Top 8 takeaways from Regulatory Summit

1. FDA is concerned about the quality of discount multivitamins

Michael (Mick) Dutcher, Deputy Director, Office of Human and Animal Food Operations highlighted an OHAFO Dietary Supplement assignment focused on the accuracy of nutrient content claims on labels of sampled discount multivitamins. Dutcher said the assignment will offer insights into how well manufacturers are formulating their discount dietary supplement multivitamin products.

2. NAC: non-binding targets

Cara Welch, PhD, FDA's new director of the Office of Dietary Supplement Programs, said she wants to hesitate on providing a definite timeline for NAC rulemaking. “If we were to proceed, we would start with the proposed rule, those comments of course are really important and then move ahead to final rulemaking as appropriate. So that’s a ways down the road, I believe FDA’s estimate for traditional notice comment and rulemaking is 3-5 years,” explained Welch. “We want to continue to look at the information we have on NAC. Rulemaking does require a certain amount of effort to ensure we're meeting all of what we think we need to issue a post rule and this would be precedent-setting. This is the first time that we are looking at this rudimentarily and so I think in a sense it may require additional work to make sure we understand how we want to use this authority–even outside of just NAC.”​

3. Green claims

Rend Al-Mondhiry, partner, Amin Talati Wasserman, LLP highlighted the increase in environmental claims (i.e. green, sustainable, recyclable, etc.) in recent years filed by consumers and non-profits. According to FTC Green Guides, “It is deceptive to misrepresent, directly or by implication, that a product or package is recyclable.”​ She added that clean, pure, biodegradable, compostable, humane, and ethical are other claims to approach with caution.

4. Ingredients that are GRAS and in the food supply are not subject to NDIN

“Ingredients that come from the food supply–they may be new dietary ingredients–but that notification requirement isn’t there. So the enforcement discretion period that we’re considering opening wouldn't apply to those notifications, because they weren’t required to have been submitted,” ​noted FDA's Welch. “So we focus a lot on the term GRAS and whether it’s actually a GRAS notification reviewed by the agency or self-GRAS. But to be really clear, the requirement is for NDIs that are in the food supply or have been notified. And so just determining your ingredients as GRAS is a very important step, but just one of those steps. It has to be in the food supply and so that's the part that we would focus on. If we’re looking at an ingredient and we're evaluating whether it's appropriate for use in a supplement, our process, is first we have to determine, is it a dietary ingredient? Is it in our area? And then is it a new dietary ingredient and then is a notification required because if it's already in the food supply a notification is not required and 413(a)(1)does not come into play.”​

5. Not all adverse event reports are created equal

An ongoing theme during Rick Kingston, PharmD’s presentation was the importance for manufacturers to know their data. The President of Regulatory and Scientific Affairs and co-founder of SafetyCall International noted that when submitting Serious Adverse Event Reports, manufacturers must understand what’s being reported, how it’s being reported, and what it means through thoughtful, best practice analysis. Kingston recommended submitting reports that are as complete as possible, acknowledge what information is unavailable and why, explain the plausibility of the reported adverse effects in the context of product use and be sure to discuss confounding variables.   Kingston is also a professor at the University of Minnesota.

6. Welch makes the case for MPLs

Welch said she is aware that not everyone is on board with Mandatory Product Listings (MPLs). “There are a lot of unknowns about mandatory product listings, but the FDA has been public with our desire to maintain the balance established by DSHEA. We're not looking to slow the introduction of products in the market. We're not looking to establish a waiting period where we can confirm the lawfulness of the product before they're listed or marketed. A simple listing requirement should not indicate pre-market approval or pre-market review. FDA has several listing and registration programs outside of dietary supplements and I'm not aware we have turned any of those into an opportunity to review or approve the information before providing the listing number.”​

7. Top industry concerns

The five leading groups representing the industry laid out their top priorities and concerns. The stakeholders cited MPLs, consistent inspections, FDA enforcement and accountability, a “rational” NDI system, supply chain, China’s unpredictability and FDA’s increasing use of the drug exclusionary clause as it relates to CBD, minor cannabinoids and mushrooms.

8. It’s pronounced “duh·shay”

Two conference presenters left some attendees miffed after they referred to the Dietary Supplement Health and Education Act of 1994 as “duh·shay·uh.” Following a very unscientific poll among attendees, it was determined that the vast majority of industry pronounces the last syllable: 'shay.'