21 U.S.C. § 348 — Food additives

(a) Unsafe food additives; exceptions. A food additive is legally "unsafe" for a particular use — meaning food containing it counts as adulterated — unless: (1) it and its use fit an exemption in effect under subsection (j); (2) there's an FDA regulation in effect under this section saying how it can be safely used, and it's used that way; or (3) for a food additive that's a "food contact substance" (something that touches food, like packaging material), there's either an in-effect regulation it's used according to, or an effective notification under subsection (h). While such a regulation or (h)(1) notification is in effect and hasn't been revoked under subsection (i), food containing the additive isn't automatically "adulterated" just because it contains it. (b) Petitions for a safe-use regulation. (1) Anyone can petition the FDA to issue a regulation setting out how a food additive can be safely used for a given purpose. (2) The petition must include, besides supporting data: the additive's identity and, where available, its chemistry and composition; a statement of the proposed conditions of use — directions, recommendations, suggested uses — plus sample labeling; data on the physical or technical effect the additive is meant to produce and how much is needed to produce it; a description of practical methods for measuring how much of the additive (or anything it forms) ends up in the food; and full study reports on the additive's safety, including the methods and controls used in those studies. (3) If the FDA asks, the petitioner must provide — or have the manufacturer provide, without showing the petitioner — a full description of how the additive is made and controlled. (4) If the FDA asks, the petitioner must provide samples of the additive, its components, and the food it will be used in. (5) The FDA must publish general notice of the proposed regulation within 30 days of the petition being filed. (c) Approving or denying the petition. (1) The FDA must either issue an order establishing a regulation — not necessarily matching what the petitioner proposed — setting the safe-use conditions (which foods, maximum amounts, how it's added, and any needed labeling or packaging requirements), and tell the petitioner why; or deny the petition by order and explain why. (2) This order must come within 90 days of filing, though the FDA can extend that, by written notice before the 90th day, up to 180 days total if it needs more time to study the petition. (3) The regulation can't issue if a fair look at the evidence fails to show the proposed use is safe — and no additive counts as "safe" if it's found to cause cancer in humans or animals when eaten, or when tested by appropriate cancer-testing methods — except this cancer rule doesn't apply to an animal-feed ingredient if the FDA finds it won't hurt the animals under the intended feeding conditions, and no residue of it will show up, by FDA-approved testing methods, in any edible part of the animal after slaughter or in food derived from it. The regulation also can't issue if the evidence shows the proposed use would deceive consumers or otherwise make the food adulterated or misbranded. (4) If the FDA decides a maximum-amount limit ("tolerance") is needed for safety, it can't set that limit higher than what's reasonably needed for the additive's intended effect, and can't approve the use if the evidence doesn't show the additive would actually achieve that intended effect. (5) In deciding if a use is safe, the FDA must consider, among other things, how much people are likely to consume of the additive and anything it forms in food; its cumulative dietary effect, accounting for chemically or pharmacologically related substances already in the diet; and safety factors that qualified experts generally consider appropriate when using animal test data. (d) FDA-initiated regulations. The FDA can, on its own initiative and at any time, propose a safe-use regulation for a food additive, explaining its reasons. Starting 30 days after publishing that proposal, the FDA can issue an order establishing the regulation. (e) Publication and effective date. Any order — including the regulation it creates — issued under (c) or (d) is published and takes effect immediately on publication, but the FDA can pause that effect if someone requests a hearing under (f). (f) Objections and hearings. (1) Within 30 days of an order's publication, anyone hurt by it can file specific objections with reasonable grounds and request a public hearing. The FDA must hold that hearing promptly, after notice, to weigh evidence relevant to the objections, and afterward must issue and make public an order addressing them. (2) That order must be based on a fair evaluation of the whole hearing record and include detailed findings and reasoning. (3) The FDA sets the order's effective date, which can't be before the 90th day after publication, unless the FDA finds an emergency justifies an earlier date and explains those emergency findings in the order. (g) Judicial review. (1) Anyone hurt by an order under (f) — including one amending or repealing a food-additive regulation — can challenge it in the federal appeals court where they live or do business, or in the D.C. Circuit, by filing within 60 days of the order. (2) The court clerk sends a copy to the FDA, which must file the full record of the proceedings; once the petition is filed the court can review the order, and once the record is filed that review power becomes exclusive to that court. Until the record is filed, the FDA can still change or withdraw its order. The FDA's factual findings stand if a fair reading of the hearing record supports them. (3) The court can't uphold the FDA's order if the FDA failed to meet the fair-evaluation and detailed-reasoning requirements of subsection (f)(2). (4) If a party asks to submit new evidence, and the court finds it material with good reason it wasn't presented earlier, the court can send it back to the FDA to take that evidence and possibly revise its findings and order, which then get filed with the court. (5) The court's decision is final, subject to Supreme Court review. Starting the court case doesn't automatically pause the order unless the court specifically orders that. (h) Notification process for food contact substances. (1) Instead of a full petition, a manufacturer or supplier of a "food contact substance" can, at least 120 days before introducing it into interstate commerce, notify the FDA of its identity, intended use, and the company's own determination that the use is safe under the standard in subsection (c)(3)(A), including the supporting basis and any other FDA-required information. (2) That notification becomes effective, and the substance can be sold, 120 days after the FDA receives it, unless within that time the FDA determines the safety hasn't been shown and tells the manufacturer or supplier — an FDA objection is a final decision that can be challenged in court. "Food contact substance" here means the specific substance named in that notification, not a similar substance made by someone else. (3) This notification process is the normal path for authorizing a food contact substance's marketing, unless the FDA decides a full petition under subsection (b) is needed to ensure adequate safety, or the manufacturer or supplier and the FDA agree to use a petition instead; the FDA can issue regulations spelling out when a petition is required, considering factors like likely consumption and potential toxicity. (4) The FDA must keep a notification confidential for 120 days after receiving it; after that, the information becomes available to the public, except for anything that's a trade secret or confidential business information. (5) The notification program only runs in a fiscal year if Congress appropriates at least a required amount for that year and the FDA certifies the rest of its food-safety center's budget matches at least its 1997 level (excluding new-program money) — with specific dollar thresholds and a phase-in period spelled out for fiscal years 1999 and 2000 onward, and the FDA must send Congress yearly cost estimates for the program. (6) "Food contact substance" means any substance meant to be part of materials used in making, packing, transporting, or holding food, when it's not meant to have a direct technical effect on the food itself. (i) Amending or repealing regulations. The FDA must set procedures — matching the same process used to create these regulations — for amending or repealing them, and for deciding when a subsection (h) notification is no longer effective. (j) Investigational exemptions. The FDA must create, by regulation, an exemption from this whole section for a food additive — and any food containing it — used solely for research by qualified experts, when the FDA finds that consistent with public health. (k) Food additives for animal food. (1) When acting on a petition for an animal-food additive, the FDA must review foreign studies the petitioner provides. (2) Within 12 months of August 14, 2018, the FDA must post online how many animal-food additive petitions are pending, how long each has been pending (including extensions), and how many study protocols have been pending review over 50 days and how many got extensions. (3) For an animal-food additive petition, the FDA must tell the petitioner what the petition needs to contain, and if the FDA wants more studies than the petitioner proposed, it must explain the scientific reason why.