It’s been 30 years since the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. That same year, Sony launched its first PlayStation, “Friends” premiered on television, Amazon was just a garage startup, and Google didn’t even exist. And even though the dietary supplement marketplace has advanced and grown since that time, from $4 billion to more than $61 billion today, the laws overseeing the industry are still stuck in the early 90’s.
Although the U.S. Food and Drug Administration (FDA) has regulated dietary supplements since 1938, originally as foods, food additives, or unapproved drugs, the passage of DSHEA in 1994 was groundbreaking. It established a definition and a distinct regulatory framework for dietary supplements ensuring quality standards, specific labeling requirements, and the promotion of responsible marketing. DSHEA paved the way for legitimizing the supplement industry and has helped support millions of consumers in their pursuit of better health and wellness. The majority of dietary supplement manufacturers in the U.S. impose strong practices, adhere to regulations, and offer safe, quality products. But the rapid market expansion, combined with the rise of e-commerce, globalization, and the evolving self-care landscape, has exposed the law's limitations and the need for modernization to better ensure safety and promote innovation.
As CEO of the Consumer Healthcare Products Association (CHPA), the leading organization representing manufacturers of dietary supplements, I, like most Americans, recognize the crucial role dietary supplements play in promoting and maintaining personal health. CHPA and the FDA both agree that the framework overseeing this category needs to be improved. There is a growing body of evidence supporting the health benefits of vitamins, minerals, and other supplements – from filling nutrition gaps to supporting prenatal health to providing increased immunity for individuals, and more. It is also well recognized that dietary supplements play a role in supporting wellness for people living with – or at risk for – certain conditions, benefits that collectively contribute to better overall public health.
With three out of every four American consumers taking a dietary supplement on a regular basis – a rate which rises to four in five for older Americans – it’s essential that this growing consumer category receives appropriate regulatory attention and resources. Part of this can be accomplished by modernizing the statutory structure to provide FDA with additional tools to further safeguard consumers, foster greater trust in the marketplace, and ensure a robust industry well into the future.
The current DSHEA framework leaves the FDA with strained resources and, arguably, gaps in authority. The agency struggles to effectively monitor the market or adequately address illegal activity. A stark example of this shortfall is the continued sale of tianeptine, an illicit opiate and dangerous drug, sometimes referred to as "gas station heroin." Tianeptine is banned in countries such as France due to its harmful effects, but in the U.S., lack of effective enforcement is allowing it to slip through the cracks. Between 2000 and 2013, there were 11 cases of tianeptine exposures reported to U.S. poison control centers – with the first deaths resulting from tianeptine reported in 2018. Just ten years later, cases jumped to nearly 400 in 2023 alone, with another death reported in March 2024.
We have an opportunity to prevent dangerous substances like this from reaching the hands of consumers by strengthening DSHEA for the modern day, but it will require a comprehensive approach to deliver true reform. For example, such reforms should require manufacturers to list their dietary supplements in an FDA-managed public database – an effort known as “mandatory product listing.” This would improve marketplace transparency by giving regulators, retailers, and the public a complete window into the products on the market. It would provide the FDA with essential data to monitor and regulate the market more effectively. But as a stand-alone measure this is not enough since other loopholes would remain and the FDA would need additional resources and efficient tools to remove more illicit products from the market.
Responsible members of the industry also support enhancements to the law that would expand FDA’s currently limited capacity to perform inspections, by allowing FDA to enlist the help of third-party auditors, which it currently cannot do. This would help increase the FDA’s ability to provide manufacturing oversight and offer greater assurances of product quality and integrity. Additionally, giving the FDA new authorities to immediately stop specific illegal activities or “prohibited acts” by bad actors would provide a new strategy for the FDA to shut down the sale of specific illegal, harmful, or banned ingredients, like tianeptine.
But modernization isn’t just about keeping bad actors out. It’s also about fostering informed consumer decision-making and providing industry with the ability to educate consumers responsibly. DSHEA was enacted before the regular use of internet marketing. Updated regulations are needed to address online information-sharing and create easier access to peer reviewed and published scientific evidence. This simple change would support consumers and healthcare providers in making informed decisions about the products they use and recommend.
Dietary supplements play a crucial role in modern consumer health, yet the law remains stuck in the past. For the 30 years since DSHEA was enacted, the state of the science surrounding the health benefits of dietary ingredients has expanded and the dietary supplement industry kept pace with this expansion. But we at CHPA believe it’s time to modernize the law to better reflect the new marketplace and evolving consumer needs. Americans deserve stronger protections and better access to safe, quality, and beneficial dietary supplement products. Comprehensive regulatory modernization is essential overdue. So, for its 30th birthday, let’s urge Congress to give DSHEA the enhancements everyone deserves.
Scott Melville is the CEO of the Consumer Healthcare Products Association (CHPA).
