Overview
On June 17, 2021, the US Food and Drug Administration (FDA) took unprecedented action and issued a Threshold of Regulation (ToR) exemption for metal carbide and metal carbide alloys that was initiated by the Agency, rather than an industry requestor.1 FDA's action raises important strategic questions for companies that intend to market new food-contact materials.
Although the ToR exemption program has existed since 1995, and FDA has issued scores of ToR exemptions for food-contact substances, those exemptions have always been issued at the request of industry.2 FDA's stated rationale to self-initiate a ToR exemption for metal carbides is to reduce the number of duplicative Food Contact Notification (FCN) submissions and other inquiries the Agency receives for metal carbides and to conserve the Agency’s resources for "issues of greater public health significance."
FDA's "Threshold of Regulation" rule (21 C.F.R. § 170.39) permits the Agency to exempt substances from the need for a specific regulatory clearance on a case-by-case basis if certain criteria are met. Namely, the substance must not be a carcinogen, must not contain constituents that are potent carcinogens, and the dietary exposure to the substance must either be below 1.5 µg/person/day or, if the substance is already regulated for direct addition to food, the exposure must be below 1% of the Acceptable Daily Intake. In this particular case, FDA noted that metal carbides are not known to be carcinogenic and are both stable and inert. Therefore, there is little or no likelihood that components of metal carbides would migrate to food at more than insignificant amounts, and the Agency concluded that it has no safety concerns in relation to their intended use in ceramic coatings and other repeated use articles.
FDA's action highlights the Agency's recent prompts to industry to use the ToR exemption when possible, rather than relying solely on the FCN pathway to market. Although FCN submissions automatically become effective 120 days from their submission date, FDA has made several public comments of late noting that the Agency often is able to process a ToR exemption in a timeframe that is faster than 120 days. An important distinction between the ToR and the FCN programs is that ToR exemptions can be relied upon by anyone, but an FCN is only effective for the manufacturer identified in the filing.
For questions regarding FDA's action, or to discuss strategy for preparing a future filing to the Agency to establish a suitable FDA legal status for your food-contact material, please contact Steptoe and Johnson LLP.
1 See Constituent Update, FDA Issues Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment, US Food and Drug Administration, June 17, 2021, available at https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-threshold-regulation-exemption-metal-carbides-food-processing-equipment.
2 A list of FDA’s TOR exemption letters may be found on FDA’s website at: https://www.accessdata.fda.gov/scripts/fdcc/?set=TOR. The metal carbide and metal carbide alloy ToR exemption is ToR 2021-003, available at https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=TOR&id=2021-003.
