03.07.19
This week, FDA commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, released a statement confirming a 2017 finding of asbestos contamination in certain cosmetic products. In the joint statement, Gottlieb (who recently announced his planned departure from the post) and Mayne also outlined “new steps that FDA is pursuing to improve cosmetics safety.”
Here is the that statement:
"Each day, cosmetic products are sold to consumers across the U.S. – some to children under the age of 18, still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids and lips. That’s why it’s so important that cosmetic products are safe, properly labeled and free of contamination. It’s also why when we hear about reports of contamination, like the 2017 reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers, we’re especially concerned.
Today, we’re providing an update on our assessment of the contaminated Claire’s and Justice products. This includes the release of new independent testing results and an associated safety alert that warns consumers against the use of certain cosmetics sold by Claire’s. We’re also announcing new steps that the FDA is taking, given existing limitations on our cosmetic oversight authority, to better ensure the safety of the cosmetic products men, women and children use every day. Our goal is to help ensure the safety of the products that consumers use and pursue steps that modernize our pursuit of that mission.
The cosmetics industry is undergoing rapid expansion and innovation. These changes help bring new opportunities and choices to consumers. There are now more varieties of cosmetic products available to consumers than ever before. But they can also bring new uncertainty, complexity and risks. And at the same time, the provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) – the law governing the FDA’s oversight of cosmetic products — have not been updated since it was first enacted in 1938. The current law does not require cosmetics to be reviewed and approved by the FDA prior to being sold to American consumers. There are reasons why the FD&C Act doesn’t require prior approval of cosmetics before marketing. Our statute is based on risk, and many cosmetics do not pose the same risks as medical products that require prior approval before they can be lawfully marketed. Our regulatory approach across our broad portfolio is not a one-size-fits-all approach.
But at the same time, when it comes to cosmetics, our authority hasn’t changed in many years even as the industry has undergone rapid evolution. Right now, when it comes to cosmetics, companies and individuals who market these products in the U.S. hold the responsibility for the safety and labeling of their products. This means that ultimately a cosmetic manufacturer can decide if they’d like to test their product for safety and register it with the FDA. To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety.
Although the FDA doesn’t have pre-market review authority, there are other tools besides the requirement for approval that the FDA uses to ensure the safe marketing of products. In the case of cosmetic products, the FD&C Act imparts the responsibility on us to monitor the cosmetics market and take action to protect consumers, if needed, in the post-market setting. Cosmetics must not be "adulterated" or "misbranded," meaning they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. The FDA’s current work focuses on reviewing scientific literature; reviewing reports of adverse events involving cosmetics that we receive from consumers and health professionals; research; surveillance; education and outreach; and pursuing enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
Update on 2017 Finding
As part of our work to protect consumers from unsafe cosmetics on the market, the FDA routinely monitors the market for cosmetic products that may pose a public health risk. This is how the FDA, in 2017, first became aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled its Just Shine Shimmer Powder and seven additional cosmetic products including: Just Shine Bronzer Brush, Makeup Palette Pinks, Blues and Glitter Cream, and Eye Shadow Palette Cool, Pinks, Eye Shadow and Glitter Cream. For its part, on Dec. 22, 2017 Claire’s removed from its stores the following products: Ultimate Mega Make Up Set, Metallic Hot Pink Glitter 48-Piece Makeup Set, Bedazzled Rainbow Heart Makeup Set, Rainbow Bedazzled Star Make Up Set, Rainbow Glitter Heart Shaped Makeup Set, Mint Glitter Make Up Set, Rainbow Bedazzled Rectangle Make Up Set, and Pink Glitter Palette with Eyeshadow & Lip Gloss.
Because the 2017 testing was done by third-party laboratories, the agency believed it was important to scientifically confirm that these reports were accurate. That’s why after Claire’s withdrew and Justice recalled suspect products from the market, the FDA began the process of conducting independent tests to determine if some of these products did in fact contain asbestos. In late February of this year, we received the results of this testing initiative.
The FDA is today announcing the results of these tests. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice. All suspect Justice products, including the one testing positive for asbestos, were previously recalled from the market in 2017. The FDA issued a Safety Alert today warning consumers to not use three of Claire’s products: Claire’s Eye Shadows – Batch No/Lot No: 08/17; Claire’s Compact Powder – Batch No/Lot No: 07/15; and, Claire’s Contour Palette – Batch No/Lot No: 04/17 because they tested positive for asbestos.
The FDA requested that Claire’s recall the products because they should not be used by consumers. Claire’s has refused to comply with the FDA’s request, and the agency does not have authority to mandate a recall. The FDA is therefore warning consumers not to use these products and will continue to communicate our safety concerns about them. We strongly encourage consumers and health care providers to report cosmetic-related adverse reactions to the FDA’s MedWatch reporting system or a consumer complaint coordinator.
