Cosmetics – FDA Regulatory Cosmetics – FDA Regulatory Programs and PerspectivesPrograms and Perspectives

Association of Food And Drug OfficialsAssociation of Food And Drug Officials117th Annual Educational Conference 117th Annual Educational Conference

June 11, 2013June 11, 2013

Patricia A. Hansen, Ph.D.Patricia A. Hansen, Ph.D.Deputy DirectorDeputy Director

Office of Cosmetics and ColorsOffice of Cosmetics and ColorsU.S. Food and Drug AdministrationU.S. Food and Drug Administration

OutlineOutline

FDA’s statutory authorities, regulations FDA’s statutory authorities, regulations

FDA regulatory tools and programsFDA regulatory tools and programs

Examples of recent issues and activitiesExamples of recent issues and activities

Interest in augmenting FDA’s statutory authoritiesInterest in augmenting FDA’s statutory authorities

Cosmetics – ScopeCosmetics – Scope

Used by most consumers every dayUsed by most consumers every dayExamples:Examples: – Moisturizers, other skin preparationsMoisturizers, other skin preparations– Hair care, hair dyes, hair straightenersHair care, hair dyes, hair straighteners– Makeup, nail polishesMakeup, nail polishes– Shaving preparationsShaving preparations– Perfumes and colognesPerfumes and colognes– Toothpastes, mouthwashes Toothpastes, mouthwashes – Face and body cleansers, deodorantsFace and body cleansers, deodorants

Multi-billion dollar industryMulti-billion dollar industryIncreasingly global industry Increasingly global industry

CosmeticCosmetic

Defined in the Federal Food, Drug, and Defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 201 (i)Cosmetic Act (FD&C Act), Section 201 (i)

Articles intended for:Articles intended for:– CleansingCleansing– BeautifyingBeautifying– Promoting attractivenessPromoting attractiveness– Altering the appearanceAltering the appearance

** Excludes “Soap” (defined very narrowly)** Excludes “Soap” (defined very narrowly)

DrugDrug

Defined in FD&C Act, Section 201 (g)Defined in FD&C Act, Section 201 (g)

Articles intended--Articles intended--– For use in the diagnosis, cure, mitigation, For use in the diagnosis, cure, mitigation,

treatment, or prevention of diseasetreatment, or prevention of disease– To affect the structure or any function of To affect the structure or any function of

the body of man or other animalsthe body of man or other animals

Cosmetics – FDA’s AuthorityCosmetics – FDA’s Authority

Cosmetics must not be adulterated or Cosmetics must not be adulterated or misbranded misbranded

The law does The law does NOTNOT provide for FDA pre- provide for FDA pre-market approval market approval

FDA’s authority is post-market onlyFDA’s authority is post-market only

Prohibited Under FD&C ActProhibited Under FD&C Act

Adulterated CosmeticsAdulterated Cosmetics

– Harmful or injurious Harmful or injurious under labeled or under labeled or customary conditions of customary conditions of useuse

FormulationFormulationContainerContainerContaminationContamination

– Unapproved Color AdditiveUnapproved Color Additive““Coal Tar Hair Dye Coal Tar Hair Dye Exemption” (Sec. 601 (a))Exemption” (Sec. 601 (a))

– Manufactured or held under Manufactured or held under “insanitary” conditions“insanitary” conditions

Misbranded CosmeticsMisbranded Cosmetics

– False or misleading labelingFalse or misleading labeling

– Required information Required information missing or presented missing or presented improperly improperly

– Deceptive containerDeceptive container

– Doesn’t comply with 1970 Doesn’t comply with 1970 Poison Prevention Poison Prevention Packaging Act (Child Packaging Act (Child resistant)resistant)

OTC DrugOTC Drug– Monograph or product-Monograph or product-

specific pre-market specific pre-market approval requiredapproval required

– Pre-market evaluation of Pre-market evaluation of safety & efficacysafety & efficacy

