Fact-checked by Grok 2 weeks ago

2'-Fucosyllactose

2'-Fucosyllactose (2'-FL) is a trisaccharide and the most abundant human milk oligosaccharide (HMO) found in breast milk, consisting of a lactose core (galactose β1-4 linked to glucose) with an α1-2-linked fucose residue attached to the terminal galactose, forming the structure Fucα1-2Galβ1-4Glc.^[1] It is biosynthesized in the mammary gland by the fucosyltransferase 2 (FUT2) enzyme, with concentrations varying by maternal secretor status: typically ranging from 1 to 5 g/L in mature milk and up to 5 g/L in colostrum among secretor mothers, but undetectable in non-secretor individuals.^[2]^[3] As a non-digestible carbohydrate, 2'-FL plays a pivotal role in infant nutrition by selectively promoting beneficial gut microbiota and providing prebiotic effects.^[4] Biologically, 2'-FL functions as an anti-adhesive agent, acting as a decoy to inhibit pathogen binding to intestinal epithelial cells, such as Campylobacter jejuni, thereby reducing the incidence of diarrhea and infections in breastfed infants.^[1] It supports gut barrier maturation, modulates immune responses by lowering pro-inflammatory cytokines like IL-1β and TNF-α, and shapes the infant microbiome toward Bifidobacterium dominance, which enhances overall host defense.^[2] Additionally, emerging evidence links early exposure to 2'-FL with improved cognitive development and reduced risks of conditions such as necrotizing enterocolitis, respiratory infections, and atopic dermatitis.^[5] Due to its health-promoting properties, synthetic 2'-FL—structurally identical to that in human milk—has been incorporated into infant formulas since first receiving FDA GRAS status in 2014, with subsequent approvals as of 2025, demonstrating safety and tolerability in clinical trials with no adverse effects on growth parameters like weight and length compared to breastfed infants.^[6]^[7] Supplementation studies show it reduces fussiness, gassiness, and inflammatory markers while decreasing respiratory illness rates by up to 8 percentage points versus unsupplemented formulas.^[6] Ongoing research continues to explore its potential in broader applications, including immune enhancement and microbiota modulation beyond infancy.^[8]

Structure and Properties

Chemical Structure

2'-Fucosyllactose (2'-FL) is a trisaccharide defined by an α-1,2-linked L-fucose residue attached to the galactose moiety of the disaccharide lactose, resulting in the molecular formula C_{18}H_{32}O_{15} and a molecular weight of 488.44 g/mol.^[9]^[10] The core structure features a β-D-galactopyranosyl unit linked via a β-1,4-glycosidic bond to D-glucopyranose, with the L-fucopyranosyl group attached through an α-1,2-glycosidic bond to the 2' position of the galactose.^[11] This configuration yields the IUPAC name α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose.^[12] Unlike other fucosylated human milk oligosaccharides such as 3-fucosyllactose, which has the fucose linked α-1,3 to the galactose (Galβ1-4(Fucα1-3)Glc), the α-1,2 linkage in 2'-FL specifically positions the fucose at the terminal 2' site on galactose (Fucα1-2Galβ1-4Glc), altering its stereochemistry and potential interactions.^[13]^[11] As the most abundant human milk oligosaccharide in the milk of secretor mothers, 2'-FL constitutes up to 30% of total HMOs.^[14]

Physical and Chemical Properties

2'-Fucosyllactose is typically obtained as a white to off-white amorphous powder.^[15]^[12] It exhibits high solubility in water, exceeding 700 g/L at 20°C, which facilitates its dissolution in aqueous solutions for various applications.^[12] This solubility stems from its trisaccharide composition. The compound demonstrates stability under neutral pH conditions and remains intact during prolonged storage in dry, cool settings, with no significant degradation observed over 24 months at 25°C and 60% relative humidity.^[12]^[16] However, it is susceptible to degradation in acidic environments below pH 4, particularly under strong acid conditions like 0.1 N HCl, where hydrolysis products such as fucose and lacto-N-triose form.^[17] Its specific optical rotation, [\alpha]_D^{20}, measures approximately +55° in water.^[18] As a hygroscopic substance, 2'-fucosyllactose absorbs moisture, potentially altering its physical form if not protected; storage recommendations include sealed, moisture-impermeable containers in ambient conditions to prevent absorption and ensure long-term stability.^[16]^[19] For purity evaluation in commercial preparations, common analytical techniques include high-performance anion-exchange chromatography with pulsed amperometric detection (HPAEC-PAD), nuclear magnetic resonance (NMR) spectroscopy for structural confirmation, and mass spectrometry (MS) for identification and quantification.^[16]^[12]

Natural Occurrence and Biosynthesis

Occurrence in Human Milk

2'-Fucosyllactose (2'-FL) is the most abundant human milk oligosaccharide (HMO) in the breast milk of secretor mothers, accounting for 20–30% of total HMOs. In mature human milk, its average concentration ranges from 2 to 3 g/L, with reported means around 2.4 g/L across diverse populations. This prevalence underscores 2'-FL's prominence among over 200 identified HMOs, where fucosylated structures like 2'-FL dominate in secretor milk.^[5]^[20] The concentration of 2'-FL varies significantly based on maternal genetics, primarily determined by secretor status linked to the FUT2 gene. Approximately 70–80% of women are secretors, producing high levels of 2'-FL (typically 2–4 g/L in mature milk), while non-secretors lack functional FUT2 enzyme activity and exhibit concentrations below 0.1 g/L, often near undetectable. This genetic dichotomy results in bimodal HMO profiles globally, with secretor milk featuring elevated fucosylated HMOs and non-secretor milk enriched in non-fucosylated alternatives. Regional differences in secretor prevalence further influence population-level variations.^[20]^[4] During lactation, 2'-FL levels are highest in colostrum, reaching up to 5 g/L, and progressively decline to 2–3 g/L in mature milk by 1–6 months postpartum. This temporal shift aligns with overall HMO dynamics, where early milk supports initial infant colonization. Concentrations are also modulated by gestational age, with preterm milk often showing altered HMO profiles, including potentially higher 2'-FL relative to term milk; maternal diet exerts a subtler influence, primarily through nutrient availability affecting glycosylation.^[21]^[20]^[4] In contrast to human milk, 2'-FL is absent or present at minimal levels in most animal milks, such as bovine milk (<0.01 g/L), highlighting species-specific biosynthetic differences driven by fucosyltransferase expression. This scarcity in cow's milk, a common base for infant formulas, emphasizes the unique oligosaccharide composition of human lactation.^[20]

