Perspectives on FDA's regulation of nanotechnology: Emerging challenges and potential solutions

Comprehensive Reviews in Food Science and Food Safety

Volumn 8, Issue 4, 2009, Pages 375-393

  Sandoval, Brianna ^a  

^a Department of International Practice   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BOVINAE; ESCHERICHIA COLI;

EID: 70349311674     PISSN: 15414337     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1541-4337.2009.00088.x     Document Type: Review

References (221)

1. -21 st Century Nanotechnology Research and Development Act, Pub. L 108-153, §10, 117Stat. 1923 (codified at 15 U.S.C. §7509 [2003]).
2. Nanoscience and Nanotechnologies: Opportunities and Uncertainties-Summary and Recommendations, The Royal Society & the Royal Academy of Engineering (2004). Available from: www.nanotec.orji.uk/finalreport.htm. Accessed Mar 30, 2007.
3. See, for example, comments of Carolyn Cairns, representing Consumers Union, FDA's Public Meeting on Nanotechnology Materials in FDA Regulated Products (October 10, 2006), transcript available from: http://www.fda.aov/ nanotechnology/meetings/transcript.hlml. Accessed Apr 9, 2007,
4. [hereinafter FDA's Public Meeting Transcript], at 62: "We recognize the important benefits that these materials can bring to certain product sectors, such as more effective medicines, safer drinking water, and energy savings, but we also know that these benefits depend entirely on responsible development of nanotechnology."
5. Pub. L 108-153, §117 Stat. 1923 (codified at 15 U.S.C. §[2003]).
6. See, for example, comments of Kathy Jo Wetter, representing ETC Croup, FDA's Public Meeting Transcript, endnote 3, at 119: "[T] he US Government has acted as a cheerleader, not a regulator, in addressing the nanotech revolution. In the all out race to secure economic advantage, health and environmental considerations have taken a back seat and socioeconomic impacts are a distant concern."
7. The inventory is available from: http://nanotechproject. org/consumerproducts. Accessed Apr 6, 2007.
8. A Survey of Ingredients in 25,000 Personal Care Products Reveals Widespread Use of Nano-Scale Materials, Not Assessed for Safety, in Everyday Products," comments submitted by Environmental Working Group to FDA's Nanotechnology Public Docket. Available for download from: http:// www.fda.gov/ohrms/dockets/dockets/06n0107/06n0107.htm. Accessed Apr 9, 2007.
9. Artificially inflating the numbers in this manner may lead to undue concern on the part of the public, but FDA must be prepared to deal with that concern, whether it is warranted or not. Subsection "Combination Products" addresses this issue in greater detail.
10. See, for example, comments of Dr. David Rejeski, representing the Project on Emerging Nanotechnologies, FDA's Public Meeting Transcript, endnote 3, at 99.
11. See Trudy E. Bell, Understanding Risk Assessment of Biotechnology, NNI, available for download from: http:// wvvw.nano.gov/Understanding-Risk- Assessment.pdf. Accessed Apr 4, 2007, at 2.
12. Studies associated with the Natl. Cancer Inst, sometimes refer to particles of up to 200 nm in size as nanoparticles. See, for example, Brightly Fluorescent European Nanoparticles May Improve Cancer Assays, Nanotechwire.com (February 11, 2007), available from: http://www.nanotechwire. com/news.asp?nid=431 3&ntid= 190&pg=1. Accessed Apr 6, 2007;
13. see also "Nano-targeting" cancer and heart disease, Washington Univ. in St. Louis (May 9, 2003), available from: http://new6-infu.wuttl.edu/ tlp5/page/normal/203.html. Accessed Apr 6, 2007.
14. In his comments at FDA's Public Meeting, Neil Desai from Abraxis Bioscience Incorporated noted that "of 152 abstracts recently cited, almost 80% actually talk about nanoparticles that are greater than 100 nanometers, not less than 100 nanometers." FDA's Public Meeting Transcript, endnote 3, at 187.
15. Nanotechnology Facts: What is Nanotechnology? NNI Website, available from: http://www.nano.tiov/html/ fncts/whatlsNano.html. Accessed Mar 26, 2007.
16. FDA and Nanotechnology Products: Frequently Asked Questions (FAQs), FDA Website, available from: http://www.fda.gov/ nanotechnology/faqs.html. Accessed Mar 26, 2007.
