FSSAI Takes Action Against Nestlé Infant Foods Over Biotin Concerns; What Parents Should Know

Parents choosing infant formula often rely on information printed on packaging and displayed on online shopping platforms.

However, a recent regulatory action involving Nestlé India has put the spotlight on both product composition and marketing claims. The Food Safety and Standards Authority of India (FSSAI) has initiated three separate adjudication proceedings against Nestlé India over alleged violations involving three infant nutrition products. The cases relate to promotional claims made for two products and a laboratory finding concerning the biotin content of another formula.

The products involved are NAN Excella Pro Stage 1, Lactogen Pro 1 and a follow-up formula manufactured by Nestlé India.

FSSAI Raises Questions Over Product Claims

FSSAI examined promotional material for NAN Excella Pro Stage 1 and Lactogen Pro 1 available on e-commerce platforms.

For NAN Excella Pro Stage 1, the regulator objected to references to “5 HMOs” and “Whey Protein.” In the case of Lactogen Pro 1, FSSAI raised concerns over the description of its whey protein as “easy to digest.”

The regulator said these promotional claims were contrary to Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The regulation places restrictions on promotional material and claims intended to increase the saleability of infant food products.

FSSAI also cited provisions of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which governs the advertising and promotion of infant milk substitutes and infant foods.

Separate Case Involves Biotin Levels

The third proceeding concerns a follow-up formula. A sample collected for laboratory testing was found to be non-compliant with the prescribed biotin requirement.

Following the initial test, the sample was sent to a Referral Laboratory for re-analysis. The second assessment also concluded that the sample did not conform to the applicable standard.

FSSAI’s prescribed range for biotin in follow-up formula is 7.5 to 50 micrograms per 100 grams of product, or 1.6 to 10.6 micrograms per 100 kcal. The exact biotin level detected in the Nestlé sample has not been disclosed publicly.

A “substandard” finding in this situation indicates that the tested sample failed to meet the specified regulatory composition. It does not automatically establish that the product is toxic or that consumption would necessarily cause a health problem.

What Is Biotin and Why Is It Required?

Biotin, commonly known as vitamin B7, is a water-soluble vitamin that helps the body process carbohydrates, fats and proteins. It is involved in several normal metabolic functions.

Because infant formula can provide a significant portion of an infant’s nutritional intake, such products are required to meet specified standards for vitamins, minerals and other nutrients. Biotin is among the nutrients for which regulatory requirements have been established.

The issue raised by FSSAI therefore relates to whether the tested product complied with the prescribed nutritional composition, rather than indicating that biotin itself is dangerous.

What Parents Should Keep in Mind

The cases filed by FSSAI are adjudication proceedings concerning alleged regulatory non-compliance. Their initiation does not mean that every batch of the products has been declared unsafe, nor does it amount to a product ban.

Parents should also differentiate between regulatory findings and marketing descriptions when selecting infant formula. Claims about particular ingredients, protein sources or digestibility should not be the only factors considered when deciding what is suitable for a baby.

The appropriate formula can depend on the infant’s age, nutritional requirements and individual circumstances. Parents should consult a paediatrician before making significant feeding changes, especially when a baby has feeding difficulties or specific nutritional or medical needs.

For now, FSSAI’s action covers three distinct issues: promotional claims concerning NAN Excella Pro Stage 1, promotional claims concerning Lactogen Pro 1, and a laboratory finding involving the biotin content of a follow-up formula sample.

The exact biotin test result has not been made public, while the regulatory range against which the sample was assessed has been specified.

Disclaimer: This article is based on regulatory findings and information available at the time of publication. Parents should consult a qualified paediatrician for advice concerning an individual baby’s feeding requirements or health.