NutraIngredients-USA's DSHEA Summit, supported by the United Natural Products Alliance (UNPA), brought together the architects of the law and key industry stakeholders to discuss the past, present and future of the U.S. dietary supplements industry.
The half-day event, which took place at the Hyatt Regency Salt Lake City on June 10, 2024, attracted over 210 high-level delegates from across the dietary supplements industry.
The DSHEA Summit, supported by the United Natural Products Alliance (UNPA), brought together the architects of the law and key industry stakeholders to discuss the past, present, and future of the US dietary supplements industry.
The half-day event, which took place at the Hyatt Regency, Salt Lake City on Monday, June 10th, 2024, attracted over 210 high-level delegates from across the dietary supplements industry.
Moderated by NutraIngredients-USA Editor-in-Chief, Stephen Daniells (at the podium), the summit started with a panel exploring the origins and passage of DSHEA.
The panel featured (from left of stage):
Patricia Knight, Senior Political Advisor, UNPA & former Chief of Staff to Senator Orrin Hatch, R-Utah
Peter Reinecke, Senior Political Advisor, UNPA & former Chief of Staff toPartner, Global Life Sciences,President and Founder, United Natural Products Alliance (UNPA)
Loren Israelsen, founder and president of the United Natural Products Alliance (second from right), opened the panel with a series of slides detailing the arc of DSHEA, from the raid on the offices of Dr. Jonathan Wright and the introduction of the Health Freedom Act in 1992 right through to passage of DSHEA in 1994.
Scott Bass then shared his thoughts on what counted most in DSHEA in 1994 from his perspective at the times as counsel for the National Nutritional Foods Association (NNFA, now called the Natural Products Association). On Scott's list were:
1. Creating a new Dietary Supplement category in the 1938 Food, Drug and Cosmetic Act without disturbing the drug, food or animal drug categories
2. Getting Rid of the “Unsafe Food Additive “ FDA theory that lasted for 14 years and kept everything new off the market. Later declared by courts as an “Alice in Wonderland theory”: requiring FDA pre-approval because putting vitamin E into a vitamin E capsule was adding an unapproved additive to the vitamin E capsule (a food).
3. Giving FDA more safety enforcement power to protect consumers—especially after L-tryptophan
4. Getting GMPs in place to give products credibility in the marketplace
5. Getting Dietary Supplement structure/function claims solidly in the law
Among the many memorable statements during the first panel were:
“DSHEA was envisioned and built around a concept that did not look to the future but to correct past problems that we didn’t want to see repeated, but we had no idea what the future would look like.” - Loren Israelsen
“The thing to understand is what propelled DSHEA is what is propelling the industry today during Covid and after. People have lost confidence in their health care systems. People want to take self-care as the way to stay healthy.” - Scott Bass
Dr. Cara Welch, director of the Office of Dietary Supplement Programs (ODSP), took the stage to provide a report card on the state of the industry from the FDA's perspective.
Dr. Welch focused on scoring three main areas: new dietary ingredient notification requirements, good manufacturing practices and structure-function claim notifications.
For more on this session, please read, DSHEA at 30: ODSP director ticks through industry report card, June 20, 2024 By Asia Sherman
Dr Welch then joined a panel discussion that also featured Loren Israelsen, President and Founder, UNPA (left), Jim Emme, CEO, NOW Health Group (second from left), and Bob Durkin, Partner, Arnall Golden Gregory LLP & former acting Director and Deputy Director, ODSP (center).
"I think it's fair to say that if you look around globally, DSHEA has been the model of success," said Israelsen.
"I think everyone agrees that DSHEA is a fantastic foundation," said Dr. Welch. "The opportunity is there for improvement."
The final panel looked to the future and how to grow a $60 billion industry even further.
An audience poll on what changes stakeholders would like to see, 49% of respondents called for the ability to make stronger claims if supported by competent and reliable scientific evidence. 23% selected, "For a dietary supplement self-regulatory body with abilities to collectively act against the bad actors."
Matt Warnock, CEO of Utah-based Ridgecrest Herbals, asks a question of the panel as the DSHEA Summit wound to a close.
Some of the memorable comments during the last session included:
“I think industry will implode if we don’t keep consumers at the forefront of our mind.” - Christine Burdick-Bell, EVP & General Counsel, Pharmavite
“Rules are there for a reason, and they are only as good as the people who follow them. There are a lot of good companies in our industry trying to do the right things for the right reason.” - Jim Emme, CEO, NOW Health Group
“DSHEA is good bones. It has done well for 30 years and can do well in the future.” – Bob Durkin, Partner, Arnall Golden Gregory LLP
