I chuckle when I hear industry members recoil at the suggestion as if the Dietary Supplement Health and Education Act of 1994 (DSHEA) was etched into marble for perpetuity. Their reaction usually involves some finger-wagging and a response like, “Oh no, we couldn’t change [fill in the blank with the proposal of your choice], it’s enshrined in DSHEA…”
By some accounts, the passage of DSHEA was near perfection.
DSHEA wasn’t perfect, and in fact, we’ve already amended it at least twice. First, the industry realized after the ephedra debacle that one of the gaps in the 1994 law was the absence of any required post-market surveillance of supplements that got into the market and subsequently created health problems. We became aware that some members of industry were actually suppressing reports of adverse events associated with their products as if hiding this data would make it go away. So in December 2006, Congress enacted mandatory serious adverse event reporting with the support of most of the industry.
Then in 2011, in response to several high-profile food adulteration incidents (remember melamine-tainted protein and contaminated peanut butter?), the law was amended again. The Food Safety Modernization Act created new requirements for food facility registration and for the verification of supply chain integrity that apply to dietary supplements as well as traditional food—again without opposition from our ranks.
In both cases, DSHEA has benefitted from a more comprehensive understanding of the marketplace. Both changes gave FDA the ability to see the dietary supplement arena more clearly, to identify potential bad actors, and to spot potential public safety concerns before they became widespread.
What hasn’t changed, however, is the careful balancing act that DSHEA struck 25 years ago between assuring widespread consumer access to a variety of natural health products on the one hand, and protection of public safety from charlatans, deliberate adulterations and reckless introductions of unsafe products on the other. This delicate tension between access and safety has, for 25 years, allowed a broad range of health-supporting ingredients to be widely available to the 75 percent of Americans taking dietary supplements, and permitted the market to expand over ten-fold to the $46 billion marketplace it is today
Earlier this year, FDA drew gasps in some quarters when it issued an invitation for a new round of potential changes to DSHEA, including a mandatory product listing. Outgoing FDA Commissioner Gottlieb stated that the agency is “interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today, and continue to safeguard consumers’ ability to access safe, compliant dietary supplements for the next 25 years.”
Dr. Gottlieb’s remarks with respect to the mandatory listing are the most intriguing: “[I]s it possible to design a product listing regime that helps us protect consumers and level the playing field for responsible industry participants by making it easier for us to take swift action against illegitimate and dangerous products, such as products that are tainted with drug ingredients? And is it possible to do this without disrupting the balance struck by DSHEA, and without imposing any significant new burdens on responsible firms? The answer to these questions may very well be yes.”
It's an acknowledgement from FDA that DSHEA was not about setting the industry loose on consumers, as some critics of the industry have suggested over the years. It was not about creating a “buyer beware” environment or relinquishing FDA’s public health obligations, as others have falsely alleged. DSHEA was, and is, about the balance struck between assuring consumer access and creating protections against a supplement entering the market that doesn’t live up to the wide margin of safety that consumers have come to expect. That’s the bedrock element of DSHEA.
In response to FDA’s invitation, various stakeholders will likely put a range of proposals on the table to change the law. Some will offer simply to clarify definitions, or enshrine agency practices in the statute. Others will be bolder, suggesting new vehicles to spur innovation and protect intellectual property. And the most progressive will seek substantial upheaval of existing regulation.
Then there’s this issue of a mandatory registry. FDA offers that a registry would “help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry.” This proposal too should be examined for its potential to create barriers to access and whether it contributes to public safety.
Whatever proposals surface, they should all be evaluated through the lens of maintaining DSHEA’s balancing act. DSHEA wasn’t etched in stone, but the tension and equilibrium between access and safety are worth preserving.