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<\/p>\n The legal notice Kenvue’s lawyers sent Dr Santosh in March 2026 accused her of “spreading unscientific myths” about sucralose.
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Published Apr 11, 2026 | 10:16 AM \u268a Updated Apr 11, 2026 | 10:16 AM<\/p>\n
ORS works through sodium-glucose co-transport, a mechanism that drives water and electrolyte absorption in the gut.<\/p>\n Synopsis: The debate Dr Santosh has raised is not about whether ERZL contains an illegal quantity of sucralose. It is about whether a product containing sucralose should sit in pharmacies, be sold alongside therapeutic ORS, and reach children in a country where the national dietary guidelines tell parents that children should avoid sugar substitutes altogether.<\/p>\n A debate over sucralose, the artificial sweetener present in ERZL, the electrolyte drink that replaced ORSL, sits at the heart of a dispute between Hyderabad paediatrician Dr Sivaranjani Santosh and Johnson & Johnson\u2019s consumer health arm Kenvue.<\/p>\n The legal notice Kenvue\u2019s lawyers sent Dr Santosh in March 2026 accused her of \u201cspreading unscientific myths\u201d about sucralose.<\/p>\n The Indian Academy of Pediatrics(IAP) position statement, released days after, defended sucralose as safe within established limits.<\/p>\n But a closer look at what India\u2019s own nutrition authority says, and what the emerging science shows, reveals a more contested picture.<\/p>\n What sucralose is<\/p>\n Sucralose is a non-caloric artificial sweetener, approximately 600 times sweeter than sugar. It contributes no calories, does not raise blood sugar, and does not affect the osmolarity of fluids.<\/p>\n FSSAI classifies it as a non-caloric sweetener and permits up to 300 mg\/L in beverages.<\/p>\n CDSCO approved its use in pharmaceutical products in 2009, and it entered the Indian Pharmacopoeia in 2010.<\/p>\n What the IAP says<\/p>\n The IAP position statement aligns with the regulatory consensus.<\/p>\n It cites JECFA and EFSA, both of which set an acceptable daily intake for sucralose at 15 mg\/kg body weight per day, and states that sucralose \u201cis regulated and considered safe within established acceptable daily intake limits.\u201d<\/p>\n The statement also references the WHO\u2019s 2023 guideline, which issued a conditional recommendation against non-sugar sweeteners for weight control, flagging potential long-term metabolic risks.<\/p>\n The IAP treats both positions as compatible, adding the qualification that \u201csafety is dose-dependent.\u201d<\/p>\n Also Read: Electrolyte drinks cannot replace ORS: Indian Academy of Pediatrics backs FSSAI ban on ORS branding<\/a> The legal notice goes further than the IAP.<\/p>\n It points out that FSSAI\u2019s 2020 labelling regulations specifically removed the \u201cnot recommended for children\u201d warning for sucralose, while retaining it for aspartame, acesulfame potassium and saccharin.<\/p>\n The notice argues this removal \u201cis in itself evidence of the safety of sucralose for general population including children.\u201d<\/p>\n It also cites EFSA\u2019s February 2026 review, which reaffirmed sucralose as safe for currently authorised uses, and describes Dr Santosh\u2019s posts as a \u201cmalicious and unscientific campaign.\u201d<\/p>\n What the EFSA 2026 review actually says<\/p>\n The EFSA review carries a detail that neither the notice nor the IAP statement foregrounds.<\/p>\n Its full title<\/a> reads: \u201cEFSA finds sucralose safe when used as currently authorised; cannot confirm safety of extending its use.\u201d<\/p>\n The second half matters. EFSA reaffirmed safety within current authorised limits but declined to confirm safety if use were extended beyond those limits.<\/p>\n It is an endorsement with a boundary, not a blanket clearance.<\/p>\n What India\u2019s own dietary authority says<\/p>\n The ICMR-National Institute of Nutrition\u2019s Dietary Guidelines for Indians 2024<\/a>, published by India\u2019s apex medical research body, states directly that \u201clong term consumption of non-calorie sugar substitutes could lead to overweight\/obesity, diabetes, hypertension and other NCDs.\u201d<\/p>\n It further states that studies \u201cindicate disruption in beneficial intestinal bacterial flora.\u201d<\/p>\n Its recommendation on children carries no qualification: \u201cpregnant and lactating women and children should avoid sugar substitutes.\u201d<\/p>\n This is not a foreign paediatric body. This is India\u2019s own national nutrition authority, published two years ago.<\/p>\n Also Read: Johnson & Johnson sends legal notice to Hyderabad paediatrician over ERZL, ORSL posts<\/a> FSSAI\u2019s internal note<\/a> on non-sugar sweeteners, prepared after its Scientific Panel deliberated the WHO 2023 guideline, retains existing ADI limits but acknowledges the evidence base did not include Asian or Indian populations.<\/p>\n It recommends that consumers use sweetened products \u201cin moderation.\u201d<\/p>\n It also states explicitly that FSSAI \u201chas not recommended these NSS for weight loss or maintenance of healthy weight, and as a means of controlling blood glucose in individuals with diabetes.\u201d<\/p>\n Regulatory approval and active recommendation are two different things.<\/p>\n What other paediatric bodies say<\/p>\n Dr Santosh has pointed out that the American Academy of Pediatrics, and the British, Canadian and Spanish paediatric associations all exercise caution on regular sweetener use in children, citing gaps in long-term data on gut microbiome disruption and future diabetes risk.<\/p>\n She describes the IAP\u2019s detailed defence of sucralose as a \u201cclearly influenced statement,\u201d given the level of conference sponsorship that Kenvue and Johnson & Johnson extend to paediatric bodies in India.<\/p>\n The IAP has not responded publicly to this accusation.<\/p>\n What the emerging science shows<\/p>\n A study published<\/a> in Frontiers in Nutrition, led by Dr Francisca Concha Celume of the Universidad de Chile, found that sucralose consumption in mice altered gut microbiome composition, disrupted glucose tolerance, and changed the expression of genes linked to inflammation and metabolism.<\/p>\n These changes passed to the next two generations, even though the offspring never consumed the sweetener.<\/p>\n The researchers described their findings as \u201cearly biological signals\u201d rather than confirmed disease, and stated the goal was \u201cnot to create alarm, but to highlight the need for further investigation.\u201d<\/p>\n The study does not establish causation, and mouse responses do not directly translate to humans. But the direction of travel in the science \u2014 gut microbiome disruption, intergenerational metabolic signals, long-term diabetes risk \u2014 maps closely onto the concerns Dr Santosh raised, and that the legal notice dismissed as \u201cunscientific myths.\u201d<\/p>\n What the WHO says<\/p>\n
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\nWhat the Kenvue legal notice says<\/p>\n
\nWhat FSSAI\u2019s own internal note says<\/p>\n
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