Monk Fruit Extract

About

What it is and where it shows up.

Monk fruit extract is a natural, non-caloric high-intensity sweetener derived from the fruit of Siraitia grosvenorii Swingle, a plant native to southern China traditionally known as Luo Han Guo. Its sweetness arises from cucurbitane glycosides called mogrosides (primarily mogroside V), which render the extract 100–400 times sweeter than sugar depending on mogroside V concentration.

Safety summary

The regulatory and scientific consensus.

The FDA has granted GRAS status to multiple monk fruit extract formulations and has not specified an ADI, noting safety is well-established at levels well above those needed for sweetening. EFSA's 2019 opinion found the toxicological database insufficient for high-purity food additive authorization, citing unresolved testicular effects in a 90-day rat study and missing chronic/carcinogenicity data; however, EFSA issued a positive safety opinion for a specific aqueous extract in 2024, leading to EU authorization under Regulation (EU) 2024/2345 for that form only. Systematic review of human RCTs confirms no severe adverse effects and potential reductions in postprandial glucose (10–18%) and insulin response (12–22%).

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Restricted	As of October 2024, only one specific aqueous extract has been authorised as a novel food under Commission Implementing Regulation (EU) 2024/2345. Highly purified mogrosides and non-aqueous extracts remain unapproved due to gaps in toxicological data and absence of industry-led applications. No E-number assigned. Authorization pathway for use as a conventional food additive (high-purity forms) remains paused at EFSA scientific risk assessment stage due to missing chronic/carcinogenicity data.source
Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom)	Restricted	Non-selective aqueous decoctions of monk fruit (fresh/dried fruit of Siraitia grosvenorii) recognised as non-novel foods in England and Wales (FSA, June 2024) based on evidence of significant pre-1997 consumption. Food Standards Scotland will issue a separate determination. Concentrated monk fruit extracts intended as high-intensity sweeteners remain unapproved and require novel food authorisation.source
National Health Commission (NHC) (China)	Approved	Listed under GB 2760-2014 as a permitted food additive in beverages, confectionery, and health supplements. China's regulatory framework relies on the long history of monk fruit as both a traditional medicine and food ingredient, allowing use without the extensive toxicological testing required in other regions.source

Who should approach with care

Whose guidance would steer them away.

Infants — FDA GRAS notices explicitly exclude monk fruit extract from use in infant formula; while its use in some infant and toddler foods has been assessed as GRAS, parents should consult a healthcare provider before offering monk-fruit-sweetened products to infants under 12 months.

Other — Individuals with hereditary fructose intolerance should exercise caution with monk fruit juice concentrate, as it contains fructose, glucose, and sucrose in addition to mogrosides, which may precipitate adverse metabolic reactions in this population.

Research citations

The sources behind this verdict.

1FDA. High-Intensity Sweeteners – FDA. fda.gov
2PubMed. Why Does Monk Fruit Extract Remain Only Partially Approved in the EU? Regulatory Barriers and Policy Implications for Food Innovation, 2025. pmc.ncbi.nlm.nih.gov
3PubMed. Monk Fruit Extract and Sustainable Health: A PRISMA-Guided Systematic Review of Randomized Controlled Trials, 2025. pubmed.ncbi.nlm.nih.gov
4PubMed. Bibliometric analysis on the literature of monk fruit extract and mogrosides as sweeteners, 2023. pmc.ncbi.nlm.nih.gov
5EFSA. Safety of use of Monk fruit extract as a food additive in different food categories – EFSA Journal 2019, 2019. efsa.europa.eu
6FSSAI. List of product(s)/ingredient(s) applications Approved under FSS (NSF & FI) Regulations, 2017 – Status as on 02 May 2025, 2019. fssai.gov.in

Independently researched8 citations