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The directive, issued on October 14, mandates the rapid withdrawal of all earlier permissions granted to Food Business Operators (FBOs) for utilizing ‘ORS’ along side their model names. Specifically, it rescinds two earlier orders, dated July 14, 2022, and February 2, 2024, that had allowed the usage of ‘ORS’ as a part of a trademark with a prefix or suffix, offered the label included a disclaimer stating, “The product is Not an ORS formulation as beneficial by WHO.”
Clarification issued on deceptive labelling
On October 15, day after the directive on October 14, FSSAI issued an in depth clarification reaffirming that the usage of ‘ORS’ in any meals product’s title, whether or not fruit-based, non-carbonated, or ready-to-drink, violates the Food Safety and Standards Act, 2006, and associated laws. The regulator said that such labelling ‘misleads customers by means of false, misleading, ambiguous, and faulty names or label declarations,’ and due to this fact contravenes a number of provisions below the Act.
A paediatrician’s combat for shopper security
This regulatory intervention stems from a persistent authorized marketing campaign by Dr. Sivaranjani Santosh, who started questioning misleading advertising practices almost a decade in the past. In 2022, she filed a Public Interest Litigation (PIL) earlier than the Telangana High Court, difficult the sale of drinks falsely marketed as ORS regardless of not assembly WHO-recommended electrolyte and glucose requirements.
Her petition highlighted how a number of corporations marketed ‘fruit juices’ and different sweetened drinks below the guise of being oral rehydration options, posing potential dangers, significantly to kids and diabetic sufferers. Dr. Sivaranjani’s complaints additionally reached Rajesh Bhushan, the then Secretary of the Ministry of Health and Family Welfare, prompting judicial and regulatory scrutiny.
Court intervention and preliminary FSSAI response
The Telangana High Court, led by the Chief Justice, sought responses from each the FSSAI and the Drug Controller General of India, recognising the potential public well being implications of deceptive ORS claims. Following this, on April 8, 2022, FSSAI issued its first directive limiting the usage of ‘ORS’ in meals labels or commercials. However, on July 14 that very same 12 months, the FSSAI knowledgeable Dr. Sivaranjani that the restriction was quickly relaxed following a writ petition filed by a number of corporations. The regulator determined to permit producers holding legitimate logos to proceed producing such merchandise below their registered names till the Controller General of Patents, Designs and Trademarks issued a ultimate choice.
WHO-approved ORS vs. sugar-loaded imitations
The World Health Organisation prescribes a typical oral rehydration answer with a complete osmolarity of 245 mOsm/L. This composition contains 2.6 grams of sodium chloride, 1.5 grams of potassium chloride, 2.9 grams of sodium citrate, and 13.5 grams of dextrose anhydrous (sugar) per litre of water.
In distinction, a number of merchandise marketed as ORS by pharmaceutical corporations include considerably larger sugar ranges, round 120 grams of complete sugar per litre, with almost 110 grams being added sugar. Their electrolyte steadiness can also be inconsistent with WHO norms, offering simply 1.17 grams of sodium, 0.79 grams of potassium, and 1.47 grams of chloride per litre.
Reflecting on the result, Dr. Sivaranjani described the FSSAI order because the fruits of years of persistence and public assist. “It was a conflict. Eight years of battle, three years of submitting PILs, and 4 to 5 years of preventing indifference. This victory belongs to not one particular person, however to individuals’s energy, all of the docs, advocates, mothers, and influencers who stood with me. I stood steadfast, and we received,” she stated.
