The 'DiaFree Gold' Capsules: What Is It, and Who May Sell It?
A district food safety officer receives a complaint through the FSSAI grievance portal about 'DiaFree Gold' capsules, sold at ₹1,850 per bottle of 60 on a marketplace website. The label describes the product as a 'proprietary Ayurvedic food supplement' and carries the claims 'reduces HbA1c by 1.2% in 30 days', 'stops insulin dependence' and 'no preservatives'. It shows a State licence number issued to a manufacturer in another state whose turnover is ₹7 crore and who sells through three outlets in three states. The label has no nutrition panel, no allergen declaration and no brown non-vegetarian mark, although the capsule shell is gelatin. The online listing repeats all claims and adds 'clinically proven'. The manufacturer's licence category reads 'proprietary food'. The officer must decide what the product legally is, which claims are actionable, and what to do in the next ten days, before the current batch sells out.
1. How should the product be classified, and is the licence held by the manufacturer the correct one?
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Two separate errors exist and they must be argued separately.
Product category. 'Proprietary food' means a conventional, standardised-format food for which no standard is prescribed. A capsule is a dosage form, not a conventional food; it falls under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, and any ingredient outside the permitted lists needs approval under the Non-Specified Food Regulations, 2017. So the licence category itself is wrong for the article being sold.
Licence slab. Turnover of ₹7 crore would normally sit in the State licence slab (above ₹12 lakh, up to ₹20 crore). But an FBO operating in two or more states must hold a Central licence, whatever its turnover. Selling through three outlets in three states therefore requires a Central licence.
Consequence. Selling under a category that does not cover the product, and outside the correct slab, is effectively carrying on business without a valid licence for that activity - a stop-activity situation plus a licensing prosecution, not merely a labelling defect. The officer should record the website, the label and the invoice trail before recommending suspension to the licensing authority.
2. Which claims are actionable, and on what evidence?
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'Stops insulin dependence' is a cure/treatment claim for a disease. The FSS (Advertising and Claims) Regulations, 2018 permit nutrient-content, nutrient-function, health and (with approval) risk-reduction claims; they do not permit a food to claim that it treats or cures diabetes. The statement also invites a diabetic patient to abandon prescribed therapy - the highest-risk kind of claim.
'Reduces HbA1c by 1.2% in 30 days' is a quantified health claim. Even if a study exists, the claim must be substantiated by evidence in the population for which the food is intended and must be phrased within the permitted categories. A specific numeric outcome framed as a treatment target is not a permitted food claim.
'Clinically proven' on the marketplace listing is an unsubstantiated superiority claim by the e-commerce FBO, which is itself a licensed food business operator with due-diligence obligations and must display the licence on the listing.
Evidence to preserve: dated screenshots with URL, label photographs, purchase invoice, and a written demand for the substantiation dossier. Section 24 of the FSS Act bars advertisements that mislead or contravene the Act, and Section 52 carries a fine up to ₹10 lakh for a misleading advertisement, separate from the misbranding offence. Both the manufacturer and the marketplace should be proceeded against.
3. Set out the enforcement sequence for the next ten days, with the specific provisions and the risk of doing nothing.
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Day 1–2: Purchase a sample as a consumer/complainant to preserve the exact retail unit; inspect the manufacturing or storage premises; seize unsold stock and the labelling plates under a proper seizure memo; direct the marketplace to delist the product and the FBO to initiate a withdrawal/recall of the batch already sold.
Day 3–5: Issue a written direction to stop further sale. Refer the sample to a NABL-accredited/notified laboratory for composition and, if required, for the declared actives.
Day 6–10: Draw up offences for adjudication before the Adjudicating Officer under Section 68: misbranding (Section 51, fine up to ₹3 lakh - no licence number, no nutrition panel, missing non-veg mark, no allergen declaration), misleading advertisement (Section 52, up to ₹10 lakh), and, if the laboratory finds the composition does not match, sub-standard food (Section 50, up to ₹5 lakh). If the product contains an undeclared pharmacological substance, the unsafe-food route under Section 59 applies and the matter becomes a prosecution, not compounding.
Risk of inaction: capsules with a disease-cure claim reach diabetic patients who may stop insulin; continued sale also destroys the only defence the FBO could otherwise raise (that the error was corrected promptly).