Existing Safety Principles Suffice For Nano-Cosmetics Evaluation – FDA
This article was originally published in The Rose Sheet
Executive Summary
FDA maintains that the current framework for cosmetic safety assessment is sufficient to control potential risks associated with nano-engineered cosmetics. However, traditional testing methods may need to be modified or new strategies developed to account for nanomaterials’ unique properties and behavior, the agency says in final guidance issued June 24.
Existing regulations and safety-substantiation principles, as laid out by federal food and drug law and past FDA communications to industry, are adequate to support the safe marketing of cosmetics containing nanomaterials, the agency concludes in final guidance published June 24.
“We consider the current framework for safety assessment sufficiently robust and flexible to be appropriate for a variety of materials, including products containing nanomaterials,” FDA states.
FDA recognizes in the guidance, titled “Safety of Nanomaterials in Cosmetic Products,” that materials on the nano scale can have different chemical, physical and biological properties, exhibit novel behavior and pose unique risks, compared with their macro-sized counterparts.
However, “we do not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful,” the agency notes.
“We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products.” – FDA Commissioner Margaret Hamburg
“As with any cosmetic product that has new or altered properties, data needs and testing methods should be evaluated to address any unique properties and function of the nanomaterials used in the cosmetic products,” according to the guidance document.
FDA cites a number of specific factors firms should consider when conducting safety assessments for cosmetics formulated with nanomaterials, including physicochemical characteristics, impurities, potential routes of exposure and dosimetry for in vitro and in vivo toxicology studies, as well as toxicological risks related to dermal penetration, potential inhalation, irritation (skin and eye) and sensitization, and mutagenicity/genotoxicity.
As in the agency’s draft guidance released in April 2012, FDA notes that traditional testing methods may not be fully applicable to nano-engineered cosmetic products due to nanomaterials’ unique properties (Also see "Clinical Studies May Be Needed For Cosmetics With Nanomaterials – FDA" - HBW Insight, 30 Apr, 2012.).
“Such distinctive physicochemical characteristics or biological interactions may affect the results or interpretation of results obtained from traditional toxicology testing, which form an integral part of safety substantiation,” the agency says.
Traditional toxicity testing strategies should be modified as needed to account for factors such as agglomeration or aggregation of nanoparticles, which can affect solubility and the suitability of traditional tests, as well as nanomaterials’ high surface energy, which can cause them to interact with the testing medium in ways that alter biological activity, according to FDA.
“In instances where traditional toxicity testing methods cannot be satisfactorily modified, FDA recommends developing new methods to adequately assess the toxicity of the nanomaterial in the cosmetic product and ensure the product is safe,” the agency says, adding: “We expect that the science surrounding nanomaterials will continue to evolve and be used in the development of new testing methods.”
FDA encourages companies to consult with its Office of Cosmetics and Colors to discuss test methods and data needed to substantiate a nanotech-containing product’s safety prior to market launch, as required under the Federal Food, Drug & Cosmetic Act.
Still No Formal Definition
FDA acknowledges in the guidance that it has not established regulatory definitions for “nanotechnology,” “nanomaterial,” “nanoscale” or related terms.
For the time being, the agency cites two considerations that will guide its approach to products that may or may not incorporate nanotechnology:
- whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm).
- whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).
The latter point was a concern for industry as presented in the draft version of another FDA guidance document, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.”
In comments to the agency, the Personal Care Products Council contended that the 1-µm ceiling could expand the universe of regulated nanomaterials “massively” and represent a departure from international standards (Also see "FDA Nanotech Guidance Draws Industry Comment On Particle Size Criteria" - HBW Insight, 19 Sep, 2011.).
A final version of that guidance released June 24 as well.
FDA’s final guidance is not likely to satisfy concerns raised by Friends of the Earth and other NGOs that have questioned the license granted to manufacturers to “self-determine” testing needs and the acceptability of using nanomaterials in cosmetics.
“Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” says FDA Commissioner Margaret Hamburg in a same-day release.
“We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products,” she adds.
The agency’s position is not likely to satisfy concerns raised by Friends of the Earth and other NGOs that have called for a moratorium on cosmetics containing nanomaterials until the science is better understood.
In comments on FDA's draft nanomaterials guidance, the groups suggested the resource was insufficient to ensure public safety, leaving “a gaping gray area in regulations in which industry can self-determine the safety of their products and the acceptability of using nanomaterials in cosmetics” (Also see "NGOs Call For Moratorium On Nanotech-Enabled Cosmetics" - HBW Insight, 20 Aug, 2012.).
FDA invites stakeholders and the public to submit feedback regarding its nanotech guidance documents “at any time.”