Food Contact Substance (FCS)
RegulatoryAlso known as: Food contact material, FCS, Indirect food additive, Food-contact packaging material
Any substance intended for use as a component of materials in contact with food, regulated by FDA through Food Contact Notifications.
What It Means
A food contact substance (FCS) is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food. FDA regulates FCS through several pathways: Food Contact Notifications (FCNs), prior sanctions, GRAS determinations, and Threshold of Regulation (TOR) exemptions. Critically, an effective FCN applies only to the manufacturer or supplier listed in the notification AND to the specific conditions of use reviewed. Food-contact authorization is dynamic and use-specific: in January 2025, FDA determined that 35 PFAS-related FCNs for grease-proofing agents were no longer effective. For supplement packaging, the relevant question is: what is the regulatory basis for each direct-contact material, for this specific use, from this specific supplier?
What It Is Not
A food-contact packaging MANUFACTURER is generally NOT a food-facility registrant simply because it makes packaging. 'FDA registered packaging' conflates three different roles: the supplement packager (Part 111 registrant), the packaging-material maker (generally not a registrant), and the brand/distributor. This phrase in marketing is a red flag for regulatory confusion, not a positive signal.
Evidence and References
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