06.01.18
The Cosmetic Ingredient Review (CIR) Expert Panel, and ICMAD have both issued statements following a report released by Women’s Voices for the Earth’s regarding CIR and the US Senate Health, Education, Labor and Pensions (HELP) committee potential legislation to address the problem of cosmetics safety.
Women’s Voices for the Earth released an investigative report—Cosmetic Ingredient Review (CIR): Failing the Public. Failing Manufacturers—in which it provides details on what it contends are “four main reasons why the CIR cannot be trusted to protect our health from harmful ingredients in cosmetics and personal care products, like deodorants, lotions, makeup, shampoos, and feminine wipes, washes and sprays.”
In its press release, the watchdog group said “We have been disappointed with the CIR for years, so why are we releasing this report now? Right now, the Senate Health, Education, Labor and Pensions committee (HELP) is considering legislation to address the problem of cosmetics safety. The cosmetics industry wants to be able to continue to use the safety determinations of the CIR and is pushing to have it included in legislation. Heck no. We deserve better. We should be requiring manufacturers to do more homework than that—especially since our health is on the line.”
The following statement was issued by Bart Heldreth, Ph.D., executive director, CIR, regarding the Women’s Voices for the Earth report:
“Over the last four decades, the Cosmetic Ingredient Review (CIR) Expert Panel has established a strong record of protecting public health through its thorough reviews and safety assessments of ingredients used in cosmetics.
CIR is comprised of world-renowned dermatologists, toxicologists, chemists, consumer protection advocates, and public health experts who have been publicly nominated by consumer, scientific and medical groups, government agencies, and industry. Some CIR panel members also serve on international standards groups. The scientific deliberations are held at public meetings and the results are published in the International Journal of Toxicology, a peer-reviewed journal. CIR was established in 1976 with involvement and support from the US Food and Drug Administration (FDA) and the Consumer Federation of America (CFA)—both entities and an industry liaison participate as non-voting members at Panel deliberations.
CIR and its review process are independent. Anonymous peer-review evaluation of all CIR final reports is a key safeguard of scientific integrity. Each member of the Expert Panel is required to meet the same conflict-of-interest standards as those of FDA advisory committee members, and all Panel members have their own careers, separate and distinct from the cosmetics industry.
The CIR Expert Panel solicits public comment at all stages of the multi-review process. If the open, scientific literature contains insufficient information or if the information submitted is insufficient to make a safety determination, CIR will call on industry and other interested parties to undertake specific studies to address these insufficiencies, or to provide previously unpublished data. CIR reports and minutes of its discussions are freely available for download on the CIR website. Unpublished studies, used in the Panel’s deliberations, are freely available upon request.
While Women’s Voices for the Earth’s report (released April 24, 2018) essentially reflects the scope and processes followed by CIR, we respectfully disagree with their suggestions that Expert Panel members are inherently conflicted. Women’s Voices for the Earth has participated in the public CIR meetings, their comments were fully addressed, and the internationally recognized experts disagreed with many of the chemical and toxicology-related statements they made. A failure of the Panel experts or other international expert bodies to agree with Women’s Voices for the Earth is not evidence that the process is fundamentally flawed, or the conclusions are wrong. Conversely, the report demonstrates Women’s Voices for the Earth’s weak understanding of 21st century safety assessment science.
Women’s Voices for the Earth erroneously suggest that there is an inherent conflict of interest and cite as examples where both industry and CIR have come to the same conclusions concerning the safety of specific ingredients. This shows a fundamental misunderstanding of CIR’s role in the overall risk management of cosmetics in the US. The primary responsibility for assuring the safety of a cosmetic product falls on the manufacturer. CIR acts as an independent third party to assess cosmetic ingredient safety. When CIR arrives as the same conclusions as industry, it merely reflects that industry has done a good job, not that some nefarious collusion is going on. Astute observation of any one of the CIR Expert Panel’s public meetings will reveal to an attendee that, the Panel often disagrees with the data and other information provided to them, whether it is from industry or any other stakeholder. Indeed, the majority of conclusions issued from CIR are not “safe as used,” but are “safe with qualifications,” “unsafe,” or “insufficient data to conclude on safety.”
Women’s Voices for the Earth erroneously suggest that CIR’s narrow operating scope of focusing on cosmetic ingredient safety, that excludes worker health and the environment, is a rationale for discrediting the safety assessments of the CIR Expert Panel. To the contrary, qualifications for assessing ingredient safety, alone, comprise expertise in chemistry, biology, toxicokinetics, toxicology, dermatology, etc. While investigating the environmental impact of any material is an important endeavor, it also requires a broad range of special and separate expertise. Accordingly, expecting the CIR Expert Panel, who have all of the expertise to assess the safety of cosmetic ingredients, to also perform environmental science, is a suggestion that only a non-science-based organization would put forth. Nobody expects the FDA to do the job of the EPA or OSHA; likewise, such should not be expected of CIR.