17. See Bell, endnote 10, at 2.
18. id.
19. id.
20. Nanotechnology White Paper, EPA Science Policy Council (December 2, 2005), available from: http://www.epa.gov/osa/ pdfs/nanotech/epa-nanotechnolouv- white-paper-t'inal-february2007.pdf. Accessed Apr 9, 2007.
21. See Bell, endnote 10, at 2.
22. Robin Fretwell Wilson, Nanotechnology: The Challenge of Regulating Known Unknowns, 34 J.L.. Med. & Ethics 704 (2006). -'This is primarily thought to occur as a result of the extremely large surface area of nanoparticles, which can make them much more reactive than their bulk counterparts. See, for example, Bell, endnote 10, at 2, 3.
23. -71 Fed. Reg. 46232 (August 11, 2006).
24. -71 Fed. Reg. 46232.
25. Nanoscience and Nanotechnologies: Opportunities and Uncertainties, Royal Society and Royal Academy of Engineering July 2004), at 79, available for download from: http:// www.nanotec.org.uk/finalRepoit.htm. Accessed Apr 7, 2007.
26. See generally, FDA's Public Meeting Transcript, endnote 3, available from: http://www.fda.gov/nanotechnology/ meetings/transcript.html. Accessed Apr 9, 2007.
27. For example, DuPont has developed a partnership with Environmental Defense to develop processes for understanding the environmental and health impacts of nanotechnology. See Section "Environmental, health, and safety impacts" of this article for additional information about this effort.
28. FDA Regulation of Nanotechnology Products, FDA Website, available from: http://www.fda.gov/nanotechnology/ regulation.html. Accessed Apr 5, 2007.
29. For example, FDA's rationale for its October 2006 Public Meeting includes the statement: "Due to their small size and extremely high ratio of surface area to volume, nanotechnology materials often have chemical or physical properties that are different from those of their larger counterparts. because of some of their special properties, they may pose different safety issues than their larger counterparts." 71 Fed. Reg. 46233 (August 11, 2006).
30. Comments of Dr. Philippe Martin, representing the European Commission, FDA's Public Meeting Transcript, endnote 3, at 27, 28.
31. Id. at 27.
32. Id. at 28.
33. Two examples include pure carbon, which can take 1 of 3 shapes at the nanoscale (graphite, diamond, and buckyball or fullerene) and titanium dioxide, which can take on at least 2 different shapes. See Bell, endnote 10, at 3.
34. See comments of Dr. Stacey Harper, representing Oregon State Univ., FDA Public Meeting Transcript, endnote 3, at 80-81.
35. See, for example, comments of Dr. Celia Merzbacher, representing NNI, FDA Public Meeting Transcript, endnote 3, at 23: "If we can't characterize nanomaterials, then we don't know what we're testing... researchers and business people alike are clamoring for standards."
36. Organizations involved in attempts to establish international standards include ISO, IEC, ANSI, and ASTM. See Bell, endnote 10, at 2.
37. See, for example, comments submitted by Consumer Union to FDA's Nanotechnology Public Docket, available for download from: http://www.fda.gov/ ohrms/dockets/ dockets/06n0107/06n0107.htm. Accessed Apr 7, 2007.
38. Examples include tests for oxidative stress, C-reactive protein, platelet aggregation, and other immune and inflammatory responses, neurotoxicity, and genetic toxicity. See, for example, comments of Consumer Union, submitted to FDA's Nanotechnology Public Docket, available for download from: http:// www.fda.gov/ohrms/dockets/dockets/06n0107/06n0107.htm, at 11 (citing various reports from U.S. and European working groups).
39. See also comments of Carolyn Cairns, FDA Public Meeting Transcript, endnote 3, at 62. Accessed Apr 7, 2007.
40. Citizen Petition to the United States Food and Drug Administration: Petition Requesting FDA Amend its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically (May 16, 2006), available for download from: http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf . Accessed Apr 9, 2007.
41. Petitioners included CTA, FOE, Greenpeace Intl., the Action Group on Erosion, Technology and Concentration (ETC Group), Clean Production Action, the Center for Environmental Health (CEH), Our Bodies, Ourselves, and the Silicon Valley Toxics Coalition (SVTC). Id.
