Consumer Product Testing Company, Inc. · Performance ClaimsPerformance Claims • Anti-aging •...

Cosmetic Testing for the U.S. Market

Craig R. Weiss Craig R. Weiss

Consumer Product Testing Company, Inc.Consumer Product Testing Company, Inc.

Objectives

• Safety Testing• Review of history of safety testing of new technologies

S f t t ti f t d• Safety testing of today• Where do we go from here• Nanomaterials: A Case Study

• Cosmetic Claims Support• Why do we make claims• Why do we make claims• What is a cosmetic efficacy claim• Types of claims

M th d l i• Methodologies• What makes a good study

Cosmetic Safety Testing•A cosmetic product shall be “generally recognized as safe”.

•There is no FDA safety standard for cosmetic products within the act.There is no FDA safety standard for cosmetic products within the act.

•In the Federal Register of March 3, 1975 (40 FR 8912 at 8916), FDA advised that "the safety of a product can be adequately substantiatedadvised that the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in g pcomposition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of

h i i d d i f i Al h h i f i l i lsuch existing data and information. Although satisfactory toxicological data may exist for each ingredient of a cosmetic product, it will still be necessary to conduct some toxicological testing with the completenecessary to conduct some toxicological testing with the complete formulation to assure adequately the safety of the finished cosmetic."

History of safety testing Animal tests were used prior to any new technology usep y gy

– ToxicitySingle dose oral toxicity (5mg/Kg) in ratsLD50 in rats

– Dermal irritancyPrimary dermal irritation in rabbitsPrimary dermal irritation in rabbits

– Ocular irritancyOcular irritation in rabbits

– SensitizationGuinea Pig sensitzation

Non-animal preclinical testing– Mutagenicity (Ames)– Microbiological APE

Cosmetic Safety Testing Today

• In 1991 the CTFA published safety testing guidelines.

• Updated March 2007.

• Cosmetic Ingredient Review panel establishes generally regarded as safe (GRAS) ingredients.

• Testing new and existing product consisting of GRAS ingredients still g g p g gneeds to be performed.

• When developing a safety profile the type of application and length ofWhen developing a safety profile the type of application and length of contact with the body must be considered

• Preclinical TestingCosmetic Safety Testing Today

Preclinical Testing

• Toxicity• Tox Risk Assessment (TRA)

• CIR Panel

• In-Vitro• Dermal irritancyy

• Skin culture techniques

• MTT Assayy

• Biomarkers PLA2, prostaglandins and interleukins

• Non skin vegetable based protein disassociation testsNon skin vegetable based protein disassociation tests

• IRRITECTION Skintex

O l i i

Cosmetic Safety Testing Today– Ocular irritancy

• HET CAM assay• Tissue culture techniques

– MTT Assayi k A2 l di d i l ki– Biomarkers PLA2, prostaglandins and interleukins

• Non tissue vegetable based protein disassociation testsIRRITECTION E– IRRITECTION Eytex

Non animal preclinical testing– Non-animal preclinical testing• Mutagenicity (Ames)• Microbiological APE• Microbiological APE

Cosmetic Safety Testing Today• Clinical TestingClinical Testing

– Prophetic patch testing• Twenty-four hour patch test

– Irritation evaluation• Forty-eight hour patch test for irritation

H R t d I lt P t h T t (HRIPT)• Human Repeated Insult Patch Test (HRIPT) – irritation and sensitization evaluation

• Cumulative patch testCumulative patch test– Irritation over time or mildness evaluation

• PhototoxicityI it ti l ti f th d t ith UV– Irritation evaluation of the product with UV energy

• Photoallergy– irritation and sensitization evaluation with of the product UV energyp gy

Cosmetic Safety Testing Today

•In-Use Studies• The product would be tested in use or exaggerated use conditions.

Evaluation conducted by physician, trained evaluator or by the test subjecttest subject.

•Products containing known irritants.

R i d•Regime product groups.

