FDA Takes Steps to Begin Compiling List of Grandfathered Dietary Ingredients
On September 5, 2017, the Food and Drug Administration (FDA) announced that it will hold a public meeting to discuss the development of an authoritative list of dietary ingredients marketed prior to October 15, 1994, before the enactment of the Dietary Supplement Health and Education Act (pre-DSHEA). The public meeting will be held on October 3, 2017 and will consist of two separate panels. The first will discuss the types of marketing evidence needed to establish eligibility for inclusion on the list. The second panel will discuss the list-making process generally. The FDA will accept public comments until December 4, 2017. More information on how to submit comments and on registering for the meeting are provided in the Federal Register Notice.
Approximately one year ago, FDA published a revised draft guidance on New Dietary Ingredients (NDI), "Dietary Supplements: New Dietary Ingredient Notification and Related Issues." This 2016 revision of its 2011 original draft guidance was not as significant as industry had hoped. For example, the FDA refused to recognize synthetic botanicals as dietary ingredients or change its view of the meaning of "present in the food supply." (See our previous alerts on the 2011 guidance here and on the 2016 revised guidance here.) However, industry did welcome FDA's proposal to establish an authoritative list of grandfathered ingredients. The September 5 announcement reflects the agency's effort to implement that proposal.
The list will be important, because it will, for the first time, provide industry with a list of ingredients that the agency will permit to be marketed as dietary ingredients without an NDI Notification (NDIN). An NDI Notification (NDIN) is the mechanism by which the safety of a dietary ingredient used in a dietary supplement must be demonstrated. However, NDINs are not required if the ingredient has either (1) been present in the food supply as an article of food in a form in which it has not been chemically altered or (2) been marketed as a dietary supplement before October 15, 1994 (i.e., that it is a pre-DSHEA (or "grandfathered" or "old") dietary ingredient). Gathering evidence to establish the latter has been challenging. Over the years, industry has worked together to develop lists of pre-DSHEA dietary ingredients, but the FDA has declined to adopt those lists as authoritative. While referring to the industry lists is a good starting point for anyone considering whether a dietary ingredient is exempt from the NDIN process, they cannot be relied upon. Even if an ingredient is included on a list, FDA may still determine that it is a new dietary ingredient, meaning that it may not be marketed without submission of an NDIN. Contesting such a determination would require production of evidence establishing that it was marketed prior to October 15, 1994. Such evidence could include, for example, sales records, bills of lading, sales contracts, manufacturing records, commercial invoices, and magazine advertisements.
In response to comments received following the 2011 version of the draft guidance, the FDA decided to develop an authoritative list of ingredients on which marketers can rely to establish pre-DSHEA status. The FDA made clear in the 2016 revised draft guidance that an ingredient's absence from the authoritative list does not preclude it from being considered a pre-DSHEA ingredient. Instead, if an ingredient is on this list, no other evidence will be needed to support pre-DSHEA status. Absence from the list will simply mean that other evidence, such as the types noted above, will be needed. Although the process and timeline for creating this list are not clear, this announcement gives the dietary supplement industry reason to be encouraged.
Determining whether a dietary ingredient is "old" can require a complex assessment. In certain cases, a combination of two "old" dietary ingredients can trigger the need for an NDIN, if the combination has not been marketed prior to October 15, 1994. Given this complexity, we recommend consulting counsel before going to market.
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The Public Meeting will take place on Tuesday, October 3, 2017, at the FDA's College Park location: CFSAN Wiley Auditorium, 5001 Campus Drive, College Park, MD 20740.
Participants are encouraged to register by September 25, 2017 to attend, either in person or via live webcast.
Comments may be submitted before December 4, 2017. See Federal Register Notice for instructions.
If you have questions regarding the FDA's announcement or would like to submit comments, please contact one of the authors.