Published Apr 11, 2026 | 10:16 AM ⚊ Updated Apr 11, 2026 | 10:16 AM
ORS works through sodium-glucose co-transport, a mechanism that drives water and electrolyte absorption in the gut.
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.
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’s consumer health arm Kenvue.
The legal notice Kenvue’s lawyers sent Dr Santosh in March 2026 accused her of “spreading unscientific myths” about sucralose.
The Indian Academy of Pediatrics(IAP) position statement, released days after, defended sucralose as safe within established limits.
But a closer look at what India’s own nutrition authority says, and what the emerging science shows, reveals a more contested picture.
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.
FSSAI classifies it as a non-caloric sweetener and permits up to 300 mg/L in beverages.
CDSCO approved its use in pharmaceutical products in 2009, and it entered the Indian Pharmacopoeia in 2010.
The IAP position statement aligns with the regulatory consensus.
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 “is regulated and considered safe within established acceptable daily intake limits.”
The statement also references the WHO’s 2023 guideline, which issued a conditional recommendation against non-sugar sweeteners for weight control, flagging potential long-term metabolic risks.
The IAP treats both positions as compatible, adding the qualification that “safety is dose-dependent.”
The legal notice goes further than the IAP.
It points out that FSSAI’s 2020 labelling regulations specifically removed the “not recommended for children” warning for sucralose, while retaining it for aspartame, acesulfame potassium and saccharin.
The notice argues this removal “is in itself evidence of the safety of sucralose for general population including children.”
It also cites EFSA’s February 2026 review, which reaffirmed sucralose as safe for currently authorised uses, and describes Dr Santosh’s posts as a “malicious and unscientific campaign.”
The EFSA review carries a detail that neither the notice nor the IAP statement foregrounds.
Its full title reads: “EFSA finds sucralose safe when used as currently authorised; cannot confirm safety of extending its use.”
The second half matters. EFSA reaffirmed safety within current authorised limits but declined to confirm safety if use were extended beyond those limits.
It is an endorsement with a boundary, not a blanket clearance.
The ICMR-National Institute of Nutrition’s Dietary Guidelines for Indians 2024, published by India’s apex medical research body, states directly that “long term consumption of non-calorie sugar substitutes could lead to overweight/obesity, diabetes, hypertension and other NCDs.”
It further states that studies “indicate disruption in beneficial intestinal bacterial flora.”
Its recommendation on children carries no qualification: “pregnant and lactating women and children should avoid sugar substitutes.”
This is not a foreign paediatric body. This is India’s own national nutrition authority, published two years ago.
FSSAI’s internal note 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.
It recommends that consumers use sweetened products “in moderation.”
It also states explicitly that FSSAI “has not recommended these NSS for weight loss or maintenance of healthy weight, and as a means of controlling blood glucose in individuals with diabetes.”
Regulatory approval and active recommendation are two different things.
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.
She describes the IAP’s detailed defence of sucralose as a “clearly influenced statement,” given the level of conference sponsorship that Kenvue and Johnson & Johnson extend to paediatric bodies in India.
The IAP has not responded publicly to this accusation.
A study published 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.
These changes passed to the next two generations, even though the offspring never consumed the sweetener.
The researchers described their findings as “early biological signals” rather than confirmed disease, and stated the goal was “not to create alarm, but to highlight the need for further investigation.”
The study does not establish causation, and mouse responses do not directly translate to humans. But the direction of travel in the science — gut microbiome disruption, intergenerational metabolic signals, long-term diabetes risk — maps closely onto the concerns Dr Santosh raised, and that the legal notice dismissed as “unscientific myths.”
The WHO’s 2023 guideline on non-sugar sweeteners issued a conditional recommendation against their regular use, flagging potential long-term risks including type 2 diabetes and cardiovascular disease.
The certainty of these findings ranges from “very low to low,” which is why the recommendation carries the word “conditional.”
The notice and the IAP statement both cite this conditionality to limit the weight of the WHO’s concern.
Dr Santosh argues the opposite: that a conditional recommendation from the world’s apex health body, based on a systematic review, constitutes legitimate scientific grounds for a practising paediatrician to urge caution.
No one disputes that sucralose in ERZL falls within FSSAI’s permitted limits.
But 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.
That question the IAP position statement does not answer.
