Answer: In our opinion, it would be counterproductive and profoundly unsound to refer to effective notifications as "licenses," or to treat them as such by proposing sublicensing. Effective notifications do authorize the use of substances for specified intended uses but in no other respect bear the indicia of licenses like patents, approved new drug applications, or certain approved new device applications.
The new law does not contemplate a broadly expansive new FDA regulation of food-contact substance production methods, polymerization techniques, or other manufacturing details as is the case with drugs or devices. Rather, the notification program, like the Food Additive Regulations it is intended to replace, establishes the fact that a substance meeting stated specifications can be used for listed intended uses. It does not, need not, and should not fix the way in which the substance will be made so long as general good manufacturing practices are observed.
Thus, for example, in clearing by notification a new polymer, the notifier is asked to advise FDA as to the manufacturing process and reaction control agents used. However, these features are not "licensed"; indeed, alternative methods of manufacture or reaction control agents can be employed so long as the final food-contact substance meets the standard set forth in the notification when it becomes effective. This makes good sense. It would be a serious mistake with potentially severe consequences to label notifications "licenses" (like approved new drug applications) since this could bring about the need to notify FDA every time a manufacturing method change is contemplated -- and might even give rise to enforced factory registrations and inspections.
The framers of the new law intended a simplification of the regulation of a recognized minimal risk, not an escalation of regulation that would have no public health benefit.
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