I have previously written that the Federal Food, Drug, and Cosmetic Act (FDCA) is antiquated and in need of an overhaul. In short, the artificial distinction between conventional foods and dietary supplements in existing regulation has become not just obsolete, but actively harmful to both consumer protection and industry integrity.

The Food and Drug Administration’s increasing reliance on enforcement discretion and informal warning letters, rather than consistent formal enforcement action, has created a system where violations are rewarded while compliance is penalized, fundamentally undermining the purpose of the FDCA and consumer protection laws generally.

Meanwhile, the agency has simultaneously allowed the convergence of these supposedly distinct regulatory categories through conventional foods enhanced with dietary ingredients, effectively acknowledging that the traditional dichotomy no longer reflects market reality. Indeed, one only needs to look at the rise of the functional food bar and beverage industry.

To be clear, these products that contain a wide array of dietary ingredients are conventional foods under existing law and, thus, are not being marketed in accordance with the requirements of food, which mandates ingredients be either FDA-approved food additives or generally recognized as safe (GRAS).

This regulatory dysfunction occurs precisely when we need effective oversight most. As Health and Human Services Secretary Robert F. Kennedy Jr. correctly observes, food and lifestyle interventions represent our most promising path to reducing the $4.5 trillion annual healthcare burden that stems largely from preventable chronic diseases.

The convergence of nutrition science, consumer demand, and economic necessity demands that Congress abandon the antiquated notion that “food is food and dietary supplements are dietary supplements” in favor of a unified regulatory framework that recognizes food and dietary supplements as twin pillars in promoting overall health and well-being. Dare I say: it is the best preventive medicine and, ultimately, the only way we will lower our annual healthcare costs.

DSHEA’s Unintended Consequences

The Dietary Supplement Health and Education Act of 1994 (DSHEA) established a regulatory framework treating dietary supplements as a subset of foods rather than drugs, creating what industry experts describe as a “regulatory gap” between legal requirements and practical enforcement capabilities. Under this framework, Congress recognized that dietary supplements served a valuable tool in promoting the overall health and well-being of the nation. However, because of restrictive FDA policies, the agency would treat these products as drugs as opposed to food.

The DSHEA framework established a new safety standard for these products, understanding that the benefits of consuming dietary supplements outweighed the potential risk. While the standard for grandfathered dietary ingredients and new dietary ingredients are slightly different, in essence, they both require “a reasonable expectation of safety” under the labeled or normal conditions of use.

In contrast, conventional food ingredients must be either FDA-approved food additives or GRAS, which is a higher standard than the “reasonable expectation of safety” standard for dietary supplements — whether FDA recognizes it in practice or not. The result is two different safety thresholds for chemically identical substances based solely on their product categorization — a distinction that has become increasingly meaningless as consumer demand for functional food products has grown significantly, resulting in product innovation that has blurred these traditional structural boundaries.

The Advent of Designer/Functional Conventional Foods

As mentioned, what the industry commonly refers to as “functional foods” are oftentimes “conventional foods” that have been enhanced with dietary ingredients intended to provide health benefits. These products include fortified juices, enriched dairy products, cereals with added vitamins, minerals, amino acids, botanicals (constituents and extracts thereof), isolated phytochemicals (e.g., polyphenols), and other dietary substances — in other words, the definition of a “dietary supplement” under the FDCA as amended by DSHEA. The functional food market, valued at $320 billion in 2024 with projections to reach $384 billion by 2028, operates entirely within the existing conventional food regulatory framework. This trend is not going anywhere.

Indeed, the FDA’s tacit tolerance of regulatory violations and permission for dietary ingredients in conventional foods demonstrates the artificial nature of the food-supplement distinction. The agency has allowed food and beverage companies to incorporate dietary ingredients into conventional food products that would not otherwise meet the GRAS standard typically required for conventional foods. This regulatory paradox means ingredients subject to more stringent safety requirements as food additives can enter the food supply through the less rigorous dietary supplement pathway.

The hemp industry is the perfect example of this issue but truly needs to be dealt with in a different manner, which I plan to write about in my next column. It’s a fix that is necessary, but Congress probably does not have the political will to stop the madness; FDA should if Congress is unwilling, but I digress.

The Market Reality

The emergence of designer conventional foods enhanced with ingredients traditionally found in supplements has made the regulatory distinction increasingly artificial. These products challenge traditional categorization, as consumers purchase them primarily for health benefits rather than taste or nutritional value, yet they remain conventional foods under regulatory law.

