Biomedical Engineering Reference
In-Depth Information
drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg,
MD.
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“We are taking a prudent scientific approach to assess each product on
its own merits and to not make broad, general assumptions about the safety of
nanotechnology products.” It must be noted that these two guidances on NMs
for food and cosmetics uses are not intended for the use of NMs in other prod-
ucts including drugs or medical devices that are regulated by the FDA.
The draft of the guidance for cosmetic regulations recommends that the
safety assessment for cosmetic products using NMs should address several
important factors. These factors include
237
:
the physico-chemical characteristics,
l
agglomeration and size distribution of nanomaterials at the toxicity testing
conditions which should correspond to those of a final product
l
impurities
l
potential product exposure levels, and the potential for agglomeration of NPs
in the final product
l
dosimetry for in vitro and in vivo toxicology studies
l
in vitro and in vivo toxicological data on ingredients and their impurities, der-
mal penetration, irritation (skin and eye) and sensitization studies, mutagenic-
ity/genotoxicity studies
l
clinical studies to test the ingredient, or finished product, in human volunteers
under controlled conditions.
l
The FDA expects that the science involving NMs will continue to evolve and lead
to the development of new toxicity testing methods.
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Thus, the safety cosmetic
products containing NMs should be evaluated by analyzing the physico-chemical
properties and the relevant toxicological effects of each ingredient as a result of
expected exposure levels from the intended use of the finished product.
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The draft of the guidance for food the role of nanotechnology was based
on its application in food manufacturing.
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Traditional manufacturing of food
substances may include particles in the nanometer range, but nanotechnology
processes can be applied in the intentional production of food substances with
nanometer particle size distributions that lead to new properties not seen in tra-
ditionally manufactured food substances
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resulting attributes that differ from
those of conventionally-manufactured products. The FDA does not judge all
products containing NMs or involving nanotechnology as either benign or harm-
ful but considers the characteristics of the finished product and its safety.
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The
FDA guidance for the evaluation of food additives, color additives, and food
contact substances recommends rigorous safety assessments.
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In January of 2009, the European Commission Directorate General for
Health and Consumers released their report.
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The report recognized the cur-
rent infancy of the procedures for assessing the potential risks of engineered
NMs which can remain the same until sufficient scientific information becomes
available to establish the possible harmful effects on humans and the environ-
ment.
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The priority of concern is focused on the free and low solubility NMs
because of inhalation exposures that may be natural and or accidental. Just as in
