FDA Status
Banned
Sweetener · CAS 553-79-7
P-4000
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
P-4000: 1/5 (Banned / Avoid)
According to the U.S. Food and Drug Administration, P-4000 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
P-4000 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
P-4000, CAS 553-79-7, is a sweetener 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 non-nutritive sweetener.
No U.S. state has enacted specific legislation targeting P-4000 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 P-4000 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 | 553-79-7 | CAS Registry |
| Category | Sweetener | 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
P-4000's 1/5 (Banned / Avoid) score reflects where this specific ingredient lands on that scale. The FDA has banned P-4000 from food use, indicating sufficient evidence of safety concerns.
How P-4000 compares
Where a safety score of 1/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (P-4000 highlighted)
41 of 4,509 scored ingredients (0.9%) share a safety score of 1/5.
What is P-4000?
P-4000--prohibited (CAS 553-79-7) is an FDA-regulated food substance used as non-nutritive sweetener.
Common Uses
non-nutritive sweetener
Frequently Asked Questions
Is P-4000 safe to consume?
P-4000 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 P-4000 used for in food?
P-4000 is commonly used as: non-nutritive sweetener. It belongs to the Sweetener category of food additives.
Is P-4000 banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting P-4000. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of P-4000?
The FDA classifies P-4000 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 P-4000?
No major health concerns have been widely documented for P-4000 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 P-4000 calculated?
The safety score of 1/5 for P-4000 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
Related Sweetener Ingredients
What to do about P-4000
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.