In 1994, I was pregnant with my first child. I had never heard of the Dietary Supplement Health and Education Act of 1994 (DSHEA). I didn’t think much about dietary supplements, though I was taking a pre-natal vitamin. I knew who Mel Gibson was, but I didn’t see the ad he made for the legislative campaign to support DSHEA until it was time to celebrate a major anniversary of its passage. I was in the healthcare arena, but I was steeped in managed care contract awards, which turned out to be like making a deal with the devil. I was, however, and continue to be, a political animal.
Once I found my way to the naturopathic world, I learned just how important the support of Senators Harkin and Hatch was to the industry, and the role some of our legends, like Loren Israelson, played in the passage of what would come to be landmark legislation. Thirty-two years later, I suspect the number of people in our industry who lived this legislative milestone is very, very small.
No one needs to have walked in my shoes as a former congressional committee staffer and lobbyist to understand the dysfunction on Capitol Hill. If I had a magic wand, I would enact legislation to require Congress to put their stock portfolios in a blind trust to even the playing field. However, this is the lot we have been dealt, and the only proven power we have to combat financial interests that are not in lock step with ours, is the voice of the people.
In 1994, engaging the public worked. Taking away supplements was a threat big enough to rally voters. Call them voters or supplement customers, a 2025 report by the European Journal of Nutrition states the overall use of supplements increased from 51.8% (2011-2012) to 61.4% in 2021-2023. CRN 2023 data asserts 74% of U.S. adults take dietary supplements and 55% qualify as “regular users.” This is relevant data. No amount of corporate influence can supercede the power of the voters, provided we ensure they have the information they need.
Why has there not been, prior to now, an attempt at comprehensive reform that can eliminate conflicting interests and serve the consumer? Fear and a lack of vision. Fear that opening up the law will result in loss of authority, power, or worse, stymie opportunity for innovation. Fear that states will win, and the feds will lose, or vice versa. A lack of vision keeps us from collaboration. The result is disparate agendas, methods and processes to “fix” the problems with DSHEA. There is no ad campaign that can (1) represent this diversity, or (2) stand up to the myriad of agendas, strategies, and campaign contributions that drive decision-making in Congress.
Ours is a global industry. We are at least a $68 billion industry that is projected to grow to $131billion by 2033. Pharma, not the companies from 1994 who led the charge, plays the leading role on Capitol Hill. Thus far, we have divided our energy and campaign contributions, and minimized our efforts, to the delight of Congress. Every year, we make our "asks" and every year we are advised to get our act together. And, every election year, we raise money for Political Action Committees. We are feeding the machine, not fostering real change and reform.
The Organic & Natural Health Association is taking a different approach and created a modernization proposal intended to create a single national, transparent framework rather than relying on isolated fixes. The proposed changes include the following:
- Mandating supplement listing without premarket approval. The bill is explicit: no premarket approval, no label pre-clearance and no delay in marketing based solely on the listing's content. At the same time, a product that should be listed but is not properly listed would be deemed adulterated, subject to a good-faith cure provision and protection for technical or clerical errors. The bill also authorizes oversight funding with funds tied to post-market activities such as inspections, new dietary ingredient (NDI) notification review, serious adverse event investigations, recalls, enforcement, and operation of the listing system.
- Establishing a new framework to clarify drug preclusion rules, ending indefinite blocking of supplements. In short, the bill protects legitimate drug innovation while preventing companies from indefinitely blocking dietary ingredients that have a long history of safe use in foods and supplements.
- Preempting state patchwork regulations, and establishing national uniformity for labeling, safety and claims. It’s important to note the bill does not eliminate state authority. States may still enforce requirements that are identical to federal law. But it prevents the creation of parallel state systems.
The bill would also allow FSA/HSA spending on supplements.
The intention of this broad modernization is to create a single national, transparent framework rather than relying on isolated fixes. It is designed to strengthen consumer trust, improve FDA oversight, preserve national uniformity, modernize the treatment of ingredients and claims and support responsible innovation under a single, clear and transparent framework. If the industry wants a durable modernization strategy, this is the kind of architecture Congress should be considering.