– GMP regulationsGMP regulations– Establishments & Establishments &

products must be products must be registeredregistered

– Serious adverse events Serious adverse events must be reportedmust be reported

CosmeticCosmetic– Pre-market approval not Pre-market approval not

requiredrequired– No pre-market clearance No pre-market clearance

of safety or efficacyof safety or efficacy– GMP guidelines onlyGMP guidelines only– Establishments & Establishments &

products not required to products not required to be registeredbe registered

– Adverse events not Adverse events not required to be reportedrequired to be reported

OTC Drug vs. CosmeticOTC Drug vs. Cosmetic

Cosmetics RegulationsCosmetics Regulations

General (21 CFR Part 700)General (21 CFR Part 700)– DefinitionsDefinitions– Requirements for Specific Cosmetic ProductsRequirements for Specific Cosmetic Products

Cosmetic Labeling (21 CFR Part 701)Cosmetic Labeling (21 CFR Part 701)

Voluntary Registration of Cosmetic Product Voluntary Registration of Cosmetic Product Establishments (21 CFR Part 710)Establishments (21 CFR Part 710)

Voluntary Filing of Cosmetic Product Ingredient Voluntary Filing of Cosmetic Product Ingredient Composition Statements (21 CFR Part 720)Composition Statements (21 CFR Part 720)

Cosmetic Product Warning StatementsCosmetic Product Warning Statements(21 CFR Part 740)(21 CFR Part 740)

Cosmetics - ChallengesCosmetics - Challenges

Limited legal authoritiesLimited legal authoritiesCompeting agency priorities Competing agency priorities

Significant changes in past 5-7 yearsSignificant changes in past 5-7 years– Manufacturing more globalManufacturing more global– Alternatives to animal testingAlternatives to animal testing– Increasingly sophisticated technology and Increasingly sophisticated technology and

complex ingredientscomplex ingredientsNanotechnologyNanotechnology““Active” ingredientsActive” ingredientsBotanicalsBotanicals

FDA and International HarmonizationFDA and International Harmonization

Over-arching goalsOver-arching goals– Facilitate international tradeFacilitate international trade– Promote mutual understandingPromote mutual understanding– Facilitate exchange of scientific and regulatory knowledge Facilitate exchange of scientific and regulatory knowledge

(as law allows)(as law allows)– Accept equivalent standards and compliance/enforcement Accept equivalent standards and compliance/enforcement

programs, provided they meet U.S. standards for public programs, provided they meet U.S. standards for public health protectionhealth protection

Critical to maintain a high level of public health Critical to maintain a high level of public health protectionprotection

International HarmonizationInternational Harmonization

International Cooperation on Cosmetics Regulation (ICCR)International Cooperation on Cosmetics Regulation (ICCR)– United States, Canada, European Union and JapanUnited States, Canada, European Union and Japan– Industry trade association partnersIndustry trade association partners

ISO TC-217 (Cosmetics) and Working GroupsISO TC-217 (Cosmetics) and Working Groups– Review draft standards and new work proposalsReview draft standards and new work proposals– Working Groups:Working Groups:

Microbiological standards and limitsMicrobiological standards and limits

Packaging, labeling and markingPackaging, labeling and marking

Analytical methodsAnalytical methods

TerminologyTerminology

Good manufacturing practices (GMPs)Good manufacturing practices (GMPs)

NanomaterialsNanomaterials

Sunscreens* (regulated as drugs in the U.S.)Sunscreens* (regulated as drugs in the U.S.)

