Infant nutrition is a lucrative and expanding market in Asia Pacific. Increasing affluence and births spur this growth – the region’s population is expected to grow by 1 billion between now and 2050. However, regulators across Asia Pacific are passing laws to govern infant nutrition production, sales and label claims.

While infant formula is not a pharmaceutical product, regulations demand a higher level of clinical evidence compared to other nutritional products. This has implications for manufacturers across the board on what to sell, where to sell, how to sell.

This report explores these regulatory changes and their impact on product innovation, sales and promotion in the region. It also offers advice to manufacturers on the types of clinical studies needed to validate claims and how to plan and manage these studies to optimize returns.

INTRODUCTION

Infant formula is a hot topic of debate among physicians, parents and regulators. These products are designed to feed one of our most vulnerable populations; in early life it may be the only form of nutrition infants consume. Because of this it is one of the most scrutinized consumer health product categories.

Condensed and powdered infant formulas first came on the market in the 1800s. Over time, manufacturers added vitamins, nutrients and probiotics to improve health benefits; they created alternative formulas to address food allergies, digestive issues and improve product shelf life.

As formulas evolved, so did label claims. Often these were not supported by robust science, drawing the attention of global regulatory bodies. They questioned unsubstantiated claims and established stricter guidelines for evidence about the safety, efficacy and performance of infant and toddler nutritional products.

These requirements – plus scrutiny by parents, physicians and other healthcare experts – put infant nutrition manufacturers in a unique position from a clinical research perspective. While infant formula is not a pharmaceutical product, regulations demand a higher level of clinical evidence compared to other nutritional products. This has implications for manufacturers across the board on what to sell, where to sell, how to sell.

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