THE SAFETY BEHIND INGREDIENTS

IN NAIL PRODUCTS

March 2, 2017

PCPC - WHO WE ARE

• Founded in 1894

• The leading national trade association for the cosmetic and personal care products industry.

• Represent more than 600 member companies: • 325 manufacture or distribute personal care products • 300 supply goods and services

• Council Departments include Science, Legal, International,

Legislative, Public Affairs and Marketing.

• We are the voice on scientific, legal, regulatory, legislative and international issues for the personal care product industry.

Introduction

MYTH: Cosmetics are not regulated

FACT: Cosmetics are not “pre-approved”

but are absolutely regulated!

AGENDA

The Government

o U.S. Food Drug and Cosmetic Act

o FDA Authority

Third-Party

o CIR

Industry

o INCI, AERS, CosmeticsInfo.org

3 Pillars Assuring Safety and Quality

What Does the Law Say?

U.S. FD&C Act:

• 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

THE GOVERNMENT

FDA Authority

• Conduct Inspections of manufacturing plants

• Issue Warning Letters

• Request Voluntary Recalls

• 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 instances where FDA has exercised

this authority have involved Drug claims or

unapproved color additives)

THE GOVERNMENT

Adverse Event Reporting

• CFSAN Adverse Event Reporting System(CAERS)

• Data on adverse events and product

complaints reported about food, dietary

supplements and cosmetics.

• Receives from multiple sources

• Consumers, Health Professionals, Industry

and Others

THE GOVERNMENT

Adverse Event Reports

• This includes 1208 reports on one product

• 70% non-serious

• 122 Billion Units sold in 2010* = 0.004 reports/million units

• Compare:

• Consumer AE Reports to FAERS on Drugs in 2014 = 823,813†

* Rexam Consumer packaging Report 2011/12, “Packaging Unwrapped”

† http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070456.htm

THE GOVERNMENT

2004-2016 Q3: 4,320 unique reports on

cosmetics or about 340 per year

over the last 13 years

Adverse Events associated with personal care products are extremely rare

Present practices are proven to work!

THE GOVERNMENT

3rd PARTY CONFIRMATION

The purpose of CIR is to determine those

cosmetic ingredients for which there is a

reasonable certainty in the judgment of

competent scientists that the ingredient is

safe under its conditions of use.

Cosmetic Ingredient Review

• CIR established in 1976 with support of FDA and Consumer Federation of America.

• The CIR and review process are independent from Council and the 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, peer-reviewed scientific literature.

3rd PARTY CONFIRMATION

CIR Expert panel

Dermatologists: • Chair, Wilma F. Bergfeld, MD, FACP – Cleveland Clinic • Team Leader, Donald V. Belsito, MD – Columbia University • Team Leader, James G. Marks, MD – Penn State College of Medicine

Toxicologists/Pathologists:

• Curtis D. Klaassen, PhD – University of Kansas Medical Center • Ronald C. Shank, PhD – University of California, Irvine • Thomas J. Slaga, PhD – University of Texas Health Science Center • Paul W. Snyder, DVM, PhD – Purdue University

Chemists:

• Daniel C. Liebler, PhD – Vanderbilt University • Ronald A. Hill, PhD – University of Louisiana at Monroe

Non-Voting Liaisons:

• Beth Jonas, PhD – representing industry • Linda Katz, MD – representing government • Rachel Weintraub, JD – representing consumers

CIR Assessment Process

• Set Priorities

• “Frequency of Use” as surrogate for exposure

• Specific safety concerns

• Develop Assessments

• Gather all published studies/reviews

• Solicit comment and unpublished data; Summarize the findings

• Panel review; identify data needs

• Incorporate all new data in report

• Panel review of all data, incl. new information

• Public deliberation / Make decision

• Publish results in peer reviewed journal

CIR Reports on Safety of Ingredients

All final CIR reports

are published in the

International Journal

of Toxicology

3rd PARTY CONFIRMATION

CIR: AN OBJECTIVE RESOURCE

• Safety data on over 4,800 cosmetic ingredients

• Reviews for each ingredient often include hundreds of studies

3rd PARTY CONFIRMATION

INCI

What is INCI?

International Nomenclature Cosmetic Ingredient (INCI)

• INCI names are developed by the International Nomenclature

Committee (INC) and published in the International Cosmetic

Ingredient Dictionary and Handbook.

• INCI names are uniform, systematic names internationally

recognized to identify cosmetic ingredients. In the U.S. and

many countries around the world, INCI names are referenced in

regulations that establish ingredient labeling for cosmetic

products.

INDUSTRY INITIATIVES

What is the INCI Dictionary?

• What: Technical compendium containing the INCI names and related

information for cosmetic ingredients.

• Use: Provides world community with accurate, transparent, and

harmonized nomenclature.

• How: By working with national governments, trade associations, and

other organizations to ensure that rules for harmonization of INCI

labeling names are developed to accommodate differing approaches in

national laws and regulations.

• Why: To have a single worldwide reference, based on sound scientific

principles, that allows the identification of the composition of personal

care products.

• Why: Harmonization is essential to the global free movement of goods.

INDUSTRY INITIATIVES

INCI

What INCI is not:

INCI is not an endorsement of an ingredient’s safety or

acceptability for use in a cosmetic.

INCI is not a pre-approved list of ingredients for any country.

It is the responsibility of the finished product manufacturer to

substantiate safety and to comply with current regulatory

requirements for the intended market

INDUSTRY INITIATIVES

INCI – Key Points

• Uniform ingredient labeling names promote a common

understanding of cosmetic composition throughout the

world

• The safety and regulatory status of ingredients can be

efficiently tracked on a global basis

• INCI system is based on sound-science which contributes to

its success

• Consumer health benefit of being able to recognize an

ingredient they may want to avoid (e.g., due to allergies)

regardless of where it’s made or sold

INDUSTRY INITIATIVES

• Cosmeticsinfo.org is an information Web site that includes

factual, scientific information on ingredients most

commonly used in cosmetics and personal care products in

the United States.

• The site is divided into two primary sections; (1) safety

information pages and (2) an ingredient database.

• Sets out how cosmetics are regulated in the U.S. and abroad,

components of cosmetic ingredient labeling, the authority of

the U.S. Food and Drug Administration (FDA) to regulate

cosmetics, and how companies evaluate the safety and

efficacy of their products.

COSMETICSINFO.ORG

INDUSTRY INITIATIVES

Includes CIR summaries and other scientific perspective

from regulatory agencies and 3rd parties

COSMETICSINFO.ORG

INDUSTRY INITIATIVES

Conclusions

• Cosmetics are regulated – cosmetics are safe

• Industry responsibility coupled with FDA oversight and CIR

third-party review has proven effective with any type of

adverse event being extremely rare.

• Consumer safety is the number one priority for cosmetic

and personal care products companies

Thank You

Thomas F. Myers, Esq. EVP - Legal & General Counsel Personal Care Products Council 1620 L Street, NW Washington, D.C. 20036 202-331-1770 myerst@personalcarecouncil.org