We understand how concerning this finding is for any consumer and parents whose children may have used one of these products. We take these concerns, and our obligation to protect consumers, seriously. Because of the health risks posed by asbestos, which are well-documented by other government agencies, we want to reassure all parents and consumers that the FDA is dedicated to exploring new ways to better protect Americans from this and other public health risks and preventing consumers from being exposed to similar risks from cosmetics. These findings serve as an important reminder that under our current authority, the FDA has only limited tools to ensure the safety of cosmetics products. We are dependent on manufacturers to take steps to ensure the safety of their products and we are calling on manufacturers to improve their oversight for risks such as those we’re identifying today. Under the current regulatory framework, cosmetics manufacturers and retailers bear critical responsibilities in assuring the safety of their products.
New Steps to Protect Consumers
That’s why today, we’re calling upon the cosmetic industry to take important new steps. Ultimately, the FDA also seeks to engage with stakeholders to work on other new opportunities to improve our overall framework for assuring the safety of the cosmetic products that consumers use.
Among the steps that we’re taking to reinforce the obligations of manufacturers, first, we’ll soon be working with cosmetics manufacturers and requesting information about what procedures they use to ensure their cosmetics are safe and, in particular, about how they ensure that talc used in any cosmetic product is free from asbestos. We will be investigating how manufacturers source talc with appropriate traceability, and whether they test raw talc and/or their finished products. We also want to know how many cosmetics products contain talc and whether manufacturers have received adverse event reports associated with talc-containing products. We believe this information will help us better identify specific cosmetic products and raw ingredient suppliers that may be more likely to be contaminated and inform steps that the FDA may be able to take to better protect consumers.
Next, although the law doesn’t require cosmetic products to be registered with the FDA, we’re also calling upon cosmetic firms to take responsible steps to voluntarily register their products and list ingredients, including talc, used in their products via the FDA's Voluntary Cosmetic Registration Program (VCRP). This program provides a mechanism for cosmetic manufacturers, distributors and packers to voluntarily file information on their products that are currently being marketed to U.S. consumers and to register their manufacturing and/or packaging facility locations. We’re also calling upon manufacturers to proactively report adverse events involving cosmetic products to our Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System. Although this is not required by current law, we believe this reporting is an important component of responsible marketing and safe oversight of these products.
At the same time, we’re committed to taking other steps to ensure safety of consumers, in accordance with the authorities provided to us by the FD&C Act and available resources, and by leveraging our authorities to the greatest extent. We’ll continue evaluating concerns about ingredients or products and will make determinations, based on currently available science, if certain cosmetic ingredients should be prohibited and restricted. Moving forward, we’ll continue our work uncovering ingredients or products of concern and will take swift action to inform and advise consumers of any identified public health risks. Ensuring the safety of cosmetics is a high priority for us.
We’re also committed to continuing our efforts specifically around talc and asbestos. In 2010, we surveyed 34 cosmetic products including body powders, face powders, foundation, eye shadow, blush and samples from four major talc suppliers and found no traces of asbestos contamination using the most sensitive techniques available. As announced today with regard to Claire’s Eye Shadows, Claire’s Compact Powder, and Claire’s Contour Palette, the FDA will continue to have products tested and take regulatory and enforcement action as needed. We’ll also continue to monitor the scientific literature for safety concerns related to talc in cosmetic products and conduct our own research. Separately, the FDA has formed an interagency working group with representatives from other federal agencies to propose draft standards to improve analytical consistency for talc testing, which will be the subject of an upcoming public forum.
Our overarching aim is to ensure the safety of cosmetic products and protect consumers. To significantly shift the safety paradigm of cosmetics in the U.S., we would need to work with stakeholders, including Congress, to modernize the outdated regulatory framework that the FDA has been operating under for more than 80 years when it comes to cosmetics. Our program for cosmetics also has remained small despite the industry’s significant expansion and global supply chain. To modernize our overall approach, we need to expand the scope of what we’re able to do commensurate with the scope of the cosmetics industry, and we’re going to seek a broader dialogue on how we can make the overall system more robust. To improve consumer safety and secure our mission for years to come, a more modern approach could include tools that are tailored for cosmetics, including appropriate frameworks for registration and listing of products and their ingredients, good manufacturing practice regulations, company reporting of adverse events, access to records (including consumer complaints) during routine or for-cause inspections, mandatory recalls, disclosure of known cosmetic allergens on a product’s label, and ingredient review.
Our focus remains on protecting Americans from unsafe products.