42. Comments of Cosmetic, Toiletry, and Fragrance Association (CTFA) Regarding Scientific and Legal Issues Associated with Nanotechnology in Personal Care Products, submitted in re: Docket Nr 2006P-0210, available for download from: http:// www.fda.gov/ohrms/dockets/dockets/06n0107/06n0107.htm. Accessed Apr 9, 2007.
43. Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, Project on Emerging Nanotechnologies, Woodrow Wilson Intl. Center for Scholars (March 2007), available for download from: http:// www.nanotechproject.org/111/32007-1 ife-cycle-assessmentessentlal- to-nanotech-commerclal-development Accessed Apr 5, 2007.
44. Id.
45. Comments of Andrew Maynard, chief scientist for the Project on Emerging Nanotechnologies, quoted in Life Cycle Assessment Essential to Nanotech Commercial Development, Project on Emerging Nanotechnologies, available from: http:// www.nanotechproject.org/111/32007-life-cycle-assessmentessentlal-to- nanotech-commerclal-development. Accessed Apr 5, 2007.
46. S. Walsh and T. Medley, A Framework for Responsible Nanotechnology, Environmental Defense, available from: http:// www.environmentaldefense.org/ documents/6081-Nano%20 Risk%20Fra.mework%20overview%20ma.nuscri pt-26feb07.pdf. Accessed Apr 5, 2007.
47. Id.
48. However, it should be noted that the Natl. Environmental Policy Act (NEPA) requires all federal agencies-including FDA-to consider the environmental effects of any "major federal action" by preparing an Environmental Assessment (EA) or Environmental Impact Statement (EIS). 42 U.S.C. §4332(c).
49. See, for example, FDA's "Nanotechnology FAQs," available from: http://www.fcla.gov/nanotechnology/faqs.html. Accessed Apr 9, 2007: "Because FDA regulates products based on their statutory classification rather than the technology they employ, FDA's regulatory consideration of an application involving a nanotechnology product may not occur until well after the initial development of that nanotechnology."
50. See, for example, comments of Consumer Union, submitted to FDA's Nanotechnology Public Docket, available for download from: http://www.fda.gov/ ohrms/dockets/ dockets/06n0107/06n0107.htm. Accessed Apr 9, 2007.
51. Consumer Union suggested that product labeling is "crucial to facilitate exposure assessment and product tracing in the event of unanticipated effects and to enable assessment of cumulative effects that occur from exposure to materials in multiple products." Id.
52. For example, products applied topically, such as sunscreens and cosmetics, may enter the water supply through the normal course of washing and bathing; unused prescription drugs may reach the environment after they are tossed in the garbage.
53. See, for example, comments of Consumer Union, endnote 48.
54. For example, carbon buckyballs, or fullerenes, have been the subject of studies that show adverse impacts on fish. See, for example, comments of John Balbus, representing Environmental Defense, FDA Public Meeting Transcript, endnote 3, at 53.
55. See also comments of George Kimbrell, representing CTA, FDA Public Meeting Transcript, endnote 3, at 143.
56. -42 U.S.C. §4332(c).
57. -42 U.S.C. §4332.
58. -42 U.S.C. §4332.
59. -21 C.F.R. §4332.
60. -21 C.F.R. §25.15. See below for additional discussion of the drug approval process.
61. See "Nanotechnology FAQs," endnote 47.
62. -21 C.F.R. §25.15.
63. Wyoming Outdoor Council v. U.S. Forest Service, 165 F.3d 43, 49 (D.C. Cir. 1999) (quoting Mobile Oil Corp. v. FTC, 562 F.2d 170, 173 [2d Cir. 1977]).
64. Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000).
65. -116 F. Supp. 2d 166, 174.
66. NEPA entitles FDA to make such exceptions, which have been codified at 21 C.F.R. §31.
67. -21 C.F.R. §25.31.
68. "Some nanoparticles readily travel throughout the body, deposit in target organs, penetrate cell membranes, lodge in mitochondria, and may trigger injurious responses." Andre Nel and others, "Toxic potential of materials at the nanolevel," Science, Vol. 311: No. 5761, 622 (2006).
69. SeeBell, endnote 10, at 4.
70. Id.
71. Id.
72. Id.
73. See comments of John Balbus, representing Environmental Defense, FDA Public Meeting Transcript, endnote 3, at 53.
74. See Bell, endnote 10, at 4.
75. Comments of David Berube, representing Intl. Council on Nanotechnology, FDA Public Meeting Transcript, endnote 3, at 58.
