A current FDA review of the definition of “dietary substance” could dramatically restrict supplements, limit consumer choice, and reshape the future of natural health in the U.S.
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THE TOPLINE
- The FDA has made its own case and is interpreting “dietary substance” narrowly—limiting supplements to what’s already in the typical American diet—despite Congress intentionally defining supplements broadly in the Dietary Supplement Health and Education Act of 1994.
- This approach could exclude a wide range of traditional, global, and innovative health products while reinforcing a regulatory system that favors pharmaceuticals and restricts what supplement companies can say about health benefits.
- While being dressed up like a safety measure, this shift is really about control that would reduce access and diversity of supplement products, stifle innovation, and align U.S. policy with more restrictive international standards.
When most people think about regulation, they picture inspections, raids, enforcement actions, or product bans. But one of the most powerful tools regulators have operates quietly in the background: definitions.
Right now, the FDA is deciding how to interpret the phrase “a dietary substance for use by man to supplement the diet by increasing the total dietary intake” that makes up a part of the definition of a dietary supplement. We gave a brief overview of this issue last week, but given it’s so important we felt it necessary to go into more detail this week because the outcome of this debate could reshape the entire supplement landscape. We need to make sure that good sense and science, not the anti-supplement agenda of FDA’s paymasters, win the day.
The Power of a Definition
Under the Federal Food, Drug, and Cosmetic Act (FDCA), dietary supplements are defined as products containing one or more “dietary ingredients” (such as vitamins, minerals, herbs or other botanicals, or amino acids). Congress intentionally wrote this definition broadly in the Dietary Supplement Health and Education Act (DSHEA) of 1994 to preserve consumer access to a wide range of health-supporting products.
One key part of that definition—in “clause (E)”—adds that a “supplement” is also:
“a dietary substance for use by man to supplement the diet by increasing the total dietary intake.”
This is clearly expansive. It reflects a common-sense idea: supplements exist to add to the diet, not merely replicate what is already commonly consumed. But the FDA has taken a very different view.
Freezing the “Diet” in Time
In the agency’s guidance, the FDA has stated that a “dietary substance” must be limited to foods and food components that humans already eat as part of their “usual diet”. In other words, if something isn’t already part of the typical American diet, it may not qualify.
There are significant problems with this interpretation. As ANH founder and Executive Director Rob Verkerk, PhD, stated in ANH’s comments to FDA on this issue, “The American diet is highly variable, increasingly globalized, and in many respects nutritionally poor. Making the modern ‘usual diet’ the limiting benchmark would perversely treat dietary inadequacy and market convention as regulatory boundaries.”
Human diets are diverse and evolving. A legitimate understanding of “dietary substance” must include:
- Foods and practices from other cultures and traditional diets
- Fermented foods, medicinal foods, and food-as-medicine traditions
- Botanicals, fungi, algae, and microbial ingredients
- Nutrients and bioactive compounds present in foods but used in concentrated forms
- Substances that are chemically equivalent to dietary components, even if produced using modern methods
The relevant question isn’t whether a substance appears in the average American grocery store. It’s whether it has a relationship to the human diet—through tradition, composition, or function. With FDA’s planned narrowing of the scope of the definition, thousands of plant, fungi-, and algal-derived ingredients from tropical regions, from the East, from Central and South America, and from the African continent, would be excluded.
In this move, FDA would drift away from the expansive view of dietary supplements that was the will of Congress in 1994, and towards a view that is central to European regulators: that supplements are there only to maintain levels of micronutrients and have no role to play in warding off, let along remedying, any kind of chronic or acute disease. The subtext that is never stated is that FDA views supplements as competition for drugs and therefore its market must be kept in check.
A Broader Strategy to Restrict Consumer Choice
This debate over “dietary substance” isn’t happening in isolation. It’s part of a broader push to establish control over our health.
The FDA has a vested interest in restricting medicines that aren’t drugs because drug company user fees fund a substantial portion of the agency’s budget. It isn’t a coincidence that natural medicines over which the agency exercises less authority—supplements, homeopathy, and compounded medicines, for example—are frequent targets of FDA attack.
The result? Fewer products, less innovation, and reduced consumer choice.
The Legal Trap: Why Supplements Can’t Be “Medicine”
Zoom out, and an even bigger issue comes into focus.
Under U.S. law, a product becomes a “drug” if it is intended to diagnose, treat, mitigate, or prevent disease. That means a supplement company cannot legally tell you what the science says about how its product affects health—if that effect relates to disease.
This creates a paradox. You can buy supplements like curcumin, omega-3s, or vitamin D, but companies can’t tell you how they may help with inflammation, heart health, or immune function if those claims even hint at crossing into disease territory.
Why? Because making those statements would trigger drug classification—and with it, a regulatory process that can cost upwards of $1 billion and take a decade.
For natural substances that cannot be patented, that pathway is a dead end.
So companies stay silent. Consumers stay uninformed. And healthcare remains dominated by pharmaceutical interventions—not because they are always superior, but because they are the only legally recognized option for treating disease. (This is why we’re preparing a petition to the FDA to change that).
The Global Angle: Regulatory Harmonization
There’s also an international dimension to consider.
The United States has long been an outlier in allowing relatively broad access to dietary supplements. In contrast, the European Union imposes stricter limits on ingredient types and dosages.
Efforts like the FDA’s current interpretation of “dietary substance,” combined with its pre-approval framework for “new” supplements and Sen. Durbin’s bill for mandatory product listing, can be understood as steps toward harmonization—aligning U.S. rules with more restrictive standards from other countries.
For large multinational corporations, this makes business easier: one set of rules across multiple markets. For consumers, it means fewer choices and less access.
A Better Path Forward
ANH-USA is not arguing for a regulatory free-for-all. Safety and transparency matter. The FDA already has the authority to remove unsafe products from the market—and it should use that authority where appropriate.
But redefining “dietary substance” in a way that excludes legitimate, diet-related ingredients is less about safety and more about control.
A better approach would:
- Respect the broad definition Congress enacted in DSHEA
- Recognize the diversity and evolution of human diets
- Allow for innovation in how dietary ingredients are developed and delivered
- Focus regulatory efforts on safety—not arbitrary categorical restrictions
What’s at Stake
At a time when chronic disease is at historic highs, restricting access to safe, health-supporting tools is the wrong direction.
Definitions may seem technical. But in this case, they determine what products you can access, what information you can receive, and ultimately, what options you have to support your health.
If the FDA succeeds in narrowing the meaning of “dietary substance,” it could change the future of natural health in America. And that’s something we can’t afford to ignore.
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