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Cosmetic Adverse Event Reporting in the U.S.
Personal Care Products Council 2017 Science Symposium and Expo
Linda M. Katz, M.D., M.P.H.
Director, Office of Cosmetics and Colors Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
October 25, 2017
Outline
2
• General overview of adverse events related to cosmetic products
• How FDA reviews adverse event data
• Trends in cosmetic-related adverse events
• How to report a cosmetic-related adverse event
• How to access FDA adverse event data
Cosmetics – Challenges
3
• FDA’s limited legal authorities • Competing agency priorities • Significant changes in past 10-15 years
– Manufacturing more global – Increased adoption of international standards for product testing (ISO) – Alternatives to animal testing – Increasingly sophisticated technology and complex ingredients with
potential structure and function effects • Nanotechnology • “Active” ingredients • Botanicals
– Several U.S. States with an articulated position on certain cosmetic ingredients
– More knowledgeable/demanding consumers, increased use of social media to share information on safety of cosmetics, access to safety estimation tools published by NGOs, use of private “seals” to promote safety of products
FDA Surveillance of Cosmetics
• Adverse event (AEs) monitoring : AEs are submitted by a reporter via MedWatch or Consumer Complaint Coordinator – Types of AEs reported to FDA:
• Serious include: hospitalization, death, disfigurement, life threatening & disability, congenital abnormalities
• Non-Serious include: rash, redness, itching, swelling, etc.
– Most often reported AEs are for: • Baby powders • Hair smoothing products • Deodorants • Men’s hair (lead acetate) and beard dyes
(PPD or coal tar dyes) • Hair dyes (PPD) & Temporary Tattoos • Hair cleansing, detangling, conditioners • Tattoos • Moisturizing skin care preparations • Baby wipes
4
Reviewing CAERS Data
5
What is CAERS?
6
CAERS stands for CFSAN Adverse Event Reporting System
• Database used to track adverse events and product complaints
associated with foods, dietary supplements, and cosmetics
• Adverse event reporting for cosmetics is completely voluntary
• When an AE report is entered into CAERS, an outgoing letter
and a redacted version of the CAERS report are submitted to the distributor
• FDA encourages firms to share any relevant information
concerning adverse events related to their products
Criteria for Serious Determination
7
• If the reviewer has determined the adverse event is serious they must choose one of the following fields in the Reviewer Event Outcome Field – Congenital abnormality – Death – Disability – Hospitalization – Life threatening – Other Serious
• Permanent hair loss • Disfigurement
– Required medical or surgical intervention to prevent permanent damage to a body organ or body structure or disfigurement
CAERS Data Have Limitations
8
• Inaccurate identification of products by reporter • Lack of ingredient information provided • Incomplete contact information for FDA to seek further information • Reports do not include all of the relevant data, such as medical
conditions or current medications • Limited ability discern association between AE and product and/or
ingredients listed • Lack of photo attachment capabilities of product or AE • Voluntary nature of AE reporting results in inaccurate account of all
concerns related to a particular product or ingredient
It is difficult to fully evaluate whether a product caused AE, because
there is important information missing in the submitted reports
Snapshot of Trends in Cosmetic- Related Adverse Events
9
Number of Cosmetic-Related Adverse Events Reported per Year 2004 – September 8, 2017
2500
2000
1500
1000
500
0
10
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Year
2016 2017
Nu
mb
er
of
AEs
Number of Cosmetic-Related Adverse Events Reported per Year
2004 – September 8, 2017*includes body
powders 6000
5000
4000
3000
2000
1000
0
11
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Who is Reporting? *includes body
powders
12
• 92% of injured consumers are Female • 80% of injured consumers are White • Report source
– 32% of reports come from Consumers (75% when minus body powders) – 62% come from industry (12% when minus body powders) – 3% are reported on behalf of a friend/relative of the consumer (8%) – Less than 1% of reports come from health professionals (2%) – Less than 1% of reports come from Local/State Government (2%) – 0.1% are reported on behalf of an attorney of the consumer (0.2%) – 1% are not classified (3%)
Review Evaluations: Serious vs. Non-Serious, 2004-2017
Non-Serious 76%
13
Serious 24%
Review Evaluations: Serious vs. Non-Serious, 2004-2017*
includes body powders
Non-Serious 18%
14
Serious 82%
Review Evaluations, 2004-2017 (n= 2,120)
Probable 41%
15
Certain 22%
Possible 17%
Unlikely 7%
Insufficient Info 13%
Review Evaluations, 2004-2017 (n= 3,852) *includes body powders
Insufficient Info 52%
16
Probable 22%
Certain 12%
Possible 10%
Unlikely 4%
Review Event Outcomes for Serious AEs, 2004-2017 (n=664)
53%
23%
13%
9% 1% 1%
Other Serious (Important Medical Events)
Req. Intervention to prvnt perm. imprmnt.
Hospitalization
Life Threatening
Disability
Death
17
Review Event Outcomes for Serious AEs, 2004-2016 (n=2,400) * includes body powders
77%
10%
6%
4% 3% 0%
Other Serious (Important Medical Events)
Death
Req. Intervention to prvnt perm. imprmnt.
