Nanotechnology: New Products Present Potential Liability


The market for nanotechnology-based consumer products is rapidly expanding. With this industry expansion, more focus is brought on the potential health risks associated with exposure to nanoparticles and on potential liability for manufacturers. Nanotechnology is used generally in cosmetics for UV filtration and as a delivery vehicle for better application. There are currently very few conclusive findings involving nanoparticle exposure and associated health risks. Environmental and consumer advocates are currently arguing for increased governmental regulation to prevent potential adverse health effects to workers and consumers from the use of nanotechnology.

Last month, a research team reported on potential human risk of harm from the inclusion of nano-sealed particles in powder cosmetic compacts in Potential for Inhalation Exposure to Engineered Nanoparticles from Nanotechnology-Based Cosmetic Powders, Environmental Health Perspectives.

The research team conducted a simulated cosmetic application on a mannequin and analyzed particle size, shape, agglomeration or clustering, and distribution for six popular cosmetic powders: three containing nanoparticles and three without. The researchers then measured the size distribution and concentration of particles that could be inhaled as a result of such application.

Specifically, the airborne particle measurements indicate that exposure to nanoparticles would come from nanoparticle clusters of less than 100 nm and as large as 20 micrometers. Nanoparticles of this range are likely to lodge in the tracheobronchial and head airway regions, but cannot reach the alveoli, the part of the lungs where air exchange takes place. Because these clusters have a combined surface area greater than that of solid particles of the same size, they may pose a different health hazard than solid particles. The researchers also found that nanomaterial exposure would take place predominately through nanoparticles and nanoparticle-containing clusters smaller than 100 nm in diameter. Particles of this size can be distributed throughout the lungs and may lodge in the alveoli, signaling the potential for long-term damage. The methodology employed in this study may be utilized to estimate exposures in humans through the short-term and long-term use of cosmetic powders such as those used in this study, as well as through other consumer products, such as sunscreens.

The authors concluded that their findings supported the need for legislation requiring manufacturers to report the use of engineered nanomaterials in their products. This, they claimed, is due to the potential for harm and the lack of information currently provided by manufacturers about nanomaterial in their products and the practical difficulty in detecting nanomaterials in those products.

This recommendation is timely because in April of 2012, the Food and Drug Administration issued a draft guidance (U.S. Food and Drug Administration, Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products, April 2012) to industry and other stakeholders on the safety assessment of nanomaterials in consumer products. The FDA recommends that a safety assessment should include consideration of the toxicity of both the ingredients and their impurities, dosimetry for in vitro and in vivo toxicology studies, and clinical testing if warranted. If the guidance is finalized, the agency intends to apply these considerations broadly to all FDA-regulated products, including cosmetic products. The public comment period closes on July 24, 2012 after which the draft guidance can be formally issued or revised. Also pending is the Safe Cosmetics Act of 2011 (HR 2359), which would require, among other things, that all ingredients contained in a product be listed in descending order of quantity without deminimus exception. The legislation will provide no trade secret protection for contents except for final concentrations.

Governo Law Firm is carefully monitoring developments in nanotechnology and its implications for public health and regulation. As experienced counsel in representing clients nationwide in claims of exposure to hazardous materials, Governo Law Firm is dedicated to providing efficient and effective legal counsel to clients seeking assistance in facing potential new laws, regulations and industry standards. If you are interested in the changing landscape of nanotechnology regulation, please contact David Governo at [email protected] or Sarah O'Leary at [email protected] or call 617-737-9045.