On April 20, 2012, the Food and
Drug Administration (FDA) announced the issuance of two sets of Draft Guidances
which provide additional guidance on the use of nanomaterials in the cosmetic
and food industries: "Safety for Nanomaterials in Cosmetic Products"
("Draft Guidance on Cosmetics") and "Assessing the Effects of
Significant Manufacturing Process Changes, including Emerging Technologies, on
the Safety and Regulatory Status of Food Ingredients and Food Contact
Substances, Including Food Ingredients that are Color Additives"
("Draft Guidance on Food"). The Draft Guidance on Food and the Draft
Guidance on Cosmetics were published in the Federal Register on April 25, 2012.
A Draft Guidance provides notice and solicits public comment before issuance of
a Final Guidance. The Draft Guidance on Cosmetics and the Draft Guidance on
Food, while non-binding, forecast the likely areas of future FDA focus and the
FDA subject-matter of likely forthcoming regulation. For these reasons, they
are important for businesses in the relevant food and cosmetics industry to
evaluate for public comment and for compliance initiatives.
These Draft Guidances follow
prior draft guidance issued by the FDA in June of 2011, titled,
"Considering Whether an FDA-Regulated Product Involves the Application of
Nanotechnology" ("June 2011 Draft Guidance"). While the FDA has
thus far declined to adopt a formal definition of "nanoproduct" or
"nanotechnology," in its June 2011 Draft Guidance, the FDA broadly
stated that in determining whether an FDA regulated product incorporates
nanotechnology, it will consider the following points: (1) whether an
engineered material or end product has at least one dimension in the nanoscale
range (approximately 1 nm to 100 nm); or (2) whether an engineered material or
end product exhibits properties or phenomena that are attributable to its
dimension(s), even if these dimensions fall outside the aforementioned
nanoscale range, up to one micrometer.
In the Draft Guidance on Cosmetics
and the Draft Guidance on Food, the FDA sets forth various factors for
manufacturers to consider and be aware of when dealing with nanomaterials. The
factors cited by the FDA are suggestive of areas of likely future scrutiny of
nanomaterial in cosmetic and food-related products and are the first major
steps toward providing some direction on how to ensure that cutting-edge
nanoproducts comply with preexisting rules.
In the Draft Guidance on
Cosmetics, the FDA acknowledges that existing product testing paradigms may
need to be modified to address newly arising concerns, and provides some
factors for manufacturers to consider when doing so. For example, the Draft
Guidance on Cosmetics underscores the importance of properly characterizing the
nanomaterial used, including its size, distribution, aggregation and
agglomeration traits. Accurate evaluation of these properties is essential to
assessing and testing a product’s characteristics. The FDA also cautions that
nanoscale impurities may result when manufacturing nanomaterials and recommends
that tests be tailored for both detecting the presence of and evaluating the
effects of any such impurities. Finally, the FDA advises that there is evidence
to suggest that in addition to exposure of the nanomaterial cosmetic products
through its intended route of intake (oral, dermal application, etc.),
nanomaterials may also be absorbed elsewhere or even systemically. Tests
should, therefore, be designed to ensure the safety of all routes or modes of
potential exposure.
The Draft Guidance on Food
offers similar direction for manufacturers when dealing with nanomaterials in
food products and food contact substances ("FCS"), such as packaging
and pigments. The FDA recommends that food manufacturers gear their safety
testing to account for changed characteristics of the nanomaterial food
products, as certain nano substances can exhibit vastly different properties or
characteristics than their macro or bulk counterparts. Additionally,
alterations in particle size distribution on the nanometer scale which alter
the properties of food and FCS may: (1) require new regulatory filings; and (2)
affect the regulatory status of the food – i.e. a food that is Generally
Accepted as Safe (GRAS) may no longer be so due to its changed composition. The
FDA recommends that manufacturers consult the FDA regarding significant changes
in manufacturing processes for a food substance, even if it is not believed
that such a change affects the safety or regulatory status of the food substance.
Both Draft Guidances make clear
that the onus of putting out a commercially safe product has been, and will
continue to be, on the food and cosmetic product manufacturer. By the issuance
of the recent Draft Guidances, the FDA appears to be cautiously and
deliberately increasing its scrutiny of nanomaterial cosmetic and nanomaterial
food products. Manufacturers with concerns about the likely impact of Final
Guidance in these areas should consult legal representatives concerning proper
public commentary. Any public comment must be submitted by July 24, 2012 –
within ninety (90) days from the FDA’s April 25, 2012 publication in the
Federal Register – for both Draft Guidances. While it is premature to fully
anticipate the nature and extent of future regulations to be promulgated –
manufacturers will want to begin to prepare data sufficient to demonstrate
proper analysis, assessment and careful consideration of the factors set forth
by FDA in these Draft guidance documents.
If you would like to learn more
about these Draft Guidances by the FDA or to discuss nanomaterial regulation in
general by any state or federal agency, please contact William
S. Rogers, Jr. the co-author of this Alert and Chair of Prince
Lobel’s Nanotechnology
Practice Group. You can reach William at 617 456
8112, or wsrogers@princelobel.com.