76. Lack of evidence of harm should not be a proxy for reasonable certainty of safety." Comments of Consumers Union, submitted to FDA's Nanotechnology Public Docket (October 6, 2006), available for download from: http://www. fda.gov/ohrms/dockets/dockets/06n0107/06n0107.htm. Ac-cessed Apr 5, 2007.
77. Id.
78. Comments of John Balbus, FDA Public Meeting Transcript, endnote 3, at 56.
79. "We have been surrounded by natural nanoparticles for eons... humans have developed natural response mechanisms to nanoparticles." Comments of Matthew Jaffee, representing United States Council for Intl. Business, FDA Public Meeting Transcript, endnote 3, at 85.
80. Despite its potential drawbacks, there Is precedent for such a moratorium. Since 2001, FDA has called for a voluntary moratorium on the introduction of food from cloned animals while the agency studies the issue. The agency released a draft risk assessment, a proposed risk management plan, and a draft guidance for industry in December 2006. FDA Issues Draft Documents on the Safety of Animal Clones, FDA News, available from: http://www.fda.gov/bbs/ topics/NEWS/2006/NEW01541 .html. Accessed May 2, 2007.
81. At the same time, however, the United States successfully challenged the EU's moratorium on genetically modified food under the WTO. See Panel Report, European Communities-Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R, Corr.1 and Add.1, 2, 3, 4, 5, 6, 7, 8 and 9, adopted 21 November, 2006.
82. Comments of Martin Philibert, FDA Public Meeting Transcript, at 94.
83. "Even if there are no inherent risks or toxicities associated with nanomaterials, the public's perception of that is not going to be realized until the toxicological studies are promoted in concert transparently with the development of novel materials." Comments of Stacey Harper, representing Oregon Nanoscience and Microtechnologies Institute, FDA Public Meeting Transcript, at 75.
84. See, for example, Bell, endnote 10.
85. Attitudes Toward Nanotechnology and Federal Regulatory Agencies: Report Findings, Peter D. Hart Research Associates, Inc. (September 2006), available for download from: http://www.na.notechproject.org/77. Accessed Apr 9, 2007.
86. Id. at 5, 7.
87. -72 Fed. Reg. 16291 (April 4, 2007).
88. See also Andrew Bridges, U.S. Seeks to Ease Irradiated Food Label, Forbes.com (April 3, 2007), available from: http ://www. forbes. com/ feeds/ap/2007/04/03/ap3579512.html. Accessed May 1, 2007.
89. See comments of FPA and GMA, submitted to FDA's Nanotechnology Public Docket, available for download from: http:// www.fda.gov/ohrms/dockets/dockets/ 06n0107/06n0107.htm. Accessed Apr 7, 2007.
90. Comments of David Rejeski, FDA Public Meeting Transcript, endnote 3, at 103: "Once people learn about technology, once we give them information, they show very little support for any kind of moratorium on nanotech R&D. They get excited about the applications, especially about the medical applications, which I think has enormous implications for FDA. This is what really excites people in these focus groups, the medical applications of nanotechnology."
91. Id. at 100.
92. Id. at 101. Rejeski also noted that all of the individuals surveyed overestimated the FDA's level of regulatory authority over cosmetics. Id.
93. Nanotechnology in $32 Billion Worth of Products: Global Funding for Nanotech R&D Reaches $9.6 Billion, Lux Research, Inc., New York (May 8, 2006), available from: http:// www.luxresearchinc.com/press/RELEASE TNR4.pdf. Accessed Apr 3, 2007.
94. Nanotech Venture Capital to Exceed $650 Million in 2006, Lux Research, Inc., New York (December 4, 2006), available from: http://www.luxresearchinc.com/press/ RELEASE VCreport.pdf. Accessed Apr 3, 2007.
95. Revenue from Nano-technology Enabled Products to Equal IT and Telecom by 2014, Exceed Biotech by 10 Times, Lux Research, Inc., New York (October 25, 2004), available from: http:// www.luxresearchinc.com/press/RELEASE SizingReport.pdf. Accessed Apr 3, 2007.