Biosynthesis in Mammals

In the mammary glands of lactating women, 2'-fucosyllactose (2'-FL) is biosynthesized through the sequential glycosylation of lactose, the core disaccharide produced by lactose synthase in epithelial cells. The key step involves α-1,2-fucosyltransferase 2 (FUT2), which catalyzes the transfer of a fucose moiety from the donor substrate GDP-fucose to the 2-position of the terminal galactose residue on lactose, forming the α-1,2 linkage characteristic of 2'-FL.^[22] This enzymatic reaction occurs primarily in the Golgi apparatus of mammary epithelial cells, where FUT2 is specifically expressed among fucosyltransferases.^[4] The production of 2'-FL is tightly regulated by genetic factors, particularly polymorphisms in the FUT2 gene, which encodes the FUT2 enzyme and determines secretor status. Individuals with the functional Se allele exhibit active FUT2, enabling 2'-FL synthesis, while loss-of-function mutations (se allele) result in non-secretor status and negligible 2'-FL production. Approximately 80% of the global population are secretors, with prevalence varying by ethnicity (e.g., higher in Europeans and lower in some Asian groups).^[20] Concentrations of 2'-FL in milk thus depend on maternal secretor status.^[4] GDP-fucose, the obligatory donor for FUT2-mediated fucosylation, is predominantly generated in mammalian cells via the de novo biosynthetic pathway from GDP-mannose. This pathway proceeds through GDP-mannose 4,6-dehydratase (GMD), which dehydrates GDP-mannose to GDP-4-keto-6-deoxymannose, followed by the bifunctional FX protein (GDP-fucose synthase), which epimerizes and reduces the intermediate to yield GDP-fucose. The de novo route supplies the majority (~90%) of cellular GDP-fucose under physiological conditions.^[23] Evolutionarily, the enrichment of 2'-FL in human milk reflects an adaptation that selectively supports infant gut colonization by Bifidobacterium species, such as B. longum subsp. infantis, which have evolved specialized fucosyllactose transporters (e.g., FL transporter-2) to efficiently utilize 2'-FL as a carbon source, thereby promoting a protective microbiota.^[24] This symbiosis enhances bifidobacteria dominance in breastfed infants, underscoring the co-evolutionary pressures shaping human milk composition.^[25]

Metabolism

Human Digestion and Absorption

2'-Fucosyllactose (2'-FL), a prominent human milk oligosaccharide (HMO), exhibits resistance to hydrolysis in the upper gastrointestinal tract due to its structural complexity. It is not broken down by salivary or pancreatic amylases, which target α-1,4-linked glucose polymers in starches, nor by intestinal brush border enzymes such as lactase-phlorizin hydrolase. The α-1,2 fucosyl linkage attached to the galactose residue in 2'-FL sterically hinders lactase from cleaving the underlying β-1,4 galactosyl-glucose bond present in lactose, ensuring the molecule remains intact throughout the stomach and small intestine.^[26]^[27] Absorption of intact 2'-FL in the small intestine is minimal, with less than 1% typically taken up into the systemic circulation, while the majority passes undigested to the colon. This low uptake occurs via paracellular or transcellular pathways in enterocytes, but the intact trisaccharide is not significantly metabolized prior to reaching the large intestine. In infants, urinary excretion of absorbed 2'-FL accounts for approximately 1% of the ingested dose, reflecting rapid renal clearance of the fucose moiety and the oligosaccharide itself.^[27]^[28] Pharmacokinetic studies in term infants demonstrate that oral intake of 2'-FL leads to peak plasma concentrations of approximately 0.3-1.0 μM, observed shortly after feeding and correlating with dietary exposure levels. These concentrations decline rapidly, with clearance primarily through urinary excretion, where fucose components are detected at higher relative percentages than in plasma.^[28]

Microbial Fermentation in the Gut

In the colon, 2'-fucosyllactose (2'-FL) is selectively utilized by specific gut microbiota, particularly species within the genus Bifidobacterium, such as B. longum subsp. infantis and B. bifidum, which possess specialized enzymes to break it down. These bacteria employ α-1,2-L-fucosidases, including those from glycoside hydrolase families GH29 and GH95, to hydrolyze the α-1,2 glycosidic linkage between the L-fucose residue and the underlying lactose moiety. B. infantis typically internalizes intact 2'-FL via ATP-binding cassette (ABC) transporters before enzymatic cleavage, whereas B. bifidum utilizes extracellular fucosidases for degradation, potentially facilitating cross-feeding with other microbes. This selective metabolism underscores 2'-FL's role as a prebiotic tailored to beneficial bifidobacteria prevalent in the infant gut. The breakdown of 2'-FL yields L-fucose, galactose, and glucose as primary monosaccharide products. Further fermentation by Bifidobacterium species produces short-chain fatty acids (SCFAs), predominantly acetate and lactate, which contribute to the colonic environment. In B. infantis, the released L-fucose is catabolized through a dedicated anaerobic pathway involving conversion to L-fucono-1,4-lactone and subsequent intermediates, culminating in the formation and secretion of 1,2-propanediol as an end product. Meanwhile, the lactose-derived galactose is processed via the Leloir pathway—employing galactokinase, galactose-1-phosphate uridylyltransferase, and UDP-galactose 4-epimerase to generate glucose-1-phosphate—while glucose enters the bifid shunt and glycolytic pathways, supporting bacterial energy needs and SCFA production. Due to its resistance to degradation by human α-fucosidases and glycosidases in the upper gastrointestinal tract, 2'-FL is delivered largely intact to the colon for microbial access. Supplementation with 1-2 g/day of 2'-FL, as in infant formula, promotes substantial growth of Bifidobacterium species in the infant gut, with ex vivo fecal fermentation models demonstrating dose-dependent increases in relative abundance up to several-fold, particularly for B. longum subsp. infantis.

