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 documentation supporting the marketing of an ingredient as a dietary ingredient pre-DSHEA. FDA has indicated that, “sales records, bills of lading, sale contracts, manufacturing records, commercial invoices, magazine advertisements, mail order catalogs or sales brochures,”2 may be used to document the marketing of an ingredient pre-DSHEA. Does this type of documentation still exist though? Since the passing of DSHEA, many companies have disposed of physical records in accordance with standard operating procedures and may not even have electronic copies.
FDA reminded everyone that not only identification of the plant and the plant part were important, but also the method of processing and production. Therefore a complicating factor was introduced because it was not standard practice at the time to document information critical to the chemical characterization or processing of the ingredient pre-DSHEA. Unfortunately, the answers to such questions are key in determining if an ingredient is in fact a pre-DSHEA dietary ingredient or an NDI requiring pre-market notification.
At the meeting, alternative forms of documentation, which may support the marketing of pre-DSHEA dietary ingredients were proposed, such as, but not limited to, the (non-authoritative) “grandfathered” or “ODI” lists 3,4,5 compiled by trade organizations after the passing of DSHEA, as most of these lists were based on anecdotal or secondary sourced information. Acknowledging that concerns have been raised regarding the regulatory compliance of some substances included on the “grandfathered”/ODI lists, it was proposed that the lists could serve as a starting point (at the very least) for the FDA to develop an authoritative list. How likely is the FDA to consider the lists established by the trade organizations though, since they have not deemed the lists authoritative for approximately the past 20 years?
It is not possible to predict how the FDA will proceed with this initiative as they did not offer their current thoughts or stance on the issue during the meeting. Regardless of the approach that is taken to attempt to compile a list of pre-DSHEA dietary ingredients, it is reasonable to assume that it will be a time intensive effort for FDA and likely industry stakeholders as well. If the outcome of such an effort could be an all-inclusive, accurate list of pre-DSHEA dietary ingredients, which is regularly maintained in a publicly accessible database, the time commitment could be worth it. Considering the many concerns surrounding the documentation that would be required to accomplish such a feat, is such an outcome possible?
References:
Public Law 103-417.
Food and Drug Administration Center for Food Safety and Applied Nutrition. 2016. Draft Guidance for Industry Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Site last visited October 5, 2017.
National Nutritional Foods Association. NNFA List of Dietary Supplement Ingredients in Use Before October 15, 1994. April 26, 1996. Site last visited October 5, 2017.
United Natural Products Alliance. Old Dietary Ingredient List. 1999. Site last visited October 5, 2017.
Council for Responsible Nutrition. CRN List of Dietary Ingredients “Grandfathered” Under DSHEA. September 1998. Site last visited October 5, 2017.