Herbal medicine regulation in Nigeria is a complex issue that balances traditional practices with modern healthcare standards. This review explores the historical evolution, current regulatory frameworks, challenges, and strategies for improving the regulation of herbal medicine in Nigeria. Herbal medicine has been an integral part of Nigerian healthcare for centuries, deeply rooted in the country's cultural heritage and traditional healing practices. It plays a vital role in addressing various health conditions, particularly in rural and underserved communities. However, concerns regarding safety, efficacy, and standardization have prompted calls for regulatory reforms to align herbal medicine practices with modern healthcare standards. The regulation of herbal medicine in Nigeria is governed by several agencies, including the National Agency for Food and Drug Administration and Control (NAFDAC) and the Traditional Medicine Development Division (TMDD) of the Ministry of Health. These agencies aim to oversee the manufacturing, importation, distribution, and sale of herbal products, ensuring compliance with safety, efficacy, and quality standards. Despite these efforts, challenges remain in reconciling traditional healing practices with modern healthcare standards, particularly in terms of safety, efficacy, and regulation. One of the primary challenges is ensuring the safety and quality of herbal medicines. While traditional healers possess valuable knowledge of medicinal plants, there is a lack of standardized procedures for sourcing, processing, and preparing herbal remedies, leading to variability in potency and efficacy. Additionally, the absence of quality control mechanisms and regulatory oversight increases the risk of contamination, adulteration, and toxicity, posing serious health hazards to consumers. Another challenge lies in evaluating the efficacy and standardizing herbal remedies to meet modern healthcare standards. Traditional healing practices often rely on empirical knowledge and anecdotal evidence rather than rigorous scientific testing, making it difficult to assess the effectiveness of herbal treatments systematically. Variations in plant species, growing conditions, and preparation methods can impact the consistency and reliability of herbal products, hindering efforts to standardize dosage, potency, and formulation. Balancing the preservation of cultural heritage with public health imperatives presents a complex dilemma in regulating herbal medicine. While traditional healing practices hold deep cultural significance and play a vital role in community identity and well-being, they must also adhere to modern standards of safety, efficacy, and accountability. Striking a balance between cultural preservation and public health requires engaging with traditional healers respectfully, fostering dialogue, and promoting collaboration between traditional and modern healthcare systems. To enhance regulation, there is a need to promote research and evidence-based practices in herbal medicine. This involves supporting scientific studies on the safety, efficacy, and pharmacological properties of medicinal plants, as well as clinical trials to evaluate their effectiveness in treating specific health conditions. By generating robust evidence, regulatory agencies can make informed decisions about product registration, quality standards, and dosage recommendations, thereby improving the credibility and acceptance of herbal medicine within the healthcare community. Empowering herbal practitioners and consumers through capacity building and education is essential for effective regulation. Training programs can provide herbalists with knowledge and skills in quality control, good manufacturing practices, andHerbal medicine regulation in Nigeria is a complex issue that balances traditional practices with modern healthcare standards. This review explores the historical evolution, current regulatory frameworks, challenges, and strategies for improving the regulation of herbal medicine in Nigeria. Herbal medicine has been an integral part of Nigerian healthcare for centuries, deeply rooted in the country's cultural heritage and traditional healing practices. It plays a vital role in addressing various health conditions, particularly in rural and underserved communities. However, concerns regarding safety, efficacy, and standardization have prompted calls for regulatory reforms to align herbal medicine practices with modern healthcare standards. The regulation of herbal medicine in Nigeria is governed by several agencies, including the National Agency for Food and Drug Administration and Control (NAFDAC) and the Traditional Medicine Development Division (TMDD) of the Ministry of Health. These agencies aim to oversee the manufacturing, importation, distribution, and sale of herbal products, ensuring compliance with safety, efficacy, and quality standards. Despite these efforts, challenges remain in reconciling traditional healing practices with modern healthcare standards, particularly in terms of safety, efficacy, and regulation. One of the primary challenges is ensuring the safety and quality of herbal medicines. While traditional healers possess valuable knowledge of medicinal plants, there is a lack of standardized procedures for sourcing, processing, and preparing herbal remedies, leading to variability in potency and efficacy. Additionally, the absence of quality control mechanisms and regulatory oversight increases the risk of contamination, adulteration, and toxicity, posing serious health hazards to consumers. Another challenge lies in evaluating the efficacy and standardizing herbal remedies to meet modern healthcare standards. Traditional healing practices often rely on empirical knowledge and anecdotal evidence rather than rigorous scientific testing, making it difficult to assess the effectiveness of herbal treatments systematically. Variations in plant species, growing conditions, and preparation methods can impact the consistency and reliability of herbal products, hindering efforts to standardize dosage, potency, and formulation. Balancing the preservation of cultural heritage with public health imperatives presents a complex dilemma in regulating herbal medicine. While traditional healing practices hold deep cultural significance and play a vital role in community identity and well-being, they must also adhere to modern standards of safety, efficacy, and accountability. Striking a balance between cultural preservation and public health requires engaging with traditional healers respectfully, fostering dialogue, and promoting collaboration between traditional and modern healthcare systems. To enhance regulation, there is a need to promote research and evidence-based practices in herbal medicine. This involves supporting scientific studies on the safety, efficacy, and pharmacological properties of medicinal plants, as well as clinical trials to evaluate their effectiveness in treating specific health conditions. By generating robust evidence, regulatory agencies can make informed decisions about product registration, quality standards, and dosage recommendations, thereby improving the credibility and acceptance of herbal medicine within the healthcare community. Empowering herbal practitioners and consumers through capacity building and education is essential for effective regulation. Training programs can provide herbalists with knowledge and skills in quality control, good manufacturing practices, and