Commercial Production

Microbial Fermentation Methods

Microbial fermentation methods for 2'-fucosyllactose (2'-FL) production primarily utilize metabolically engineered bacteria and yeasts to synthesize this human milk oligosaccharide de novo or via salvage pathways, leveraging the expression of fucosyltransferases and GDP-L-fucose biosynthetic enzymes.^[29]^[30] These approaches enable scalable industrial production by mimicking mammalian glycosylation pathways, with human α-1,2-fucosyltransferase (FUT2) or homologous enzymes serving as templates for engineering.^[31] Common host strains include Escherichia coli and Saccharomyces cerevisiae, which are genetically modified to express key genes such as futC or wcfB (encoding fucosyltransferases) alongside GDP-L-fucose pathway components like manB, manC, gmd, and wcaG.^[29]^[31] In E. coli, deletions of competing genes like lacZ and wcaJ minimize byproduct formation, while in yeast, integration of heterologous pathways enhances fucose utilization from substrates like xylose.^[30]^[32] Other GRAS (Generally Recognized as Safe) hosts, such as Bacillus subtilis and Priestia megaterium, have been engineered similarly for improved safety and efficiency in food-grade applications.^[33]^[34] The production process typically involves fed-batch fermentation in bioreactors, using lactose as the acceptor substrate and glycerol or glucose as carbon sources to sustain growth and glycosylation.^[31]^[33] Fermentations last 48-72 hours under controlled pH (6.5-7.0) and temperature (30-37°C), with yields reaching up to 88 g/L in optimized B. subtilis strains and over 140 g/L in E. coli, achieving molar conversion rates of 92-95% from lactose.^[31]^[33]^[35] In yeast systems, titers of 25 g/L have been reported with xylose co-substrates, demonstrating versatility in substrate utilization.^[32] Downstream purification begins with cell removal via ultrafiltration or centrifugation, followed by concentration and impurity removal using activated carbon adsorption and ion-exchange chromatography to isolate 2'-FL.^[36]^[37] Final crystallization from ethanol or simulated moving bed chromatography yields products with >95% purity, suitable for nutraceutical use.^[38]^[39] Recent advances from 2023-2025 include combinatorial pathway engineering in E. coli for enhanced flux through rate-limiting steps, achieving titers over 100 g/L in pilot scales, and CRISPR-Cas9-mediated genome editing in Pichia pastoris to streamline integration of multi-gene cassettes, resulting in titers up to 22.35 g/L.^[40]^[41] Additionally, engineering of P. megaterium has introduced GRAS-compliant platforms with initial yields of 20-30 g/L, prioritizing safety for infant formula applications.^[34] These developments emphasize modular pathway optimization and cofactor balancing to boost scalability.^[42]

Enzymatic and Chemical Synthesis

Enzymatic synthesis of 2'-fucosyllactose (2'-FL) primarily employs cell-free systems utilizing recombinant α-1,2-fucosyltransferases, such as human FUT2 or bacterial homologs like FucT2 from Helicobacter pylori, to catalyze the transfer of L-fucose from GDP-L-fucose to the terminal galactose of lactose, forming the α-1,2 glycosidic linkage.^[43] These systems require pre-synthesized or in situ generated GDP-L-fucose as the donor substrate, with reactions typically conducted under mild aqueous conditions at neutral pH and ambient temperatures to preserve enzyme activity.^[44] To enhance efficiency and reduce costs associated with expensive GDP-L-fucose, multi-enzyme cascades have been developed that integrate GDP-L-fucose biosynthesis. A representative cascade involves L-fucokinase/GDP-L-fucose phosphorylase (FKP) for converting L-fucose and GTP into GDP-L-fucose, coupled with α-1,2-fucosyltransferase (e.g., HpFucT or TeFucT) for fucosylation of lactose, and pyruvate kinase (PK) for cofactor regeneration via ATP hydrolysis.^[44] Batch reactions using these cascades achieve 50-80% molar conversion yields, with isolated 2'-FL yields reaching 65% after purification by anion-exchange chromatography and gel filtration.^[43] Scalability is facilitated by immobilizing enzymes on supports like magnetic beads or SpyCatcher-SpyTag systems, enabling reuse and continuous-flow processing while maintaining high regioselectivity.^[45]^[46] Chemical synthesis of 2'-FL relies on total synthesis strategies that couple protected fucose donors to lactose acceptors, often using glycosyl donors like fucosyl trichloroacetimidates or thioglycosides under Lewis acid catalysis to control stereochemistry at the anomeric center.^[47] A common approach employs a 6'-O-protected lactose acetonide as the acceptor to direct regioselective α-1,2 fucosylation, followed by deprotection to yield the free trisaccharide.^[47] However, these methods are less prevalent than enzymatic routes due to challenges in achieving high stereoselectivity amid multiple hydroxyl groups and the need for extensive protecting group manipulations, which increase synthetic steps and purification demands.^[47] Recent advances in hybrid chemo-enzymatic methods (2024-2025) combine chemical synthesis of protected intermediates with enzymatic fucosylation using thermostable glycosyltransferases, improving overall yields and enabling automated modular assembly suitable for good manufacturing practice (GMP) production of 2'-FL.^[46]^[48] These approaches leverage chemical protection for precise acceptor preparation followed by one-pot enzymatic extension, reducing synthetic complexity while achieving >90% regioselectivity in scaled reactions.^[48]

Health Benefits

Gut Microbiota Modulation

2'-Fucosyllactose (2'-FL) acts as a selective prebiotic, promoting the growth of beneficial bacteria such as Bifidobacterium species in the infant gut while inhibiting pathogenic ones like Clostridioides difficile. In randomized clinical trials with formula-fed infants, supplementation with 2'-FL increased Bifidobacterium relative abundance to approximately 60%, approaching levels observed in breastfed infants (around 47%).^[49] This bifidogenic effect is driven by 2'-FL's structure, which Bifidobacterium strains efficiently utilize, leading to enrichment up to 64% in in vitro infant fecal simulations.^[50] Conversely, 2'-FL inhibits the proliferation of Clostridioides difficile in complex gut microbial communities, reducing cell numbers by over 90% at concentrations of 4-8 mg/mL in infection models.^[51] In adults or older children without additional supplementation, 2'-FL shows minimal impact on microbiota composition, with no significant shifts in Bifidobacterium abundance at typical doses.^[52] Fermentation of 2'-FL by infant gut microbiota enhances production of short-chain fatty acids (SCFAs), particularly acetate and butyrate, which support anti-inflammatory responses and serve as energy sources for colonocytes. In simulated infant colon models using fecal inocula, 2'-FL significantly elevated acetate levels (p=0.007) compared to controls, with intermediate SCFA profiles between lactose and galacto-oligosaccharides (GOS).^[53] Butyrate production also increased in fast-fermenting infant simulations (p=0.046), contributing to overall SCFA accumulation.^[53] Fecal batch fermentations further demonstrate that 2'-FL boosts acetate and butyrate concentrations, with cumulative levels rising notably over 24 hours, though exact percentages vary by donor microbiota.^[54] In early infancy, 2'-FL shapes the developing gut microbiota to mimic profiles seen in breastfed infants, characterized by Bifidobacterium dominance and reduced diversity. Clinical supplementation trials show that 2'-FL-enriched formulas result in microbiota compositions closely resembling those of breastfed infants, with elevated Actinobacteriota phyla (60% vs. 47%).^[49] In vitro cultivation of infant microbiomes confirms that 2'-FL shifts communities toward B. breve-dominant states (up to 72% abundance), akin to breastfed patterns.^[55] When combined with GOS, 2'-FL exhibits synergistic effects that amplify microbiota diversity and fermentation efficiency in post-weaning models. In infant fecal simulations, the 2'-FL and GOS combination accelerated GOS degradation and elevated Bifidobacterium abundance to 68%, surpassing individual treatments (57% for GOS, 64% for 2'-FL alone).^[50] This synergy enhances overall microbial diversity by promoting faster SCFA production and balanced community shifts, particularly in transitional infant guts.^[56]

