Regulatory Developments

FDA Proposes Changes to FCN Program

January 27, 2022

The U.S. Food and Drug Administration (FDA) issued a proposed rule on January 26, 2022, to amend procedures for determining when a food contact substance notification (FCN) is no longer effective. 87 Fed. Reg. 3949. FDA states that the proposed rule would allow industry and FDA more flexibility in responding to new information on the safety and use of food contact substances. The amendments aim to create administration mechanisms to improve the program’s overall efficiency. Comments are due by April 11, 2022.

Background

Food contact substances, or substances that are intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food and are not intended to have any technical effect in food, are regulated by FDA as indirect food additives and subject to premarket review unless authorized or exempt through FDA-specified procedures. The premarket FCN process is the primary method FDA utilizes to review food contact substances and uses. The FCN process requires that a manufacturer or supplier of a food contact substance submit details on the identity, intended use, safety, and environmental impact of that food contact substance at least 120 days prior to its introduction into commerce. FDA evaluates and determines if it is safe for such intended use. The FCN is only effective for the substance, its intended use, and the manufacturer or supplier identified in the submission. FDA may determine that the FCN is no longer effective if data demonstrate the intended use is no longer safe.

Overview of Key Proposed Amendments

FDA is proposing to amend the regulations to allow other reasons as justification to determine that an FCN is no longer effective. Highlights of the additional reasons, which may be the basis for FDA to determine that an FCN is no longer effective, include the following:

  • Information available to FDA that demonstrates that the manufacturer or supplier specified in the FCN has stopped or intends to stop producing, supplying, or using a food contact substance for the intended use;
     
  • The intended use of the food contact substance identified in the FCN is authorized by a food additive regulation; and/or
     
  • The intended use of the food contact substance identified in the FCN is covered by a Threshold of Regulation (TOR) exemption.
     

FDA notes that the proposed rule would also “give the manufacturer or supplier the opportunity to respond to our safety concerns or to otherwise show why an FCN should continue to be effective before we could determine that an FCN is no longer effective.” Under the proposed rule, FDA would inform the manufacturer or supplier specified in the FCN in writing of its concerns and a date by which data must be provided to FDA to address the identified concerns. If the manufacturer or supplier fails to provide the required information within the specified timeframe or does not provide adequate data to address the concerns raised by FDA, FDA may determine the FCN is no longer effective without having to conclude the intended use is no longer safe. For example, if a manufacturer or supplier no longer produces the food contact substance that is the subject of the FCN, this amended procedure would allow FDA to determine the FCN is no longer effective without further comment. Current regulations do not provide a mechanism for either the manufacturer or FDA to address these business circumstances and only allow FDA the ability to determine an FCN is no longer effective for safety reasons.

The proposed amendments also provide flexibility if the intended use of the substance that is the subject of the FCN is already authorized by an existing food additive regulation. FDA would be able to remove duplicative authorizations when it determines the FCN is no longer effective because the intended use is authorized under an existing food additive regulation. This would reduce burden on FDA and avoid confusion when others attempt to obtain authorization through an FCN for that same substance and use.

Similarly, if FDA is able to demonstrate the FCN is the subject of a TOR exemption, the proposed amendments allow FDA to remove the duplicative FCN and increase efficiency for the food industry.

FDA includes proposed changes to amend certain aspects of the confidential details provided in the FCN during its determination that an FCN is no longer effective. FDA states the proposed rule would allow it to “include all safety and functionality data and information submitted with or incorporated by reference into the notification or submitted in reference to an effective FCN” in its disclosure. FDA intends “to include all correspondence and written summaries of oral discussions relating to the notification or to FDA’s determination that an FCN is no longer effective.”

The rule would become effective 60 days after publication of the final rule in the Federal Register.

Commentary

The FCN process is one of the most efficient notification processes within FDA. There are no FDA fees associated with the submission. The proprietary submission process allows manufacturers and suppliers considerable protection for expanded uses of currently authorized food contact substances or for submitting notifications for entirely new food contact substances. The proposed changes appear to allow both FDA and industry greater flexibility in determining when the FCN is no longer effective. The process described in the proposed amendments appears to allow an opportunity to provide FDA additional details prior to any final decisions. The proposed amendments will also increase efficiency and provide clarification on unnecessary or duplicative notifications. The changes to require disclosure of certain aspects of confidential information in the proposed rule do cause some concern as many in the food contact substance space know it is very competitive. The benefit of the FCN program is the ability to maintain a large degree of confidentiality during the submission process when establishing the safety and intended use of a food contact substance. The ambiguity of language in the proposed rule on the aspect of disclosure of confidential information is worth review and comments to ensure interested parties are not unintentionally allowing disclosure of information viewed as confidential or business sensitive during the FDA proposed process changes to determine the FCN is no longer effective.


 
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