•Hygiene products.

•Pediatric products.

Cosmetic Safety Testing TodayP d t t b d d th d i l id tiProducts to be used around the eye need special consideration.-An ophthalmology in-use study should be considered.Child ’ d t d dditi l t tiChildren’s products need additional testing-An in-use study monitored by a pediatrician should be considered.If th i di t t GRAS dditi l t ti d t bIf any the ingredients are not GRAS, additional testing needs to be considered.A l HRIPT P l-A larger HRIPT Panel

-Multiple In-Vitro studies

Cosmetic Safety Testing, where do we go from here?FDA Draft Guidance for Industry: Safety of Nanomaterials inFDA Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic product

– Considerations in safety assessmentConsiderations in safety assessmentPhysico-chemical characteristics

– Morphology– Surface features– Charge

ImpuritiespExposure limits Toxicokinetics

The passage through the body of a toxic agent or its metabolites– The passage through the body of a toxic agent or its metabolitesToxicodynamics

– The physiological mechanisms by which toxins are absorbed, distributed, metabolized and excreted

Cosmetic Safety Testing, where do we go from here?FDA Draft Guidance for Industry: Safety of Nanomaterials inFDA Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic product– Toxicology Considerationsgy

Intended useExposure levelPotential for toxicityRoute of exposureUptake and absorption

– Nanomaterials can settle, diffuse, and aggregate differentially according to their size, density, and surface chemistry Therefore, the assessment of the agglomeration or aggregation of nanomaterials in any test media used in vivo or in vitro testnanomaterials in any test media used in-vivo or in vitro, test systems should be addressed.

Cosmetic Safety Testing, where do we go from here?FDA Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic product

– Toxicity testingMi i i i i h ld i l dMinimum toxicity testing should include:

– Acute toxicity testingSingle dose 5mg/KgS g e dose 5 g/ gLD50

– Repeated dose toxicity (21-28 days)– Subchronic toxicity (90 days)– Skin irritation

Dermal photoirritation (phototoxicity)– Dermal photoirritation (phototoxicity)– Skin sensitization– Mutagenicity– Genotoxicity

– Additional In-Vitro testing is under consideration for irritation only

Cosmetic Claims Support

Claims are made to:Claims are made to: – Inform the consumer– Stay competitive

• To sell products• To sell products

Cosmetic Efficacy Claims Support•A cosmetic claim is not a structure/function claim

•Efficacy Studies are used to validate claimsEfficacy Studies are used to validate claims

• Advertising is regulated by the Federal Trade Commission

•Efficacy claim on cosmetics labels must be supported by valid (Industry Standards) studiesvalid (Industry Standards) studies

•Validation studies must comply with industry standards

• Labeling is regulated by the FDAM d t t t t i di t i t t• Mandatory statements: ingredients, warnings, etcetera

Cosmetic Efficacy Claims Support•Formulation ClaimsFormulation Claims

•Contains Aloe•Contains Honey “ A natural humectant”•Oil Free

•Performance claimsPerformance claims• Hypoallergenic• Dermatologist Tested• Ophthalmologist TestedOphthalmologist Tested• Suitable for contact lens wearers• Instantly boosts hydration levels by over X%• SPF 15• SPF 15• In 2 weeks, consumers perceive a 74% decrease in fine lines and

wrinkles• Under most circumstances only performance claims need to be validated

Cosmetic Efficacy Claims SupportPerformance ClaimsPerformance Claims

• Anti-aging• Fine line and wrinkles

( )