Immune and Metabolic Effects

2'-Fucosyllactose (2'-FL) exhibits immunomodulatory effects by enhancing secretory IgA (sIgA) production in the gut mucosa, which supports mucosal immunity and pathogen neutralization in infants. In randomized controlled trials, infants fed formula supplemented with 2'-FL showed significantly higher fecal sIgA levels compared to those on standard formula, approaching concentrations observed in breastfed infants (p < 0.001).^[27] This enhancement contributes to reduced infection risk, including lower incidence of pathogen-specific diarrhea in breastfed infants of secretor mothers compared to non-secretor mothers.^[57] Additionally, 2'-FL modulates Toll-like receptor 4 (TLR4) signaling by attenuating CD14 expression in enterocytes, thereby quenching lipopolysaccharide-induced inflammatory responses and reducing pro-inflammatory cytokine production.^[58] In metabolic health, 2'-FL promotes fat loss and anti-obesity effects through mechanisms involving intestinal mucus layer modulation and incretin secretion. Supplementation with 3 g/day of 2'-FL in overweight adults undergoing a calorie-restricted diet and exercise program led to greater reductions in fat mass (-1.6 kg) and body fat percentage (-1.2%) compared to placebo, while preserving fat-free mass.^[59] In high-fat diet-fed mouse models, 2'-FL protected against obesity by thickening the colonic mucus layer (increased bacteria-free layer thickness, p=0.01) via upregulated mucin production genes (e.g., Muc2) and increased goblet cell differentiation, alongside elevated glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) levels that improved glucose tolerance and reduced fat mass accumulation.^[60] Recent research highlights 2'-FL's potential in mitigating age-related metabolic decline. In aged mouse models, 2'-FL supplementation alleviated weight gain, dyslipidemia, glucose intolerance, and insulin resistance, while reducing systemic inflammation through modulation of the adaptive immune system.^[61] These effects were associated with improved insulin sensitivity and lower inflammatory markers, demonstrating 2'-FL's role in addressing metabolic disorders in aging.^[62] 2'-FL supports cognitive development by facilitating fucose incorporation into brain glycans, which enhances synaptic plasticity and learning in rodent models. Oral supplementation during lactation improved memory consolidation, spatial learning, and hippocampal long-term potentiation (LTP) in rats, with faster operant conditioning acquisition (3.4 sessions to criterion vs. 4.0 in controls).^[63] These benefits occur via gut-brain communication through the vagus nerve, linking 2'-FL's intact structure to neuronal glycan modifications essential for cognitive function.^[64] Further studies are needed to confirm long-term benefits and effects in diverse populations, including variations due to genetic factors like secretor status.^[65]

Applications

In Infant Nutrition

2'-Fucosyllactose (2'-FL) is commonly supplemented in infant formulas at concentrations of 0.2 to 1.0 g/L to replicate the composition of human breast milk, where total human milk oligosaccharides (HMOs) range from 10 to 15 g/L in mature milk.^[4] This addition supports infant growth and development by promoting outcomes closer to those observed in breastfed infants, including enhanced tolerance and reduced inflammatory responses.^[57] Randomized controlled trials (RCTs) have shown that 2'-FL supplementation leads to improved weight gain in formula-fed infants, with no adverse effects on linear growth or head circumference compared to unsupplemented formulas.^[66] Additionally, infants receiving 2'-FL exhibit lower plasma inflammatory cytokine levels, aligning their immune profiles more closely with those of breastfed peers.^[67] Gut microbiota analyses from these RCTs indicate increased bifidobacteria abundance and β-diversity patterns resembling breastfed infants, fostering a healthier microbial environment.^[68] Clinical evidence also points to allergy risk reduction; a 2025 prospective trial reported a lower incidence of atopic dermatitis (14.0% vs. 19.8%; odds ratio 0.66) in infants fed 2'-FL-enriched formula compared to standard formula, suggesting potential protective effects against early allergic conditions.^[69] As a prebiotic, 2'-FL selectively stimulates beneficial gut bacteria, contributing to these microbiota-related benefits.^[49] The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has reviewed human-identical milk oligosaccharides (HiMOs) like 2'-FL in infant formulas, concluding they are safe and well-tolerated in healthy term infants with no differences in growth or gastrointestinal tolerance versus control formulas.^[70] For preterm infants, ESPGHAN notes potential benefits from HMOs but lacks specific routine recommendations due to limited evidence.^[71] Standardized levels in formulas are often set at around 0.5 g/100 kcal to align with estimated HMO intake from breast milk.^[65] 2'-FL was first commercialized in infant formulas in 2016 after receiving FDA Generally Recognized as Safe (GRAS) status, marking a key advancement in formula composition. By 2025, it has become a standard ingredient in numerous global infant formula brands, driven by market expansion and regulatory approvals.^[72]

In Adult Nutraceuticals and Therapeutics

2'-Fucosyllactose (2'-FL) is incorporated into adult nutraceuticals primarily as a prebiotic supplement to support gut health and weight management, with typical daily doses ranging from 2 to 5 grams administered in capsule or powder form.^[73]^[74] These products are marketed for conditions such as irritable bowel syndrome (IBS) and metabolic syndrome, where 2'-FL supplementation at 3 to 5 grams per day has been associated with reduced gastrointestinal symptoms and improved bowel function in clinical settings.^[75]^[76] For instance, a 5-gram daily mix including 2'-FL demonstrated decreases in IBS symptom severity scores over 12 weeks.^[75] In therapeutic contexts, 2'-FL shows investigational promise for obesity management, with a completed clinical trial in 2024 evaluating 3 grams per day over 12 weeks, which supported greater body fat reduction (-1.19%) and preserved fat-free mass compared to placebo in overweight adults initiating exercise programs.^[59] Such effects may briefly reference broader metabolic improvements like enhanced fat oxidation, as observed in supplementation trials.^[59] Delivery forms for adult use include synbiotics combining 2'-FL with Bifidobacterium species, such as B. longum subsp. infantis, to enhance microbiota modulation and SCFA production in the gut.^[77]^[78] Additionally, 2'-FL is formulated into beverages at approximately 1 gram per serving for convenient daily intake, promoting adherence in nutraceutical regimens.^[74] The global market for 2'-FL in adult nutraceuticals and therapeutics reached approximately $240 million in 2025, representing about 30% of the total market fueled by rising demand from aging populations seeking gut and metabolic support.^[79]

