) and heavy metals, which are known carcinogens [7].  Besides known ingredients, products can also become contaminated throughout various stages of the production process. This makes product testing crucial for ensuring the safety of diaper rash creams.  How Do Harmful Chemicals Contaminate Diaper Rash Creams? Contamination can happen at various stages of producing diaper rash creams: Raw material sourcing: Ingredients may be contaminated before reaching the manufacturer. Manufacturing process: Equipment or packaging materials can introduce toxicants. Chemical reactions: Ingredients in the product may react to one another or degrade with time to produce other chemicals.  Storage and transportation: Improper conditions can lead to chemical changes or contamination. Many brands are unaware of these issues, as thorough testing is not always required or performed consistently. The only way to truly ensure product safety is through comprehensive, independent testing. Non-Targeted Testing for Diaper Rash Cream Safety The prevalence of harmful chemicals and potential contaminants in diaper rash creams underscores the critical need for comprehensive product testing. With infants' highly absorbent skin in the diaper area being particularly vulnerable to toxic substances, ensuring the safety of these products is paramount. Transparency in product formulations and rigorous safety assessments are essential for parents to make informed choices about the products they use on their babies. However, current labeling practices and limited testing requirements often fall short of providing a complete picture of a product's chemical composition and potential risks.  To address this gap, the Million Marker Research Institute (MMRI) is expanding its database of product testing initiatives to focus on diaper rash creams. MMRI plans to test 30 products using non-targeted testing methods, employing advanced techniques like high-resolution mass spectrometry. This approach allows for the detection of a wide range of known and unknown chemical compounds, enabling the identification of unexpected contaminants that may have been introduced during manufacturing, storage, or transportation. By conducting this comprehensive analysis, MMRI aims to provide a more complete assessment of product safety, making it easier for parents to find safe products for their babies. Furthermore, we seek to connect clean suppliers with brands, fostering a market transformation that prioritizes safer formulations. This initiative not only contributes to a deeper understanding of product safety but also helps drive positive changes in the industry, potentially making the market safer for generations to come. Why Your Support Matters By investing in our product testing initiatives, you're not just supporting a single study – you're helping to create a safer future for all children. Your donation will: Fund state-of-the-art laboratory testing Aid our research into safer ingredient alternatives Enable us to share our findings with parents, manufacturers, and regulators Support our consumer-facing database of scored products Help us advocate for stricter safety standards in baby care products Together, we can ensure that the products meant to care for our most vulnerable are truly safe and effective.   Resources [1] https://www.sciencedirect.com/science/article/pii/S0013935122023957  [2] https://www.gminsights.com/industry-analysis/diaper-cream-market  [3] https://pmc.ncbi.nlm.nih.gov/articles/PMC4914412/#  [4] https://pmc.ncbi.nlm.nih.gov/articles/PMC8880311/  [5] https://pmc.ncbi.nlm.nih.gov/articles/PMC7121289/  [6] https://www.safecosmetics.org/chemicals/petrolatum/  [7] https://www.sciencedirect.com/science/article/abs/pii/S0160412018310316