Hospitalization
Life Threatening
Disability
18
Percentage of AEs by Product Category, 2004-2017 (n=6,099)
39%
19
17%
10%
5%
6%
4%
4%
2%
3%
2%
1%
2%
2%
Shaving Preparations 0%
Bath Preparations 1%
Suntan Preparations 1%
Oral Hygiene Products
Manicuring Preparations
Fragrance Preparations
Multiple Products
Not Coded
Baby Products
Makeup Preparations (Not For Eyes)
Eye Makeup Preparations
Personal Cleanliness
Hair Coloring Preparations
Unclassified Products
Skin Care Preparations
Hair Preparations (Non-Coloring)
0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
Percentage of AEs by Product Category, 2004-2017 (n=14,341) *
includes body powders
58%
20
16%
7%
4%
2%
1%
2%
2%
2%
Shaving Preparations 0%
Bath Preparations 0%
Suntan Preparations 0%
Oral Hygiene Products 1%
Manicuring Preparations 1%
Multiple Products 1%
Baby Products 1%
Not Coded
Makeup Preparations (Not For Eyes)
Eye Makeup Preparations
Personal Cleanliness
Hair Coloring Preparations
Unclassified Products
Skin Care Preparations
Hair Preparations (Non-Coloring)
Fragrance Preparations
0% 10% 20% 30% 40% 50% 60% 70%
Trends in Categories of Cosmetic Products Associated with AEs
21
Hair Preparations
22
• Hair conditioners • Hair Sprays • Hair Straighteners • Permanent Waves • Rinses • Shampoos • Tonics, Dressings, and other Hair Grooming Aids • Wave Sets • Other Hair Preparations
Trends in AEs Related to Hair Preparations (Non-Coloring), 2012-2017
93
23
63 93 77
1457
241
1600
1400
1200
1000
800
600
400
200
0
2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Trends in AEs Related to Hair Preparations (Non-Coloring),
2012-2017
74 54 78 51 78 208
33
19 9 15 26
1379
1600
1400
1200
1000
800
600
400
200
0 2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Shampoos
Hair Preparations (Non-Coloring)
24
Fragrance Preparations
25
• Colognes and Toilet Waters
• Perfumes
• Powders (Dusting and Talcum, excluding Aftershave Talc)
• Sachets
• Other Fragrance Preparations
Trends in AEs Related to Fragrance Preparations,
2012-2017
4
26
2 5
1478
2563
4061 4500
4000
3500
3000
2500
2000
1500
1000
500
0 2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Trends in AEs Related to Fragrance Preparations, 2012-2017*includes body
powders
4 0
2 0
5 0 6 7 6
1472
2556
4055
4500
4000
3500
3000
2500
2000
1500
1000
500
0 2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Powders (Dusting, Talcum, excluding Aftershave Talc)
Fragrance Preparations
27
Unclassified Cosmetic Products
28
• Other Cosmetic Products
– Permanent Tattoos
– Temporary Tattoos
Trends in AEs Related to Unclassified Cosmetic Products,
2012-2017
27
29
42 45
92
79
21
100
90
80
70
60
50
40
30
20
10
0 2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Trends in AEs Related to Unclassified Cosmetic Products, 2012-2017
24
3
21
39 47
61
17
21
6
45 18
4
100
90
80
70
60
50
40
30
20
10
0 2012 2013 2014 2015 2016 2017
Nu
mb
er
of
AEs
Year
Permanent Tattoos
Unclassified Cosmetic Products
30
How to Report an Adverse Event for a Cosmetic Product
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How to Report an Adverse Event
www.fda.gov/Cosmetics
Report a Problem
32
How to Report an Adverse Event
33
3 Ways to Report an Adverse Event
34
Where Do Reported Adverse Events Go?
CAERS
CFSAN Adverse Events Reporting System
35
39
How Does FDA Use the Information in CAERS?
• CAERS is used as a source of cosmetics-related safety signals
• Reports are routinely evaluated by reviewers in CFSAN
• If a potential signal is identified, further investigations may be
performed
• FDA may use CAERS data for regulatory decision making to
promote public health and/or communicate safety information related to cosmetic products or ingredients to the public
https://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm#FAQs
40
Accessing CAERS Data
41
Two Ways CAERS Data are Available to the Public 1.CAERS Data Files: provides raw data consisting of individual case safety reports submitted by consumers and health professionals extracted from CAERS
(https://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm#files)
– Report number – Date report was created – Date of adverse event – Product role – Industry code and name – Demographic information (age and gender) – Product – Symptoms – Outcome
2. Freedom of Information Act (FOIA) request
More information can be found at: https://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm
1. Downloading CAERS Data
39
Conclusion
40
• Cosmetic-related adverse events can be reported voluntarily by phone, online, or by paper
• FDA adverse event data is available for download or by submitting a Freedom
of Information Act Request
• CAERS is a source of information on cosmetics-related safety signals
• FDA reviews CAERS data and may use it to promote public health and/or
communicate safety information related to cosmetic products or ingredients to the public
• Because AE reporting is voluntary, the quality and quantity of reports is
sparse
• FDA encourages more manufacturers and health professionals to report
cosmetic-related AEs
Acknowledgements
41
• Claudia Valenzuela, M.P.H.
• Nakissa Sadrieh, Ph.D.
Questions
42
