The Regulation of Dietary Supplement in the U.S. and Major Change in the Guidance for New Dietary Ingredient Notifications.
The reporting of adverse events by industry is mandatory, and it is voluntary for consumers and health professionals. FDA take actions to remove products from market only when there are evidences demonstrating adulteration of the product or/and misbranded, or causing serious adverse effects to human. In the past decade, several fatal events related to dietary supplement.
According to DSHEA, the dietary supplement manufactures do not need to get FDA’s approval before producing or selling the products unless the product contains a NDI. NDI is defined as a dietary ingredient that was not marketed in the U.S. before October 15, 1994. If the product contains NDI, the industry must submit NDI premarket safety notification to FDA at least 75 days
before marketing. However, it is the manufacture itself determines the presence of NDI in their products.
The new NDI guidance aims to help improving public’s understanding of NDI notification requirements and improve the quality of NDI notification submitted by companies. For example, it further explains the term “dietary ingredient” in the NDI definition. Dietary ingredient means the ingredient markets in or as a dietary supplement, or for use in a dietary supplement.
Though the new NDI guidance intends to improve the safety of dietary supplements by restricting the definition of NDI and expanding the scope of NDI requires notification to FDA. The arguments will continue because the submission of safety notification is still on a voluntary basis. In the U.S., the law put dietary supplements under the umbrella of “food” regulation, which determines
the regulation of dietary supplements is prone to food rather than drug. With more understanding the situation of dietary supplement regulation, the public can read the information of the products better.
Adv Food Technol Nutr Sci Open J. 2017; 3(1): e5-e6. doi: 10.17140/AFTNSOJ-3-e011