Dietary Supplements Containing Plant Extracts￼
You may be unsure of the regulatory authority of the FDA over dietary supplements. This article will cover DSHEA, the New Dietary Ingredient Act, and Adverse event reporting. In addition, we’ll discuss DSHEA’s impact on the safety and effectiveness of dietary supplements. This article also includes information on the new DSHEA dietary ingredient and its potential for adverse events.
According to the Dietary Supplement Health and Education Act, dietary supplements must contain a recognizable nutrients, such as vitamins and minerals, herbs, botanicals, amino acids, and other “dietary substances” obtained from food. They can also be a combination of dietary ingredients. However, there is no one universal definition of dietary supplements.
The US Food and Drug Administration regulates dietary supplements under the Federal Food, Drug, and Cosmetic Act. The Act created a new regulatory framework for these supplements. There is no requirement that firms obtain FDA approval before marketing them to the public, and firms do not have to provide evidence of their safety before going on the market. The exception to the Act is dietary supplements that contain new dietary ingredients that are not naturally occurring in the food supply and are not chemically altered.
FDA’s regulatory authority over dietary supplements
The U.S. Food and Drug Administration (FDA) has limited resources to review dietary supplements. Because of this, it prioritizes investigations into products that are suspected of being adulterated or fraudulent. FDA inspectors review products that are on the market, but they cannot review dietary supplements before they are sold to consumers. Instead, consumers may contact the manufacturer of the product or a commercial laboratory for analysis.
The FD&C Act outlines three categories of dietary supplement claims. These are health claims, structure/function claims, and nutrient content claims. Each category has different requirements for substantiating claims. For example, “plant-based” claims should be qualified by a statement stating the prevalence of the nutrient deficiency disease in the U.S.
New dietary ingredient
Plant extracts and other dietary ingredients can be included in DS formulations. Generally, any herbal or botanical marketed as DS prior to 15 October 1994 are grandfathered, but if not, it’s considered a new dietary ingredient (NDI). As such, dietary supplements containing NDIs must be premarket-noticed. However, NDIs in a formulation that contain nongrandfathered plant extracts may be exempted from premarket notification.
Before a dietary ingredient is permitted to enter the marketplace, the FDA must receive notification from a company that it contains a standardized substance that can be safely manufactured and used for human consumption. If the dietary ingredient is a new dietary ingredient, the company must ensure that it is safe for consumers under labeling conditions and that it doesn’t pose any health risk. Applicants must submit a dietary ingredient notification to the FDA in a timely fashion.
As a result, NDIs are restricted to a small group of ingredients. While some substances may be grandfathered, others have to be marketed outside the U.S. Regardless, marketing within the U.S. before October 15, 1994 will qualify as NDI. Further, NDIs must also meet the requirements for the safety and effectiveness of products containing them. While the new guidelines have some limitations, they do represent a step in the right direction.
Adverse event reporting
The FDA requires manufacturers to report adverse events of nutritional supplements containing plant extracts, including herbal products, to their public health centers. Until now, many adverse events involving plant extracts have not been reported to the government. However, FDA has begun an initiative to improve the reporting of these events. This initiative has two parts: reporting adverse events by physicians and reporting by pharmacists.
The FDA requires manufacturers to report serious adverse events of dietary supplements containing plant extracts within 15 business days of receipt. The agency has concerns about the quality of documents sent by fax. Furthermore, the agency does not accept reports of non-serious adverse events. If you experience an adverse event, the FDA requires that you report it within 15 days.