Who is the Cosmetic Ingredient Review?
The CIR program was created 35 years ago by the cosmetics industry with the support of the FDA and the Consumer Federation of America. CIR’s singular mission is to thoroughly review and assesses the safety of ingredients used in cosmetics in an open, unbiased, and expert manner, and to publish the results in the open, peer-reviewed scientific literature.
Oversight of the program is provided by a steering committee comprised of 3 industry representatives (the President of the Personal Care Products Council, the Executive VP for Science at the Council, and the Chair of the Council’s CIR Science and Support Committee) and 4 public representatives (Consumer Federation of America, Society of Toxicology, American Academy of Dermatology, and the Chair, CIR Expert Panel).
CIR’s procedures call for an initial review of available published and unpublished scientific data relevant for assessing the safety of a cosmetic ingredient or family of cosmetic ingredients. That review is offered for public comment. A draft report is then considered by the CIR Expert Panel. If additional data are needed, an insufficient data announcement describes the required information and interested parties are given time to provide the data. The Expert Panel then issues a tentative safety assessment for public comment. Comments are evaluated and a final safety assessment is prepared.
Recognizing that additional data may later become available, CIR re-reviews every ingredient when the new data become available, but no less than every 15 years. This ensures that CIR’s determinations are current.
How long have you been employed by the CIR, and what is your role?
I’ve been the Director of the CIR since 1993 and I’m responsible for the day-to-day operation of the review process and the long-range planning to identify future priorities. Prior to joining CIR, I spent 22 years at the U.S. Food and Drug Administration – moving to FDA directly after receiving my PhD in Biophysics from Penn State.
Do you care about cosmetic safety?
Yes! The CIR program offers a unique opportunity to assess the safety of ingredients used in cosmetics and the ex-FDAer in me just loves that we have that capability.
Is there a specific process when testing the safety of an ingredient, before it is made available on the market?
No, there isn’t a one-size-fits-all approach to establish safety – nor should there be.
For example, some ingredients simply cannot penetrate the outer layer of the skin (the keratinized stratum corneum) and as long as such an ingredient is not inhaled, ingested, or otherwise enter the body, all we have to do is establish that the ingredient will not damage the surface of the skin.
For ingredients that may penetrate the skin, well, we need to know rather a lot more! Where do these ingredients go once they are in the body? Does the body process (metabolize) them? What is produced (metabolites) as a result of processing? Can the ingredient or its metabolites cause damage to genetic material, affect endocrine processes, or cause other adverse health effects? Special concern always exists for any ingredient with regard to the potential to cause cancer, effects on fetal development or reproductive toxicity.
And while natural ingredients are widely used and consumers appear to be comfortable with their safety, ingredients derived from plants often are the most problematic to assess. This is primarily because we don’t always know which of the chemicals in the plant are in the plant extract used in the cosmetics. And some of what can be found in plants can be dangerous. Think poison ivy. And even when a concern is not obvious, we need to be vigilant as in the case of aloe-derived ingredients. There is no question that aloe-derived ingredients are widely used and can be used safely, but only if the limits on potentially hazardous anthraquinones that we established are adhered to. We try to leave no stone unturned, so to speak.
How many cosmetic ingredients are on the market?
There are around 6000 ingredients currently reported to be used in cosmetics, based on the U.S. FDA’s Voluntary Cosmetic Registration Program.
How many cosmetic ingredients haven’t been tested for safety?
Under the provisions of the Food, Drug, and Cosmetic Act, each company that sells a cosmetic product is required to substantiate the safety of ingredients in that product. With the ongoing movement away from testing safety using animals, more and more will be done without animal testing.
Perhaps a better question would be: How many cosmetic ingredients haven’t been assessed for safety?
Before I talk about what CIR has done, note that the FDA has reviewed many ingredients used in cosmetics. FDA has evaluated the safety of ingredients used as food additives, color additives, pharmaceuticals, and even medical devices. Additionally, the Research Institute for Fragrance Materials has completed safety assessments of many ingredients used as fragrances.
