Biomedical Engineering Reference
In-Depth Information
The Center office begins by conceding that “FDA believes the current general framework for
safety assessment which includes hazard identification, dose-response assessment, exposure assess-
ment, and risk characterization is generally robust and flexible enough to be considered appropriate
for nanomaterials, even though they can have properties that may be different from conventional
ones.”
*
That does not hold true for safety tests:
However, standard safety tests may need to be modified or new methods developed to address (1)
the key chemical and physical properties that may affect the toxicity profile of nanomaterials and (2)
the effects of those properties on the function of the cosmetic formulation. The safety assessment for
cosmetic products using nanomaterials should address the physico-chemical characteristics of the
nanomaterials, impurities, if present, and the potential product and ingredient exposure levels to help
determine what other testing may be needed. The safety assessment should include consideration of the
toxicity of both the ingredients and their impurities; dosimetry for
in vitro
and
in vivo
toxicology stud-
ies, if needed; and clinical testing, if warranted. The safety assessment should also address the issues
of toxicokinetics and toxicodynamics. The overall package of data and information should substantiate
the safety of the product under the intended conditions of use.
†
Each of the points mentioned is discussed in some detail in the document. The guidance con-
cludes with a summary that is worth quoting at length:
Summary of Recommendations—In summary, inclusion of nanomaterials in an FDA-regulated prod-
uct or a change in the nanomaterials used might affect the quality, safety, effectiveness, and/or public
health impact of the product. Therefore, as with any cosmetic product that has new or altered properties,
data needs and testing methods should be evaluated accordingly to address the unique properties and
function of the nanomaterials used in the cosmetic products as well as the questions that continue to
remain about the applicability of traditional safety testing methods to products that involve nanotech-
nology. FDA recommends that the safety assessment for cosmetic products using nanomaterials should
address several important factors such as
•
The physico-chemical characteristics
•
Agglomeration and size distribution of nanomaterials at the toxicity testing conditions which
should correspond to those of a final product
•
Impurities
•
Potential product exposure levels, and the potential for agglomeration of nanoparticles in the
final product
•
Dosimetry for
in vitro
and
in vivo
toxicology studies
•
In vitro
and
in vivo
toxicological data on ingredients and their impurities, dermal penetration,
irritation (skin and eye) and sensitization studies, mutagenicity/genotoxicity studies
•
Clinical studies to test the ingredient, or finished product, in human volunteers under con-
trolled conditions
FDA expects that the science surrounding nanomaterials will continue to evolve and be used in the
development of new testing methods.
In conclusion, the safety of a cosmetic product should be evaluated by analyzing the physico-chem-
ical properties and the relevant toxicological endpoints of each ingredient in relation to the expected
exposure levels resulting from the intended use of the finished product. If you wish to use a nanomate-
rial in a cosmetic product, either a new material or an altered version of an already marketed ingredient,
FDA encourages you to meet with us to discuss the test methods and data needed to substantiate the
product's safety, including short-term toxicity and other long-term toxicity data as appropriate. We wel-
come your contacting us with other questions relating to the use of nanomaterials in cosmetic products.
‡
*
Id.
at 9.
†
Id
.
‡
Id
. at 18-19.
