Nanomaterials in Consumer Products and FDA Regulation George A. Kimbrell The International Center for Technology Assessment Nano & Bio In Society Conference August 10, 2006

CTA is a Washington, D.C.-based non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society. CTA is devoted to fully exploring the economic, ethical, social, environmental and political impacts that can result from the applications of technology or technological systems. CTA is a Washington, D.C.-based non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society. CTA is devoted to fully exploring the economic, ethical, social, environmental and political impacts that can result from the applications of technology or technological systems. CTA’s Nanotechnology Project: 2002-present. CTA’s Nanotechnology Project: 2002-present.

Introduction Topic: Developments in the U.S. Regulatory Environment Topic: Developments in the U.S. Regulatory Environment My Focus: Nanomaterial Consumer Products and FDA My Focus: Nanomaterial Consumer Products and FDA –Other US Federal Agencies with some regulatory authority under existing statutes over different aspects of nanotechnology: EPA, NIOSH, CPSC. Why: Consumer products composed of nanomaterials have arrived and are particularly prevalent in the personal care product sector, which falls under FDA’s regulatory umbrella. Why: Consumer products composed of nanomaterials have arrived and are particularly prevalent in the personal care product sector, which falls under FDA’s regulatory umbrella.

Overview I. Nanomaterial consumer products currently available on U.S. market shelves. II.FDA’s current stance on nanomaterial consumer product testing and regulation. III.Contrast FDA’s view with that of the scientific community on the properties and risks of nanomaterials. IV.CTA’s legal petition.

Measures of Nanotechnology’s Maturation R&D surging: global nanotech R&D= $9 billion, with $1 trillion estimated for 2015 (Lux Research 2006) R&D surging: global nanotech R&D= $9 billion, with $1 trillion estimated for 2015 (Lux Research 2006) Term “nano” approaches ubiquitous status in U.S. society and media (>18,000 citations in U.S. media in 2005) Term “nano” approaches ubiquitous status in U.S. society and media (>18,000 citations in U.S. media in 2005) The “gold rush” for nano-patents continues- over 4,000 U.S. patents issued to date (Lux Research 2006) The “gold rush” for nano-patents continues- over 4,000 U.S. patents issued to date (Lux Research 2006) Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate… Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate…

I. Nanomaterials in Consumer Products: The Future is Now (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

Nanomaterials in Consumer Products Lux Research’s 2006 Nanotechnology Report: more than $32 billion in nano-products sold in 2005, 2X the total of Lux Research’s 2006 Nanotechnology Report: more than $32 billion in nano-products sold in 2005, 2X the total of Wilson Center’s Project on Emerging Nanotechnologies 2006 Consumer Product Database: over 200 self- identified nano-products now on U.S. market shelves. Wilson Center’s Project on Emerging Nanotechnologies 2006 Consumer Product Database: over 200 self- identified nano-products now on U.S. market shelves. Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stain- resistant clothing, and light emitting diodes used in computers, cell phones, and digital cameras. Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stain- resistant clothing, and light emitting diodes used in computers, cell phones, and digital cameras.

Nanomaterials in Consumer Products: The Personal Care Industry Leading the Way (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

No Where Are Nanomaterials Reaching the Consumer Faster than in Personal Care Products Royal Society’s 2004 Report noted their prevalence. Royal Society’s 2004 Report noted their prevalence. Wilson Center’s Consumer Product Datebase: largest single category (125 products) is health and fitness (including sunscreens, cosmetics, and other personal care products). Wilson Center’s Consumer Product Datebase: largest single category (125 products) is health and fitness (including sunscreens, cosmetics, and other personal care products).