•Skin elasticity•Skin soothing claims

f f i i ki(appearance)• Skin elasticity• Skin firmness

•Safe for sensitive skin•Reduce the appearance of celluliteSkin firmness

• Age spots• Skin texture

• Hair product claimsBounce Manageability

• Moisturization • Humectantcy

B i f i

g yColorFrizz and split ends•Nail product claims• Barrier function

• Flaky skin• Skin tone

Nail product claimsPeelingCrackingStrengtheningSkin tone

• Oil control • Comedone control

Strengthening


• Clinical significance versus statistical significanceClinical significance versus statistical significance• Clinical significance: Can you see the changes made as a result of the products

performance.• Statistical significance: Does the data pro e a real change as tested b statistical• Statistical significance: Does the data prove a real change, as tested by statistical

methods, chi squared, t-test, ANOVA, SAS, etcetera. • Regulators want to see both clinical and statistical significant product benefits to

b i l isubstantiate a claim.• Clinical photography is often used as an integral part of proving significance


Claims can be substantiated, or validated using one or both of the following waysthe following waysSubjective Support

“In two weeks consumers perceived a X% decrease in fine lines and wrinkles”– In two weeks consumers perceived a X% decrease in fine lines and wrinkles – “Long wearing”– Sensory Claims– Calibrated expert graders

Objective Supportj pp– Bio-instrumentation

- Instantly boost hydration level by X%- Reduction of wrinkles by X%

– Calibrated expert graders


• Claims that can be substantiated by subjective methods– Sensory Claims

• Odor and malodor • StingSting• Feel

– Consumer preference• Product A versus B• Test product versus the consumers “normal” product

– Self perceived product benefitsSelf perceived product benefits• In-use questionnaire based studies


• Claims that MUST be substantiated by objective methods– Quantitative claimsQ

• Wrinkle and fine line reduction• Firmness• Moisturization (percentage)• Elasticity• Skin tone• Skin tone• Sebum production• Flaking sking

Cosmetic Efficacy Claims Support Methods

All efficacy studies for skin product should be performed in an appropriate environmental room.


MoisturizationMoisturization

• Electrical conductance/capacitance• Corneometer ®• Novameter ®• Novameter ®

• Transepidermal water lossp• TEWL Meter ®• Vapometer ®• Servomed Evaporimeter ®


• Wrinkle and fine line reduction•• PrimosPrimos 3D3D®

•State of the art imaging systemto quantify wrinkles and fine linesto quantify wrinkles and fine lines

• Competitive instrumentation, • Foytes ® system• Skin-Visiometer® SV 600

• Competitive technology • Image analysis of silicone replicasg y p• Calibrated expert grading


S i /T i

Viscoelasticity

• Suction/Torsion• Cutometer• Dermflex• Twistometer

• Competitive instrumentation• Balistometer

• Competitive technology• Pinch/Recoil methodPinch/Recoil method


Skin Tone Measurements

• L*A*B* measurement instruments• L*A*B* measurement instruments• Minolta Chromameter• IMS Smartprobe• Datacolor

• Competitive instrumentationCompetitive instrumentation• Digital photography with computer color analysis

• Competitive Technology• Expert calibrated grading


Clinical Photography

•Visia CR Photographic System

Ch i•Charmview

•Digital Microscope Systems•Digital Microscope Systems

•Epiflash systemsp y

Contents of a “Good” Study•Good Designed Preapproved Protocol byGood Designed Preapproved Protocol by

•Primary Investigator (PI)•Sub-investigatorsSt d S•Study Sponsor

•Institutional Review Board•Amendments if necessary

•Appropriate Subject Selection •Number as based on biostatical power computations•Type as defined in the demographics in the protocolType as defined in the demographics in the protocol

•Compliant Subjects•Protocol •C li t ith th li i i t•Compliant with the clinics requirements

•Visits•Medical history

I f d C t th t i HIPA li t•Informed Consent that is HIPA compliant

Questions

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Contact Information

C i R W iCraig R. WeissConsumer Product Testing Company, Inc.

70 Ne D tch Lane70 New Dutch LaneFairfield, NJ 07004

Phone (973) 808-7111Facsimile (973) 244 7503Facsimile (973) 244-7503E-mail [email protected]

Consumer Product Testing Company, Inc. · Performance ClaimsPerformance Claims • Anti-aging •...

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