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What data will FDA consider as evidence that a substance is a pre-DSHEA dietary ingredient?

Updated: Feb 3, 2022

On Oct.3, 2017, the Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of substances that were in use as dietary ingredients prior to the passing of the Dietary Supplement Health and Education Act (DSHEA).1 Under DSHEA, ingredients which were marketed in the United States (U.S.) as a dietary ingredient (in or as a dietary supplement) before Oct. 15, 1994. These are considered pre-DSHEA dietary ingredients, also commonly referred to as “grandfathered” or “old dietary” ingredients (ODIs), and do not require the filing of a pre-market New Dietary Ingredient Notification (NDIN) with the FDA. Currently, there is not an authoritative list that includes substances considered to be pre-DSHEA dietary ingredients. The lack of a such a list presents uncertainty to manufacturers in determining if an ingredient is in fact a pre-DSHEA dietary ingredient or in need of an NDIN. In 2016, the FDA indicated it was, “…prepared to develop an authoritative list of pre-DSHEA ingredients, based on independent and verifiable data,”2 but has so far failed to be more definitive as to what the “independent and verifiable data” should constitute. Because FDA does not have access to records supporting the marketing of substances pre-DSHEA or the resources to research the issue, industry, by default, will have to contribute to this effort. Encouraging words were spoken by Steven Tave, director of Office of Dietary Supplement Programs: “That absence of evidence [of a dietary supplement being sold prior to the 1994 cut-off date] does not mean evidence of absence.”

The first question the FDA posed to stakeholders during the recent meeting was, “What evidence is necessary to show that an ingredient was marketed before October 15, 1994?” Stakeholders briefly presented thoughts and concerns related to the topic, as the FDA listened. Of course, public health and safety was stressed as being of utmost importance when evaluating dietary ingredients and dietary supplements, and industry stakeholders remain responsible for maintaining adequate information to provide “reasonable assurance that the ingredient does not present significant or unreasonable risk of illness or injury.”1 Meaning that evidence of historical use may qualify for exemption from an NDIN, but the substance must also be safe.

Many of the stakeholders expressed concerns, however, such as the ability to access and recover docum