Nanomaterials in Consumer Nanomaterials in Consumer Products and FDA RegulationProducts and FDA Regulation

George A. KimbrellGeorge A. Kimbrell

The International Center for Technology The International Center for Technology AssessmentAssessment

Nano & Bio In Society Conference Nano & Bio In Society Conference

August 10, 2006August 10, 2006

CTA is a Washington, D.C.-based non-profit, bi-CTA is a Washington, D.C.-based non-profit, bi-partisan organization committed to providing the partisan organization committed to providing the public with full assessments and analyses of public with full assessments and analyses of technological impacts on society. CTA is devoted technological impacts on society. CTA is devoted to fully exploring the economic, ethical, social, to fully exploring the economic, ethical, social, environmental and political impacts that can environmental and political impacts that can result from the applications of technology or result from the applications of technology or technological systems.technological systems.

CTA’s Nanotechnology Project: 2002-present. CTA’s Nanotechnology Project: 2002-present.

IntroductionIntroduction

Topic: Developments in the U.S. Regulatory Topic: Developments in the U.S. Regulatory EnvironmentEnvironment

My Focus: Nanomaterial Consumer Products and My Focus: Nanomaterial Consumer Products and FDAFDA– Other US Federal Agencies with some regulatory Other US Federal Agencies with some regulatory

authority under existing statutes over different aspects authority under existing statutes over different aspects of nanotechnology: EPA, NIOSH, CPSC.of nanotechnology: EPA, NIOSH, CPSC.

Why: Consumer products composed of Why: Consumer products composed of nanomaterials have arrived and are particularly nanomaterials have arrived and are particularly prevalent in the personal care product sector, prevalent in the personal care product sector, which falls under FDA’s regulatory umbrella. which falls under FDA’s regulatory umbrella.

OverviewOverview

I. I. Nanomaterial consumer products currently Nanomaterial consumer products currently available on U.S. market shelves. available on U.S. market shelves.

II.II.FDA’s current stance on nanomaterial FDA’s current stance on nanomaterial

consumer product testing and regulation. consumer product testing and regulation.

III.III. Contrast FDA’s view with that of the Contrast FDA’s view with that of the scientific scientific community on the properties community on the properties and risks of and risks of nanomaterials. nanomaterials.

IV.IV. CTA’s legal petition. CTA’s legal petition.

Measures of Nanotechnology’s Measures of Nanotechnology’s

MaturationMaturation R&D surging: global nanotech R&D= $9 billion, with $1 R&D surging: global nanotech R&D= $9 billion, with $1

trillion estimated for 2015 (Lux Research 2006)trillion estimated for 2015 (Lux Research 2006) Term “nano” approaches ubiquitous status in U.S. Term “nano” approaches ubiquitous status in U.S.

society and media (>18,000 citations in U.S. media in society and media (>18,000 citations in U.S. media in 2005)2005)

The “gold rush” for nano-patents continues- over 4,000 The “gold rush” for nano-patents continues- over 4,000 U.S. patents issued to date (Lux Research 2006)U.S. patents issued to date (Lux Research 2006)

Perhaps most importantly, nanotechnology Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate… commercialization is moving forward at a rapid rate…

I. Nanomaterials in Consumer I. Nanomaterials in Consumer Products: The Future is Now Products: The Future is Now

(Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

Nanomaterials in Consumer ProductsNanomaterials in Consumer Products

Lux Research’s Lux Research’s 2006 Nanotechnology Report2006 Nanotechnology Report: more : more than $32 billion in nano-products sold in 2005, 2X than $32 billion in nano-products sold in 2005, 2X the total of 2004. the total of 2004.

Wilson Center’s Wilson Center’s Project on Emerging Project on Emerging NanotechnologiesNanotechnologies 2006 Consumer Product 2006 Consumer Product Database: over 200 self-identified nano-products Database: over 200 self-identified nano-products now on U.S. market shelves.now on U.S. market shelves.

Products include paints, coatings, sporting goods, Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, sunscreens, cosmetics, personal care products, stain-resistant clothing, and light emitting diodes stain-resistant clothing, and light emitting diodes used in computers, cell phones, and digital cameras.used in computers, cell phones, and digital cameras.