Friends of the Earth Nanomaterials, Sunscreens and Cosmetics Report Findings At least 116 cosmetics, sunscreens, and personal care products containing nanomaterials commercially available. At least 116 cosmetics, sunscreens, and personal care products containing nanomaterials commercially available. includes well-known companies such as Johnson & Johnson, Chanel, Estee Lauder, Revlon, and L’Oreal. includes well-known companies such as Johnson & Johnson, Chanel, Estee Lauder, Revlon, and L’Oreal. Report available at

Nano-product spotlight: Nano-sunscreens Engineered nanoparticles make them transparent or “cosmetically clear,” rather than white. Engineered nanoparticles make them transparent or “cosmetically clear,” rather than white. legally patented for their novelty. legally patented for their novelty. Widely-available and used, “free” particles; placed directly on skin. Widely-available and used, “free” particles; placed directly on skin. Nanoparticles of titanium dioxide and zinc oxide shown to be photoactive in some studies, producing free radicals and causing DNA damage to human skin cells when exposed to UV light. Nanoparticles of titanium dioxide and zinc oxide shown to be photoactive in some studies, producing free radicals and causing DNA damage to human skin cells when exposed to UV light. As with nano-cosmetics, jury is still out on ease of skin penetration. As with nano-cosmetics, jury is still out on ease of skin penetration.

Report Case Study: Carbon Fullerenes Fullerenes, also known as buckyballs, used in some face and anti-aging creams and have been found to cause brain damage in fish, kill water fleas, and have bactericidal properties. Fullerenes, also known as buckyballs, used in some face and anti-aging creams and have been found to cause brain damage in fish, kill water fleas, and have bactericidal properties. Even low levels have been found to cause damage to human liver cells. Even low levels have been found to cause damage to human liver cells. Found in 7 products in survey. Found in 7 products in survey.

II. FDA’s Regulatory Umbrella: The Federal Food, Drug, and Cosmetic Act (FFDCA) FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical devices, animal feed, and combination products (21 U.S.C. Ch. 9 et seq.) FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical devices, animal feed, and combination products (21 U.S.C. Ch. 9 et seq.) Many currently available nano-products fall under FDA’s broad regulatory scheme Many currently available nano-products fall under FDA’s broad regulatory scheme –Cosmetics (21 U.S.C. § 361 et seq) –Sunscreens (21 U.S.C. § 321(g)) (classified as human drugs)

FDA’s Regulatory Stance on Nanomaterials in Consumer Products With regard to nanotechnology, FDA regulates “products not technologies.” With regard to nanotechnology, FDA regulates “products not technologies.” FDA informally defines nanotechnology with reference to the definition of the NNI, including FDA informally defines nanotechnology with reference to the definition of the NNI, including –1. the existence of materials or products at the atomic, molecular or macromolecular levels, where at least one dimension that affects the functional behavior of the drug/device product is in the length scale range of approximately nanometers; –2. the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and, –3. the ability to control or manipulate the product on the atomic scale

FDA’s Regulatory Stance (continued) FDA regulates a “wide range of products, including foods, cosmetics, drugs, devices, and veterinary products, some of which may utilize nanotechnology or contain nanomaterials.” FDA regulates a “wide range of products, including foods, cosmetics, drugs, devices, and veterinary products, some of which may utilize nanotechnology or contain nanomaterials.” FDA is aware of “several FDA regulated products [that] employ nanotechnology,” including “cosmetic products claim[ing] to contain nanoparticles to increase the stability or modify the release of ingredients” and “nanotechnology- related claims made for certain sunscreens.” FDA is aware of “several FDA regulated products [that] employ nanotechnology,” including “cosmetic products claim[ing] to contain nanoparticles to increase the stability or modify the release of ingredients” and “nanotechnology- related claims made for certain sunscreens.”

FDA’s Regulatory Stance (continued) FDA treats nanomaterial product ingredients no differently than bulk material ingredients or products. FDA’s current stance is to regulate (or decline to regulate) based on safety assessment of the same material in bulk form (e.g., nano- sunscreens) FDA treats nanomaterial product ingredients no differently than bulk material ingredients or products. FDA’s current stance is to regulate (or decline to regulate) based on safety assessment of the same material in bulk form (e.g., nano- sunscreens) With regard to its regulation of nanomaterial products, FDA “believes that the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we regulate. Particle size is not the issue.” With regard to its regulation of nanomaterial products, FDA “believes that the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we regulate. Particle size is not the issue.”