As we continue our critical work to protect consumers, we look forward to advancing the important dialogue with our colleagues in the cosmetics industry on ways to further enhance the FDA’s efforts to ensure the safety of cosmetic products. We’re confident that by working collaboratively with all stakeholders, we can enhance the agency’s ability to conduct this vital work and provide consumers with greater assurance around the safety of the cosmetic products used throughout the U.S. each day.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
Here is the that statement:
"Each day, cosmetic products are sold to consumers across the U.S. – some to children under the age of 18, still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids and lips. That’s why it’s so important that cosmetic products are safe, properly labeled and free of contamination. It’s also why when we hear about reports of contamination, like the 2017 reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers, we’re especially concerned.
Today, we’re providing an update on our assessment of the contaminated Claire’s and Justice products. This includes the release of new independent testing results and an associated safety alert that warns consumers against the use of certain cosmetics sold by Claire’s. We’re also announcing new steps that the FDA is taking, given existing limitations on our cosmetic oversight authority, to better ensure the safety of the cosmetic products men, women and children use every day. Our goal is to help ensure the safety of the products that consumers use and pursue steps that modernize our pursuit of that mission.
The cosmetics industry is undergoing rapid expansion and innovation. These changes help bring new opportunities and choices to consumers. There are now more varieties of cosmetic products available to consumers than ever before. But they can also bring new uncertainty, complexity and risks. And at the same time, the provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) – the law governing the FDA’s oversight of cosmetic products — have not been updated since it was first enacted in 1938. The current law does not require cosmetics to be reviewed and approved by the FDA prior to being sold to American consumers. There are reasons why the FD&C Act doesn’t require prior approval of cosmetics before marketing. Our statute is based on risk, and many cosmetics do not pose the same risks as medical products that require prior approval before they can be lawfully marketed. Our regulatory approach across our broad portfolio is not a one-size-fits-all approach.
But at the same time, when it comes to cosmetics, our authority hasn’t changed in many years even as the industry has undergone rapid evolution. Right now, when it comes to cosmetics, companies and individuals who market these products in the U.S. hold the responsibility for the safety and labeling of their products. This means that ultimately a cosmetic manufacturer can decide if they’d like to test their product for safety and register it with the FDA. To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety.
Although the FDA doesn’t have pre-market review authority, there are other tools besides the requirement for approval that the FDA uses to ensure the safe marketing of products. In the case of cosmetic products, the FD&C Act imparts the responsibility on us to monitor the cosmetics market and take action to protect consumers, if needed, in the post-market setting. Cosmetics must not be "adulterated" or "misbranded," meaning they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. The FDA’s current work focuses on reviewing scientific literature; reviewing reports of adverse events involving cosmetics that we receive from consumers and health professionals; research; surveillance; education and outreach; and pursuing enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
Update on 2017 Finding
As part of our work to protect consumers from unsafe cosmetics on the market, the FDA routinely monitors the market for cosmetic products that may pose a public health risk. This is how the FDA, in 2017, first became aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled its Just Shine Shimmer Powder and seven additional cosmetic products including: Just Shine Bronzer Brush, Makeup Palette Pinks, Blues and Glitter Cream, and Eye Shadow Palette Cool, Pinks, Eye Shadow and Glitter Cream. For its part, on Dec. 22, 2017 Claire’s removed from its stores the following products: Ultimate Mega Make Up Set, Metallic Hot Pink Glitter 48-Piece Makeup Set, Bedazzled Rainbow Heart Makeup Set, Rainbow Bedazzled Star Make Up Set, Rainbow Glitter Heart Shaped Makeup Set, Mint Glitter Make Up Set, Rainbow Bedazzled Rectangle Make Up Set, and Pink Glitter Palette with Eyeshadow & Lip Gloss.
Because the 2017 testing was done by third-party laboratories, the agency believed it was important to scientifically confirm that these reports were accurate. That’s why after Claire’s withdrew and Justice recalled suspect products from the market, the FDA began the process of conducting independent tests to determine if some of these products did in fact contain asbestos. In late February of this year, we received the results of this testing initiative.
The FDA is today announcing the results of these tests. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice. All suspect Justice products, including the one testing positive for asbestos, were previously recalled from the market in 2017. The FDA issued a Safety Alert today warning consumers to not use three of Claire’s products: Claire’s Eye Shadows – Batch No/Lot No: 08/17; Claire’s Compact Powder – Batch No/Lot No: 07/15; and, Claire’s Contour Palette – Batch No/Lot No: 04/17 because they tested positive for asbestos.
The FDA requested that Claire’s recall the products because they should not be used by consumers. Claire’s has refused to comply with the FDA’s request, and the agency does not have authority to mandate a recall. The FDA is therefore warning consumers not to use these products and will continue to communicate our safety concerns about them. We strongly encourage consumers and health care providers to report cosmetic-related adverse reactions to the FDA’s MedWatch reporting system or a consumer complaint coordinator.
