Overview
The US Food and Drug Administration (FDA) is proposing to amend its regulation at 21 C.F.R. § 170.105 regarding the bases upon which the agency may determine that a Food Contact Notification (FCN) is no longer effective, and the procedures to be followed on doing so. FDA is also proposing to amend its regulation at 21 C.F.R. § 170.102 on the confidentiality of information related to an FCN to include information submitted in connection with such determinations. (See 87 Fed. Reg. 3949 (Jan. 26, 2022)).
We understand from recent presentations by FDA representatives that this proposal has been in the works for some time. Currently, Section 170.105 allows FDA to determine that an FCN is no longer effective because the intended use of the food contact substance (FCS) is no longer safe for the intended use in food-contact applications. The regulation, however, does not provide for other bases upon which FDA can make the "no longer effective" determination, such as relying on a commitment from a manufacturer that a FCS is no longer being produced or marketed for the food-contact use described in a given FCN. This construction has created the unsatisfactory situation in which manufacturers have voluntarily agreed to cease introduction into interstate commerce of certain FCSs that are the subject of effective FCNs, but the FCNs continue to remain effective. (See, e.g., information on the market phase-out of certain short chain per- and polyfluoroalkyl substances (PFAS) and the market phase-out of certain long chain PFAS on FDA’s website here). FDA's goal is to amend the regulation to provide the bases for making a final determination that the affected FCNs are no longer effective in such cases. Importantly, such a determination may be made without the need to evaluate the continued safety of the intended use of the FCS in question.
In addition to allowing FDA to make the determination that an FCN is no longer effective when a manufacturer informs FDA that the company is no longer producing, supplying, or using a FCS in the applications covered by the FCN, the proposed regulation also would allow FDA to make the same determination based on "other" data or information available to the agency. For example, FDA could make the determination that an FCN is no longer effective if the agency learns from another company that the manufacturer is no longer producing, supplying, or using the food contact substance in the United States.
Further, along with the "no longer producing, supplying, or using the FCS for the applications covered by the FCN" reason for allowing FDA to make a determination that an FCN is no longer effective, FDA has included two additional bases: (1) the agency may determine that an FCN is no longer effective because the intended use is authorized by a food additive regulation; and (2) the agency may determine that an FCN is no longer effective because the intended use is covered by a "Threshold of Regulation" (TOR) exemption. These additional bases for making a "no longer effective" determination are geared toward easing the burden on FDA when multiple manufacturers or suppliers submit FCNs for the same intended use of the same FCS. Given that FCN clearances are proprietary to the manufacturer, while food additive regulations and TOR exemptions may be relied upon by any manufacturer of the FCS, issuing a single regulation or TOR exemption for a given use of a FCS would be more efficient for FDA when numerous manufacturers request their own FCN clearances for the same use of a given FCS. We would envision the application of the regulatory provisions allowing FDA to make a "no longer effective" determination for an FCN based on a regulatory clearance or TOR exemption to be forward-looking, as FDA does not accept new FCN filings for uses of FCSs that are already the subject of applicable food additive regulations or TOR exemptions. An example here would be FDA's issuance, at its own initiative, of TOR exemption 2021-003 for the use of metal carbides and metal carbide alloys as a component or ceramic coating in repeat-use applications such as parts in food processing equipment (see our article about this unprecedented TOR exemption here.) This TOR covers the same FCS and uses identified in several effective FCNs.
The proposed regulation stipulates that, in cases in which FDA has data or information demonstrating that the intended use of an FCS is no longer safe, FDA will inform the affected manufacturer of the agency’s concerns before determining that the FCN is no longer effective. Similarly, FDA will inform the affected manufacturer or supplier prior to making a determination that an FCN is no longer effective pursuant to one of the following, newly added bases: (1) FDA receives information from a source other than the manufacturer or supplier identified in an FCN that the FCS is no longer produced, supplied, or used for the intended food-contact use in the United States; (2) the intended use of a FCS is authorized by a food additive regulation; or (3) the intended use of a FCS covered by a TOR exemption. In all such cases, the manufacturer or supplier of the FCS will have the opportunity to supply data or other information to inform the agency's decision prior to FDA's final determination that the FCN is no longer effective. (In a case where FDA receives a request from the manufacturer or supplier to determine that an FCN is no longer effective because it is no longer being produced, supplied, or used for the intended food contact uses in the United States, FDA will notify the requestor as to whether FDA will grant the request.)
Overall, the proposed regulation appears to provide for a less burdensome and more definitive means of "closing out" FCNs that are no longer desired or needed when the basis for a "no longer effective" determination is not an issue of safety. The comment period for this Proposed Rule will run for 75 days (comments are due by April 11, 2022). If you have any questions or would like assistance in interpreting or preparing comments on the proposed rule, please do not hesitate to contact us.