FDA’s Tools for Monitoring Compliance FDA’s Tools for Monitoring Compliance and Enforcing Legal Requirementsand Enforcing Legal Requirements

InspectionsInspections

Import entry review and field examinationsImport entry review and field examinations

Import AlertsImport Alerts

Warning LettersWarning Letters

SeizuresSeizures

InjunctionsInjunctions

FDA’s Risk-Based Enforcement FDA’s Risk-Based Enforcement PrioritiesPriorities

Oral care products (esp. low or no Oral care products (esp. low or no alcohol mouthwash)alcohol mouthwash)

Eye-area cosmeticsEye-area cosmetics

Skin care productsSkin care products

Certain hair care productsCertain hair care products

Color additivesColor additives

What information does FDA use in developing What information does FDA use in developing priorities and evaluating the safety of cosmetics?priorities and evaluating the safety of cosmetics?

FDA’s database of adverse event reports FDA’s database of adverse event reports

Historical recall data and inspectional findingsHistorical recall data and inspectional findings

Data from FDA’s Voluntary Cosmetic Registration Program Data from FDA’s Voluntary Cosmetic Registration Program

FDA research, other published scientific literatureFDA research, other published scientific literature

Data from other government agencies (such as the NTP)Data from other government agencies (such as the NTP)

Findings of the Cosmetic Ingredient Review (CIR) Expert PanelFindings of the Cosmetic Ingredient Review (CIR) Expert Panel

Findings of other authoritative bodies (such as the IOM) Findings of other authoritative bodies (such as the IOM)

Data and information from the cosmetic industry, othersData and information from the cosmetic industry, others

Adverse EventsAdverse EventsOctober 2011 - September 2012October 2011 - September 2012

Total of 381 adverse events reported (over 130 Total of 381 adverse events reported (over 130 required medical care) required medical care) – Skin care preparations 43%Skin care preparations 43%

– Hair straighteners 15%Hair straighteners 15%

– Hair care preparations (non-coloring) 14%Hair care preparations (non-coloring) 14%

– Hair care preparations (coloring) 13%Hair care preparations (coloring) 13%

– Makeup (not eye area) 8%Makeup (not eye area) 8%

– Eye-area makeup 6%Eye-area makeup 6%

– Personal cleanliness products 4%Personal cleanliness products 4%

– Baby products 2%Baby products 2%

– Oral hygiene, fragrance, suntan products 1% eachOral hygiene, fragrance, suntan products 1% each

* Numbers do not add to 100%, some reports involve more than one product* Numbers do not add to 100%, some reports involve more than one product

FDA’s Initiative to Increase Awareness of FDA’s Initiative to Increase Awareness of Adverse Event Reporting for CosmeticsAdverse Event Reporting for Cosmetics

Updated web with consumer education information Updated web with consumer education information regarding reporting of AERsregarding reporting of AERs

– ““Bad Reaction to Cosmetics? Tell FDABad Reaction to Cosmetics? Tell FDA””

Produced a webinar on the importance of reporting Produced a webinar on the importance of reporting AEs involving cosmetics and how to submit a reportAEs involving cosmetics and how to submit a report

Distributed information at meetings of public health Distributed information at meetings of public health officials and organizationsofficials and organizations

Developing plan for outreach to health professionals Developing plan for outreach to health professionals providing direct care providing direct care

FDA’s Voluntary Cosmetic FDA’s Voluntary Cosmetic Registration Program (VCRP)Registration Program (VCRP)

Created in the 1970’s as way to gather post-market data Created in the 1970’s as way to gather post-market data Assists FDA in monitoring the marketplace and Assists FDA in monitoring the marketplace and assuring cosmetic safetyassuring cosmetic safetyElectronic submissions began December 2005Electronic submissions began December 2005

Current status (01/04/2013)Current status (01/04/2013)– 1671 registered establishments1671 registered establishments– 1968 firms with product ingredient statements filed1968 firms with product ingredient statements filed– 41179 number of active products41179 number of active products

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Cosmetic Import Into the United States FY 2003-2010

Import Entries 753.809 939.893 1146.049 1358.918 1465.113 1588.082 1824.173 2095.362

2003 2004 2005 2006 2007 2008 2009 2010

Import RefusalsImport Refusals

In FY2012 there were a total of 2358 cosmetic In FY2012 there were a total of 2358 cosmetic import refusalsimport refusals

