FDA Status
GRAS
Sweetener
Monk Fruit Extract
FDA status: GRAS. EU: Novel Food. No U.S. state has enacted a specific ban yet.
5.0 / 5
Composite safety Generally Safe
Score 5 of 5
Monk Fruit Extract: 5/5 (Generally Safe)
According to the U.S. Food and Drug Administration, Monk Fruit Extract is classified GRAS by the FDA, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 5 out of 5 (Generally Safe), and the European Union separately classifies it as novel food. It is used in a moderate number of tracked products.
- 71th percentile by tracked product prevalence
The verdict
Monk Fruit Extract is classified GRAS by the FDA, and no U.S. state has moved to restrict it. It is used in a moderate number of tracked products (71th percentile by tracked product count).
- 5/5
- Generally Safe
- GRAS
- FDA status
- 71th pctile
- by product prevalence
- 0
- state regulations
Monk Fruit Extract is a sweetener additive holding a composite safety score of 5 out of 5 (Generally Safe). According to the U.S. Food and Drug Administration's Substances Added to Food inventory, it is currently classified as GRAS, while the European Union lists it as Novel Food. This ingredient appears in approximately 123 tracked food products across our database. It is most commonly used as Beverages, yogurt, tabletop sweeteners.
No U.S. state has enacted specific legislation targeting Monk Fruit Extract 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 Monk Fruit Extract 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 | GRAS | FDA SAFFA |
| EU Status | Novel Food | EC 1333/2008 |
| E-Number | - | EU additive register |
| CAS Number | - | CAS Registry |
| Category | Sweetener | FDA functional class |
| Composite Safety Score | 5 / 5 (Generally Safe) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 123 | 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
Novel Food
U.S. State Regulations
0 states
None enacted
Safety Assessment
Monk Fruit Extract's 5/5 (Generally Safe) score reflects where this specific ingredient lands on that scale. The FDA classifies Monk Fruit Extract as "Generally Recognized As Safe" (GRAS), meaning qualified experts consider it safe under intended conditions of use.
How Monk Fruit Extract compares
Where a safety score of 5/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Monk Fruit Extract highlighted)
31 of 4,509 scored ingredients (0.7%) share a safety score of 5/5.
What is Monk Fruit Extract?
Natural sweetener 150-200x sweeter than sugar.
Common Uses
Beverages, yogurt, tabletop sweeteners
Frequently Asked Questions
Is Monk Fruit Extract safe to consume?
Monk Fruit Extract has a safety score of 5/5 (Generally Safe). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Monk Fruit Extract used for in food?
Monk Fruit Extract is commonly used as: Beverages, yogurt, tabletop sweeteners. It belongs to the Sweetener category of food additives.
Is Monk Fruit Extract banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Monk Fruit Extract. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Monk Fruit Extract?
The FDA classifies Monk Fruit Extract as "GRAS", while the EU status is "Novel Food". 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 Monk Fruit Extract?
No major health concerns have been widely documented for Monk Fruit Extract at this time. It holds a safety score of 5/5 (Generally Safe). As with all food additives, ongoing scientific review may identify new findings.
How is the safety score for Monk Fruit Extract calculated?
The safety score of 5/5 for Monk Fruit Extract 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 Monk Fruit Extract
Use the regulatory picture, not a single score, to decide.
- Check the FDA status (GRAS) and EU status (Novel Food) 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.