Historical & Regulatory Factors - Dietary Supplements & Herbal Medications

HISTORICAL & REGULATORY FACTORS

Under the DSHEA, dietary supplements are not considered over-the-counter drugs in the USA but rather food supplements used for health maintenance. Although dietary supplements are regulated as food, consumers may use them in the same fashion as drugs and even use them in place of drugs or in combination with drugs.

In 1994, the United States Congress, influenced by growing “consumerism” as well as strong manufacturer lobbying efforts, passed the DSHEA. DSHEA required the establishment of Good Manufacturing Practice (GMP) standards for the supplement industry; however, it was not until 2007 that the FDA issued a final rule on the proposed GMP standards. This 13-year delay allowed supplement manufacturers to self-regulate the manufacturing pro-cess and resulted in many instances of adulteration, misbranding, and contamination. Therefore, much of the criticism regarding the dietary supplement industry involves a lack of product purity and variations in potency. Under the new GMP standards, large and small dietary supplement manufacturers should now be in compli-ance with this legislation. The FDA, however, has limited resources to adequately investigate and oversee compliance with manufactur-ing standards, particularly since many ingredient suppliers are based overseas. Furthermore, the dietary supplement ingredient supply chain is complex and federal regulators are not able to adequately inspect manufacturing facilities in a timely or efficient matter.

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. These reports are intended to identify trends in adverse effects and would help to alert the public to safety issues.