Reasons for refusalReasons for refusal– Drugs/medical devices improperly marketed as Drugs/medical devices improperly marketed as

cosmetics 19%cosmetics 19%– Labeling violations 61%Labeling violations 61%– Color additive violations 17%Color additive violations 17%– Poisonous/harmful contaminants, filth/insanitary Poisonous/harmful contaminants, filth/insanitary

conditions 3%conditions 3%

Currently 12 Import Alerts for cosmeticsCurrently 12 Import Alerts for cosmetics

Subject to “detention without physical examination”Subject to “detention without physical examination”

Broad categories for cosmetic-specific alerts include:Broad categories for cosmetic-specific alerts include:– Unapproved color additivesUnapproved color additives– Poisonous or deleterious substances Poisonous or deleterious substances – LabelingLabeling– Filth/insanitary conditionsFilth/insanitary conditions

Other related Import Alerts:Other related Import Alerts:– 17-03 – Amniotic Fluid (Bovine)17-03 – Amniotic Fluid (Bovine)– 17-04 - Bulk High-Risk Bovine Tissue from BSE Countries17-04 - Bulk High-Risk Bovine Tissue from BSE Countries– 66-38 - Skin Care Products with Anti-aging Claims66-38 - Skin Care Products with Anti-aging Claims– 66-41 - Unapproved New Drugs66-41 - Unapproved New Drugs– 66-74 - Dentifrice Products Containing Diethylene Glycol (DEG66-74 - Dentifrice Products Containing Diethylene Glycol (DEG))

Import Alerts for CosmeticsImport Alerts for Cosmetics

FDA Inspection of Cosmetic FDA Inspection of Cosmetic FacilitiesFacilities

Facilities of all sizes are subject to inspectionFacilities of all sizes are subject to inspection

100-150 U.S. facilities inspected annually100-150 U.S. facilities inspected annually

Inspections can be routine or “for cause”Inspections can be routine or “for cause”

Small number of foreign inspectionsSmall number of foreign inspections

Historical focus on manufacturing facilitiesHistorical focus on manufacturing facilities

Microbiological Safety of Cosmetics - Microbiological Safety of Cosmetics - Updating and Restructuring FDA ToolsUpdating and Restructuring FDA Tools

Revise Chapter 23 of FDA’s Bacteriological Revise Chapter 23 of FDA’s Bacteriological Analytical Manual (BAM)Analytical Manual (BAM)

Develop/Revise FDA Compliance GuidanceDevelop/Revise FDA Compliance Guidance– Compliance Policy Guide (CPG)Compliance Policy Guide (CPG)– Compliance ProgramCompliance Program

Develop Guidance for IndustryDevelop Guidance for Industry– Stakeholder input from November 2011 public meeting Stakeholder input from November 2011 public meeting – Laboratory data and other technical informationLaboratory data and other technical information

FDA Cosmetics Research FDA Cosmetics Research

Method developmentMethod development

Product surveysProduct surveys

Skin penetration and absorption studiesSkin penetration and absorption studies

NanotechnologyNanotechnology

Photosciences/PhotobiologyPhotosciences/Photobiology

Laboratory Surveys – Lead in LipstickLaboratory Surveys – Lead in Lipstick

400 lipsticks on the U.S. market in Spring 2010400 lipsticks on the U.S. market in Spring 2010– Market Sample: Market Sample:

All the major retailersAll the major retailers

Number of lipsticks for each brand Number of lipsticks for each brand →→ market share market share

A few lipsticks from niche marketsA few lipsticks from niche markets

Product Surveys – Lead in LipstickProduct Surveys – Lead in Lipstick

ConclusionsConclusions

Lipsticks average ~1 Lipsticks average ~1 µg Pb/gµg Pb/g

10 out of the 400 lipsticks (< 3 %) had > 3.36 µg Pb/g10 out of the 400 lipsticks (< 3 %) had > 3.36 µg Pb/g

