Food Policy Watch

Banned Ingredients by the US FDA: The Definitive 21 CFR 189 List

Unlike most of the world, the FDA keeps an explicit list of substances prohibited from human food. Here is the full 21 CFR Part 189 list plus the additives and flavorings the FDA has since revoked, with the label names to watch for.

Jul 13, 2026|12 min read
By Sanket Patel|Updated 2026-07-13|6 sources|Editorial standards
Banned Ingredients by the US FDA: The Definitive 21 CFR 189 List

What "banned by the FDA" actually means

A federal prohibition is stronger than the everyday word "banned" implies. Most ingredients people describe as banned are really not authorized, restricted to certain limits, or dropped by retailers. The Part 189 substances are different: the FDA has determined they may not be used in human food at all, usually because they were shown to be unsafe, carcinogenic in animal studies, or otherwise hazardous. A handful are food-contact prohibitions rather than direct ingredients, but the effect is the same, they may not touch the food supply.

Separately, the FDA can revoke a previously approved use. When that happens the substance moves off the "allowed" list, manufacturers get a compliance window to reformulate, and after that date the ingredient is effectively banned even if it is not written into Part 189. Red No. 3 and brominated vegetable oil are the highest-profile recent examples, and both have dedicated ingredient profiles: Red Dye No. 3 and brominated vegetable oil.

A Definitive List of Banned Ingredients

Last updated: July 13, 2026

These are the substances the U.S. FDA has prohibited from human food. If any of these appears on a U.S. food label, treat it as a hard stop, not a preference. The names in each entry are the aliases and label cues that identify the substance.

Prohibited flavorings (21 CFR Part 189)

  • Coumarin — tonka bean extract; once used as a vanilla-like flavor. Prohibited.
  • Calamus — including calamus oil and calamus extract (sweet flag / Acorus calamus). Prohibited.
  • Cinnamyl anthranilate — a synthetic fruit/cinnamon flavoring. Prohibited.
  • Safrole — and its related forms oil of sassafras, isosafrole, and dihydrosafrole. Once used in root beer and sassafras flavorings. Prohibited.

Prohibited sweeteners

  • Dulcin — an early artificial sweetener (para-phenetolcarbamide). Prohibited.
  • Cyclamate — including sodium cyclamate and calcium cyclamate. Banned since 1969–1970; see the cyclamates profile for the history. Prohibited.
  • P-4000 — 5-nitro-2-propoxyaniline, an intensely sweet compound. Prohibited.

Prohibited preservatives and processing aids

  • Diethyl pyrocarbonate (DEPC) — a beverage cold-sterilant. Prohibited.
  • Monochloroacetic acid — a preservative. Prohibited.
  • Thiourea — an antioxidant/preservative. Prohibited.
  • NDGA (nordihydroguaiaretic acid) — a fat antioxidant. Prohibited.
  • Chlorofluorocarbon (CFC) propellants — once used as the aerosol propellant in food sprays such as whipped-cream toppings. Prohibited.

Prohibited beverage additive

  • Cobalt salts (cobaltous salts) — once added to beer as a foam stabilizer. Prohibited.

Prohibited cattle materials (BSE safeguard)

  • Prohibited cattle materials — the "specified risk materials" and related tissues from beef: the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column, and dorsal root ganglia of older cattle, the tonsils and distal small intestine of all cattle, mechanically separated (MS) beef, and material from nonambulatory ("downer") or uninspected cattle. Prohibited from human food as a mad-cow-disease (BSE) safeguard.

Prohibited food-contact substances

These may not contact food, so they never appear as an ingredient, but they are part of the same prohibition list:

  • Lead solder — in food cans.
  • Tin-coated lead foil — capsules on wine bottles.
  • Flectol H — a polymer antioxidant.
  • Mercaptoimidazoline — a rubber accelerator.
  • 4,4'-Methylenebis(2-chloroaniline) — also known as MOCA.
  • Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins — a polymer additive prohibited from any food-contact use.

Additives and flavorings the FDA has since revoked

Not written into Part 189, but their authorization has been withdrawn, so U.S. food use is being ended:

  • Brominated vegetable oil (BVO) — also brominated soybean oil. Authorization revoked; formerly a citrus-soda emulsifier.
  • FD&C Red No. 3 — also Red 3, erythrosine. Authorization for food and ingested drugs revoked, with a reformulation deadline.
  • Partially hydrogenated oils (industrial trans fats) — no longer "generally recognized as safe"; the primary source of artificial trans fat. Watch for partially hydrogenated anything in the oils line.
  • Benzophenone — revoked synthetic flavoring.
  • Ethyl acrylate — revoked synthetic flavoring.
  • Methyl eugenol — revoked synthetic flavoring.
  • Myrcene — revoked synthetic flavoring.
  • Pulegone — revoked synthetic flavoring.
  • Pyridine — revoked synthetic flavoring.
  • Styrene — revoked for synthetic flavor use.

How to use this list at the store

The prohibited Part 189 substances are, in practice, extremely rare on a modern U.S. label, that is the whole point of a ban. Where this list earns its keep is the revoked group, because products formulated before a revocation date can linger on shelves through their reformulation window. The realistic shopping checklist is short:

  1. Scan the oils line for anything reading partially hydrogenated. This is the most common survivor and the clearest artificial-trans-fat signal.
  2. Scan the color line for FD&C Red No. 3, Red 3, or erythrosine, especially on brightly colored candy, frosting, and some maraschino cherries.
  3. On citrus-flavored sodas, check for brominated vegetable oil or BVO.
  4. If you see any Part 189 flavoring name, such as safrole, oil of sassafras, or coumarin, on an imported or novelty product, do not buy it.

Because these names are easy to miss in a long ingredient list, this is exactly the kind of check the IngrediCheck ingredient checker app is built for: it reads the full ingredient list against the prohibited-and-revoked set and flags a match immediately, so a banned substance does not slip past on a crowded label.

Banned, not authorized, or just restricted?

One caution before you treat every scary headline as a ban. The word gets stretched to cover several different legal statuses, and mixing them up leads to bad shopping decisions. An ingredient can be flatly prohibited (this list), not authorized under a positive list, permitted with strict limits, revoked with a phase-out window, or simply dropped by a retailer's clean-label policy. Titanium dioxide is a good example of the confusion: it is no longer authorized in the EU but still permitted in the U.S., which is a very different thing from a Part 189 prohibition. For the state-by-state picture that increasingly drives these questions in the U.S., see the 2026 state ingredient bans guide.

The Bigger Picture

The United States gets criticized for a permissive food system, and on many additives that criticism is fair. But 21 CFR Part 189 is the part of the rulebook where the FDA draws an absolute line, and it is worth knowing where that line sits. The list is short because a true federal prohibition is a heavy instrument, reserved for substances the agency concluded have no safe use in food at all.

For a shopper, the practical takeaway is that "banned by the FDA" is a small, specific set, and the higher-frequency risk is a recently revoked additive still working through its reformulation window. Keeping this list in your pocket, or letting a scanner keep it for you, turns a research project into a two-second check at the shelf.

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