Cosmetic products and ingredients (except colors) are not subject to premarket clearance by the Food and Drug Administration (FDA) and the manufacturer is responsible for the safety of any cosmetic product it distributes. In the past, the FDA has taken action to bar or restrict use of certain materials in cosmetics because they have been shown to be unsafe and these materials are identified in the agency’s regulations. The FDA’s publication of a draft guidance document on the “Safety of Nanomaterials in Cosmetic Products” in April 2012 highlights the agency’s current concern that standard test methods and safety testing protocols presently used by the cosmetic industry to support product safety may not adequately assess whether nanomaterials are safe to use in cosmetic and personal care products.
The FDA has previously stated that it does not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful.1 However, the agency believes that application of nanotechnology may result in product attributes that differ from those of conventionally manufactured products, and thus merits examination.
In its first product category-specific guidance on this subject, the FDA is encouraging companies that already use a nanomaterial in a cosmetic product, either a new material or an altered version of an already marketed ingredient, to meet with the agency to discuss the test methods and the data needed to substantiate the product’s safety, including chronic toxicity and other longterm toxicity data as appropriate. The draft guidance identifies the potential safety issues and sets forth the FDA’s current thinking about developing a framework for evaluating them.
Companies may ultimately be asked to submit safety files in support of any nanomaterials used in their products. At present, however, the FDA is recommending that the safety assessment of nanomaterial ingredients and finished cosmetic products in which they are used, should address the following factors:
- the physico-chemical characteristics of the nanomaterial;
- the size distribution of nanomaterials in the finished product;
- impurities that may be created due to nanomaterial production methods;
- potential product exposure levels and the potential for agglomeration
- 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;
- long-term stability of nanomaterials in the finished product ; and
- clinical studies to test the ingredient, or finished product, in human volunteers under controlled conditions and conditions of intended use.
The FDA cautions that 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.
When considering whether an FDA-regulated product, including a cosmetic product, contains nanomaterials or otherwise involves the application of nanotechnology, the FDA will ask the following:
- whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1nm to 100nm); or
- whether an engineered material or end product exhibits 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.
These considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. Additionally, as the FDA states in its June 2011 guidance, such factors may change in the future as new information becomes available and to refinement in future product-specific guidance documents.
Comments to the draft guidance on the “Safety of Nanomaterials in Cosmetic Products” (Docket No. FDA-2011- D-0489) may be submitted to the FDA until July 24, 2012. The full draft guidance is available by clicking here.2