Research and Regulation

Key Clinical Studies

Recent randomized controlled trials (RCTs) in infants have demonstrated the potential of 2'-fucosyllactose (2'-FL) supplementation to mitigate certain health risks. A 2022 RCT involving 194 infants with cow's milk protein allergy fed extensively hydrolyzed formula supplemented with 2'-FL (1.0 g/L) and lacto-N-neotetraose (LNnT) (0.5 g/L) reported a 40% reduction in upper respiratory tract infection episodes (0.09 vs. 0.15 per month; p = 0.003) and lower ear infection incidence (2.1% vs. 7.3%) compared to unsupplemented formula over 12 months.^[80] Similarly, a 2025 prospective cohort study with 338 full-term infants found that formula enriched with 2'-FL was associated with lower incidences of infantile colic (10.5% vs. 15.3% in standard formula) and atopic dermatitis (14.0% vs. 19.8%), suggesting a protective effect against early allergic and gastrointestinal issues, though not reaching statistical significance for all outcomes.^[81] These findings build on earlier evidence of reduced inflammatory cytokines in infants receiving 2'-FL-supplemented formula. In adults, clinical research has explored 2'-FL's role in metabolic and microbiome modulation. A 2024 RCT with 41 overweight adults administering 3 g/day of 2'-FL for 12 weeks showed a significant reduction in fat mass (1.642 kg decrease) and body fat percentage (1.19% decrease) compared to placebo, alongside better preservation of fat-free mass during weight loss.^[82] A 2025 RCT in 89 healthy older adults (mean age 67.3 years) supplemented with 5 g/day of 2'-FL for 6 weeks increased gut Bifidobacterium levels, elevated fasting insulin by 23.6%, HDL cholesterol by 6.0%, and fibroblast growth factor 21 (FGF21) levels, with Bifidobacterium responders exhibiting improved visual memory performance.^[83] Mechanistic studies have linked 2'-FL to cognitive benefits in children. A 2020 observational study analyzing human milk HMO profiles in 244 mother-infant pairs found that higher 2'-FL concentrations at 1 month of age correlated with enhanced cognitive development scores at 24 months, independent of breastfeeding duration or demographics.^[84] This association supports the role of 2'-FL in neurodevelopment, potentially through gut-brain axis modulation. Recent research has addressed gaps in long-term effects and synergies with other human milk oligosaccharides (HMOs). A 2025 analysis of infant formula supplementation indicated no adverse impact on growth trajectories up to 12 months, suggesting sustained safety.^[81] Studies from 2024-2025 highlight synergies, such as 2'-FL combined with galacto-oligosaccharides enhancing bifidogenic effects and reducing inflammation more effectively than 2'-FL alone in infant models, informing updated formulations.^[85]

Safety Profile and Regulatory Status

2'-Fucosyllactose (2'-FL) received Generally Recognized as Safe (GRAS) status from the U.S. Food and Drug Administration (FDA) in 2016 for use in infant formulas and other foods, based on evaluations in GRAS Notices such as GRN 650.^[86] Toxicology studies in rodents demonstrated an acute oral LD50 greater than 5 g/kg body weight, indicating low acute toxicity.^[87] In adults, consumption up to 20 g/day has been shown to be safe and well-tolerated, with no serious adverse effects reported; however, mild gastrointestinal symptoms such as flatulence, stomach pain, and loose stools may occur at higher doses.^[88]^[89] For infants, 2'-FL is safe at concentrations of 1-2 g/L in formula, supporting normal growth and tolerance without reported allergic reactions, consistent with its origin as a human milk oligosaccharide.^[90]^[57] Regulatory approvals include authorization by the European Food Safety Authority (EFSA) in 2015 for use in infant and follow-on formulae at up to 1.1 g/L.^[91] Approvals in China and Japan followed by 2022, enabling its inclusion in infant nutrition products, with further approvals for specific strains in China as of 2025.^[92]^[93]^[94] In 2025, updates in GRAS Notice 1257 and related assessments expanded conditions for adult use, including potential metabolic health claims supported by emerging data on gut modulation.^[95] Post-market surveillance and toxicology evaluations, including in vitro and in vivo genotoxicity assays, confirm no evidence of genotoxicity or carcinogenicity, with no adverse events reported in human consumption to date.^[96]^[97]

