The Two-Front Battle to Make America Healthy

Food Reform Meets Pre-Chronic Prevention and Chronic Disease Reversal

The RFI response to HHS is due before 11:59pm ET this coming Monday - July 14th. As we prepare our submission for the Food is Health community, we've identified two critical regulatory battlefronts that must be addressed simultaneously to truly Make America Healthy Again.

The first battle is about unleashing the power of food to communicate its health benefits. The second is creating an entirely new regulatory framework for the 88% of Americans who are metabolically unhealthy but not yet diagnosed with chronic disease - what we call the "pre-chronic" population.

These aren't separate fights. They're two sides of the same coin in transforming our sick-care system into a true health-care system.

We have drafted two detailed RFIs for submission. You are welcome to add your comments to the drafts. Follow the links:

• Submission 1: Modernizing Food-Health Regulations to Enable Evidence-Based Chronic Disease Claims

• Submission 2: Enabling Innovation in Pre-Chronic Disease Prevention & Chronic Disease Reversal

The Numbers That Should Terrify Us

Here's the reality check: We spend $1.7 trillion on poor nutrition and $1.9 trillion treating its health effects. Meanwhile, 96 million U.S. adults have prediabetes, and over 80% don't even know it. Only 1 in 8 American adults is metabolically healthy.

Yet right now, a walnut farmer can't tell you their walnuts may reduce heart disease risk without FDA declaring their nuts an "unapproved drug." At the same time, millions of pre-diabetic Americans can't get insurance coverage for continuous glucose monitors that could help them avoid becoming diabetic.

This is systemic failure at its finest.

Battle One: Free Food to Speak the Truth

The Absurdity of Current Regulations

Under current FDA rules, any claim that food can prevent, treat, or mitigate disease transforms that food into a "drug." When Diamond Foods cited peer-reviewed research about walnuts and heart health, FDA warned that "your walnut products are drugs."

Meanwhile, sugary cereals can claim to "support heart health" by adding synthetic fiber.

Our food innovators are trapped in regulatory purgatory:

Brightseed uses AI to discover plant compounds that could manage fatty liver disease. But these bioactives don't fit FDA's definition of "nutrients," so they can't make health claims without triggering drug status.

One Bio converts agricultural waste into fibers that combat inflammation. Their science suggests these could reduce diabetes risk, but they're stuck with generic "supports gut health" language.

Bonumose spent 6+ years in court fighting FDA's "arbitrary and capricious" decision to label their low-glycemic sweetener tagatose as "Added Sugar" - despite acknowledging it doesn't act like sugar in the body.

Holobiome explores the gut-brain axis with probiotics for mental health. Their only options? Become a prescription drug or make vague wellness claims.

Our Reform Recommendations

1. Create a Tiered Evidence System

• Keep gold-standard claims for proven relationships

• Expand qualified health claims with clear disclaimers like "Emerging research suggests..."

• Allow biomarker claims ("helps maintain healthy blood sugar") without triggering drug status

• Mandate 120-day FDA response times, not years

2. Establish "Food as Medicine" Fast Track

• Accept surrogate endpoints (A1c, blood pressure) instead of waiting for 10-year disease studies

• Grant conditional approvals with post-market research requirements

• Prioritize claims addressing diabetes, obesity, cardiovascular disease

• Waive fees for small businesses

3. Leverage Real-World Evidence

• Accept continuous glucose monitor data from hundreds of users

• Create blockchain-verified outcome registries

• Enable "citizen science" for population-level validation

• Update evidence standards to include well-designed real-world studies

4. Create Functional Food Categories

• Establish clear category between food and drug

• Expand medical foods to include chronic diseases like diabetes

• Allow pre-market notification instead of full approval for qualified products

• Harmonize USDA and FDA standards

Battle Two: Recognize Chronic Disease Isn’t a Foregone Conclusion

The 88% Solution

While we fight to let food communicate its benefits, we must simultaneously create an entirely new regulatory framework for the vast majority of Americans who are metabolically unhealthy but not yet diagnosed along with those who are looking to eliminate their chronic disease not just treat it through synthetic promises.

This "pre-chronic" population represents our greatest opportunity. Studies show intervening at this stage can prevent or reverse progression to full-blown disease. Yet our entire regulatory system treats these people as either "healthy" (no coverage) or "sick" (full medical model).

Companies like Hims & Hers, Function, and others have already recognized this gap. They're building billion-dollar businesses by serving people in the pre-disease phase - keeping them healthy rather than waiting for them to get sick enough to qualify for traditional healthcare. The only thing holding back rapid emergence of these options is access to healthcare premium and the current health insurance/benefit/employer/broker scheme.