96. Sen. Allen Announces Congressional Nanotechnology Caucus, NNI Website (April 2004), available from: http:// www.nano.gov/html/about/NNIConf04.html. Accessed Apr 3, 2007.
97. See, for example, Wyden, Burr, Cordon, Hall Kick Off Congressional Nanotechnology Caucus, press release from Senator Wyden's website Qanuary 31, 2007), available from: http://wyden.senate.gov/media/2007/01312007 Nanotech.htm. Accessed Mar 26, 2007.
98. About the NNI: History, NNI Website, available from: http://www.nano.gov/ html/about/history.html. Accessed Mar 26, 2007.
99. NNI Environmental, Health, and Safety Issues, NNI Website, available from: http://www.nano.gov/html/society/EHS.htm. Accessed Apr 9, 2007.
100. Pub. L. 108-153, 117 Stat. 1923 (codified at 15 U.S.C. § [2003J).
101. Natlonal Nanotechnology Initiative: FY 2008 Budget and Highlights, NNI, available for download from: http:// www.nano.gov/NNI FY08 budget summarv-highlights.pdf. Accessed Apr 9, 2007.
102. Id.
103. The agencies entitled to receive a portion of NNI's funding are: NSF, DOD, DOE, DHHS (NIH), DOC (NIST), NASA, EPA, USDA (CSREES), DHHS (NIOSH), USDA/FS, DHS, DOJ, DOT (FHWA). Id.
104. H.R. Rep. Nr 108-89 (2003), generally, and at 8. See also S. Rep. Nr 108-147 (2003).
105. Michael R. Taylor, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?, Project on Emerging Nanotechnologies, Woodrow Wilson Intl. Center for Scholars (October 2006), at 14 and 46, available for download from: http:// www.nanotechproject.org/82/10506-regulating-the-products- ofnanotechnology. Accessed Mar 26, 2007.
106. See Nanotechnology FAQs, endnote 14.
107. See Taylor, endnote 100, at 15.
108. Nanotechnology FAQs, endnote 14.
109. See, for example, CTA's Citizen Petition to FDA, endnote 38.
110. Peter B. Hutt and Richard A. Merrill, Food and Drug Law: Cases and Materials, Second Edition, Foundation Press, New York (1991) at 380.
111. Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837 (U.S. 1984).
112. -21 U.S.C. §321(g)(1).
113. -21 U.S.C. §355(a).
114. See Hutt and Merrill, endnote 105, at 515.
115. The Food and Drug Administration's Process for Approving New Drugs, Report of tne Subcommittee on Science, Research and Technology of the House Committee on Science and Technology, 96th Congress, 2nd Session (1980), reprinted in Hutt and Merrill, endnote 105, at 519.
116. Id.
117. -21 U.S.C. §355(d).
118. -21 U.S.C. §355(k)(1). For all approved drugs, "the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to clinical experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, as the Secretary may by general regulation, orby order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine. whether there is or may be grounds for invoking subsection (e) of this section," where subsection (e) permits FDA to withdraw approval of a previously approved drug. See also FDA regulations promulgated pursuant to this statutory authority and requiring prompt reporting of serious adverse events (21 C.F.R. §and periodic reporting of all data regarding a drug's safety and efficacy (21 C.F.R. §314.81).
119. All persons required to keep records under the section, "shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records." 21 U.S.C. §
120. -21 U.S.C. §
121. Nanomedicine and Nano Device Pipeline Surges 68%, Nanotechwire.com (January 4, 2006), available from: http://www. nanotechwire.com/news.asp?nid= 2743. Accessed Apr 8, 2007.
122. Database available from: http://nanotechproject.org/87 #Tools. It should be noted that not all of these products are marketed or directly available to consumers. Some of the applications included in the database are used by researchers and doctors for drug discovery and imaging, while others require a prescription. 118 Id.
123. The approval letter for Emend required the applicant (Merck & Company, Inc.) to commit to providing additional data relating to the nanoparticle formulation, suggesting that FDA was attuned to potential concerns about particle size. Emend Approval Letter(s), CDER Approval Package for Application Number 21-549, available for download from: http:// www.fda.gov/cder/foi/nda/2003/21-549 Emend Approv.pdf. Accessed May 2, 2007.
