FDA, industry experts reflect on DSHEA at 30 Summit

On June 10, in Salt Lake City, I had the pleasure of attending the DSHEA at 30 Summit, which NutraIngredients-USA hosted in association with the United Natural Products Alliance (UNPA).

The half-day event brought together experts to reflect on the history of the Dietary Supplement Health and Education Act of 1994, explore the modern marketplace and look to the future amid calls for regulatory modernization.

Below, over a dozen attendees — including speakers — offered their perspective on the DSHEA at 30 Summit and nearly 30-year-old law that principally governs how dietary supplement products are regulated.

“DSHEA has shown a robustness over three decades that is testament to those who crafted it, and it’s clear that it isn’t going away. The law isn’t perfect and not without its critics but listening to the stories of its passage at the DSHEA Summit, you have to marvel that it ever passed in the first place. One of the big take-homes from the Summit was just how far the science has advanced since 1994 and how there must be a way to accurately communicate those advances to consumers. This is just one of the challenges for the next generation of industry leaders.”

Related:Lion of DSHEA – Loren Israelsen – reflects on 30 years

“The DSHEA Summit provided a good opportunity to not only hear about the history behind the law but also how it impacted this product category, and FDA’s regulation of supplements, over the past almost 30 years. This discussion, and other opportunities that are being planned in the coming months, are important to FDA as we look to modernize our dietary supplement oversight by allowing us to recognize areas of success, identify room for improvements and help to ensure a strong, well-regulated marketplace."

“The Summit displayed a great sense of desire for innovation and a lessening of outdated government bureaucratic roadblocks. Also on display was a surprising legacy of 1990s concerns from industry over issues such as pharma (never an enemy) and a desire to evade basic consumer safety needs like mandatory product listing and the elimination of the non-existent self-GRAS [generally recognized as safe] exemption to new dietary ingredient notifications. There are tweaks needed to DSHEA, some of which can be accomplished administratively; the future for growth internationally seems inevitable.”

“The DSHEA at 30 Summit in Salt Lake City was an excellent event. I learned a great deal from the leaders who were hands on in shaping the formation of DSHEA in 1994. The entire industry owes them a huge debt of gratitude for doing the heavy lifting to get bipartisan support for the bill in the Senate and the House of Representatives. Our industry would not be what it is today without DSHEA. 

One point that the pioneers were lamenting is there are items in DSHEA that don’t always work well in today’s world — a view shared by the leadership of FDA. This is a key lesson for us today as we develop possible changes to the original DSHEA bill: There are many unintended consequences today from some of the work done in 1994. 

Both industry and regulators have presented many big new ideas to alter the landscape of DSHEA. We as an industry are frequently canvassed to support these ideas as they are, without the opportunity to challenge the assumptions that are involved in these new ideas, particularly the concept of mandatory product listing.

Another major assumption is FDA will actually enforce in accordance to these proposed new rules. The agency has stated it will not enforce against the bad actors who are committing criminal fraud selling products that are nothing but excipients with no active ingredients. FDA has stated it will not enforce in these cases because the agency views such an action as supporting the business interests of the companies filing trade complaints. This creates an enforcement vacuum, which has now led to states creating their own DSHEA rules. The New York weight loss law is an example of this type of consequence. If FDA won’t enforce existing rules, then others will fill the void. Versions of this bill are now in the works in at least five other states.

We as an industry need to heed the lessons learned from the DSHEA pioneers that new ideas need to be vetted.”

"The DSHEA Summit provided a multi-stakeholder forum for a dialogue around what works in DSHEA and what does not 30 years after its implementation. My biggest takeaway was FDA and industry must be aligned on implementation of DSHEA before we consider modifying it. FDA needs teeth for its enforcement initiatives, so the agency is not waiting for the Department of Justice to take cases. The industry needs clarity on what is an old dietary ingredient, but also needs the agency to catch up to the current science related to innovation so companies are positioned to interpret the language around what qualifies as a dietary ingredient with the requisite expertise."

“It is clear from the discussions that mandatory product listing is an FDA priority. It surprised me that Dr. Welch said that FDA doesn’t know what companies are manufacturing dietary supplements or where to find them. It is unrealistic to think that mandatory product listing will garner a list of companies other than those already registering their facilities and submitting structure-function claims. Industry is asking FDA to enforce against companies selling products laced with drugs, ingredients that are the subject of import alerts, and other adulterants while masquerading as dietary supplements. It would also be very encouraging to see follow up on warning letters.”