III. Size Does Matter: ‘Nano’ is best understood to mean fundamentally different Different fundamental physical, biological, and chemical properties Different fundamental physical, biological, and chemical properties New properties create unique and unpredictable human health and environmental risks New properties create unique and unpredictable human health and environmental risks –Exponentially increased surface area creates increased reactivity and enhanced intrinsic toxicity –Size creates unprecedented mobility to human body and environment

The Views of the Scientific Community The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR): The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR): –“Experts are of the unanimous opinion that the adverse effects of nanoparticles cannot be predicted (or derived) from the known toxicity of material of macroscopic size, 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 not possible to infer the safety of nanomaterials by using information derived from the bulk parent material.”

New Nano-specific Toxicity Testing Paradigms 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 new chemicals and undergo extra safety checks before they hit the market to ensure they do not pose a threat to human health.... We recommend that chemicals produced in the form of nanoparticles and nanotubes be treated as new chemicals....” New paradigms of toxicology testing have been proposed (Nel et al., Science (2006); Oberdorster et al., Particle and Fibre Toxicology (2005)). New paradigms of toxicology testing have been proposed (Nel et al., Science (2006); Oberdorster et al., Particle and Fibre Toxicology (2005)). Nonetheless, FDA assumes its existing battery of testing is “probably adequate” for testing the safety of engineered nanoparticles. Nonetheless, FDA assumes its existing battery of testing is “probably adequate” for testing the safety of engineered nanoparticles.

IV. First-ever Legal Action On Risks Of Nanotechnology May 2006: CTA and coalition of consumer, health, and environmental groups file legal petition challenging FDA’s failure to regulate human health and environmental threats from nanomaterials. May 2006: CTA and coalition of consumer, health, and environmental groups file legal petition challenging FDA’s failure to regulate human health and environmental threats from nanomaterials. As of yet, FDA has taken no steps to address the unique dangers presented by nanomaterials. Instead, the agency relies on safety testing guidelines developed for assessing risks of bulk materials. As of yet, FDA has taken no steps to address the unique dangers presented by nanomaterials. Instead, the agency relies on safety testing guidelines developed for assessing risks of bulk materials. But scientists agree that the properties and adverse effects of nanoparticles cannot be reliably predicted from the properties of the material in bulk form. But scientists agree that the properties and adverse effects of nanoparticles cannot be reliably predicted from the properties of the material in bulk form.

Petition Calls for FDA Regulation of Nanomaterial Products, including: Comprehensive nanomaterial-specific regulations Comprehensive nanomaterial-specific regulations New paradigms of nano-specific toxicity testing New paradigms of nano-specific toxicity testing Classification of nanomaterials as new substances Classification of nanomaterials as new substances Mandatory nanomaterial product and ingredient labeling Mandatory nanomaterial product and ingredient labeling Compliance with the National Environmental Policy Act (NEPA) Compliance with the National Environmental Policy Act (NEPA)

Petition Focus: Nano-sunscreens Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-market regulation. Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-market regulation. Red flags regarding free radical creation and DNA damage; unanswered questions about skin penetration. Red flags regarding free radical creation and DNA damage; unanswered questions about skin penetration. Despite their unique dangers and patented differences, FDA considers nano-sunscreens equivalent to bulk material sunscreens. Despite their unique dangers and patented differences, FDA considers nano-sunscreens equivalent to bulk material sunscreens. Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre- marketing testing data proving the drugs’ safety and efficacy. Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre- marketing testing data proving the drugs’ safety and efficacy.

Looking Forward FDA’s first public meeting on Nanotechnology--October 10, 2006: A good first step, albeit overdue FDA’s first public meeting on Nanotechnology--October 10, 2006: A good first step, albeit overdue FDA must act quickly if it hopes to avoid repeating the mistakes of past regulatory failures (e.g., asbestos, DDT, PCBs) FDA must act quickly if it hopes to avoid repeating the mistakes of past regulatory failures (e.g., asbestos, DDT, PCBs) A regulatory framework is needed that protects human health and the environment from the impacts of nanomaterials A regulatory framework is needed that protects human health and the environment from the impacts of nanomaterials

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