India's Legislative Shield Against Infant Formula Risks And Lessons From The Abbott Case

According to the plaintiffs' lead counsel, Tor Hoerman, Abbott's conduct demonstrated a long-standing awareness of the dangers posed by its formula yet the company chose not to adequately warn families and physicians. This lack of communication is central to the ethical and legal debate, as the firm's decision to withhold critical safety information contributed to severe, irreversible brain damage to the infant. Conversely, Abbott's spokesperson, Scott Stoffel, expressed strong disagreement with the verdict, which he stated, was not unanimous. Stoffel affirmed that the company would explore all legal avenues to overturn what it views as an erroneous decision, emphasizing the lack of scientific evidence directly linking the company's preterm infant formula to NEC. Stoffel maintained that such specialized formulas align with standard care practices for feeding premature infants.

This case extends its implications beyond the courtroom into the realms of public health and regulatory oversight. The absence of NEC risk disclosures on Abbott's product labels highlights urgent questions about the adequacy of existing regulatory frameworks. This situation raises concerns regarding whether current policies sufficiently protect vulnerable populations, such as premature infants, from potential hazards inherent in infant nutrition products. The situation parallels a similar incident involving Enfamil-formula maker Reckitt Benckiser Group Plc. In March, an Illinois jury ordered Reckitt to pay $60 million to the family of a premature infant who died after consuming the company's cow's milk-based formula. These cases collectively emphasize the necessity for stringent regulatory measures and transparent corporate practices.

The verdict against Abbott Laboratories underscores the critical need for heightened transparency and accountability within the pharmaceutical and food industries. Companies must ensure that all potential risks associated with their products are clearly communicated to both medical professionals and consumers to prevent undue harm. The ethical responsibility lies in prioritizing public health over corporate profits. This case illustrates the role of scientific evidence in legal contexts. While Abbott refutes the link between its formula and NEC, the jury's decision reflects a broader consensus on the importance of precautionary principles in infant care. Continued research is imperative to establish definitive causal relationships, which will guide future clinical practices and regulatory policies. The $500 million fine against Abbott Laboratories highlights the paramount importance of disclosing all potential risks associated with infant nutrition products. As this case progresses through potential appeals, it will continue to shape the legal landscape and influence future regulatory policies, reinforcing the overarching duty of care needed to protect vulnerable premature infants.

In stark contrast to the situation in the US, where legal battles expose the critical gaps in infant formula regulation, India has proactively implemented legislative measures to mitigate similar risks. The World Health Assembly of the World Health Organisation adopted The International Code of Marketing of Breast-milk Substitutes^[1] in the year 1981 after a long drawn Nestle Boycott over the booklet titled “The Baby Killer” (published by the British NGO- War On Want in 1974). The Code is a global public health strategy aimed at restricting the marketing of breast milk substitutes, such as infant formula, to ensure that mothers are not discouraged from breastfeeding and that substitutes are used safely if needed.^[2] Since 1981, 84 countries have enacted legislations implementing all or many of the provisions of the Code and subsequent relevant WHA resolutions.^[3] India became one of the first few countries in Asia to fully implement the International Code of Marketing of Breast milk Substitutes with the enactment of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992.

Have you ever noticed seeing an advertisement for baby formula on television, social media, or in print media in India? The reason you won't find such advertisements is due to the stringent regulations imposed by the Infant Milk Substitutes, Feeding Bottles & Infant Foods (Regulation of Production, Supply & Distribution) Act, 1992, commonly known as the IMS Act. This legislation explicitly bans the promotion and advertisement of infant milk substitutes, feeding bottles, and certain infant foods to safeguard public health by encouraging breastfeeding. The IMS Act has been instrumental in ensuring that the health of infants is prioritized. The Act's primary objective is to promote breastfeeding, which is universally recognized as the best source of nutrition for infants. Breastfeeding provides essential nutrients, helps build the infant's immune system, and fosters a strong mother-child bond. To support this objective, the IMS Act imposes several critical restrictions and requirements:

1. Prohibition of Advertisements: The IMS Act strictly prohibits any form of advertising for infant milk substitutes, feeding bottles, and specific infant foods. This includes commercials on television, advertisements on social media, and promotions in print media. By doing so, the act aims to prevent misleading information that may discourage mothers from breastfeeding their babies.

2. Prohibition of Incentives: The act also bars manufacturers and suppliers from offering incentives to healthcare workers, institutions, or associations to promote the use of infant milk substitutes over breastfeeding. This measure ensures that healthcare professionals provide unbiased advice that prioritizes the well-being of the infant.

3. Enforcement of Labelling Requirements: The IMS Act mandates that labels on infant milk substitutes and related products carry clear warnings and information about the benefits of breastfeeding and the potential health risks of using these substitutes. This includes explicit statements that breast milk is the best for babies and that any infant milk substitute should only be used on the advice of a healthcare professional.

4. Educational Initiatives: The legislation promotes the dissemination of accurate and non-promotional information regarding infant nutrition. Healthcare providers and institutions are encouraged to educate parents and caregivers about the advantages of breastfeeding and the proper use of infant foods if necessary.

The intention behind the IMS Act is rooted in public health considerations. Breastfeeding has been shown to reduce the incidence of various infant illnesses, including respiratory infections, diarrheal diseases, and allergies. Additionally, breastfeeding has long-term health benefits, such as lower risks of obesity and certain chronic conditions in later life. By restricting the marketing and promotion of infant milk substitutes and feeding bottles, the IMS Act aims to minimize the unnecessary and potentially harmful use of these products, thereby protecting infant health and promoting optimal nutrition practices.

The Abbott Laboratories case serves as a poignant reminder of the vital role that legislations like the IMS Act play in safeguarding infant health. The IMS Act serves as a robust legislative framework in India to promote breastfeeding and regulate the use of infant milk substitutes. By prohibiting advertisements and ensuring that unbiased information reaches parents and caregivers, the act contributes significantly to the well-being and health of infants. This approach reflects a strong commitment to public health, ensuring that the nutritional needs of infants are met in the safest and most effective manner. Also, there is a prohibition on using any pictures of infant or a woman or both on the packaging or any other picture or graphic material which is intended to increase the sale of such product. In State of Gujarat v. Pankajkumar Bhurabhai Thakkar^[4], it was held that package and/or the advertisement of infant milk food, infant formula and any other special infant food marketed as breast milk substitutes, should not have a picture of infant or picture of mother breastfeeding infant or other forms of pictures or text which might idealize the use of such product. Furthermore, Nestle India Limited and Ors. v. Union of India and Ors.^[5], is a case which arose out of extremely peculiar circumstances. The question in the present case was about inconsistency between the Prevention of Food Adulteration Act, 1954 and its Rules and the provisions of IMS Act. This case was filed in the year 1995 before FSSA came into being. Under the PFA Act it was made mandatory that all infant milk products carry the warning “BREAST MILK IS BEST FOR YOUR BABY” and under IMS Act, the prescribed notice was “MOTHER'S MILK IS BEST FOR YOUR BABY”. Nestle was engaged in the manufacturing of infant food namely LACTOGEN and CERELAC which carried the warning “BREAST MILK IS BEST FOR YOUR BABY”. A complaint was filed by an organisation named Association of Consumer Action on Safety and Health (ACASH), against Nestle under Section 6 and 7 and Section 2(f) of the IMS Act stating that by printing the words “FROM 4 MONTHS OF AGE” instead of “AFTER THE AGE OF 4 MONTHS” they were in con-compliance with provisions of IMS Act. Now a very peculiar legal quandary arose in this case wherein if Nestle complied with PFA it would violate IMS Act and vice versa. As there were irreconcilable contradictions between the two Acts, the Court applied the principle of Lex non cogit ad impossibilia i.e., the law does not compel the doing of impossibilities and since it became impossible for the petitioner company to adhere to the provisions of both the enactments simultaneously, the Court stated that they cannot be prosecuted for the same. However, position became different once both the Acts were aligned with each other.

In conclusion it would be wise to state that, this legislation is aimed at discouraging the use of infant milk substitutes, feeding bottles and infant food; and encouraging breastfeeding. There have been a lot of feminist movements lately which call for normalising the perception towards breastfeeding in public. They argue that there is no difference between the salad one eats in a restaurant and a child who is being breastfed on the table next to it. Both are the acts of nourishing one's body as both persons are engaged in eating/drinking food. Hence, body shaming or making women awkward by staring at them while they breastfeed must be strongly discouraged and the act of breastfeeding should be perceived to be as normal as drinking water.

The author is an Assistant Professor in Law at Panjab University. Views are personal