2 out of the 400 lipsticks (0.5 %) had > 5 µg Pb/g2 out of the 400 lipsticks (0.5 %) had > 5 µg Pb/g

No evidence that levels of lead in lipstick would pose a No evidence that levels of lead in lipstick would pose a safety concernsafety concern

Issue - Nanomaterials in Issue - Nanomaterials in CosmeticsCosmetics

Currently Reported UsesCurrently Reported Uses

– Nanodispersed SystemsNanodispersed SystemsLiposomes (nanosomes)Liposomes (nanosomes)Solid lipid nanoparticlesSolid lipid nanoparticlesNanoemulsionsNanoemulsions

– Other NanoparticlesOther NanoparticlesNanocapsulesNanocapsulesPolymer systemsPolymer systemsMetal Oxide NanoparticlesMetal Oxide Nanoparticles

Recommendations of FDA Recommendations of FDA Nanotechnology Task Force Nanotechnology Task Force

• FDA should issue guidanceFDA should issue guidance• Identify issues to consider in assessing safety Identify issues to consider in assessing safety

• Clarify information manufacturers should provide to FDAClarify information manufacturers should provide to FDA

• Clarify when nanomaterial use may change regulatory statusClarify when nanomaterial use may change regulatory status

• FDA should evaluate current testing approaches FDA should evaluate current testing approaches

• FDA should assess data needsFDA should assess data needs

Draft cosmetics guidance published April 2012Draft cosmetics guidance published April 2012

Final guidance currently in clearanceFinal guidance currently in clearance

Active laboratory research programActive laboratory research program

Issue - Tattoo Inks and Issue - Tattoo Inks and Tattoo PigmentsTattoo Pigments

Tattoo inks are a mixture of pigments and diluents Tattoo inks are a mixture of pigments and diluents intended for introduction into the skinintended for introduction into the skin

FDA traditionally has not exercised its color additive FDA traditionally has not exercised its color additive regulatory authority over tattoo inks or tattoo regulatory authority over tattoo inks or tattoo pigmentspigments– Historically, few adverse events reportedHistorically, few adverse events reported– Relatively small segment of the population with Relatively small segment of the population with

tattoostattoos

The practice of tattooing is regulated by state and The practice of tattooing is regulated by state and local jurisdictionslocal jurisdictions

Tattoo InksTattoo InksChanges in the LandscapeChanges in the Landscape

Tattoos growing in popularity – 25% of Tattoos growing in popularity – 25% of population sports a tattoo!population sports a tattoo!

Reports of adverse reactions linked to Reports of adverse reactions linked to tattoos and permanent makeup have steadily tattoos and permanent makeup have steadily increased over past decadeincreased over past decade

Reactions sometimes hard to controlReactions sometimes hard to control

Recovery can be painful, effects long-lastingRecovery can be painful, effects long-lasting

Tattoo Inks - FDA’s Future PlansTattoo Inks - FDA’s Future Plans

Gain better understanding Gain better understanding – Tattoo ink composition, methods of preservationTattoo ink composition, methods of preservation– Manufacturing practicesManufacturing practices– All segments of the industry All segments of the industry

Continued outreach with all stakeholdersContinued outreach with all stakeholders

Possible changes in regulatory approachPossible changes in regulatory approach– Standards for finished tattoo inks?Standards for finished tattoo inks?– Changes in FDA’s color additive enforcement policy with Changes in FDA’s color additive enforcement policy with

respect to tattoos?respect to tattoos?

Issue – Cosmetic Labeling Claims Issue – Cosmetic Labeling Claims When do they cross the line?When do they cross the line?