Nanomaterials in Consumer Products: The Nanomaterials in Consumer Products: The Personal Care Industry Leading the WayPersonal Care Industry Leading the Way

(Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

No Where Are Nanomaterials Reaching the No Where Are Nanomaterials Reaching the Consumer Faster than in Personal Care Consumer Faster than in Personal Care

ProductsProducts Royal Society’s 2004 Report noted their Royal Society’s 2004 Report noted their

prevalence.prevalence.

Wilson Center’s Consumer Product Wilson Center’s Consumer Product Datebase: largest single category (125 Datebase: largest single category (125 products) is health and fitness (including products) is health and fitness (including sunscreens, cosmetics, and other personal sunscreens, cosmetics, and other personal care products). care products).

Friends of the Earth Friends of the Earth Nanomaterials, Nanomaterials, Sunscreens and CosmeticsSunscreens and Cosmetics Report Report

FindingsFindings At least 116 cosmetics, At least 116 cosmetics,

sunscreens, and personal sunscreens, and personal care products containing care products containing nanomaterials nanomaterials commercially availablecommercially available..

includes well-known includes well-known companies such as companies such as Johnson & Johnson, Johnson & Johnson, Chanel, Estee Lauder, Chanel, Estee Lauder, Revlon, and L’Oreal.Revlon, and L’Oreal.

Report available at Report available at http://www.foe.org/camps/comm/nanotech/ http://www.foe.org/camps/comm/nanotech/

Nano-product spotlight: Nano-Nano-product spotlight: Nano-sunscreenssunscreens

Engineered nanoparticles make Engineered nanoparticles make them transparent or “cosmetically them transparent or “cosmetically clear,” rather than white.clear,” rather than white.

legally patented for their novelty.legally patented for their novelty.

Widely-available and used, “free” Widely-available and used, “free” particles; placed directly on skin.particles; placed directly on skin.

Nanoparticles of titanium dioxide Nanoparticles of titanium dioxide and zinc oxide shown to be and zinc oxide shown to be photoactive in some studies, photoactive in some studies, producing free radicals and producing free radicals and causing DNA damage to human causing DNA damage to human skin cells when exposed to UV skin cells when exposed to UV light.light.

As with nano-cosmetics, jury is As with nano-cosmetics, jury is still out on ease of skin still out on ease of skin penetration.penetration.

Report Case Study: Carbon FullerenesReport Case Study: Carbon Fullerenes

Fullerenes, also known as Fullerenes, also known as buckyballs, used in some buckyballs, used in some face and anti-aging creams face and anti-aging creams and have been found to and have been found to cause brain damage in fish, cause brain damage in fish, kill water fleas, and have kill water fleas, and have bactericidal properties.bactericidal properties.

Even low levels have been Even low levels have been found to cause damage to found to cause damage to human liver cells.human liver cells.

Found in 7 products in Found in 7 products in survey.survey.

II. FDA’s Regulatory Umbrella: The Federal II. FDA’s Regulatory Umbrella: The Federal Food, Drug, and Cosmetic Act (FFDCA)Food, Drug, and Cosmetic Act (FFDCA)

FDA is charged with regulating the safety and FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical as well as other substances such as medical devices, animal feed, and combination products devices, animal feed, and combination products (21 U.S.C. Ch. 9 (21 U.S.C. Ch. 9 et seq.et seq.))

Many currently available nano-products fall under Many currently available nano-products fall under FDA’s broad regulatory schemeFDA’s broad regulatory scheme– Cosmetics (21 U.S.C. § 361 Cosmetics (21 U.S.C. § 361 et seqet seq) ) – Sunscreens (21 U.S.C. § 321(g)) (classified as Sunscreens (21 U.S.C. § 321(g)) (classified as

human drugs) human drugs)

FDA’s Regulatory Stance on Nanomaterials FDA’s Regulatory Stance on Nanomaterials in Consumer Productsin Consumer Products

With regard to nanotechnology, FDA regulates “products With regard to nanotechnology, FDA regulates “products not technologies.”not technologies.”

