Notes from the Dietary Supplements Regulatory Summit
FDA’s Yiannas: ‘At the end of the day you’re not selling products, you’re selling trust’
He made the comparison yesterday during his keynote speech at the Dietary Supplements Regulatory Summit in Washington, DC.
“The data is clear; we’re living amid a global trust bust. Consumers have lost trust in the institutions that have failed them, and this is an important responsibility for us,” he said to an audience of dietary supplement industry members at the Mayflower Hotel.
The summit was a joint project between five major trade associations in the dietary supplements space: the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA).
“When I look across this room, I think that this entire industry wins or loses together. Supplement safety isn’t a competitive issue,” Yiannas added.
Yiannas, though new to the FDA, is not new to food safety and dietary supplements. He stepped into Dr Stephen Ostroff’s role as deputy commissioner for food policy and response in January after Dr Ostroff’s retirement. To this role, Yiannas brings with him about a decade of experience from Walmart, the world’s largest retailer, where he was VP of food safety.
Before that, he worked as director of safety and health at Walt Disney World for about 20 years.
“I joined [FDA] after 30 years in the private sector,” he said. “I like to joke I went from the happiest place on earth, to the busiest place on earth, and now I’m at the—I’ll let you fill it in yourself.”
His roles combined meant that he has been responsible for the food safety of billions of guests at Walt Disney World resorts, as well as 240 million grocery shoppers at Walmart stores each week. “Mitigating and managing consumer and public safety risk is my lifestyle, it’s what I’ve done my entire life,” he added, highlighting that at Walmart, safety of OTC, dietary supplements, and prescription drugs also fell under his responsibility.
Data is clear: Consumers remember category, not brand
During his speech, Yiannas called for more industry cooperation.
“I’ve seen in survey after survey in the food sector that there’s a halo effect. If there’s a particular problem [with a product], some consumers will think that the problem is broader, not just from a specific brand,” he said.
“In fact, the surveys that I’ve done in the past years [suggest that] consumers tend to forget the brands pretty quickly. They remember category of product pretty long, and the thing that they remember the longest is country of origin. So it’s a sign that we have to work together.”
Especially considering that consumer expectations today are very different than what it has been in the past. When Yiannas joined Walmart, price was a top concern. Today, more consumers are scrutinizing sourcing of ingredients that go into a product instead of the price of the final product.
The way forward in Yiannas’ book
Yiannas assured his audience that, despite the departure of FDA commissioner Scott Gottlieb last month, everything the former commissioner planned to address (such as a sweeping plan to revamp DSHEA) remains.
“Our commitment to working with you on supplements has not waned,” he said. “The announcements and messages he delivered in February will continue. The change in leadership doesn’t change our plans to work with you in evaluating the regulatory framework.”
So what’s the way forward? In Yiannas' speech, he listed modernization of dietary supplements regulation is a top priority.
“We want to modernize our efforts to ensure consumers continue to have access to safe and lawful ingredients. At the same time, the FDA’s committed to protecting the public from unsafe and unlawful products,” he said.
“The growth and the number of adulterated and mislabeled products, including those not declared on the label, misleading claims, create dangers to consumers that we all have to manage,” he added.
Advisory list, product database
One example he used was the launch of the Dietary Ingredient Advisory List last month, which was met with mixed reactions in the industry. The list included ingredients the agency said “appear to be unlawfully marketed in dietary supplements.”
“The FDA’s goal is to create a model regulatory framework that understands the industry’s responsibility for producing safe and lawful products,” Yiannas added. “Most do so. I know you do, because you care about the quality of your products and the customers that you serve.”
“That’s why in the FDA 2020 budget request to Congress that there is a requirement that individual products be listed with FDA. This is not an attempt to change the basic structure of DSHEA, but it’s a tweak that we believe will improve the transparency in the marketplace and enable us to expose illegitimate products and help level the playing field for responsible players without imposing significant new rules.”