,The East African Community (EAC) has released DEAS 1310:2025 Scientific Substantiation of Health ClaimsGuidelines, providing a clear and structured approach for assessing whether health claims made on foods are scientifically valid and acceptable. The guidelines apply to health claims covered under EAS 805 and aim to protect consumers by ensuring that only truthful, evidence-based claims are used on food labels and in marketing.
The document explains what qualifies as a health claim and groups them into three categories:
Nutrient function claims, which describe the normal physiological role of a nutrient in the body;
Other function claims, which relate to beneficial effects on normal body functions or biological activities; and
Reduction of disease risk claims, which link food consumption to a reduced risk of developing a disease by modifying specific risk factors, without implying disease prevention.
To support these claims, the EAC emphasizes that high-quality scientific evidence is essential. Health claims should mainly be supported by well-designed human intervention studies, while observational studies may contribute as supporting evidence. Animal studies and laboratory data can help explain mechanisms but are not sufficient on their own. Authorities must evaluate the totality of evidence, including data that supports or contradicts the claimed health effect.
The guidelines also describe a step-by-step substantiation process, starting from defining the food or food constituent and the claimed health effect, identifying suitable measurements or biomarkers, reviewing all relevant scientific studies, and assessing study quality and statistical validity. Claims must demonstrate a clear cause-and-effect relationship, show benefits achievable through normal dietary intake, and be relevant to the intended population.
In addition, safety considerations are built into the evaluation. The amount of a food or constituent needed to achieve the claimed effect must not pose health risks or exceed established upper intake levels. Authorities must consider cumulative exposure from multiple dietary sources and potential impacts on vulnerable population groups.
The guidelines further strengthen communication and enforcement measures. Competent authorities are required to formally inform Food Business Operators (FBOs) of the outcome of claim evaluations, provide guidance where claims are substantiated, and require immediate corrective action if claims are found to be false, misleading, or unsubstantiated. If corrective actions are not taken, authorities may notify the public to prevent consumer misinformation.
Finally, the EAC confirms that health claims are subject to ongoing monitoring and re-evaluation, either periodically or when new scientific evidence becomes available. The guidelines align with Codex Alimentarius risk analysis principles and apply to foods intended for the general population, excluding foods for children aged 36 months and below.