By S&S Co. Advocates & Solicitors · Published 14 April 2026 · Informational content, not legal advice: see our disclaimer
Why Claims Substantiation Matters
A health or nutrition claim on a food label: whether it is a specific statement like 'high in protein' or a more general one like 'supports immunity'. Is not simply a marketing choice. Under the Food Safety and Standards (Advertising and Claims) Regulations, any such claim made on packaging or in advertising must be capable of being substantiated with credible scientific evidence, and the burden of substantiation rests on the food business operator making the claim, not on a complainant to disprove it.
The Distinction Between Nutrition Claims and Health Claims
A nutrition claim describes a food's nutrient content in objective, measurable terms: 'low fat', 'source of fibre', 'no added sugar'. And is generally easier to substantiate against a defined compositional threshold. A health claim goes further, asserting a relationship between the food or a nutrient in it and health or a physiological function: 'supports digestive health', 'boosts immunity'. Health claims of this kind require a materially higher evidentiary standard, since they are asserting an effect on the body rather than merely describing composition, and generic or vague health claims without a defined, testable basis are particularly vulnerable to enforcement action.
What Counts as Acceptable Substantiation
Substantiation typically needs to be grounded in recognised scientific literature, clinical or nutritional studies specific to the claim being made, and, where the claim tracks an established nutrient function, alignment with the specific conditions (such as minimum nutrient content per serving) that regulation attaches to using that claim. A generic reference to a nutrient's health benefits in the abstract, without tying it to the actual composition and dosage present in the specific product, is generally not treated as sufficient.
Consequences of an Unsubstantiated Claim
An unsubstantiated or misleading claim can attract a show-cause notice and, ultimately, adjudication proceedings under the FSS Act, in addition to separate exposure under the Consumer Protection Act for misleading advertisement, and, for straightforward exaggerated or absolute claims, has in practice drawn direct regulatory advisories requiring their removal. Given the overlapping exposure, food businesses making claims for a new product should build a documented substantiation file for each claim before the product goes to market, not after a notice is received.
Frequently Asked Questions
Who has to prove that a health claim on a food label is true?
The food business operator making the claim bears the burden of substantiating it with credible scientific evidence; it is not for a complainant or regulator to disprove the claim first.
Is there a difference between a nutrition claim and a health claim?
Yes. A nutrition claim describes measurable nutrient content (e.g., 'low fat'), while a health claim asserts a relationship between the food and a health or physiological effect (e.g., 'supports immunity') and generally requires stronger substantiation.
Can a food business rely on general nutritional science to justify a specific product claim?
Generally not on its own. Substantiation should tie the general science to the actual composition and dosage present in the specific product carrying the claim, not merely the nutrient's benefits in the abstract.
What is the practical risk of making an unsubstantiated claim?
Exposure to a show-cause notice and adjudication under the FSS Act, alongside separate potential exposure under the Consumer Protection Act for misleading advertisement.
References & Further Reading
This article references the following statutory provisions. Readers should always verify current rules, fees and timelines against the applicable statute and rules as amended, since these are revised from time to time.
- Food Safety and Standards (Advertising and Claims) Regulations, 2018.
- Food Safety and Standards Act, 2006, adjudication provisions under Section 68.