An October report authored by Michael R. Taylor, Esq., former FDA Deputy Commissioner for Policy (1991-1994) may not be warmly received by all nanomanufacturers. Taylor’s report focuses on what he sees as FDA’s three primary purposes in relation to nanotechnology: (1) ensure product safety; (2) foster innovation; and (3) maintain public confidence in nanoproducts. Taylor analyzes existing FDA pre-market review and post-market monitoring powers over nanotechnology products and finds several insufficiencies.
The essence of Taylor’s report is distilled in Table 2 on page 27 of the article, in a table entitled “Capacity of FDA’s Legal Authority to Achieve the Primary Goals of Regulatory Oversight for Nanotechnology Products.” The table provides a quick summary of how Taylor views the FDA’s current power to regulate the nanotechnology industry.
Specifically, Taylor identiies four FDA Pre-Market Oversight Goals:
1. Obtain information on new nanoproducts early in the development process;
2. “Define and enforce public safety standards for nano-materials, including the nature and extent of testing required to satisfy them;”
3. “Place the initial and continuing burden to demonstrate safety on the nanotechnology product’s sponsor;” and
4. “Review the nanotechnology product’s safety prior to marketing and improve conditions as needed to ensure safety.”
And four FDA Post-Market Oversight Goals:
1. “Require post-marketing monitoring and testing of nanotechnology products as needed to ensure safety;”
2. “Require timely adverse event reporting;”
3. “Inspect manufacturing establishments and examine records related to nanotechnology product safety;” and
4. “Remove from the market nanotechnology products that appear to pose a significant safety hazard and or no longer meet the applicable safety standard.”
Taylor then evaluates what he perceives to be the effectiveness of FDA’s current authority to implement these goals across nine different product categories: Cosmetics, Whole Foods, Dietary Supplements, GRAS Food Ingredients, Food Additives, Food Packaging, Medical Devices, OTC Drugs, and New Drugs.
Medical Devices and New Drugs fare best under Taylor’s analysis, while Cosmetics, Whole Foods, and Dietary Supplements fall at the other end of his spectrum. Taylor’s analysis suggests, however, that virtually every product category could benefit from a strengthening of FDA’s existing regulatory authority.
Taylor further implies that FDA will not be able to reach the above-referenced goals unless Congress drastically increases its funding. To this end, Taylor asserts FDA’s 2007 budget falls 56% short of what it needs to perform the same tasks required of it in 1996.
The report concludes with helpful information concerning FDA’s existing nanotechnology activities, additional tools Taylor believes FDA needs to do its job, and several recommendations regarding how FDA should approach the significant gaps in the nano-regulatory picture he paints.
“Regulating the Products of Nanotechnology: Does FDA Have the Tools it Needs?,” Taylor, M., Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, October, 2006.