Overview
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Unlike pharmaceuticals, supplements do not require FDA approval before being marketed.
However, manufacturers are responsible for ensuring the safety of their products and accurate labeling.
In 2025, the FDA announced a major reorganization by establishing the Human Foods Program (HFP), aiming to modernize and strengthen the evaluation of food ingredients and dietary supplements.
Introduction
The U.S. dietary supplement market continues to grow, with over 100,000 products available and an annual market size exceeding $60 billion.
In response to this expansion, the Food and Drug Administration (FDA) has intensified its efforts to ensure the safety and effectiveness of these products, implementing significant regulatory and organizational changes in 2025.
Structural Reorganization
In October 2024, the FDA began implementing the Human Foods Program (HFP), restructuring the former Center for Food Safety and Applied Nutrition.
This initiative aims to enhance coordination and regulatory efficiency, focusing on consumer safety.
Focus on New Ingredients and Safety
The FDA has intensified surveillance over new ingredients in dietary supplements, requiring manufacturers to submit evidence of safety before marketing.
The agency is also updating its guidance to align with the new organizational structure and ensure consumers have access to accurate product information.
Enforcement Actions
Recently, the FDA issued warnings and recalls for supplements contaminated with undisclosed substances like diclofenac and omeprazole found in products sold online.
These actions highlight the importance of continued enforcement efforts to protect public health.
Conclusion
The FDA’s actions in 2025 reflect a renewed commitment to the safety and efficacy of dietary supplements.
With structural reorganization and a stronger focus on new ingredients, the agency seeks to ensure that consumers have access to safe, accurately labeled products.
Collaboration among regulators, manufacturers, and consumers will be critical to maintaining the integrity of the supplement market and protecting public health.
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References
Learn more about FDA. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.