Key Elements of Contemporary Regulation of Cosmetics in the United States

Transcription

1 Key Elements of Contemporary Regulation of Cosmetics in the United States Jay M. Ansell, Ph.D., D.A.B.T. In-Cosmetics North America New York City Oct 11, 2017

2 Agenda Three Pillars Industry Responsibility 3 rd Party Confirmation Regulatory Oversight Demonstrated Effectiveness Conclusions The views and opinions expressed are mine and do not necessarily reflect the official policy or position of PCPC or it s members.

3 Key Elements of Contemporary Regulation Risk Assessment Hazard Identification Exposure Assessment Safety Assessment Risk Management. A coordinated, economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events. How all the pieces come together to deliver safe, high quality personal care products to consumers around the world.

4 3 Pillars Assuring Safety and Quality Industry Responsibility 3rd Party Confirmation Government Oversight

5 Industry - Roles & Responsibility The U.S. FD&C Act does not require pre-market approval but it absolutely requires that Cosmetic products and ingredients must be safe for consumers under labeled or customary conditions of use. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products and ingredients. Prohibits adulterated or misbranded cosmetics whether from ingredients, contaminants, processing, packaging, or shipping. Companies have primary responsibility for the safety of their products.

6 A History of Commitment to Safety CTFA Cosmetic Ingredient Dictionary (1973) 24,026 Monographs (June 2017) Recognized by US, EU, Canada, Japan & China Acknowledged by many more: Argentina, Australia, Columbia, Israel, the Republic of Korea, Mexico, Norway, Saudi Arabia and South Africa Consumers can identify ingredients by common names - everywhere

7 Advancing Best Science - ICCR International Cooperation on Cosmetics Regulation Voluntary group of cosmetics regulatory authorities Meet annually to discuss common issues on cosmetics safety and regulation & allows a constructive dialogue with relevant cosmetics industry trade associations. ICCR provides a multilateral framework to maintain and enable the highest level of global consumer protection by working towards and promoting regulatory convergence, while minimizing barriers to international trade.

8 Advancing Best Science - ICCR Members: Brazil, Canada, the EU, Japan, US Observers: 2016; representatives from China, Saudi Arabia, South Africa and Thailand. 2017; Argentina, Colombia, South Korea, South Africa and Taiwan. Industry Participation: ABIHPEC; Cosmetics Alliance Canada (CAC); Cosmetics Europe; EFfCI; ICMAD; JCIA; PCPC

9 Active Work Areas: ICCR GMPs Allergens; Identification and Regulation Nanotechnology/Nanomaterials Product Preservation Traces; Framework & Limits Microbiology; Identification, Enumeration & Limits Integrated Safety Assessment In Vivo, In Vitro, Computational Methods Threshold of Toxicological Concern (TTC) & Read-Across

10 Advancing Best Science ISO TC 217 Beginning in NGO of 162 national Standards Institutes. 244 active committees; >500 subcommittees, ISO s mission, to facilitate international trade though Standards which make transparent, the requirements for participation in the global market place. Many of the participating experts consider spreading knowledge, sharing technological advances and developing best management practices have a clear public health benefit in producing safe, high quality personal care products.

11 Standards and projects under the direct responsibility of ISO/TC Cosmetics 2017 ISO TC-217 has published 27 International Standards or Technical Reports: WG 1 -- Microbiological standards and limits; 12 WG 3 -- Analytical methods; 6 WG 4 -- Terminology; 2 WG 7 -- Sun protection test methods; 4 o WG 2 -- Packaging, labeling and marking; 1 o WG 6 -- GMP (Good Manufacturing Practice); 2 Additionally another 9 Standards are under development. Many of these Standards have either been explicitly adopted into regulation or are, at a minimum, recognized by regulatory authorities worldwide.

12 Providing the Tools Council Guidelines Safety Microbiology Quality Assurance Conferences and Workshops Safety Assessment Quality Systems Committee Meetings Peer to Peer exchanges

13 Industry Assuring Safety & Quality 21 st Century Science and Management Practices Quality, Safety And Microbiology Guidelines International Standards and Practices ISO - Methods and Management Systems ICCR Sharing Best Practices & Regulatory Convergence INCI International Nomenclature Establishing effective programs and practices to build in product quality and assure consumer safety.

14 3 rd Party Conformation: Cosmetic Ingredient Review established in 1976 with support of FDA and Consumer Federation of America. The CIR and review processes are independent from cosmetics industry. The safety of ingredients used in cosmetics are thoroughly reviewed and assessed in an open, unbiased, and expert manner. The results are publishes in the open, peerreviewed scientific literature.

15 An Expert Panel in an Open Process Nine voting members include physicians and scientists. Publicly nominated by consumer, scientific and medical groups, government agencies and industry. Three non-voting liaison members representing FDA, Consumer Federation of America, and Industry. The Panel meeting are open to the public and process includes multiple opportunities for public comment. CIR final reports are published in the International Journal of Toxicology.