References

[1]
Structure-Function Relationships of Human Milk Oligosaccharides
May 4, 2012 · Specific α1–2-fucosylated HMO have been shown to serve as antiadhesive antimicrobials to protect the breast-fed infant against infections with ...
[2]
Human Milk Oligosaccharides: A Comprehensive Review towards ...
This review aims to provide an overview of human milk oligosaccharides as regards their biochemical, physiological, and clinical properties while also focusing ...
[3]
Human Milk Oligosaccharides: 2′-Fucosyllactose (2′-FL) and ...
The authors reviewed the published evidence on the presence of oligosaccharides in human milk (HMO) and their benefits in in vitro and in vivo studies.
[4]
The Role of Two Human Milk Oligosaccharides, 2′-Fucosyllactose ...
HMOs improve the host defense mechanism by strengthening the gut barrier function [40]. The HMO, 2′-FL inhibits Campylobacter jejuni infection and C. jejuni- ...
[5]
Review of the Clinical Experiences of Feeding Infants Formula ...
Sep 21, 2018 · Infant formula with 2′-FL supports immune and gut health and is closer compositionally and functionally to human milk.<|control11|><|separator|>
[6]
The Human Milk Oligosaccharide 2'-Fucosyllactose Shows an ... - NIH
Several studies have reported that 2'-FL has beneficial effects in infants. However, there are few studies on its immune-enhancing effects.
[7]
2-Fucosyllactose | C18H32O15 - ChemSpider
Molecular formula: C18H32O15. Average mass: 488.439. Monoisotopic mass ... [IUPAC name – generated by ACD/Name]. 6-Desoxy-α-L-galactopyranosyl-(1->2)-β ...
[8]
https://pmc.ncbi.nlm.nih.gov/articles/PMC10084749/
[9]
Strain-specific strategies of 2′-fucosyllactose, 3 ... - Nature
Sep 28, 2020 · The fucosylated trisaccharide 2′-fucosyllactose (Fucα1–2Galβ1–4Glc, 2′FL) is the most abundant HMO representing from 12 to 45% of the total HMO ...
[10]
Safety of 2′‐fucosyllactose (2'‐FL) produced by a derivative strain ...
Dec 14, 2022 · Chemical identity of 2'-FL. Chemical substance. Chemical (IUPAC) name, α-l-Fucopyranosyl-(1→2)-β-d-galactopyranosyl-(1→4)-d-glucopyranose.
[11]
3-Fucosyllactose (3-FL) Analytical Reference - Elicityl
3-Fucosyllactose (3-FL) Analytical Reference · Glycan structure: Galβ1-4(Fucα1-3)Glc · Chemical formula: C18 H23 O15.
[12]
Strategies for Enhancing Microbial Production of 2′-Fucosyllactose ...
Sep 12, 2022 · 2′-Fucosyllactose (2′-FL) is the most abundant HMO, accounting for approximately 30%, among approximately 200 identified HMOs with different structures.
[13]
2'-Fucosyllactose | Therapeutic Goods Administration (TGA)
Jan 20, 2022 · Chemical name: O-6-Deoxy-alpha-L-galactopyranosyl-(1-2)-beta-D-galactopyranosyl-(1-4)-D-glucose. Molecular formula: C18H32O15. CAS Number ...
[14]
[PDF] GRAS notice 749 for 2'-O-fucosyllactose - FDA
Molecular Weight: 1. Chemical Structure of 2FL. 2. Chemical ... Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory.
[15]
[PDF] GRAS notice 1035, Lacto-N-fucopentaose I with 2′-fucosyllactose
May 13, 2022 · Test the LNFP-1/2'-FL stabilit y during storage. 2. Define the optimal storage conditions and corresponding re-test dates or best before dates.
[16]
Safety Assessment of 2'-Fucosyllactose (2'-FL) as a Novel Food for ...
Aug 1, 2024 · Optical rotation [α] 20D +54.4 to +55.9°. The novel food is produced in line with Hazard Analysis and Critical Control Point (HACCP) principles.Missing: physical | Show results with:physical
[17]
[PDF] 2'-Fucosyllactose SD - BASF
Good solubility in water. Specification. Assay min. 94% IDM. For further information see separate document: "Standard Specification" (not ...
[18]
2′‐fucosyllactose: an abundant, genetically determined soluble ...
Nov 18, 2013 · 2′-FL is resistant to digestion and reaches the colon where it is partially fermented, behaving as soluble prebiotic fiber.
[19]
Human milk oligosaccharide secretion dynamics during ...
2'-FL peaks at approximately 3-5 g/L in colostrum and decreases to 1-2 g/L by 6 months postpartum. Lacto-N-tetraose (LNT) ranges from 2-3 g/L in early ...<|control11|><|separator|>
[20]
Elucidating Human Milk Oligosaccharide biosynthetic genes through ...
May 4, 2022 · While α-1,2-fucosylation of glycans in humans can be accomplished by both FUT1 and FUT2, only FUT2 is expressed in mammary gland epithelial ...
[21]
Biological functions of fucose in mammals - PMC - NIH
In mammals, GDP-fucose is synthesized through two pathways—the de novo synthesis pathway and the fucose salvage pathway (Figure 3). The de novo pathway ...
[22]
Evolutionary adaptation in fucosyllactose uptake systems supports ...
Aug 28, 2019 · In vitro studies have suggested that human milk oligosaccharides (HMOs) in breast milk promote the formation of a bifidobacteria-rich microbiota ...
[23]
Evolutionary adaptation in fucosyllactose uptake systems ... - PubMed
Aug 28, 2019 · In vitro studies have suggested that human milk oligosaccharides (HMOs) in breast milk promote the formation of a bifidobacteria-rich microbiota ...
[24]
https://www.science.org/doi/10.1126/sciadv.aaw7696
[25]
Functional effects of human milk oligosaccharides (HMOs) - PMC
Mar 17, 2023 · HMOs fulfil a variety of physiologic functions including potential support to the immune system, brain development, and cognitive function.
[26]
Infants Fed a Lower Calorie Formula With 2′FL Show Growth and 2
Nov 24, 2015 · Plasma and urine samples were collected to quantitate systemic 2′FL in formula-fed and HM-fed infants. Results from the biological samples that ...
[27]
Improved production of 2′-fucosyllactose in engineered ...
Aug 23, 2021 · The production of 2′-FL was further increased to 3.45 g/L by fortifying GDP-mannose synthesis. Further deleting gal80 enabled the engineered ...
[28]
Fucosyllactose in an Engineered Escherichia coli C41 (DE3 ... - PMC
We developed a powerful cell factory by using a lacZ-mutant Escherichia coli C41 (DE3)ΔZ to ulteriorly increase 2′-FL production by feeding inexpensive ...
[29]
Construction of an engineered Escherichia coli for effective ...
The final strain produced 59.22 g/L of 2′-FL with 95% molar conversion rate of lactose and 92% molar conversion rate of fucose in a 5 L fermenter. These ...
[30]
Enhanced 2'-Fucosyllactose production by engineered ... - OSTI.GOV
Oct 22, 2020 · The resulting engineered yeast produced 25.5 g/L of 2'-FL with a volumetric productivity of 0.35 g/L∙h in a fed-batch fermentation with lactose ...
[31]
Engineered Bacillus subtilis for the de novo production of 2