124. Both Abraxane and Taxol utilize paclitaxel, but the albumin nanoparticles in Abraxane give it a superior response rate to Taxol, and the maximum tolerated dose of Abraxane is 50% higher than Taxol. Medical Review(s), CDER Approval Package for Application Number 21 -660, available for download from: http:// www.fda.gov/cder/foi/nda/2005/21660 ABRAXANE medr.PDF. Accessed May 2, 2007.
125. Doxil's nanoformulation decreases the toxicity of doxorubicin, an anticancer agent. Vance McCarthy, Pharma Explores Business Opportunities for Nanotech, Nano Science and Technology Inst. (February 22, 2006), available from: http:// www.nsti.org/news/item.html?id=43. Accessed May 3, 2007.
126. Package inserts for each drug can be downloaded from the "Drugs@FDA" section of the FDA website available from: http:// www.accessdata.ida.gov/scripts/cder/drugsatfda/index.cfm. Accessed May 2, 2007.
127. Comments of Dr. Neil Desai, representing Abraxis Bioscience Incorporated, FDA Public Meeting Transcript, endnote 3, at 186.
128. Hutt and Merrill, endnote 105, at 588.
129. PUb. L. 87-781, 76 Stat. 780 (October 10, 1962).
130. -21 C.F.R. §330.
131. Id.
132. Id.
133. As previously noted, the FDA made a similar decision to presume that foods produced through the rDNA process were GRAS and therefore not subject them to additional testing requirements. See Alliance for Bio-Integrity, 116 F. Supp. 2d 166.
134. According to the Project on Emerging Nanotechnology's database of consumer products, available from: http:// nanotechproiect.org/index.php?id= 44&action=advanced. Accessed Apr 5, 2007.
135. -21 C.F.R. §
136. "'Micronization' refers to a process of grinding materials down rather than a particle-size classification, and may or may not lead to the production of nanosize particles." Taylor, endnote 100, at 42.
137. CTA's Citizen Petition to FDA, endnote 38.
138. CTFA's comments in response to CTA's Petition to FDA, endnote 40; see also comments of Annette Santamaria, representing CTFA, FDA Public Meeting Transcript, endnote 3, at 168.
139. National Nanotechnology Initiative: FY 2008 Budget and Highlights, endnote 96; Nanotechnology FAQs, endnote 14.
140. PUb. L. 94-295, 90 Stat. 539 (1976).
141. Overview of Regulations, FDA Website, available from: http://www,fda.gov/c.arh/devadvic.e/overview.html. Accessed Apr 10, 2007.
142. Id.
143. "These 'general controls' include the basic adulteration and misbranding provisions as well as applicable good manufacturing practice (GMP) regulations, banned device regulations, and notification and repair, replacement, or refund requirements." Hutt and Merrill, endnote 105, at 749.
144. Nanomedicine and Nano Device Pipeline Surges 68%, Nanotechwire.com (January 4, 2006), available from: http ://www.nanotechwire.com/news.asp?nid=2 743. Accessed Apr 8, 2007.
145. Overwew of the Office of Combination Products, USFDA Website, available from: http://www.fda.gov/oc/ combination/overview.html. Accessed Mar 29, 2007. See also 21 C.F.R. §for the full definition of "combination product."
146. Overview of the Office of Combination Products, endnote 141.
147. Id.
148. -21 C.F.R. §3.
149. Nanotechnology FAQs, endnote 14.
150. Taylor, endnote 100, at 30.
151. -21 U.S.C. §1 (s).
152. Id. Examples include common food ingredients such salt, sugar, flour, and so on.
153. Taylor, endnote 100, at 34.
154. -21 U.S.C. §331 and §342.
155. -21 U.S.C. §348.
156. -21 C.F.R. §170.3.
157. Taylor, endnote 100, at 36.
158. Regardless of whether the technologies employed are new or conventional, FD&C Act standards remain constant, requiring manufacturers to establish that food is safe and labeling claims are substantiated based on sound scientific evidence." comments by FPA and GMA submitted to FDA's Nanotechnology Public Docket, available for download from: http://www.fda.gov/ ohrms/dockets/dockets/06n0107/06n0107. htm. Accessed Apr 7, 2007.
159. -155 Id. at 3.
