As FDA is preparing a GRAS proposed rule, currently under review at the Office of Management and Budget (OMB), major congressional committees have signaled sustained interest in strengthening oversight of self-affirmed GRAS determinations.
This push is grounded in a familiar narrative: To protect consumers, FDA must have a clear line of sight into what is on the market. That logic is hard to dispute. But here’s the emerging tension: While transparency dominates conversations in some FDA-regulated categories, a parallel and long-standing gap in dietary supplements continues to receive far less attention.
And this matters. Supplements are a large, mainstream category used daily by more than 75% of Americans, and consumer trust depends on FDA having basic visibility into what products are on the market. If transparency is becoming a core regulatory principle, the question is whether it is being applied consistently across all categories FDA oversees.
The transparency case for GRAS reform
Advocates for GRAS reform argue that the current system allows food manufacturers to independently conclude that a substance is safe without notifying FDA. With no centralized public list of self-affirmed determinations, some stakeholders worry FDA may lack complete market visibility when scientific questions arise. It’s no surprise, then, that proposals circulating in Washington frame enhanced GRAS transparency as a logical step toward strengthening public confidence.
For example, the Make America Healthy Again (MAHA) movement frames this as a transparency failure, and in addition to Congress taking notice, FDA Commissioner Marty Makary has signaled strong support for reform to ensure the agency has better visibility into substances entering the food supply.
These concerns are not without merit. But transparency debates in the food sector are raising a question, if visibility is essential for FDA oversight, shouldn’t the same logic be applied to dietary supplements?
The forgotten transparency gap
The dietary supplement market—now worth over $60 billion with more than 100,000 products—operates without a mandatory product listing (MPL). FDA has previously supported MPL and even requested authority for it in past budget proposals. MPL would require dietary supplement manufacturers to submit basic product information (names, ingredients and levels) to FDA, creating a public, searchable database.
Despite multiple legislative attempts over the years, efforts to establish MPL have stalled due to a mix of stakeholder concerns, competing priorities and broader political dynamics. Today, discussion of MPL has been far quieter, even as reforms in other regulatory categories gain momentum.
So, while GRAS reform garners attention, the supplement marketplace still lacks a basic product listing. For a category used by millions of Americans, that contrast is noteworthy and increasingly hard to ignore. And if transparency is truly essential to public confidence, this gap deserves equal attention.
Policy inconsistencies and the limits of transparency
The broader transparency conversation highlights a recurring challenge in FDA policymaking: Visibility often increases obligations without increasing resources. FDA and state agencies already face capacity constraints, and any influx of new notifications, whether for food ingredients or supplements, must be assessed within existing workloads.
Even with improved visibility, FDA will still have to prioritize oversight based on risk. Transparency can support safety, but it is not a standalone regulatory solution. And importantly, this reality applies as much to dietary supplements as it does to conventional foods.
Practical solutions exist
The good news is that transparency does not need to come at the expense of efficiency or innovation. Food industry groups have proposed a GRAS Transparency Register, a centralized log of self-affirmed determinations that gives FDA visibility without changing the underlying GRAS pathway. Companies could protect proprietary data while FDA retains the authority to request information when concerns arise.
Similarly, a modernized mandatory product listing system for supplements would give FDA a clearer picture of the marketplace, product names, ingredients and levels, without creating a premarket approval framework. Both approaches aim to enhance transparency in a way that is achievable, proportionate and aligned with consumer expectations.
The real elephant in the room
The core issue is not whether transparency is valuable, as it is broadly supported across sectors. The real question is whether transparency reforms are being applied consistently. Selective transparency leaves gaps in oversight and raises doubts about whether policy choices reflect a comprehensive approach.
As Washington focuses on improving FDA’s visibility into food ingredients, it’s time to acknowledge long-standing gaps in dietary supplement oversight. A modern listing system for supplements would better align FDA’s tools with consumer expectations and ensure transparency is applied consistently across categories.
Until these gaps are addressed, the national conversation on transparency will remain incomplete, and the elephant in the room will continue to grow.
