UNPA / May 16 FDA Public Meeting -- "Responsible Innovation in Dietary Supplements"

Dear Colleagues,

Yesterday UNPA held a conference call with Cara Welch, Acting Special Assistant to the Deputy Commissioner for Policy, Planning, Legislation, and Analysis, to discuss the upcoming FDA public meeting which will address "responsible innovation in dietary supplements" (May 16, 2019). The full announcement can be seen here.

Here is a summary of our call with Cara:

1. This public meeting is intended to explore several significant issues within DSHEA. They include the scope of dietary ingredients under Section 201(ff)(1) -- specifically, dietary ingredients used to supplement the diet. Is this definition too expansive? Has it been misused? What are the alternatives?
   
   
2. A second issue is to look at the question of dietary ingredients that have been in the diet and a trend that has been developed to establish DIs as in the food supply (GRAS affirmation) or by other means and then to introduce such DIs into dietary supplements.
   
   
3. Incentives associated with New Dietary Ingredient notification. FDA is interested to explore means to promote compliance and enforcement with the NDI provisions, the challenges of enforcement, as well as a discussion of what incentives would encourage broader NDI notification.

These topics will be structured into three sessions with speakers invited by FDA that represent industry, academia, and public interest groups.

Within the NDI discussion, UNPA has been invited to present views with respect to synthetic botanicals, an ever-hot topic. I will present for UNPA. FDA also invited UNPA to present comments during the final public session. Larisa Pavlick will speak for UNPA and place our comments into the public record.

FDA stressed what this public meeting is not about. It is not about CBD. That will be a different day. It's not about "amendments to DSHEA" (or "DSHEA 2.0" as we refer to it internally). It is not intended to discuss the topic of mandatory product registration or other issues that have been floated within industry press or at various trade association meetings.

In short, we are advised this meeting is intended to continue from prior public meetings to more fully explore issues around the definition of dietary ingredient, use of DIs in the food supply, and various issues surrounding new dietary ingredients.

Of course, we are pleased to be invited by FDA to participate. We will seek your input as we develop our presentation on synthetic botanicals. This represents the official beginning of UNPA's DSHEA 2.0 working group. Please look for an invitation to join this working group to participate in the full range of issues that will include: 

• FDA's interest in statutory changes to DSHEA
  
  
• Industry's ideas about improvements or expansions to DSHEA that would support responsible commerce
  
  
• Mandatory product registration
  
  
• Incentives and other opportunities for IP protection and development
  
  
• All other issues of interest raised by UNPA membership

We look forward to representing UNPA at this important meeting and exploring these issues with the membership going forward.

Cordially,
LDI