The market has effectively voted for convergence. Consumers spend hundreds of billions of dollars annually on conventional foods marketed for their functional health benefits. FDA, meanwhile, lacks the political will or sheer desire to impose the legal distinction through actual enforcement rather than warning letters that have had little impact except to encourage others to violate the law.

The Perverse Incentives of Selective Enforcement

When regulatory agencies exercise enforcement discretion, they fundamentally alter the risk-reward calculation for industry compliance. Companies operating in good faith invest significant resources in regulatory compliance, while bad actors continue operations knowing enforcement action is unlikely.

This creates a competitive disadvantage for compliant companies and provides economic incentives for violations — exactly the opposite of effective regulation. We all know intuitively that inconsistent application of rules leads to lower overall compliance rates. When companies observe that regulations are selectively enforced, they will adapt their behavior accordingly, often choosing to test regulatory boundaries rather than strictly adhering to legal requirements.

In other words, companies worried about gaining a foothold or losing market share will naturally push the envelope if they see other companies doing it.

Food as Medicine: Scientific and Economic Reality

The scientific evidence supporting food as medicine interventions has reached a tipping point that demands regulatory recognition. A sophisticated model published in PLoS Medicine estimated that healthy food subsidies could save billions in healthcare costs and prevent hundreds of thousands of heart disease deaths and diabetes cases.

Modern nutrition science reveals that micronutrients in naturally occurring forms are more bioavailable and act as antioxidants to tackle inflammation and promote cellular regeneration. These advances support what ancient civilizations understood: as Hippocrates proclaimed, “Let food be thy medicine and medicine be thy food.” The convergence of traditional wisdom with modern science demands regulatory frameworks that recognize this reality rather than maintain artificial distinctions.

Beyond the False Dichotomy

The solution requires congressional action to establish a unified risk-based regulatory framework applying a consistent “reasonable expectation of safety” standard across both conventional foods and dietary supplements. This approach would eliminate regulatory inconsistencies, close existing loopholes, and better protect consumers by focusing regulatory resources on actual safety risks rather than technical categorizations.

A unified framework would offer several advantages: consistent safety standards based on risk rather than arbitrary product categories; simplified compliance for manufacturers through clear, consistent requirements; and better alignment with international regulatory approaches that emphasize risk assessment over categorical distinctions.

Implementation Through Legislative Reform

Implementing this unified framework requires congressional amendment of the Federal Food, Drug, and Cosmetic Act. Key legislative changes would include establishing a single definition encompassing both conventional foods and dietary supplements, codifying the “reasonable expectation of safety” standard as the universal requirement, creating a tiered approach to premarket notification based on risk rather than product category, and strengthening post-market surveillance across all product types.

The transition could be managed through comprehensive guidance documents clarifying risk assessment procedures, phased implementation timelines allowing manufacturer adaptation, streamlined review processes for ingredients with established safety profiles, and technical assistance for small businesses.

Grandfathering provisions for existing products with established safety records would prevent market disruption while encouraging innovation within the new framework. However, unlike with DSHEA, ingredient lists will need to be developed and submitted by industry to FDA within 6 months of legislation.

Recognizing Market Reality

The time has come to acknowledge that consumer behavior and market innovation have already determined the outcome of this regulatory debate. Designer conventional foods with health benefits represent a $320 billion market that exists precisely because consumers understand what regulators have been slow to recognize: the artificial distinction between basic nutrition and health-promoting foods no longer serves any meaningful purpose; in fact, it hurts long-term health outcomes.

Secretary Kennedy’s emphasis on addressing chronic disease through nutrition aligns with both scientific evidence and economic necessity. Whether one agrees with all his positions, the fundamental premise that “food and lifestyle is the only way to bring down healthcare costs” reflects an understanding that regulatory frameworks must evolve to support rather than hinder this approach. I have been a big proponent of this approach and we now have a limited opportunity to go big or go home.

The FDA has demonstrated through its enforcement discretion policies and tolerance of regulatory convergence that it lacks either the authority or will to address these problems within the existing framework. Only congressional action can establish the unified regulatory approach that modern nutrition science, market reality, and healthcare economics demand.

The proposed framework would not weaken consumer protection but actually strengthen it by focusing regulatory attention on real risks rather than bureaucratic categories. Products posing higher risks would require more robust substantiation regardless of their traditional classification, while lower-risk ingredients with established safety profiles could move through streamlined processes.