16 Expert Panel -- Chair and Teams Leaders Wilma F. Bergfeld, M.D., F.A.C.P. - Panel Chairperson - Head of Clinical Research and Dermatopathology, The Cleveland Clinic Foundation - Past President of the American Academy of Dermatology and the Women s Dermatological Society Donald V. Belsito, M.D. - Team Leader - Leonard C. Harber Professor of Dermatology, Department of Dermatology Columbia University Medical Center James G. Marks, M.D. - Team Leader - Professor of Dermatology, Department of Dermatology, Pennsylvania State University College of Medicine Milton S. Hershey Medical Center

17 CIR Expert Panel Meetings Meets 4 times per year in Washington, DC Day 1; Team meetings Day 2; Entire Panel meets Compare conclusions Resolve differences Formulate Conclusions Open to Public

18 Potential Conclusions The Panel may make one of four basic decisions: Safe Ingredients safe in current concentrations and practices of use. Safe with qualifications An ingredient can be used safely, but only under certain conditions. (Maximum concentration, rinse-off v. leave-on or other restrictions). Unsafe Ingredients with specific adverse effects that make them unsuitable for use in cosmetics. Use Not Supported by the Data and Information Submitted to the CIR There remains Insufficient Data or Information and reported uses for more than two years after the Expert Panel Final Report.

19 CIR - Roles & Responsibility Not the primary assessment but provides an independent check on industry performance Panel Responsible for Best Science & Best Management Practices Transparent processes Open Sourcing of data Reports published in the Intern. Journal of Toxicology. The science can be pursued by anyone who is inspired to agree or disagree with the expert panel s conclusions!

20 FDA Authority Government - Oversight ENFORCEMENT Conduct Inspections of manufacturing plants Issue Warning Letters Request Voluntary Recalls including Press Releases Domestic -- Working with Department of Justice Have a restraining order issued Seize Products Up to and Including Criminal prosecution. Imports -- With Customs and Border Protection Prevent Entry (Most have involved Drug claims or Unapproved color additives)

21 Demonstrated Effectiveness

22 A Proven Record of Safety FDA Product Experience Reports Voluntary Cosmetic Reporting U.S. companies participating 2.03 reports/ Million units FDA estimates 30-40% Represents 5 to 7 unconfirmed EXPERIENCES reported for every million units sold Reactions to Cosmetics are Very Rare

23 Today -- FDA Adverse Event Reporting System FDA CFSAN Adverse Event Reporting System (CAERS) CAERS captures any adverse events or complaints related to foods, dietary supplements, or cosmetics. Include minor to major medical events, but also complaints about offtaste or color, defective packaging, and other non-medical issues. Receives reports of adverse health events and product complaints from multiple sources healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others)

24 Some Limitations of Passive Surveillance May Under Estimate Under-reporting Missing data May Over Estimate Unconfirmed, both product and event Association does not necessarily indicate causation Erroneous reporting Duplicate reports Confounding Variables Inconsistencies and changes over time (product name change or coded differently) Does CAERS Data Have Limitations?

25 FDA CAERS Jan June 2017 Total entries: 90,786 Cosmetics: 11,753 ~13% of total & 10,745 unique Outcome: None/Non-serious: 3332 Vitamins/Minerals/Proteins/Unconv. Diet(Human/Animal): 48,501

26 Potential Problematic Categories Hair relaxers/straighteners/permanents 2014 Hair dyes/colors 445 Tattoos and tattoo inks 340 Hair removal 61

27 Adverse Event Reports Reports^ Reports Reports Reports ,085 Reports # ,576 Reports # 122 Billion Units sold in 2010* 2011 ~ 3 unconfirmed reports / BILLION units Consumer AE Reports to FAERS on Drugs 2014 = 1,289,133 ^ FDA, Letter to Honorable Lamar Alexander, Oct 17, 2016 * Rexam Consumer packaging Report 2011/12, Packaging Unwrapped. #

28 FDA Noted Increase in 2015/ 2016 This is a dramatic increase from previous years. For example, only 445 reports were submitted in There are a couple of reasons for this. There are the high-profile cases that generated many reports and FDA s commitment to education and outreach has raised awareness of the need for consumers and health care professionals to report adverse events involving cosmetics. Using Adverse Event Reports to Monitor Cosmetic Safety, FDA Single Brand 1627 Single Outcome htm

29 Adverse Events associated with personal care products are extremely rare Present Practices are Proven to Work!

30 Conclusions Cosmetics are safe and meet consumer s quality expectations. Industry achieves this by implementing and sharing Best Practices Industry responsibility coupled with FDA oversight and CIR review is proven effective with any type of adverse event being extremely rare. Finally, industry is committed to continuous improvement and expects to continue working cooperatively with authorities ensuring world class performance in our industry.

31 QUESTIONS? Jay M. Ansell, Ph.D., DABT Vice President - Cosmetic Programs Personal Care Products Council 1620 L Street, N.W. Washington, D.C USA ansellj@personalcarecouncil.org