Cosmetics marketed with drug claims are misbrandedCosmetics marketed with drug claims are misbranded

6+ Warning Letters issued in autumn 2012 – generated 6+ Warning Letters issued in autumn 2012 – generated strong industry and media responsestrong industry and media response

Examples of claims: Examples of claims: – Kills bacteria and reduces inflammation Kills bacteria and reduces inflammation – Prevents (or heals) scarring and stretch marksPrevents (or heals) scarring and stretch marks– Stimulates the production of “youth proteins”Stimulates the production of “youth proteins”– Boosts the activity of genesBoosts the activity of genes– Increases collagen productionIncreases collagen production

Switching Gears…Switching Gears…

… … Congressional interest in Congressional interest in revisiting FDA’s statutory authorities revisiting FDA’s statutory authorities for cosmetics…for cosmetics…

Congressional Interest in Revisiting FDA’s Congressional Interest in Revisiting FDA’s Statutory Authorities for CosmeticsStatutory Authorities for Cosmetics

1970’s1970’s– Several hearingsSeveral hearings

– No legislation passedNo legislation passed

More recently, several bills introduced but not More recently, several bills introduced but not enacted. Most significant:enacted. Most significant:– 2009 FDA Globalization Act2009 FDA Globalization Act

Covered all FDA-regulated products, with significant new Covered all FDA-regulated products, with significant new authorities for cosmeticsauthorities for cosmetics

– 2010 Safe Cosmetic Act2010 Safe Cosmetic ActFocused on cosmeticsFocused on cosmetics

– 2011 Safe Cosmetics Act2011 Safe Cosmetics ActA re-working of the 2010 bill of the same nameA re-working of the 2010 bill of the same name

Congressional Interest in Revisiting FDA’s Congressional Interest in Revisiting FDA’s Statutory Authorities for CosmeticsStatutory Authorities for Cosmetics

And even more recently…And even more recently…

– HR 4262 introduced by Reps. Pallone and DingellHR 4262 introduced by Reps. Pallone and DingellA re-working of the cosmetics elements in the earlier A re-working of the cosmetics elements in the earlier FDA Globalization ActFDA Globalization Act

– HR 4395 introduced by Rep. LanceHR 4395 introduced by Rep. LanceFocus on cosmeticsFocus on cosmetics

Congressional Interest in Revisiting FDA’s Congressional Interest in Revisiting FDA’s Statutory Authorities for CosmeticsStatutory Authorities for Cosmetics

Common Elements in Bills Recently IntroducedCommon Elements in Bills Recently Introduced– Mandatory facility registrationMandatory facility registration

– Mandatory product ingredient listingMandatory product ingredient listing

– Mandatory adverse event reportingMandatory adverse event reporting

– Explicit authority to issue regulations addressing good Explicit authority to issue regulations addressing good manufacturing practices (GMPs)manufacturing practices (GMPs)

Elements With Varying Treatment in Bills Recently Elements With Varying Treatment in Bills Recently IntroducedIntroduced– Safety substantiation/evaluation (products, ingredients, Safety substantiation/evaluation (products, ingredients,

“contaminants”)“contaminants”)

– Recall authorityRecall authority

– Records maintenance and accessRecords maintenance and access

– OtherOther

Congressional Interest in Revisiting FDA’s Congressional Interest in Revisiting FDA’s Statutory Authorities for CosmeticsStatutory Authorities for Cosmetics

Will there be renewed activity in 2013?Will there be renewed activity in 2013?

Stay tuned!Stay tuned!

Contact InformationContact Information

Office of Cosmetics and ColorsOffice of Cosmetics and Colors5100 Paint Branch Parkway5100 Paint Branch ParkwayCollege Park, MD 20740College Park, MD 20740Phone: 1-240-402-1130Phone: 1-240-402-1130

Linda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and ColorsLinda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors

Patricia A. Hansen, Ph.D., Deputy Director, Office of Cosmetics and Colors Patricia A. Hansen, Ph.D., Deputy Director, Office of Cosmetics and Colors patricia.hansen@fda.hhs.gov

Thank You For Your Interest!Thank You For Your Interest!Questions?Questions?