The U.S. Food and Drug Administration (FDA) plays a pivotal role in overseeing dietary supplements to ensure they are safe, wholesome, and accurately labeled before reaching consumers. Unlike conventional foods and drugs, dietary supplements do not require FDA pre-market approval. However, manufacturers are obligated to ensure that their products are safe, produced under Current Good Manufacturing Practices (CGMP), and that any health claims are truthful and not misleading.
The FDA actively monitors and inspects supplement manufacturing facilities, evaluates the labeling of these products, and takes enforcement actions against products that pose health risks to consumers. In addition to federal requirements, products offered in the stream of commerce may also be subject to additional requirements by specific U.S. states.
At Asebey Life Science Law, we provide specialized legal services to help clients comply with the intricate regulatory landscape governing dietary supplements. We have expertise in advising on compliance with CGMPs, crucial for maintaining the identity, purity, strength, and composition of dietary supplements. We also assist clients in responding to FDA enforcement actions, conducting facility audits, and ensuring that all product claims are substantiated, accurate, and compliant with regulations.
Our aim is to empower our clients to successfully market their products while adhering to the highest standards of safety and compliance, thereby fostering public health and consumer confidence.