Latest Guidances on “Nano” Product Development and Regulation


By Bob Roth

Two new draft guidances related to the use of nano materials in FDA-regulated products have been issued for public consideration and comments. These draft guidances, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant Manufacturing Process Changes, follow last year’s general guidance on when nanotechnology applies to FDA-regulated products. These draft guidances are the initial salvos in what promises to be an extensive and likely wide-ranging consideration by FDA of the many issues inherent in these new technologies. How long might this process take? Given that the rapidly advancing field of nanotechnology has a very clear clinical promise in many areas, yet has as many scientific questions as answers, we anticipate the nano dialogue will be long and evolving.

If these draft guidances are the first you have encountered, we highly recommend taking a step back to review the report of the 2007 Nanotechnology Task Force. This internal FDA group of experts was tasked with considering issues, with regard to safety, of the wide range of FDA-regulated products that are anticipated to use nanomaterials. Such materials, technically defined as having at least one dimension on the order of nanometers, were anticipated to have applications to human and animal drugs, medical devices, foods, cosmetics, etc., as well as non-medical products. Of greatest importance, these aren’t “your father’s Ford;” that is, a product that incorporates nanotechnology will be dramatically different in terms of chemical and structural properties, and risks, from those products previously available. Until proven otherwise, it is necessary to expect that surface reactivities, general biological activities, toxicologic reactions, structure-function relationships, environmental interactions, etc., will be novel for nanoproducts. Accordingly, the methods used to evaluate nanoproducts may need to be specially designed, and predicting how nanomaterials will interact with biological systems cannot be assumed or inferred from what is known before.

We believe it is important that FDA gradually develop considerable in-house, hands-on experience with these products, both from a research approach and from independent testing procedures. Some basic principles will certainly develop over time, principles that are likely to be applicable to many types of nanomaterials and nanoproducts. Even as such expertise develops it seems clear that not all issues can possibly be identified and understood at the time of a nanotechnology product’s approval, and we expect that post-market safety surveillance activities will similarly undergo revisions over time.

Although many FDA drug and device approvals represent incrementally improved versions of known active ingredients in previously-approved products, the likely result of incorporating nanomaterials will be quantum leaps to new FDA-regulated products. Just as DNA technology has revolutionized the field of disease understanding and drug development, we think nanotechnology has equivalent potential to dramatically alter the products we use every day. This is an FDA blog, and therefore there is an unavoidable focus on regulatory issues, yet in this particular arena the science will drive the regulation more than vice-versa.

Bob Roth is Vice President and Worldwide Medical Director at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.