Biomedical Engineering Reference
In-Depth Information
A more thorough investigation of the long-term effects of NMs on the skin
shows that the uncoated anatase form of TiO
2
undergoes a photocatalytic reac-
tion that degraded the surface of newly installed prepainted steel roofs in areas
that came in contact with sunscreen coated hands of workers.
232
The rapid
growth in nanotechnology and its fast upsurge of commercial products is more
than likely to create more gaps in regulation such as these.
The nano-enabled drugs are just in the initial stages of the drug regulatory
processes to date and within a few decades, have the potential to comprise a
dominant group within the class of innovative pharmaceuticals and therapeu-
tics. With the current apparent philosophy of regulators regarding the safety
of NMs and their focus on cost-effectiveness of assessment and monitoring
that these products give rise to few if any nano-specific issues it may take a
few disastrous consequences before proper action is taken.
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The increased
research in the applications of NMs for medical purposes may create heightened
policy challenges that will warrant attention to safety regulations.
234
These may
lead to new models of safe drug discovery and development more systemati-
cally toward easing the burden of currently incurable diseases.
235
The most recent news release from the US FDA concerning NMs was issued
in April 20, 2012 and addresses the use of NMs in food and cosmetics.
236
The
two draft guidance documents are entitled “Guidance for Industry: Assessing
the Effects of Significant Manufacturing Process Changes, including Emerg-
ing Technologies, on the Safety and Regulatory Status of Food Ingredients and
Food Contact Substances, Including Food Ingredients that are Color Additives”
and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”
The draft on food gives the manufacturers the factors that should be considered
when determining whether changes in manufacturing processes such as nano-
technology will result in a significant change that may affect the identity of the
food substance, affect the safety of the use of the food substance, affect the reg-
ulatory status of the use of the food substance, or needs a regulatory submission
to FDA.
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Similarly, the draft guidance on cosmetics is focused on the safety
assessment of NMs when used in cosmetic products. In this guidance, the legal
requirements for nanomaterial-based cosmetics are the same as those for other
cosmetics. Although cosmetics do not require premarket approval, companies
and individuals who market cosmetics have legal responsibilities regarding the
safety of their products which must be properly labeled.
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The draft suggests
the modification of existing methods or the development of new methods of
safety assessments of cosmetic products containing NMs. Consultation with the
agency are encouraged in both guidances before releasing their products to mar-
ket so that FDA experts can help address questions related to the safety, other
attributes, and the regulatory status of nanotechnology products.
236
The US
FDA is investing in an FDA-wide nanotechnology regulatory science program
to enhance its scientific capabilities and to develop necessary data and tools to
identify properties of NMs as well as to assess possible impacts on products.
“Understanding nanotechnology remains a top FDA priority. FDA is strength-
ening the scientific tools and methods for evaluating food products, cosmetics,