FDA informally defines nanotechnology with reference to FDA informally defines nanotechnology with reference to the definition of the NNI, includingthe definition of the NNI, including– 1. the existence of materials or products at the atomic, 1. the existence of materials or products at the atomic,

molecular or macromolecular levels, where at least one molecular or macromolecular levels, where at least one dimension that affects the functional behavior of the dimension that affects the functional behavior of the drug/device product is in the length scale range of drug/device product is in the length scale range of approximately 1-100 nanometers;approximately 1-100 nanometers;

– 2. the creation and use of structures, devices and 2. the creation and use of structures, devices and systems that have novel properties and functions systems that have novel properties and functions because of their small size; and,because of their small size; and,

– 3. the ability to control or manipulate the product on the 3. the ability to control or manipulate the product on the atomic scale atomic scale

FDA’s Regulatory Stance (continued)FDA’s Regulatory Stance (continued)

FDA regulates a “wide range of products, FDA regulates a “wide range of products, including foods, cosmetics, drugs, devices, including foods, cosmetics, drugs, devices, and veterinary products, some of which may and veterinary products, some of which may utilize nanotechnology or contain utilize nanotechnology or contain nanomaterials.”nanomaterials.”

FDA is aware of “several FDA regulated FDA is aware of “several FDA regulated products [that] employ nanotechnology,” products [that] employ nanotechnology,” including “cosmetic products claim[ing] to including “cosmetic products claim[ing] to contain nanoparticles to increase the stability contain nanoparticles to increase the stability or modify the release of ingredients” and or modify the release of ingredients” and “nanotechnology-related claims made for “nanotechnology-related claims made for certain sunscreens.” certain sunscreens.”

FDA’s Regulatory Stance (continued)FDA’s Regulatory Stance (continued)

FDA treats nanomaterial product ingredients FDA treats nanomaterial product ingredients no differently than bulk material ingredients no differently than bulk material ingredients or products. FDA’s current stance is to or products. FDA’s current stance is to regulate (or decline to regulate) based on regulate (or decline to regulate) based on safety assessment of the same material in safety assessment of the same material in bulk form (e.g., nano- sunscreens)bulk form (e.g., nano- sunscreens)

With regard to its regulation of nanomaterial With regard to its regulation of nanomaterial products, FDA “believes that the existing products, FDA “believes that the existing battery of pharmacotoxicity tests is battery of pharmacotoxicity tests is probably probably adequateadequate for most nanotechnology products for most nanotechnology products that we regulate. Particle size is not the that we regulate. Particle size is not the issue.”issue.”

III. Size Does Matter: ‘Nano’ is best III. Size Does Matter: ‘Nano’ is best understood to mean understood to mean fundamentally differentfundamentally different

Different fundamental physical, Different fundamental physical, biological, and chemical biological, and chemical propertiesproperties

New properties create unique and New properties create unique and unpredictable human health and unpredictable human health and environmental risksenvironmental risks

– Exponentially increased surface Exponentially increased surface area creates increased area creates increased reactivity and enhanced reactivity and enhanced intrinsic toxicity intrinsic toxicity

– Size creates unprecedented Size creates unprecedented mobility to human body and mobility to human body and environmentenvironment

The Views of the Scientific CommunityThe Views of the Scientific Community

The European Commission’s Scientific Committee The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks on Emerging and Newly Identified Health Risks (SCENIHR): (SCENIHR): – ““Experts are of the Experts are of the unanimousunanimous opinion that the adverse opinion that the adverse

effects of nanoparticles cannot be predicted (or derived) effects of nanoparticles cannot be predicted (or derived) from the known toxicity of material of macroscopic size, from the known toxicity of material of macroscopic size, which obey the laws of classical physics.” which obey the laws of classical physics.”

The British Institute for Occupational Medicine: The British Institute for Occupational Medicine: – ““It is accepted, therefore, that It is accepted, therefore, that it is not possibleit is not possible to infer to infer

the safety of nanomaterials by using information derived the safety of nanomaterials by using information derived from the bulk parent material.”from the bulk parent material.”

New Nano-specific Toxicity Testing New Nano-specific Toxicity Testing Paradigms are RequiredParadigms are Required

The U.K. Royal Society and Royal Academy of Engineering:The U.K. Royal Society and Royal Academy of Engineering:– ““Substances made using nanotechnology should be considered Substances made using nanotechnology should be considered

new chemicals and undergo extra safety checks before they hit the new chemicals and undergo extra safety checks before they hit the market to ensure they do not pose a threat to human health . . . . market to ensure they do not pose a threat to human health . . . . We recommend that chemicals produced in the form of We recommend that chemicals produced in the form of nanoparticles and nanotubes be treated as new chemicals . . . .”nanoparticles and nanotubes be treated as new chemicals . . . .”

