FDA Food Contact Material: Compliance Guide
In 2023, the FDA issued warning letters to multiple manufacturers of food contact articles — including a major manufacturer of reusable plastic food containers — for failing to provide adequate documentation that their food contact substances were approved for their intended use. The common thread in all the letters: the companies had test data showing their products were safe, but they could not produce a properly structured Declaration of Compliance that mapped each substance in the material to its regulatory clearance. The FDA's position was unambiguous: data without a properly structured declaration is not compliance documentation.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA) and 21 CFR Parts 170–199, any material intended to contact food during manufacturing, packaging, storage, or preparation must be approved by the FDA or be Generally Recognized as Safe (GRAS). The manufacturer or supplier issues a Declaration of Compliance (DoC) — a self-declared document that certifies the material meets FDA regulatory requirements. On the Sustalium platform, food-contact declarations are one of the most cross-referenced document types we see: a food packaging supplier issues a Declaration of Compliance to its downstream customer, who must then present it to their own buyer or retailer audit.