Frequently Asked Questions on Food Contact Notifications: The Logistics
Are the existing Food Additive Regulations and Threshold of Regulation exemption letters still valid?
Yes. They will remain in effect unless specifically revoked by FDA. However, expansions of existing clearances in most, if not all, cases will be obtained through the FCN process.
How many products can a single FCN cover?
Aside from original FCNs, which were allowed to become effective in place of existing petitions, an FCN can only cover one uncleared FCS. If a company is interested in using a product that contains more than one uncleared substance, a separate FCN must be filed for each uncleared FCS. This issue is likely to be the subject of considerable discussion, because there is no apparent reason why a notification could not cover more than one substance, particularly in the case of formulations.
Not all components of an FCS, however, require separate FDA clearance (e.g., substances needed to make a basic resin, like catalysts); the question of which components need clearance is being addressed by FDA on a case-by-case basis.
When does the review period begin to run?
The 120-day review period begins to run upon FDA's receipt of the FCN.
There is some difference of opinion as to what "receipt" means. For our purposes in fixing a date, we hand-deliver our FCNs to FDA, so we can get a stamped "received" acknowledgment from FDA. Were a dispute to arise regarding the timing issue, we think this would be read by a court of law as the "receipt" date contemplated by FDAMA.
On the other hand, it should be recognized that FDA has been taking the position that receipt of the FCN means the time it is delivered to the reviewing office. This will be a few days after the date the FCN is delivered to FDA due to security arrangements at the agency that create a delay between the initial delivery to FDA and actual arrival of the submission at the reviewer's desk. Ordinarily, this lapse of time is minimal so the difference of opinion can be considered inconsequential.
When is an FCN submission considered accepted by FDA?
In its proposed rules, FDA has outlined an operating plan for accepting notifications.
Under that plan, FDA is conducting initial reviews of FCNs to determine whether any basic information is missing, and will request additional information by telephone (confirmed by a letter). If the request is answered in a satisfactory way, within approximately two weeks, then FDA will issue a letter accepting the FCN.
In the event an FCN is accepted, the 120-day period continues to run from the original date of receipt. FDA has indicated its intent to decide on the acceptability of an FCN, and to provide the appropriate responsive letter within 30 days of receipt. Unhappily, since FDA is not required to issue the acceptance letters, our experience is that this 30-day timeframe has been followed loosely, with some acknowledgment letters issuing only a few weeks in advance of the effective date of the notification.
A filer can agree to let the review period start over in the case of unacceptable FCNs that cannot be corrected very quickly (again, within two weeks of FDA's request for additional information). If supplemental information cannot be provided quickly, the FCN will need to be withdrawn or FDA will send a letter refusing to accept the FCN. The submitter of an FCN also may choose to leave an FCN pending to draw a formal objection from FDA. This will set the stage for judicial review of FDA's decision.
Where will FDA publish effective notifications?
Effective notifications are listed on the agency's Web site at the following address: http://www.fda.gov/food/ingredientspackaginglabeling/packagingfcs/notifications/default.htm. No other publication is provided.
Will FDA issue a written letter indicating that the FCN is effective?
Currently, FDA is sending such letters identifying the notification, including a description of the substance and any limits on its intended conditions of use, and the date on which the notification became effective.
The agency has indicated that it plans to continue providing these letters unless the administrative burden becomes too great.