Jun 2, 2022 · The finally engineered strain BS21 could produce 88.3 g/L 2′-FL with a yield of 0.61 g/g lactose in a 3-L bioreactor, without the addition of ...Plasmids, Strains, And... · Plasmid Construction And Dna... · 2′-Fl Production By...<|control11|><|separator|>
[32]
Metabolic engineering of Priestia megaterium for 2'-fucosyllactose ...
Jan 4, 2025 · This study addresses the need for a safe and economical production of 2'-FL by employing Generally Recognized As Safe (GRAS) microbial strain, Priestia ...
[33]
(PDF) Efficient Purification of 2′-Fucosyllactose by Membrane ...
Nov 15, 2022 · The target 2′-fucosyllactose was eluted in a targeted manner using activated carbon adsorption and ethanol gradient elution technology. The 2′- ...
[34]
Process for efficient purification of neutral human milk ...
The obtained 2'-fucosyllactose solution was then treated with activated carbon (Norit DX1 Ultra). For 1 l of a 50% 2'-fucosyllactose solution 40 g activated ...<|separator|>
[35]
Separation of 2'-o-fucosyllactose from fermentation broth
Crystallization or recrystallization is one of the simplest and cheapest methods to isolate a product from a reaction mixture, separate it from contaminations ...
[36]
History and Prospects of Methods for Industrially Producing Human ...
Oct 2, 2023 · Jennewein S, Helfrich M (2013) Process for purification of 2'-fucosyllactose using simulated moving bed chromatography (EP2857410); Matwiejuk ...
[37]
Combinatorial engineering of microbial cell factory for 2
Combinatorial engineering of microbial cell factory for 2'-fucosyllactose biosynthesis. June 2025; Process Biochemistry 156. DOI:10.1016/j.procbio.2025.05.024.
[38]
Engineering Pichia pastoris for Efficient De Novo Synthesis of 2
The de novo biosynthesis pathway of 2′-FL was constructed using genome-editing technology based on CRISPR-Cas9 with an initial titer of 1.01 g/L.
[39]
https://www.glycoforum.gr.jp/article/26A18.html
[40]
fucosyllactose using recombinant bacterial enzymes - PubMed
Aug 23, 2001 · The isolation of 2'-fucosyllactose was accomplished by anion-exchange chromatography and gel filtration to give 65% yield. MeSH terms.
[41]
Efficient Biosynthesis of 2′-Fucosyllactose Using an In Vitro Multienzyme Cascade
### Summary of In Vitro Multienzyme Cascade for 2'-Fucosyllactose Synthesis
[42]
Glycan synthesis with SpyCatcher-SpyTag immobilized Leloir ...
Oct 24, 2025 · Immobilization of enzymes can counteract this disadvantage, making synthesis more cost-effective. In this study, we report a versatile ...<|control11|><|separator|>
[43]
Automated chemoenzymatic modular synthesis of human milk ...
May 29, 2024 · In this study, we presented a method that integrated magnetic bead-based manipulation and modular chemoenzymatic synthesis of human milk oligosaccharides (HMOs ...1 Introduction · 2.3 Enzymes · 3 Results
[44]
Kilogram scale chemical synthesis of 2′-fucosyllactose
Apr 1, 2019 · A kilogram scale preparation of 2′-fucosyllactose has been performed. · The developed route involves only one purification step using column ...
[45]
Recent progress in chemoenzymatic synthesis of human glycans - PubMed
### Abstract
[46]
Bifidogenic Effect of 2′-Fucosyllactose (2′-FL) on the Gut ... - MDPI
Adding 2′-FL to an infant formula containing 4 g/L of GOS + FOS resulted in a stronger bifidogenic effect compared to the formula without 2′-FL.
[47]
Combining galacto-oligosaccharides and 2′-fucosyllactose alters ...
We show that, combining GOS and 2′-FL accelerates GOS fermentation by the infant fecal microbiota of 8-week-old infants.
[48]
2'-Fucosyllactose inhibits proliferation of Clostridioides difficile ...
Oct 27, 2022 · 2'-FL significantly inhibited the outgrowth of the ATTC 43599 strain within a complex human gut microbial community in the CDi-screen.
[49]
Modulating the developing gut microbiota with 2'-fucosyllactose and ...
Feb 7, 2025 · Here, we assess the influence of 0.5 g/L 2-fucosyllactose (2'FL) ... Briefly, vessels were maintained at 37 °C and pH 7 under anaerobic ...<|separator|>
[50]
The effect of 2′-fucosyllactose on simulated infant gut microbiome ...
Sep 13, 2019 · Approximately 1% of ingested HMOs are absorbed into the infant's systemic circulation and are excreted into the urine, where they also may ...
[51]
2′-fucosyllactose alone or combined with resistant starch increases ...
Jul 16, 2023 · Over a 24-h period, overall cumulative acetate, butyrate, and total SCFA accumulation were higher with 2′-FL+RS vs. 2′-FL alone when fecal ...
[52]
Infant microbiome cultivation and metagenomic analysis reveal ...
Nov 16, 2023 · We investigate microbiome responses to 2'-fucosyllactose (2'FL), a prevalent HMO and a common infant formula additive, by establishing individualized ...
[53]
Supplementation of 2'-Fucosyllactose in Formula-Fed Infants Has ...
Sep 9, 2025 · Supplementation of 2'-Fucosyllactose in Formula-Fed Infants Has Potential Benefits to Reduce the Risks of Infantile Colic and Atopic Dermatitis ...
[54]
Combining 2′-fucosyllactose and galacto-oligosaccharides exerts ...
2′-FL and GOS combinations have potential applications in advanced infant formulas and supplements to promote gut health and reduce inflammation.
[55]
2′-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially ...
... 2′FL ranged from a mean of 0.7 ± 0.1 g/L in milk collected in Ghana to a mean of 3.4 ± 0.4 g/L in milk collected in California. In contrast to human milk ...
[56]
Immunomodulatory and Prebiotic Effects of 2′-Fucosyllactose in ...
Supplementation of 2′-FL in early life has a pre-biotic and intestinal trophic effect and promotes maturation of the immune system.Missing: pharmacokinetics | Show results with:pharmacokinetics
[57]
Fucosyllactose Ingestion on Weight Loss and Markers of Health
Fucosyllactose (FL), which includes 2′-FL and 3-FL, represents the predominant category of human milk oligosaccharides (HMOs) in human milk, with 2′-FL ...Missing: prevalence | Show results with:prevalence
[58]
https://gut.bmj.com/content/65/1/33
[59]
2'‐Fucosyllactose attenuates aging‐related metabolic disorders ...
Sep 20, 2024 · 2'-Fucosyllactose relieved aging-related metabolic disorders by modulating both the adaptive immune system and gut microbial profile.
[60]
(PDF) 2'‐Fucosyllactose attenuates aging‐related metabolic ...
The results revealed that 2'‐FL significantly relieved aging‐related metabolic disorders, including weight gain, lipid deposition, dyslipidemia, glucose ...
