journal article·2026-08-05

Law and Ethics of Nanotechnology: Traditional Legal Tools Advancing Nanomedicine

Ilise Feitshans

physica status solidi (a)· Volume 223· Issue 15
Publisher page

Abstract

Science fiction from the last decades is rapidly becoming science in daily life. For example, nanotechnology does cool things like creating driverless cars for people who are blind and storing solar energy to drive electric cars. Nanotechnology makes possible 3D printing of housing, clothing, and food and miraculous treatments for previously incurable disease. In the larger social context, the economic impact of applying nanotechnologies and nano‐enabled discoveries is transforming many aspects of daily life. To realize these societal benefits, several different disciplines come together in daily legal practice. Scientific researchers need a rudimentary understanding of the legal parameters that govern their work: tools for preventing tort liability; intellectual property laws benefits and limitations; regulatory frameworks and international treaties governing their commercialized research products; and basic laws that are impacted by innovations. Meanwhile, there is a crying need for lawyers to grasp basic underpinnings and ramifications for applied technologies. Therefore, the Virginia Mountain Valley Lawyers Alliance (VMVLA) Specialty Bar created the first ever Law and Ethics Special Sessions for Nanotexnology, described here. This article provides a broad brush overview of areas where traditional laws apply despite the challenges raised by emerging commercialization of nano‐enabled products benefiting civil society. This article also engages in “issue spotting,” the legal research tool for anticipating areas of the law where, due to gaps or uncertainties, future litigation might occur. The purpose of issue spotting is to recognize foreseeable problems, but not to try to solve them until specific facts and circumstances occur. The greatest challenge, however, is not any need to create new infrastructures, because there are plenty of laws. The challenge is to have sufficient working understanding of both the laws and the science in order to fashion reasonable, equitable, and workable solutions to reasonably foreseeable problems. This article concludes that civil society therefore can maximize the benefits of applied nanotechnology under law, if the decisionmakers involved in its use are well informed about basic information concerning both: the relevant science and law. The Special Session of Law and Ethics of Nanotechnology in the NANOTEXNOLOGY conference therefore offers an excellent starting point for creating reciprocal understanding across disciplines in order to advance robust policies and implement existing laws.
Source: crossref · Quality: baseline

Research context

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Past President Specialty Bar Association VMVLA and Fulbright Scholar in Law of Nanotechnology Catholic University of Central Africa School of Law Cameroon

References (46)

