DISCUSSION: The Regulatory Landscape and Emerging Oversight Strategies

COMMENT: Input from Michael R. Taylor

Submitted by Evan Michelson     on 10/24/07 8:48 AM

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The following is a response from Michael Taylor to the posting on the potential use of nano-lycopene in food products. Mike is the author of the FDA report in the library (also available at http://www.nanotechproject.org/82... ).

"This interesting hypothetical raises a number of scientific and regulatory issues affecting the nature of FDA oversight. First, on a purely scientific basis, FDA has said that the safety of nanoscale particles needs to be assessed on a case by case basis, which means the developer of a nanoscale lycopene could not assume it is safe based on the status of the conventional scale product. The regulatory picture is much more complicated. The hypothetical lycopene drink could be positioned by the developer as either a dietary supplement or a "food in conventional form." If successfully positioned as a supplement, the developer would at most have to submit a pre-market notification to FDA with information on the basis for the developer's belief in the product's safety but without any FDA-required pre-market safety testing. If the product is marketed as a "food in conventional form," the lycopene would have to have legal status either as an FDA-approved food additive or as a substance that is "generally recognized as safe." For both food additives and GRAS substances, the legal requirement is that there must have been significant pre-market testing to demonstrate that there is "a reasonable certainty of no harm" from the intended ingestion of the substance."

--Michael R. Taylor, Research Professor of Health Policy, School of Public Health and Health Services, The George Washington University