On July 1, 2011, the Food and Drug Administration (FDA) released a highly anticipated draft guidance document on the use of new dietary ingredients in dietary supplements. While the document does not create new requirements, once finalized, it will represent a significant step forward in FDA’s efforts to fully implement the requirements of the 1994 Dietary Supplements Health & Education Act (DSHEA).
Under DSHEA, a new dietary ingredient (NDI) is an ingredient that was not marketed in the U.S. in or as a dietary supplement before October 15, 1994. If a dietary supplement contains an NDI, firms are required to notify FDA within 75 days of marketing it and provide information demonstrating that it is reasonably expected to be safe. The one statutory exception to that rule is a notification is not required if the NDI “is present in the food supply as an article used for food in a form in which the food has not been chemically altered.”
Despite the fact that there are over 55,000 dietary supplements on the market today, FDA has received only about 700 NDI notifications since 1994. One reason for that relatively low number is believed to be confusion about how to interpret the statutory provisions. For example, what information is needed to show that a product was marketed before 1994? What if the ingredient was manufactured in a different way? What does “has not been chemically altered” mean? Are separate notifications required for each supplement containing the same NDI?
The guidance represents FDA’s attempt to provide the industry with its interpretation of these provisions and its expectations with respect to compliance. The guidance is organized in a “Question and Answer” format, and provides detailed information about what is and what is not an NDI, what NDIs require a notification, and what information should be in a notification. A few notable items include:
- FDA expects a notification for every finished dietary supplement product containing an NDI, even if the NDI itself is the subject of an NDI notification;
- FDA believes components of foods marketed before October 1994 are NDIs if they were not marketed in or as supplements;
- The use of many common manufacturing processes could cause a food ingredient to be considered “chemically altered,” thereby requiring a notification; and
- There is no authoritative list of ingredients that were marketed in dietary supplements before October 1994. To demonstrate such marketing, FDA expects documentation such as actual business records, promotional materials, or press reports.
The complete text of the guidance document is available here.
You can submit comments on the draft guidance at any time; however, to ensure that they are considered before FDA begins working on the final version, it requests that comments be submitted within 90 days.