Show source-provided references
1. Hoover M. D. · 2014
2. Global Health Impacts of Nanotechnology Law: Advances in Safernano Regulation
3. Executive Summary of the Special Session on Law and Ethics of Nanotechnology Safety and Health: Nanomedicine Transforming Disability into Health
4. 10.1038/s41565‐021‐00912‐510.1038/s41565‐021‐00912‐5 ↗
5. World Health Organization, International Agency for Research on Cancer · 2010
6. Mapping Our Genes: Genome Projects: How Big How Fast · 1988 · 21
7. Feitshans I. L. · 1994
8. Executive Summary of the Special Session on Law and Ethics of Nanotechnology Safety and Health: Nano Medicine Transforming Disability Into Health
9. European Commission “Towards A European Strategy For Nanotechnology Luxembourg Office for Official Publications of the European Communities ”2004 4 chrome‐extension://efaidnbmnnnibpcajpcglclefindmkaj/https://nanonet.pl/wp‐content/uploads/2018/02/Towards‐a‐European‐Strategy‐for‐Nanotechnology.pdf.
10. US National Nanotechnology Initiative (NNI) nano.gov Fr: Subcommittee on Nanoscale Science Engineering and Technology Committee on Technology of the National Science and Technology Council Updated Agenda:The National Nanotechnology Initiative Supplement to the President's 2023 Budget citing its goals p31 accessed February 2023 https://www.nano.gov/BudgetSupplements/.
11. 10.3390/Agriculture1210167210.3390/Agriculture12101672 ↗
12. Feitshans I. · 2021
13. Food is Medicine: Next Steps Towards Feeding the World Using Nanotechnology Law
14. United Nations Food and Agriculture Organization “Report on FAO/WHO Experts Meeting on Food and Nanotechnology ” accessed December 9 2009 http://www.oecd.org/chemicalsafety/risk‐assessment/iata‐integrated‐approaches‐to‐testing‐andassessment.htm.
15. 10.3390/foods1009211410.3390/foods10092114 ↗
16. European Commission “Commission Regulation (EU) 2022/1396 of 11 August 2022 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the presence of ethylene oxide in food additives (Text with EEA relevance) ” EUR‐Lex accessed 2022 https://eur‐lex.europa.eu/eli/reg/2022/1396/oj.
17. Feitshans I. · 1998
18. US DHHS NIOSH Video comments by NIOSH Director Dr John Howard for Nanotexnology 2023 video available on request from the VMVLA archives. See alsonano.govfor detailed discussion of the safety and health research agenda.
19. 10.1038/s41565‐019‐0396‐z10.1038/s41565‐019‐0396‐z ↗
20. Law and Policy of Nanotechnology in Food: Global Commerce Promoting Global Health from Field to Fork
21. US Congress Food Drug and Cosmetic Act21 U.S.C.A. § 301 et seq US FDA 21 CFR 70.3(i) “safe” means that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.
22. US Congress Food Drug and Cosmetic Act21 U.S.C.A. § 301 et seqChapter I‐‐Food And Drug Administration Department Of Health And Human Services Subchapter A GeneralPart 73 ‐‐ Listing Of Color Additives Exempt From Certification. 721 of the FD&C Act (section 402(c) of the FD&C Act). Under 21 CFR 70.3(i)
23. EFSA Scientific Committee S.More V.Bampidis et al. “Guidance on Risk Assessment of Nanomaterials to be Applied in the Food and Feed Chain: Human and Animal Health ” accessed August 3 2021 https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2021.6768.
24. ANSES · 2019
25. US Congress Food Drug and Cosmetic Act21 U.S.C.A. § 301 et seq.Subchapter A GeneralPart 73 ‐‐ Listing of Color Additives Exempt From Certificationsubpart A – Foods (A) Identity. 1) The Color Additive Titanium Dioxide Is Synthetically Prepared TiO2 Free from Admixture With other substances. (c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally subject to the following restrictions: (1) The quantity of titanium dioxide does not exceed 1percent by weight of the food.
26. Titanium Dioxide: E171 no Longer Considered Safe when used as a Food Additive(European Food Safety Authority 2021) https://www.efsa.europa.eu/en/topics/topic/nanotechnologyEFSA See also ANSES Opinion of the French Agency for Food Environmental and Occupational Health and Safety on the risks associated with ingestion of the food additive E171(French Agency for Food Environmental and Occupational Safety and Health 2019) https://www.anses.fr/en/system/files/ERCA2019SA0036EN.pdf.
27. EFSA “Self‐task Mandate Proposed by the Scientific Committee to Develop an Updated Guidance Document for Risk Assessment of Nanomaterials and Materials Containing Nanoparticles in the Food Chain ” accessed July 14 2024 chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.efsa.europa.eu/sites/default/files/2024‐12/innovation‐food‐risk‐assessment‐methodology‐efsa.pdf.
28. US President D. J.Trump The White House Executive Order 14212 of February 13 2025 “Establishing the President's Make America Healthy Again Commission ”https://www.federalregister.gov/documents/2025/02/19/2025‐02871/establishing‐the‐presidents‐make‐america‐healthy‐again‐commission.
29. US President The White House Make America Healthy Again Commission “The MAHA Report: Make America Healthy Again ” First Report May 22 2025 29 https://www.whitehouse.gov/maha/.
30. https://youtu.be/xRdQNHzWRKo.
31. 10.2174/157488471266617050916125210.2174/1574884712666170509161252 ↗
32. See also OECD · 2015
33. OECD · 2023
34. Feitshans I. · 2022 · 53
35. Stillings L. L. · 2017
36. European Commission EFSA Panel on Food Additives and Flavourings (FAF) Maged Proposal for harmonised classification and labelling pursuant to Article 37(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification labelling and packaging of substances and mixtures amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353 p. 1).
37. US President The White House Make America Healthy Again Commission “The MAHA Report: Make America Healthy Again ” First Report May 22 2025 https://www.whitehouse.gov/maha/.
38. Feitshans I. · 2019
39. Ç. Z.Ünsal “Nanomedicine: Technology Challenges the Old Ways Does it Challenge Traditional Ethics? ”presentation at NANOTEXNOLOGY 2024 Law and Ethics of Nanotechnology Special Session Nanomedicine Transforming Disability into Health(2024).
40. Is There a Human Right to Reproductive Health?
41. 10.1016/j.lfs.2019.03.05710.1016/j.lfs.2019.03.057 ↗
42. Spider Silk Jeans or Spider Silk Genes? The Future of Genetic Testing in the Workplace
43. Papadouli V. · 2025
44. C.Zeybek Unsal “Stem Cell Research Legislation of 19 Countries ”Presentation at NANOTEXNOLOGY 2025 Law and Ethics of Nanotechnology Special Session Nanomedicine Transforming Disability into Health(Unpublished Doctoral Thesis 2025).
45. A.Kornilakis “AI as Caretaker and Companion‐ Ethical and Legal Personality Aspects ” Background paper available upon request from VMVLA archives.
46. I. L.Feitshans “Handbook for Parliamentarians Concerning the Ratification of the Convention Preventing Counterfeit Medicines (Medicrime) ”presented at OECD Paris France November 2015 English French Russian and Spanish(Council of Europe Parliamentary Assembly of the Council of Europe (PACE) 2015) https://www.coe.int/en/web/medicrime/the‐medicrime‐convention.