160. Comments of Kathy Jo Wetter, representing ETC Group, FDA Public Meeting Transcript, endnote 3, at 118.
161. See database entries for Nanoceuticals™ Slim Shake Chocolate by RBC Life Sciences®Inc. (U.S.A.), Nanotea by Shenzen Become Industry & Trade Co., Ltd. (China), and Canola Active Oil by Shemen Industries (Israel). The inventory is available from: http://www.nanotechproject. org/44/consumer- nanotechnology. Accessed Apr 9, 2007.
162. They include, for example, 2 food storage products in the Sharper Image® FresherLonger™ product line, as well as refrigerators by Samsung® and LG® Id.
163. Jennifer Kuzma and Peter VerHage, Nanotechnology in Agriculture and Food Production: Anticipated Applications, Project on Emerging Nanotechnologies, Woodrow Wilson Intl. Center for Scholars (September 2006), available for download from: http://www.nanotechproject.org/50/live-webcast- agrifoodnanotechnologv-reserach-and-development. Accessed Apr 8, 2007.
164. Study: Nanotechnology in Food and Food Processing Worldwide 2003-2006-2010-2015, Helmut Kaiser Consultancy, Tübingen, Germany (2006), available from: http:// www, hkc22.com/nanofood. html. Accessed Apr 8, 2007.
165. Id. at 4.
166. -21 U.S.C. §321(ff).
167. 163See, for example, Peter Barton Hutt, FDA Statutory Authority to Regulate the Safety of Dietary Supplements, 31 Am. J. L. and Med. 155(2005).
168. Pub. L. 103-417, 108 Stat. 4325 (October 25, 1994). See also Taylor, endnote 100, at 32.
169. See Hutt, endnote 163, at 157.
170. Database available from: http://www.nanotechproject. org/44/consumer- nanotechnology. Accessed Apr 9, 2007.
171. -21 U.S.C. §and §362.
172. -21 C.F.R. §740.10.
173. See, for example, Taylor, endnote 100, at 28; see also comments of Jane Houlihan, representing Environmental Working Group, FDA Public Meeting Transcript, endnote 3, at 137.
174. This is often accomplished through the industry's chief trade organization, the Cosmetic, Toiletry, and Fragrance Association (CTFA).
175. See Cosmetic Ingredient Review Homepage, available from: http://www.cir-safety.org/. Accessed Mar 29, 2007.
176. See Voluntary Cosmetic Registration Program Homepage, available from: http://www.cfsan.fda.gov/~dms/cos-regn.html. Accessed Mar 29, 2007.
177. CTFA Consumer Commitment Code, CTFA, available from: http://www.ctfa.org/ Content/NavigationMenu/Consumer Information/Consumer Commitment: Code/Consumer Commitment Code.htm. Accessed Mar 29, 2007.
178. Database available from: http://www.nanotechproject.org/ 44/consumer-nanotechnology. Accessed Apr 9, 2007.
179. Comments of Michael jaffee, representing the U.S. Council for Intl. Business, FDA Public Meeting Transcript, endnote 3, at 88.
180. CTFA Consumer Commitment Code, endnote 173.
181. Id.
182. -40 Fed. Reg. 8912 at 8916 (March 3, 1975).
183. -40 Fed. Reg. 8912 at 8916.
184. See, for example, comments of Environmental Working Group, submitted to FDA's Nanotechnology Public Docket, available for download from: http://www.fda.gov/ohrms/ dockets/dockets/06n0107/06n0107.htm. Accessed Apr 7, 2007.
185. FDA Nanotechnology Homepage, available from: http:// www.fda.gov/ nanotechnologv/. Accessed Apr 9, 2007.
186. FDA Nanotechnology task Force Homepage, available from: http://www.fda.gov/nanotechnology/nano tf.html. Accessed Apr 9, 2007.
187. Co-chairman Lutter's Opening Remarks, FDA Public Meeting Transcript, endnote 3, at 8.
188. Meeting Notice, 71 Fed. Reg. 56158 (September 26, 2006). The announcement further stated: "FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologies, and medical devices, whether there are new or emerging scientific issues that should be brought to FDA's attention, and any other scientific issues about which the regulated industry, academia, and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDA-regulated products."
189. The report is now available from: http://www.fda.gov/ nanotechnology/taskforce/report2007.html. Accessed Apr 9, 2007.
190. Nanotechnology FAQs, endnote 14.
191. Statement of Norris Alderson before Committee on Science, House of Representatives, September 21, 2006, available from: http://www.fda.gov/ola/ 2006/nanotechnology0921 .html. Accessed Apr 6, 2007.