New paradigms of toxicology testing have been proposed New paradigms of toxicology testing have been proposed (Nel (Nel et al.et al., , ScienceScience (2006); Oberdorster (2006); Oberdorster et al.et al., , Particle and Particle and Fibre ToxicologyFibre Toxicology (2005)). (2005)).

Nonetheless, FDA assumes its existing battery of testing is Nonetheless, FDA assumes its existing battery of testing is “probably adequate” for testing the safety of engineered “probably adequate” for testing the safety of engineered nanoparticles.nanoparticles.

IV. First-ever Legal Action On Risks Of IV. First-ever Legal Action On Risks Of NanotechnologyNanotechnology

May 2006: CTA and coalition of May 2006: CTA and coalition of consumer, health, and environmental consumer, health, and environmental groups file legal petition challenging groups file legal petition challenging FDA’s failure to regulate human health FDA’s failure to regulate human health and environmental threats from and environmental threats from nanomaterials.nanomaterials.

As of yet, FDA has taken As of yet, FDA has taken no stepsno steps to to address the unique dangers presented address the unique dangers presented by nanomaterials. Instead, the agency by nanomaterials. Instead, the agency relies on safety testing guidelines relies on safety testing guidelines developed for assessing risks of bulk developed for assessing risks of bulk materials.materials.

But scientists agree that the properties But scientists agree that the properties and and adverse effects of nanoparticles adverse effects of nanoparticles cannot be reliably predictedcannot be reliably predicted from the from the properties of the material in bulk form.properties of the material in bulk form.

Petition Calls for FDA Petition Calls for FDA Regulation of Nanomaterial Regulation of Nanomaterial

Products, including:Products, including: Comprehensive nanomaterial-specific Comprehensive nanomaterial-specific

regulationsregulations New paradigms of nano-specific toxicity New paradigms of nano-specific toxicity

testingtesting Classification of nanomaterials as new Classification of nanomaterials as new

substancessubstances Mandatory nanomaterial product and Mandatory nanomaterial product and

ingredient labelingingredient labeling Compliance with the National Compliance with the National

Environmental Policy Act (NEPA)Environmental Policy Act (NEPA)

Petition Focus: Nano-sunscreensPetition Focus: Nano-sunscreens

Sunscreens are classified by FDA as human Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-drugs and should be subject to rigorous pre-market regulation.market regulation.

Red flags regarding free radical creation and Red flags regarding free radical creation and DNA damage; unanswered questions about DNA damage; unanswered questions about skin penetration.skin penetration.

Despite their unique dangers and patented Despite their unique dangers and patented differences, FDA considers nano-sunscreens differences, FDA considers nano-sunscreens equivalent to bulk material sunscreens.equivalent to bulk material sunscreens.

Petition calls for nano-sunscreen recall until Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre-manufacturers submit and FDA reviews pre-marketing testing data proving the drugs’ marketing testing data proving the drugs’ safety and efficacy.safety and efficacy.

Looking ForwardLooking Forward FDA’s first public meeting on Nanotechnology--FDA’s first public meeting on Nanotechnology--

October 10, 2006: A good first step, albeit overdueOctober 10, 2006: A good first step, albeit overdue FDA must act quickly if it hopes to avoid repeating FDA must act quickly if it hopes to avoid repeating

the mistakes of past regulatory failures (e.g., the mistakes of past regulatory failures (e.g., asbestos, DDT, PCBs)asbestos, DDT, PCBs)

A regulatory framework is needed that protects A regulatory framework is needed that protects human health and the environment from the human health and the environment from the impacts of nanomaterialsimpacts of nanomaterials

For More InformationFor More Information

George A. Kimbrell, George A. Kimbrell, International Center for Technology International Center for Technology

AssessmentAssessment(202) 202-547-9359(202) 202-547-9359

gkimbrell@icta.orggkimbrell@icta.org,, www.icta.orgwww.icta.org