FDA Status
GRAS
Monk Fruit Extract is a sweetener additive holding a composite safety score of 5 out of 5 (Generally Safe). The U.S. Food and Drug Administration currently classifies it 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.
Peer-reviewed research has flagged 1 distinct area of health concern for Monk Fruit Extract, which factors directly into the assigned safety score. 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.
5.0 / 5
Composite Safety Generally Safe
Safety Score: 5 out of 5
Safety Rating 100.0%
EU Status
Novel Food
U.S. State Regulations
0 states
None enacted
Safety Assessment
Monk Fruit Extract receives a safety score of 5/5 (Generally Safe) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA classifies Monk Fruit Extract as "Generally Recognized As Safe" (GRAS), meaning qualified experts consider it safe under intended conditions of use.
Research has identified 1 area of health concern associated with Monk Fruit Extract. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Monk Fruit Extract?
Natural sweetener 150-200x sweeter than sugar.
Health Concerns
- No known health concerns. Ancient Chinese use.
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?
Research has identified the following health concerns for Monk Fruit Extract: No known health concerns. Ancient Chinese use.. These findings inform its safety score of 5/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
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.
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Related Data Sources
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial