Navigating regulatory challenges and safety considerations in lactation supplement development: A Nigeria and US Comparison

Abstract

Navigating regulatory challenges and ensuring safety in the development of lactation supplements is crucial for meeting the needs of breastfeeding mothers. This review examines the regulatory frameworks governing lactation supplements in Nigeria and the US, highlighting key differences and similarities, as well as challenges and strategies for ensuring product safety and compliance. In Nigeria, the regulatory landscape for lactation supplements is characterized by a lack of stringent regulations and enforcement mechanisms, leading to concerns about product safety and quality. In contrast, the US has a well-established regulatory framework overseen by the Food and Drug Administration (FDA), which sets strict standards for product safety, efficacy, and labeling. Challenges in Nigeria include limited regulatory capacity, inadequate enforcement of existing regulations, and a lack of awareness among consumers about product safety. In the US, challenges include the complex regulatory process, high compliance costs, and the need for continuous monitoring of safety and efficacy. Strategies for ensuring product safety and compliance in Nigeria include strengthening regulatory capacity, improving enforcement mechanisms, and raising awareness among consumers about safe product choices. In the US, strategies include streamlining the regulatory process, enhancing post-market surveillance, and fostering collaboration between regulators, industry stakeholders, and healthcare providers. Overall, navigating regulatory challenges and ensuring safety in the development of lactation supplements require a multifaceted approach that addresses regulatory gaps, enhances enforcement mechanisms, and promotes consumer awareness. Collaboration between regulatory authorities, industry stakeholders, and healthcare providers is essential to ensure that lactation supplements are safe, effective, and meet the needs of breastfeeding mothers in Nigeria and the US.