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Proprietary Rights in a Food Contact Notification

According to the Food and Drug Administration Modernization Act of 1997 (FDAMA), an effective food contact notification (FCN) applies only to the specific product identified in the FCN and not to similar (or identical) products made or supplied by others.[1] As a consequence, an FCN takes on a proprietary nature, and, in that sense, grants a proprietary right. The question arises, however, as to who holds the proprietary right—is it the notifier or the manufacturer/supplier? The answer can be of importance to the way in which an FCN is couched, and, in fact, in the marketing and contractual decisions that lead up to filing an FCN.

FDA's Inventory of Effective Pre-market Notifications for Food-Contact Substances, identifies two categories of entities (usually companies) associated with an FCN: "notifier" and "manufacturer of the FCS.”[2] For companies that are identified as both the notifier and the manufacturer, there is no meaningful difference between the two categories as the proprietary right extends to the same entity in either case. The problem arises when the identity of the notifier is different than that of the manufacturer.

It is easy to assume under these circumstances that the notifier of an FCN holds a proprietary right in the FCN, i.e., the notifier and its customers are the only companies permitted to rely on the FCN (i.e., use the identified food contact substance), and the manufacturer of the substance holds no rights in the FCN beyond being able to market the substance to the notifier. In fact, if a notifier identifies another company in the FCN as the manufacturer/supplier, that other company may actually obtain a proprietary interest in the FCN that the notifier never intended or wanted. The issue—and the confusion—revolves around the terminology used by FDA in describing effective notifications and the provisions of the statute which created the program.

The FCN system was enacted with passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The proprietary nature of an FCN came about as a result of the interplay between two provisions of this Act. First, Section 409(h)(1) provides that a manufacturer or supplier of a food contact substance may submit an FCN to FDA at least 120 days prior to the introduction or delivery for introduction in interstate commerce of the food-contact substance. Second, Section 409(h)(2)(C) provides as follows:

In this paragraph, the term "food contact substance" means the substance that is the subject of a notification submitted under paragraph [409(h)(1)], and does not include a similar or identical substance manufactured or prepared by a person other than the manufacturer identified in the notification.

In other words, an effective FCN covers only the substance described in the FCN as manufactured or prepared by the company identified in the FCN. These two provisions seem to suggest that the statute envisioned that notifications would be filed only by a manufacturer or supplier of a product (409(h)(1)) and thus would only cover that manufacturer's or supplier's product and its use by its customers (409(h)(2)(C)).

In implementing the FCN system, however, FDA decided to permit companies other than manufacturers, and what we would traditionally consider to be a supplier, to submit notifications. FDA did this by defining in its administrative guidance document the term "manufacturer/supplier" to include "any persons supplying the FCS, including companies supplying the FCS to themselves for manufacture of a food-contact material.”[3] Accordingly, the term "supplier" includes companies that sell the FCS, as well as companies that use the FCS to make a food-contact material, i.e.,users of the FCS. Thus, the companies identified as "manufacturers" on FDA's website can include manufacturers, suppliers of the FCS to others, and users of the FCS who are said to "supply the FCS to themselves."

Unlike the term "supplier," which FDA at least defines in a guidance document, the term "notifier" is not even mentioned in FDAMA and is never defined by FDA. The term would seem to refer to the company that submits the FCN to FDA, and as FDAMA permits only the manufacturer or supplier to "notify FDA about the use of an FCS," it would also seem that only a manufacturer or supplier can be a notifier. In this sense, use of the term would seem to incorporate a redundancy. However, this is not the case. FDA appears to be willing to accept a notification from any party, regardless of its status as a manufacturer or supplier. Indeed, there is at least one FCN on FDA's website in which a law firm is listed as the notifier, i.e., a party which is not a manufacturer, supplier, or user.

As indicated previously, in cases in which there is a common identity between the notifier and the manufacturer, there can be no question as to the ownership interest in the proprietary right. It is, in fact, the manufacturer's product that is the subject of the notification, and it is the manufacturer and its customers who can rely upon the notification. A third party manufacturer which makes a similar or identical product cannot rely on the notification, and must file its own if it wishes to sell into that market.

However, what is the result when the notifier is a user of the food contact substance and has identified in its notification another company as the manufacturer of the substance? It seems clear from the statute that under these circumstances the notifier is limited to using only the identified manufacturer's product as the food contact substance. By its terms, the FCN does not permit the notifier to use a third party manufacturer's product even if it is identical. For the notifier, this situation may be avoided by having FDA list the notifier as the manufacturer/supplier of the product and making clear in the FCN that it does not intend to purchase any particular company's product for use as the FCS, but any product that meets the specifications that are set out in the notification.

However, an even more difficult question arises as to whether the manufacturer gains any rights in the notification, i.e., whether the manufacturer can sell the food contact substance to users other than the notifier based upon the FCN. In light of the work and expense involved in obtaining a clearance for a food-contact substance under the FCN program, it is unlikely that a notifier/user would go through all of this trouble if it knew that its work would be used by a manufacturer to sell its product not only to the notifier, but to the notifier's competitors.

A manufacturer may claim that it and all of its customers have the right to rely upon the notification with respect to the manufacturer's product that is cleared since the terms of the statute (409(h)(2)(C)) indicate that the notification is only effective for the identified product. However, the notifier may take the position that only it has the right to rely upon the notification with respect to the manufacturer's product because the manufacturer did not submit the notification under Section 409(h)(1) and the notifier was not acting as an agent on its behalf. In legal parlance, submission of a notification could be considered a condition precedent to claiming the proprietary interest.

FDA takes the view (at least informally) that the manufacturer may, indeed, rely upon an FCN filed by a third party-notifier. However, in light of the available statutory interpretations and the rather confusing regulatory implementation of the statute, it is not at all clear that a court would find the same way.

Needless to say, notifiers who are not product manufacturers should try to avoid this problem by negotiating, with the manufacturer/supplier of the product prior to submission of the FCN, an agreement that reflects the clear intent of the parties with respect to such proprietary interests.


[1] See 21 U.S.C. 409(h)(2)(C).

[2] Although FDA's table employs the heading "manufacturer of the FCS," the entities listed in this column may include suppliers, which, as discussed below, the statute identifies as the equivalent of a manufacturer.

[3] Guidance for Industry: Preparation of Food Contact Notifications: Administrative (May 2002)