192. Report available for download from: http://nano.gov/NN1 EHS research needs.pdf. Accessed Apr 6, 2007.
193. NN1: History, NNI Website, available from: http:// wwvy.nano. gov/htm l/about/hi story, html. Accessed Apr 9, 2007.
194. NN1: Participants, NNI Website, available from: http://www.nano.gov/html/ about/nniparticipants.html. Accessed Apr 9, 2007.
195. Funding recipients are: NSF, DOD, DOE, DHHS (NIH), DOC (NIST), NASA, EPA, USDA (CSREES), DHHS (NIOSH), USDA/FS, DHS, DOJ, and DOT (FHWA). National Nanotechnology Initiative: FY 2008 Budget and Highlights, endnote 96.
196. Comments of Scott McNeil, representing NCL, FDA Public Meeting Transcript, endnote 3, at 219.
197. NCL Homepage, available from: http://ncl.cancer.gov/. Accessed Apr 9, 2007.
198. Id.
199. Id.
200. In her comments at FDA's Public Meeting, Dr. Celia Merzbacher noted that the Organization for Economic Cooperation and Development (OECD) and the Intl. Organization for Standardization (ISO) are 2 international organizations that have been devoting a great deal of effort to developing 3 areas of standardization: terminology and nomenclature; instrumentation and metrology; and health, safety, and the environment. Comments of Dr. Celia Merzbacher, FDA Public Meeting Transcript, endnote 3, at 23.
201. Id.
202. See, for example, comments of the Alliance of Social and Ecological Consumer Organisations (ASECO), submitted to FDA's Nanotechnology Public Docket, available for download from: http://www.fda.gov/ohrms/dockets/dock.ets/06n0107/ 06n0107. htm. Accessed Apr 5, 2007.
203. See, for example, comments of Erich Pica, representing Friends of the Earth, FDA Public Meeting Transcript, endnote 3, at 151.
204. Gary E. Marchant and Douglas J. Sylvester, Transnational Models for Regulation of Nanotechnology, 34 J.L. Med. & Ethics 714, 715(2006).
205. See, for example, comments of Michael Jaffee, FDA Public Meeting Transcript, endnote 3, at 68: "We... strongly encourage FDA to regulate applications that use nanotechnology according to the same guiding scientific principles that have already allowed this agency to effectively protect, promote, and improve public health."
206. Comments of Kathy Jo Wetter, FDA Public Meeting Transcript, endnote 3, at 115.
207. Comments of Dr. Martin Philbert, FDA Public Meeting Transcript, endnote 3, at 125.
208. Dr. Philbert points out, for example, the absurdity of suggesting that a material of 101 nm no longer presents a risk of toxicity simply because NNI has drawn the line at 100 nm. id.
209. See, for example, comments of John Balbus, FDA Public Meeting Transcript, endnote 3, at 56.
210. In the case of food bioengineering, for example, FDA developed a policy statement for foods derived from new plant materials, and issued guidance for industry to promote early food safety evaluation for new proteins produced through biotechnology and intended for food use. See Statement of Policy: Foods Derived From New Plant Varieties; Notice, 57 Fed. Reg. 22984 (May 29, 1992).
211. See, also, Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use, available from: nttp://www.cisan.fda.gov/~dms/bioprgu2, html#ftn1;
212. Notice, 71 Fed. Reg. 35688 (June 21, 2006). Accessed Apr 5, 2007.
213. Comments of David Rejeski, FDA Public Meeting Transcript, at 104.
214. International Dairy Foods Ass'n v. Amestoy, 92 F.3d 67 (2d Cir. 1996).
215. -92 F.3d 67.
216. See, for example, comments of Dr. Philippe Martin and Dr. Michael Taylor, FDA Public Meeting Transcript, endnote 3, at 32, 126, 127.
217. Comments of David Rejeski, FDA Public Meeting Transcript, endnote 3, at 103.
218. Comments of Kenneth David, representing Michigan State Univ., FDA Public Meeting Transcript, endnote 3, at 43.
219. Id. at 73, 74.
220. The dynamic and complex nature of nanotechnology makes it imperative that
221. See comments of Michael Taylor, representing the Univ. of Maryland School of Public Health, FDA Public Meeting Transcript, endnote 3, at 110.