FDA Status
Approved
Flavoring Agent · CAS 58-08-2
Caffeine
FDA status: Approved. EU: not separately listed. No U.S. state has enacted a specific ban yet.
4.0 / 5
Composite safety Low Risk
Score 4 of 5
Caffeine: 4/5 (Low Risk)
According to the U.S. Food and Drug Administration, Caffeine is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 4 out of 5 (Low Risk). It is more widely-used than most tracked additives.
- 85th percentile by tracked product prevalence
The verdict
Caffeine is FDA-approved, and no U.S. state has moved to restrict it. It is more widely-used than most tracked additives (85th percentile by tracked product count).
- 4/5
- Low Risk
- Approved
- FDA status
- 85th pctile
- by product prevalence
- 0
- state regulations
Caffeine, CAS 58-08-2, is a flavoring agent additive holding a composite safety score of 4 out of 5 (Low Risk). According to the U.S. Food and Drug Administration's Substances Added to Food inventory, it is currently classified as Approved, while the European Union lists it as not separately listed. This ingredient appears in approximately 713 tracked food products across our database. It is most commonly used as flavoring agent or adjuvant.
No U.S. state has enacted specific legislation targeting Caffeine 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 Caffeine 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 | Approved | FDA SAFFA |
| EU Status | Not separately listed | EC 1333/2008 |
| E-Number | - | EU additive register |
| CAS Number | 58-08-2 | CAS Registry |
| Category | Flavoring Agent | FDA functional class |
| Composite Safety Score | 4 / 5 (Low Risk) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 713 | 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
Caffeine's 4/5 (Low Risk) score reflects where this specific ingredient lands on that scale. The FDA has approved Caffeine for use in food products under specified conditions.
How Caffeine compares
Where a safety score of 4/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Caffeine highlighted)
4,369 of 4,509 scored ingredients (96.9%) share a safety score of 4/5.
What is Caffeine?
Caffeine (CAS 58-08-2) is an FDA-regulated food substance used as flavoring agent or adjuvant.
Common Uses
flavoring agent or adjuvant
Frequently Asked Questions
Is Caffeine safe to consume?
Caffeine has a safety score of 4/5 (Low Risk). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Caffeine used for in food?
Caffeine is commonly used as: flavoring agent or adjuvant. It belongs to the Flavoring Agent category of food additives.
Is Caffeine banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Caffeine. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Caffeine?
The FDA classifies Caffeine as "Approved", 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 Caffeine?
No major health concerns have been widely documented for Caffeine at this time. It holds a safety score of 4/5 (Low Risk). As with all food additives, ongoing scientific review may identify new findings.
How is the safety score for Caffeine calculated?
The safety score of 4/5 for Caffeine 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 Caffeine
Use the regulatory picture, not a single score, to decide.
- Check the FDA status (Approved) 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.