We understand how concerning this finding is for any consumer and parents whose children may have used one of these products. We take these concerns, and our obligation to protect consumers, seriously. Because of the health risks posed by asbestos, which are well-documented by other government agencies, we want to reassure all parents and consumers that the FDA is dedicated to exploring new ways to better protect Americans from this and other public health risks and preventing consumers from being exposed to similar risks from cosmetics. These findings serve as an important reminder that under our current authority, the FDA has only limited tools to ensure the safety of cosmetics products. We are dependent on manufacturers to take steps to ensure the safety of their products and we are calling on manufacturers to improve their oversight for risks such as those we’re identifying today. Under the current regulatory framework, cosmetics manufacturers and retailers bear critical responsibilities in assuring the safety of their products.
New Steps to Protect Consumers
That’s why today, we’re calling upon the cosmetic industry to take important new steps. Ultimately, the FDA also seeks to engage with stakeholders to work on other new opportunities to improve our overall framework for assuring the safety of the cosmetic products that consumers use.
Among the steps that we’re taking to reinforce the obligations of manufacturers, first, we’ll soon be working with cosmetics manufacturers and requesting information about what procedures they use to ensure their cosmetics are safe and, in particular, about how they ensure that talc used in any cosmetic product is free from asbestos. We will be investigating how manufacturers source talc with appropriate traceability, and whether they test raw talc and/or their finished products. We also want to know how many cosmetics products contain talc and whether manufacturers have received adverse event reports associated with talc-containing products. We believe this information will help us better identify specific cosmetic products and raw ingredient suppliers that may be more likely to be contaminated and inform steps that the FDA may be able to take to better protect consumers.
Next, although the law doesn’t require cosmetic products to be registered with the FDA, we’re also calling upon cosmetic firms to take responsible steps to voluntarily register their products and list ingredients, including talc, used in their products via the FDA's Voluntary Cosmetic Registration Program (VCRP). This program provides a mechanism for cosmetic manufacturers, distributors and packers to voluntarily file information on their products that are currently being marketed to U.S. consumers and to register their manufacturing and/or packaging facility locations. We’re also calling upon manufacturers to proactively report adverse events involving cosmetic products to our Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System. Although this is not required by current law, we believe this reporting is an important component of responsible marketing and safe oversight of these products.
At the same time, we’re committed to taking other steps to ensure safety of consumers, in accordance with the authorities provided to us by the FD&C Act and available resources, and by leveraging our authorities to the greatest extent. We’ll continue evaluating concerns about ingredients or products and will make determinations, based on currently available science, if certain cosmetic ingredients should be prohibited and restricted. Moving forward, we’ll continue our work uncovering ingredients or products of concern and will take swift action to inform and advise consumers of any identified public health risks. Ensuring the safety of cosmetics is a high priority for us.
We’re also committed to continuing our efforts specifically around talc and asbestos. In 2010, we surveyed 34 cosmetic products including body powders, face powders, foundation, eye shadow, blush and samples from four major talc suppliers and found no traces of asbestos contamination using the most sensitive techniques available. As announced today with regard to Claire’s Eye Shadows, Claire’s Compact Powder, and Claire’s Contour Palette, the FDA will continue to have products tested and take regulatory and enforcement action as needed. We’ll also continue to monitor the scientific literature for safety concerns related to talc in cosmetic products and conduct our own research. Separately, the FDA has formed an interagency working group with representatives from other federal agencies to propose draft standards to improve analytical consistency for talc testing, which will be the subject of an upcoming public forum.
Our overarching aim is to ensure the safety of cosmetic products and protect consumers. To significantly shift the safety paradigm of cosmetics in the U.S., we would need to work with stakeholders, including Congress, to modernize the outdated regulatory framework that the FDA has been operating under for more than 80 years when it comes to cosmetics. Our program for cosmetics also has remained small despite the industry’s significant expansion and global supply chain. To modernize our overall approach, we need to expand the scope of what we’re able to do commensurate with the scope of the cosmetics industry, and we’re going to seek a broader dialogue on how we can make the overall system more robust. To improve consumer safety and secure our mission for years to come, a more modern approach could include tools that are tailored for cosmetics, including appropriate frameworks for registration and listing of products and their ingredients, good manufacturing practice regulations, company reporting of adverse events, access to records (including consumer complaints) during routine or for-cause inspections, mandatory recalls, disclosure of known cosmetic allergens on a product’s label, and ingredient review.
Our focus remains on protecting Americans from unsafe products.
As we continue our critical work to protect consumers, we look forward to advancing the important dialogue with our colleagues in the cosmetics industry on ways to further enhance the FDA’s efforts to ensure the safety of cosmetic products. We’re confident that by working collaboratively with all stakeholders, we can enhance the agency’s ability to conduct this vital work and provide consumers with greater assurance around the safety of the cosmetic products used throughout the U.S. each day.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