While most consumers may not know that CIR exists, they have relied on our objectivity and expertise for more than 40 years. We take great pride in the work that we do. Nevertheless, all processes have potential for improvement and we strive to make regular re-evaluations to ensure the effectiveness of our efforts and our ability to appropriately complement FDA’s oversight.“
ICMAD also issued its own statement, noting that it and its more than 900 member-companies support the efforts of the CIR’s Expert Panel and its robust 40-year history of protecting public health through extensive reviews and safety assessments of the ingredients used in cosmetics. The association said it concurs with the statement issued Heldreth.
According to Dr. John Bailey, former director of FDA’s Office of Cosmetics and Colors and executive vice president for science at the Personal Care Product Council, “The CIR is an important, invaluable and unequaled program that contributes directly to consumer safety and provides valuable assistance to FDA and the regulated cosmetic industry. The CIR panel of world-class experts, working for more than 40 years, provides an independent, systematic, transparent and science-based review of the safety of ingredients used in cosmetics as well as inactive ingredients in drugs. These reckless attacks on the credibility of the CIR fail to recognize the important contributions of the CIR to global cosmetic safety.”
Questions regarding the safety of ingredients and conflicts of interest are taken seriously; however, personal care products and cosmetics companies have a long-standing commitment to product safety. Scientific tests and studies guided by FDA and EPA regulations are paramount in the manufacturing of these products. CIR is the leading scientific body dedicated to a thorough, objective and independent review. CIR’s focus is the safety of the public’s health and their findings are published in the peer-reviewed scientific journal, The International Journal of Toxicology.
We do agree that modernizations to cosmetics regulations must be made, but our focus is to ensure that the updated law continues to foster innovation, guarantee safety and keep the US as a worldwide leader in the cosmetics industry. Attacking CIR with unfounded claims is not the way to achieve true modernization of the proposed legislation. We look forward to continuing a productive dialogue with Senate and House staff on the modernization of cosmetic regulations to provide long-term support for American companies’ leading role in promoting quality, safety and innovation in the global cosmetics industry.”
Women’s Voice urged the public to contact the Senate to express a ‘vote of no confidence’ in the CIR, and to ask Congress to require better safety standards for cosmetic ingredients.
Women’s Voices for the Earth released an investigative report—Cosmetic Ingredient Review (CIR): Failing the Public. Failing Manufacturers—in which it provides details on what it contends are “four main reasons why the CIR cannot be trusted to protect our health from harmful ingredients in cosmetics and personal care products, like deodorants, lotions, makeup, shampoos, and feminine wipes, washes and sprays.”
In its press release, the watchdog group said “We have been disappointed with the CIR for years, so why are we releasing this report now? Right now, the Senate Health, Education, Labor and Pensions committee (HELP) is considering legislation to address the problem of cosmetics safety. The cosmetics industry wants to be able to continue to use the safety determinations of the CIR and is pushing to have it included in legislation. Heck no. We deserve better. We should be requiring manufacturers to do more homework than that—especially since our health is on the line.”
The following statement was issued by Bart Heldreth, Ph.D., executive director, CIR, regarding the Women’s Voices for the Earth report:
“Over the last four decades, the Cosmetic Ingredient Review (CIR) Expert Panel has established a strong record of protecting public health through its thorough reviews and safety assessments of ingredients used in cosmetics.
CIR is comprised of world-renowned dermatologists, toxicologists, chemists, consumer protection advocates, and public health experts who have been publicly nominated by consumer, scientific and medical groups, government agencies, and industry. Some CIR panel members also serve on international standards groups. The scientific deliberations are held at public meetings and the results are published in the International Journal of Toxicology, a peer-reviewed journal. CIR was established in 1976 with involvement and support from the US Food and Drug Administration (FDA) and the Consumer Federation of America (CFA)—both entities and an industry liaison participate as non-voting members at Panel deliberations.
CIR and its review process are independent. Anonymous peer-review evaluation of all CIR final reports is a key safeguard of scientific integrity. Each member of the Expert Panel is required to meet the same conflict-of-interest standards as those of FDA advisory committee members, and all Panel members have their own careers, separate and distinct from the cosmetics industry.
The CIR Expert Panel solicits public comment at all stages of the multi-review process. If the open, scientific literature contains insufficient information or if the information submitted is insufficient to make a safety determination, CIR will call on industry and other interested parties to undertake specific studies to address these insufficiencies, or to provide previously unpublished data. CIR reports and minutes of its discussions are freely available for download on the CIR website. Unpublished studies, used in the Panel’s deliberations, are freely available upon request.