“Participating in the DSHEA Summit provided an excellent opportunity to explore the history, understand the current situation in the U.S., and engage in forward-looking discussions. I firmly believe that most of our industry desires more modernized legislation to ensure high-quality, effective products reach consumers, and specifically for probiotics to take their place within the statute. In my view, the majority of industry is ready to engage in constructive dialogue with the FDA to advance to the next step. Based on IPA's experience with governments worldwide, I believe open and productive discussions are achievable.”

"The DSHEA Summit was a big success. It educated current and next generation industry leaders about just how important DSHEA has been and can continue to be to consumer access and responsible industry growth. It also revealed just how unique the political dynamics and environment were in 1994 that enabled the enactment of DSHEA and that those circumstances don’t exist today and may never again. Our discussions also brought forth the reality that while we can each have ideas about how DSHEA could be improved, first priority must be given to defending DSHEA. Responsible industry must invest more in education and advocacy, but also in self-regulatory steps that enhance and support FDA’s efforts to weed out bad actors and irresponsible practices that threaten to undermine consumer safety and confidence."

“A large part of discussions at last week’s Summit centered around DSHEA’s 1994 framework being crafted to suit the market at a time when manufacturers of products like herbs, vitamins, fish oil and protein powders were primarily reaching consumers through catalogs and brick-and-mortar stores. Regulators back then did not anticipate today's rapidly evolving digital marketplace.

Now, 30 years later, we’re faced with a different marketplace with new, innovative ingredients, claims, marketing tactics and an environment that evolves in days, not years. The current regulatory structure does not fit the way consumers commonly access information in the digital age. Many companies are responsible and go above and beyond the existing regulatory requirements for manufacturing, packaging and marketing, such as submitting safety information on new ingredients to the FDA. But the agency has no way to know when new ingredients, products or companies enter the market. Just as technology has evolved from floppy discs to cloud computing, our regulatory systems must also be modernized to protect the 21st-century consumer who has access to an expanding dietary supplement marketplace.”

"The recent DSHEA Summit was a wonderful celebration of its 30th anniversary, and it provided an exciting opportunity to tackle pressing questions about the future of the dietary supplement industry. The event gathered influential figures from the natural products sector and regulatory bodies for dynamic discussions on the industry's past, present and future. The panelists were exceptional, and so were the topics covered.

The discussions brought to light the industry’s challenges and issues with regulatory enforcement, igniting a call for improvements within the current framework. While differing opinions on strategies emerged, FDA's reaffirmed stance on enforcement limitations added an electrifying element to the discussion."

“I was honored to share the stage with other industry experts — including Loren Israelsen and Scott Bass who championed the creation of DSHEA 30 years ago — and encouraged by the open dialogue centered around setting the industry up for continued growth in the years to come. The enactment of DSHEA has allowed the industry to grow, thrive and support consumers on their journey to good health through supplementation, which will only remain possible through further collaboration with all parties involved. 

While the room was filled with differing opinions, it will take our collective perspectives and passion to address industry needs we could have never imagined when crafting DSHEA in 1994, including enhancing consumer education to combat the spread of misinformation, strengthening protections against bad actors and their tactics to uphold industry integrity and the efforts of responsible players in the space, and crystalizing processes so we’re all working from the same guidebook.”

“Understanding our history can help us make better future decisions, and the DSHEA Summit allowed us to look back in time to the discussions and events happening when DSHEA was enacted. One of my takeaways is to be careful to demand change for the sake of change. Updating DSHEA should not be taken lightly, and any action should consider ramifications not just in the near future but for years to come. I especially enjoyed hearing Loren Israelsen talking about the genesis of DSHEA and how the current interpretation of the drug preclusion clause, which allows drug companies to call ‘dibs’ on botanical ingredients that went through the IND [investigational new drug application] process, was not the intent or the spirit of how DSHEA was written.”

“The DSHEA Summit was a well-structured and moderated event that provided a wonderful opportunity for stakeholders in the natural wellness space to come together, appreciate and contextualize the origins and initial purposes of DSHEA, align concerning the current status of regulation in the space, and exchange ideas about what adjustments or improvements are needed. We need to use this opportunity to move forward in achieving our shared goals together. DSHEA is a remarkable statute that accomplished both expected and unexpected results. We should work to improve upon DSHEA and not simply abandon it or rush into new legislation that betrays its underlying principle of empowering consumers to make informed decisions about managing their own health and wellness.”