FDA Status
Banned
Food Additive · CAS 4548-53-2
FD&C Red No. 4
FDA status: Banned. EU: not separately listed. No U.S. state has enacted a specific ban yet.
1.0 / 5
Composite safety Banned / Avoid
Score 1 of 5
FD&C Red No. 4: 1/5 (Banned / Avoid)
According to the U.S. Food and Drug Administration, FD&C Red No. 4 is banned by the FDA, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 1 out of 5 (Banned / Avoid).
The verdict
FD&C Red No. 4 is banned by the FDA, and no U.S. state has moved to restrict it.
- 1/5
- Banned / Avoid
- Banned
- FDA status
- -
- EU status
- 0
- state regulations
FD&C Red No. 4, CAS 4548-53-2, is a food additive additive holding a composite safety score of 1 out of 5 (Banned / Avoid). According to the U.S. Food and Drug Administration's Substances Added to Food inventory, it is currently classified as Banned, while the European Union lists it as not separately listed. It is most commonly used as Various food applications.
No U.S. state has enacted specific legislation targeting FD&C Red No. 4 to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
No major peer-reviewed health concerns are presently documented for FD&C Red No. 4 at consumer exposure levels, though scientific review is ongoing and positions can shift. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| FDA Status | Banned | FDA SAFFA |
| EU Status | Not separately listed | EC 1333/2008 |
| E-Number | - | EU additive register |
| CAS Number | 4548-53-2 | CAS Registry |
| Category | Food Additive | FDA functional class |
| Composite Safety Score | 1 / 5 (Banned / Avoid) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | Not yet tracked | Open Food Facts (US) |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
EU Status
Not specified
U.S. State Regulations
0 states
None enacted
Safety Assessment
FD&C Red No. 4's 1/5 (Banned / Avoid) score reflects where this specific ingredient lands on that scale. The FDA has banned FD&C Red No. 4 from food use, indicating sufficient evidence of safety concerns.
How FD&C Red No. 4 compares
Where a safety score of 1/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (FD&C Red No. 4 highlighted)
41 of 4,509 scored ingredients (0.9%) share a safety score of 1/5.
What is FD&C Red No. 4?
Fd&c Red No. 4--delisted (CAS 4548-53-2) is an FDA-regulated food substance used as a food additive.
Common Uses
Various food applications
Frequently Asked Questions
Is FD&C Red No. 4 safe to consume?
FD&C Red No. 4 has a safety score of 1/5 (Banned / Avoid). It is banned by the FDA. Check with a healthcare provider for personalized advice.
What is FD&C Red No. 4 used for in food?
FD&C Red No. 4 is commonly used as: Various food applications. It belongs to the Food Additive category of food additives.
Is FD&C Red No. 4 banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting FD&C Red No. 4. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of FD&C Red No. 4?
The FDA classifies FD&C Red No. 4 as "Banned", and the EU may apply different standards. The FDA and EU use separate evaluation frameworks, the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
What health concerns are associated with FD&C Red No. 4?
No major health concerns have been widely documented for FD&C Red No. 4 at this time. It holds a safety score of 1/5 (Banned / Avoid). As with all food additives, ongoing scientific review may identify new findings.
How is the safety score for FD&C Red No. 4 calculated?
The safety score of 1/5 for FD&C Red No. 4 is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
What to do about FD&C Red No. 4
This additive is flagged, worth checking labels for.
- Check the FDA status (Banned) and EU status (unlisted) before assuming it is risk-free. How we score
- Compare it against the most-restricted additives in the U.S. supply. View rankings
- Scan a whole ingredient label at once to flag the concerning entries. Label checker
Safety scores summarise regulatory status and published concerns; they are not medical or dietary advice.
Every figure on PlainIngredients is rendered directly from FDA, EU, EFSA and U.S. state regulatory records, no number is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.