While Women’s Voices for the Earth’s report (released April 24, 2018) essentially reflects the scope and processes followed by CIR, we respectfully disagree with their suggestions that Expert Panel members are inherently conflicted. Women’s Voices for the Earth has participated in the public CIR meetings, their comments were fully addressed, and the internationally recognized experts disagreed with many of the chemical and toxicology-related statements they made. A failure of the Panel experts or other international expert bodies to agree with Women’s Voices for the Earth is not evidence that the process is fundamentally flawed, or the conclusions are wrong. Conversely, the report demonstrates Women’s Voices for the Earth’s weak understanding of 21st century safety assessment science.
Women’s Voices for the Earth erroneously suggest that there is an inherent conflict of interest and cite as examples where both industry and CIR have come to the same conclusions concerning the safety of specific ingredients. This shows a fundamental misunderstanding of CIR’s role in the overall risk management of cosmetics in the US. The primary responsibility for assuring the safety of a cosmetic product falls on the manufacturer. CIR acts as an independent third party to assess cosmetic ingredient safety. When CIR arrives as the same conclusions as industry, it merely reflects that industry has done a good job, not that some nefarious collusion is going on. Astute observation of any one of the CIR Expert Panel’s public meetings will reveal to an attendee that, the Panel often disagrees with the data and other information provided to them, whether it is from industry or any other stakeholder. Indeed, the majority of conclusions issued from CIR are not “safe as used,” but are “safe with qualifications,” “unsafe,” or “insufficient data to conclude on safety.”
Women’s Voices for the Earth erroneously suggest that CIR’s narrow operating scope of focusing on cosmetic ingredient safety, that excludes worker health and the environment, is a rationale for discrediting the safety assessments of the CIR Expert Panel. To the contrary, qualifications for assessing ingredient safety, alone, comprise expertise in chemistry, biology, toxicokinetics, toxicology, dermatology, etc. While investigating the environmental impact of any material is an important endeavor, it also requires a broad range of special and separate expertise. Accordingly, expecting the CIR Expert Panel, who have all of the expertise to assess the safety of cosmetic ingredients, to also perform environmental science, is a suggestion that only a non-science-based organization would put forth. Nobody expects the FDA to do the job of the EPA or OSHA; likewise, such should not be expected of CIR.
While most consumers may not know that CIR exists, they have relied on our objectivity and expertise for more than 40 years. We take great pride in the work that we do. Nevertheless, all processes have potential for improvement and we strive to make regular re-evaluations to ensure the effectiveness of our efforts and our ability to appropriately complement FDA’s oversight.“
ICMAD also issued its own statement, noting that it and its more than 900 member-companies support the efforts of the CIR’s Expert Panel and its robust 40-year history of protecting public health through extensive reviews and safety assessments of the ingredients used in cosmetics. The association said it concurs with the statement issued Heldreth.
According to Dr. John Bailey, former director of FDA’s Office of Cosmetics and Colors and executive vice president for science at the Personal Care Product Council, “The CIR is an important, invaluable and unequaled program that contributes directly to consumer safety and provides valuable assistance to FDA and the regulated cosmetic industry. The CIR panel of world-class experts, working for more than 40 years, provides an independent, systematic, transparent and science-based review of the safety of ingredients used in cosmetics as well as inactive ingredients in drugs. These reckless attacks on the credibility of the CIR fail to recognize the important contributions of the CIR to global cosmetic safety.”
Questions regarding the safety of ingredients and conflicts of interest are taken seriously; however, personal care products and cosmetics companies have a long-standing commitment to product safety. Scientific tests and studies guided by FDA and EPA regulations are paramount in the manufacturing of these products. CIR is the leading scientific body dedicated to a thorough, objective and independent review. CIR’s focus is the safety of the public’s health and their findings are published in the peer-reviewed scientific journal, The International Journal of Toxicology.
We do agree that modernizations to cosmetics regulations must be made, but our focus is to ensure that the updated law continues to foster innovation, guarantee safety and keep the US as a worldwide leader in the cosmetics industry. Attacking CIR with unfounded claims is not the way to achieve true modernization of the proposed legislation. We look forward to continuing a productive dialogue with Senate and House staff on the modernization of cosmetic regulations to provide long-term support for American companies’ leading role in promoting quality, safety and innovation in the global cosmetics industry.”
Women’s Voice urged the public to contact the Senate to express a ‘vote of no confidence’ in the CIR, and to ask Congress to require better safety standards for cosmetic ingredients.
