“Nanotechnology, along with the promise and benefits that it brings, may also raise some questions and concerns over safety and effectiveness,” says Ritu Nalubola, Ph.D, senior policy advisor at the Food and Drug Administration. Some of the most significant regulatory considerations revolve around unveiling the properties of nanomaterials and understanding the relevance of those properties to the regulatory status of the specific products.
To provide a framework for the regulatory oversight of emerging technologies in general and of nanotechnology products in particular, in 2011 the Emerging Technologies Policy Coordination Committee prepared two strategic documents. “Building on these U.S. government policy principles, the FDA developed its own agency-specific regulatory approach, and these emphasize our mission to protect and promote public health, adopt risk-based regulatory approaches based on sound science, and develop transparent and predictable regulatory pathways that are grounded in the best available science,” says Dr. Nalubola.
The definition of nanoparticles—including their size, which has commonly been placed in the 1-100 nm range—continues to present ample interest for regulatory purposes. “There are challenges in deciding how to address aggregates, agglomerates, and some other complex structures, and whether, in addition, we should also take into account novel engineering properties for regulatory purposes”, Dr. Nalubola commented.
In 2011, the FDA issued a draft guidance that provides a broad screening tool for regulatory processes. “The FDA draft guidance recognizes our interests in size, but also that our interest extends beyond size, and that other properties are also relevant for safety and efficacy reviews,” she said. The guidance document encourages industry to seek FDA consultation early during product development, to ensure that any questions related to safety, effectiveness, and regulatory status can be adequately and timely identified and addressed.
“We also articulated our general position, which is that we do not categorically judge all nanotechnology products as being inherently benign or harmful but, rather, that we are looking at products and their characteristics on a case-by-case basis,” she added. This ensures that the current regulatory framework is sufficiently robust and flexible enough to consider a variety of nanomaterials, and to concomitantly identify existing regulatory gaps.
The FDA is actively engaged in the national nanotechnology initiative and participates in some of its research activities. “On the policy side, and in context of the Emerging Technologies Interagency Policy Coordination Committee, we have ongoing dialogues on developing policy approaches and policy-related coordination, and we also participate in the international arena with our regulatory counterparts,” Dr. Nalubola said.
From more than 80,000 articles on nanoparticles that were available on PubMed in January 2014, over half were published after 2010, revealing the interest and progress that are marking this area. As a multidisciplinary field, nanotechnology impacted diverse disciplines including agriculture, engineering, energy production, communications, information technology, cosmetics, and biomedicine. Among these, the diverse biomedical applications provide a clear indication that Ehrlich’s era of the “magic bullet” is becoming reality.