CIR has completed safety assessments of over 2300 cosmetic ingredients, focusing on the ingredients most widely used in cosmetics. So, formal safety assessments are in place for the ingredients used in most products, but our work continues so that we may address all ingredients used in all products.
What causes an ingredient to be placed on a list of high priority for review?
We look at the uses of an ingredient as reported to FDA’s Voluntary Cosmetic Registration Program. Our thinking is that the more widely an ingredient is used, the more people will be exposed, and the more important it is to assess its safety. Independent of the use data, we look for information suggesting that the ingredient is a possible hazard. Such information includes the FDA’s program to collect information on adverse reactions to cosmetics, monitoring the scientific literature, etc. While such information usually does not establish that a hazard exists, it can suggest that possibility and signal a higher priority for us to do a complete evaluation.
Who makes up the CIR panel?
The CIR Expert Panel has 9 scientist and physician members with expertise matched to the approaches for evaluating safety I described earlier.
The Panel Chair is Wilma F. Bergfeld, M.D., F.A.C.P. Dr. Bergfeld is the Head of Clinical Research and Dermatopathology at the Cleveland Clinic Foundation. She is the founding president of the Women’s Dermatological Society and is a past-president of the American Academy of Dermatology.
There are two teams that independently review the scientific data on each ingredient.
One team leader is Donald V. Belsito, M.D. Dr. Belsito is the Leonard C. Harber Professor of Clinical Dermatology at Columbia University Medical Center. He is a past-president of the American Contact Dermatitis Society.
On this team are:
Curtis D. Klaassen, Ph.D., Professor of Pharmacology and Toxicology, School of Medicine, University of Kansas Medical Center. Dr. Klaassen is a past-president of the Society of Toxicology.
Paul W. Snyder, D.V.M., Ph.D., Professor of Toxicologic Pathology and Director, Veterinary Clinical Immunology and Histopathology Laboratories, School of Veterinary Medicine, Department of Comparative Pathobiology at Purdue University. Dr. Snyder also has an adjunct faculty appointment in the Indiana University School of Medicine.
Daniel C. Liebler, Ph.D., Professor of Biochemistry, Pharmacology and Biomedical Informatics, Vanderbilt University School of Medicine. Dr. Liebler is also the Director, Ayers Institute for Precancer Detection and Diagnosis.
The other team leader is James G. Marks, Jr., M.D., Professor of Medicine, Chairman of the Division of Dermatology, Pennsylvania State University College of Medicine. Dr. Marks is a past-president of the American Contact Dermatitis Society.
On his team are:
Ronald A. Hill, Ph.D., Associate Professor of Medicinal Chemistry, College of Pharmacy, University of Louisiana at Monroe. Dr. Hill is the author of the chapter on hormone-related disorders–nonsteroidal therapies in Textbook of Organic Medicinal and Pharmaceutical Chemistry.
Ronald C. Shank, Ph.D., Professor and Chair, Dept. of Community & Environmental Medicine, University of California, Irvine. Dr. Shank is also the Director of UCI’s Environmental Toxicology Program.
Thomas J. Slaga, Ph.D., Department of Pharmacology, University of Texas Health Science Center, Interim Director, San Antonio Cancer Institute. Dr. Slaga is the founder and editor-in-chief of Molecular Carcinogenesis.
Three non-voting liaison members also serve on the CIR Expert Panel.
Rachel Weintraub, Esq., Senior Counsel, Consumer Federation of America
Halyna Breslawec, Executive VP for Science, Personal Care Products Council
Linda Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors and Chief Medical Officer, FDA’s Center for Food Safety and Applied Nutrition
Does the CIR publish its findings of its safety assessments?
CIR posts its findings on the CIR website, where it also posts draft reports for public review and comments. Publishing CIR’s safety assessments is a core part of the CIR mission. We submit our reports for publication in the peer-reviewed International Journal of Toxicology. Three supplemental issues of the IJT appear each year to ensure wide dissemination of the findings of the CIR Expert Panel. There is an additional benefit to this approach in that industry usually does not have to perform additional animal testing when such data already are captured in CIR safety assessments.