Frequently Asked Questions on Food Contact Notifications: Proprietary Rights

March 1, 2001

Can a notifier license its FCN to a third party?

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.

Can a notifier transfer or assign its FCN to a third party?

In the event of the sale of a business, a change in corporate control, or a change in the name of the notifying company, the company should be able to transfer an FCN to the successor organization simply by informing FDA of the change and providing authoritative documentation of the legal basis for the transfer.

A formal procedure to govern assignment or transfer transactions is not contemplated --probably because an FCN confers only a very short-term exclusivity, since anyone can file a similar notice that will become effective in 120 days. Rather, notice to the agency is all that is needed so that the agency can keep track of the extent of use of notified substances.

Nothing in the statute or proposed regulations provides that a notification can be assigned or transferred to a competitor. Certainly, a competitor can rely on the data the original filer has submitted to file its own FCN and prove the safety of the competing product if it can show that the characteristics of its product are the same. In short, there is so little incentive for the purchase of a notification that no special procedures exist -- or are likely to be established -- to facilitate purchases.

Can a notifier's proprietary right to an FCN expire?

FDA has the power to cancel an FCN if, at any time after the FCN becomes effective, FDA determines that the substance is unsafe.

In advising the FCN submitter that its FCN is effective, FDA may warn the notifier that it must alert FDA if the notifier becomes aware of data that raise questions about the safety of the intended use of the food-contact substance. In the event such data develops, the notifier's FCN could be cancelled.

Does an effective FCN grant an exclusive proprietary right?

One feature of an FCN that differs from a Food Additive Petition is the proprietary nature of an FCN. Unlike a patent or trademark, a notifier's proprietary right to an effective FCN is not necessarily exclusive. Another party or competitor can submit an FCN to FDA for the same substance and, provided FDA does not object, obtain its own notification in the normal course.

This process can be repeated by anyone who collects and submits adequate chemistry and toxicology data demonstrating that the substance is safe. A subsequent notifier can obtain and rely on the non-confidential data submitted by previous notifiers -- including migration and toxicology data.