[61]
Dietary 2'-Fucosyllactose Enhances Operant Conditioning and Long ...
Nov 16, 2016 · Oral supplementation of 2'-fucosyllactose during lactation improves memory and learning in rats. J Nutr Biochem. 2016;31:20–7. 10.1016/j ...
[62]
Effects of a human milk oligosaccharide, 2′-fucosyllactose, on ...
We show that feeding a diet with 2′-FL increases LTP at the hippocampus, in conscious rats and mice. 2′-FL also enhanced memory consolidation, spatial learning ...
[63]
Effects of addition of 2-fucosyllactose to infant formula on growth and ...
The human milk oligosaccharide 2′-fucosyllactose modulates CD14 expression in human enterocytes, thereby attenuating LPS-induced inflammation. Gut. (2016) ...
[64]
Similar to Those Who Are Breastfed, Infants Fed a Formula ...
Concentrations of HMOs vary among individuals and over the course of lactation (7, 9, 10, 11), the most abundant of which is 2′-fucosyllactose (2′-FL), which ...
[65]
Safety and efficacy of a probiotic-containing infant formula ...
Feb 22, 2022 · L. reuteri-containing infant formula with 2'FL supports age-appropriate growth, is well-tolerated and may play a role in shifting the gut microbial pattern.<|control11|><|separator|>
[66]
Technical review by the ESPGHAN special interest group on gut ...
Mar 24, 2025 · The ESPGHAN SIG-GMM conducted a systematic review to evaluate the clinical outcomes of HiMO-supplemented infant formulas in healthy infants (0– ...
[67]
None
Summary of each segment:
[68]
Infant Formula With a Specific Blend of Five Human Milk ... - Frontiers
The concentrations of the five HMOs in TG1 and TG2 were 0.87 and 1.45 g/L for 2′FL, 0.10 and 0.14 g/L for DFL, 0.29 and 0.48 g/L for LNT, 0.11 and 0.18 g/L for ...<|control11|><|separator|>
[69]
https://pmc.ncbi.nlm.nih.gov/articles/PMC12457806/
[70]
https://onlinelibrary.wiley.com/doi/10.1002/jpn3.70032
[71]
2'-FL Benefits: What is Fucosyllactose? Gut & Immune Support
Verify Dosage: Infant formulas: 0.2–1.0 g/L; adults: 1–5 g daily. 4. Assess Synergies: Opt for products combining 2'-FL with probiotics or postbiotics. 5.
[72]
Human Milk Oligosaccharides Support Normal Bowel Function...
Changes in the overall IBS Symptom Severity Score during 12 weeks of daily supplementation with a 5-g mix of 2'-fucosyllactose and lacto-N-neotetraose in the ...
[73]
2'FL Prebiotic Formula Improved Gut Bacteria in Patients with GI ...
This study demonstrated that consumption of the 2'-FL-containing nutritional formula was associated with clinically meaningful improvements in GI symptoms and ...
[74]
Administration of Human Milk Oligosaccharide (2′-fucosyllactose ...
Oral 2'-FL supplementation reduces dysbiosis and increases SCFA production in children and young adults following HSCT. Ongoing phase II studies of 2'-FL ...
[75]
Impact of 2′‐fucosyllactose on adult gut microbiota composition ...
Mar 26, 2025 · This study demonstrated beneficial bifidogenic effect of 2′-FL in an adult complex microbial community and the potential of scoring evaluation as a ...Missing: nutraceuticals | Show results with:nutraceuticals
[76]
fucosyllactose and Bifidobacterium longum subsp. infantis EFEL8008
Jul 22, 2025 · Aim: This study aimed to evaluate the combination of 2'-fucosyllactose (2'-FL) and Bifidobacterium longum subsp. infantis (B. infantis) ...
[77]
2′-Fucosyllactose synbiotics with Bifidobacterium bifidum to ...
The recommended dose of 2′-FL is 0.7–2.4 g/L. 2′-FL can act as a substrate for the gut microbiota, including B. bifidum, and regulate the dynamic balance of the ...
[78]
2'-Fucosyllactose (2'-FL) Analysis Report 2025: Market to Grow by a ...
Rating 4.8 (1,980) May 2, 2025 · The 2'-Fucosyllactose (2'-FL) market is experiencing robust growth, driven by increasing awareness of its health benefits, particularly in ...
[79]
https://www.archivemarketresearch.com/reports/2-fucosyllactose-2-fl-416560
[80]
https://doi.org/10.3390/nu14030530
[81]
https://doi.org/10.5223/pghn.2025.28.5.291
[82]
GRN No. 650 - GRAS Notices - FDA
2'-O-fucosyllactose. Intended Use: For use in term infant formula at a ... May 26, 2016. GRAS Notice (releasable information):, GRN 650 (in PDF) (5.9 MB).
[83]
fucosyllactose (2′-FL) from Escherichia coli K12 MG1655 strain ...
Jun 16, 2022 · The petitioner estimated the maximum dietary exposure of 2′-FL in adults to be 5.9 g/day (90th percentile; adult users, 50+ years of age). At ...
[84]
[PDF] GRAS Notice 1040, 2'-fucosyllactose - FDA
Nov 12, 2021 · ... 2'-fucosyllactose (2'-FL} produced with ... In the supplement, Jennewein states that the substitution of extraneously added food-grade lactase ...
[85]
Oral supplementation of healthy adults with 2′-O-fucosyllactose ...
HMO are not digested in the upper GI tract, and only 1–2 % is absorbed in infants( , ). The majority of ingested HMO reach the large intestine where they ...
[86]
Safety of 2'-O-fucosyllactose as a novel food ingredient pursuant to ...
Jul 20, 2015 · 2'-O-fucosyllactose (2'-FL) is a synthetic trisaccharide, which is ... 2'-FL for up to 36 months of storage. An increase in water ...
[87]
Safety of 2'-O-fucosyllactose - EFSA - European Union
Jul 20, 2015 · 2'-O-fucosyllactose (2'-FL) is a synthetic trisaccharide, which is intended to be used in infant and follow-on formulae, foods for special medical purposes.
[88]
When will 2'-fucosyl lactose (2'-FL) be approved in China？
Apr 26, 2022 · 2' -FL is the highest oligosaccharide in human milk and one of the first HMOs approved by FDA and EU to be used in infant milk powder, common ...
[89]
Manufacturing strain of Kyowa Hakko Bio's 2'-fucosyllactose, a ...
Jun 23, 2022 · Kyowa Hakko Bio is now moving forward to the next step of the approval process which is the 2'-FL authorization of use as food additive in ...
[90]
[PDF] GRAS Notice (GRN) 1257, 2'-fucosyllactose - Regulations.gov
Jan 13, 2025 · Studies Conducted with 2'-FL in Infant Formula at 3.0 g/ L. Parschat et al. (2021) - NCT03513744. A multi-centered, randomized, double-blinded ...
[91]
[PDF] GRAS Notice 1157, 2'-fucosyllactose with amendments - FDA
May 30, 2023 · ... adults and adults with IBS, ulcerative colitis, Crohn's disease, or celiac ... 2'-fucosyllactose; 3'-FL = 3'-fucosyllactose; 3'-SL = 3 ...
[92]
Pre-clinical safety evaluation of the synthetic human milk ... - PubMed
Nov 18, 2013 · 2'FL was non-mutagenic in vitro. A 90-day rat study showed no adverse effects up to 5000 mg/kgbw/day, with a NOAEL of 5000 mg/kgbw/day.