Those in the chronic population represents the other opportunity. 90% of our $4.9T is related to chronic disease that is exponentially increasing. And of that $4T related to chronic disease, up to 90% of chronic disease is directly related to modifiable lifestyle factors. The evidence-based six pillars of lifestyle health and nutrition are still questioned within medicine as being “proven” as solutions for reversing chronic disease and those with these lifestyle diseases are only offered “treatment” options to manage their disease as opposed to therapeutic lifestyle change interventions that have been proven to reverse chronic disease swiftly and effectively for a fraction of the cost of current interventions.

The Pre-Chronic Framework

Distinct Regulatory Approach

• Create clear line between pre-chronic (<5.7% A1C) and chronic (≥5.7% A1C) care

• Lighter-touch oversight for pre-chronic innovations

• Maintain rigorous standards for treating established disease

• Enable "sandbox" programs for preventive technologies

Payment Model Revolution

• Medicare/Medicaid coverage for evidence-based prevention before diagnosis

• Cover CGMs, nutrition therapy, and health coaching for at-risk populations

• Launch "Pre-Chronic Care Bundles" paying for outcomes, not visits

• Reform and expand Medicare Diabetes Prevention Program

FDA Flexibility for Prevention

• Expand "general wellness" exemptions for risk-reduction tools

• Support over-the-counter access to preventive diagnostics

• Create middle-ground "Preventive Agents" pathway

• Right-size regulation to actual risk level

Unleash Telehealth and Digital Innovation

• Harmonize state licensure for preventive care

• Make pandemic telehealth flexibilities permanent

• Embrace direct-to-consumer preventive models

• Remove prior authorization for preventive services

The Chronic Framework

Lifestyle Medicine becomes Embedded in Care Delivery

• Prioritize board certification in lifestyle medicine

• Lifestyle Medicine is offered as an option for all with Chronic Disease

• Public health campaigns focused on the six pillars of lifestyle health

• Pharmacists council patients about the six pillars at dispensing

• Lifestyle medicine becomes core to medical school cirriculum

• Every touchpoint within the healthcare delivery model is linked with lifestyle and behavior change

• All chronic disease patients are offered access to intensive therapeutic lifestyle change interventions

Payment Models Reengineered

• Medicare/Medicaid higher reimbursement for disease reversal and lifestyle modification than disease treatment

• Cover CGMs, intensive therapeutic lifestyle change interventions for those diagnosed with chronic disease

• Require lifestyle medicine clinical oversight when GLP-1s are covered

• Create CPT modifiers for lifstyle medicine interventions offered within standard visits

• Launch "Disease Reversal Bundles" paying for outcomes, not visits

• Reengineer risk coding to incent disease reversal and remission not treatment

• Restructure value-based care models within CMMI to incentivize long-term remission and disincentivize long-term treatment

• Shift focus from treatment to reversal/remission

Create Community Cohorts Within Care Delivery

• Embrace group visits

• Establish new reimbursement models for care delivered in cohorts

• Create family care delivery models

• Reimbursement for establishing community cohorts supporting lifestyle modification (walking groups, group cooking)

Redesign Care Delivery Model for Lifestyle Support

• Restructure regulations for setting of care requirements

• Remove all telehealth barriers

• Embed lifestyle health coaches into all care delivery

• Offer unlimited access to tech-based lifestyle modification nudging tools

• Design a models that remove the physician oversight requirement to improve access and affordability

The Integrated Vision: Where Food Meets Prevention

Here's where both battles converge into a unified strategy:

Food as the First Line of Defense

Imagine a world where:

• Your prediabetic status qualifies you for "food prescriptions" covered by insurance

• Grocery stores can accurately label foods with their metabolic health benefits

• Your CGM data automatically triggers personalized nutrition recommendations

• Food companies compete on health outcomes, not just taste and price

The New Healthcare Value Chain

Instead of profiting from disease, the system rewards prevention:

• Life insurers become health insurers, paying for your Brightseed bioactives

• Employers get tax breaks for providing One Bio anti-inflammatory fibers

• Your Holobiome psychobiotic yogurt counts as mental health treatment

• Bonumose tagatose is recognized as diabetes prevention, not "Added Sugar"

Technology as the Enabler

Real-world evidence transforms how we validate health claims:

• Blockchain-verified registries track population health outcomes

• AI analyzes millions of CGM readings to validate food benefits

• Wearables provide continuous feedback on dietary interventions

• Digital therapeutics merge with functional foods for personalized prevention

• Establish a new platform and ecosystem for healthcare delivery

The Regulatory Punch List

To make this vision reality, specific changes are needed:

Legislative

• Amend 21 U.S.C. §321(g)(1)(B) to exclude health-claimed foods from "drug" definition

• Create pre-chronic safe harbors in fraud and abuse laws

• Expand tax code Section 213(d) to include preventive nutrition

FDA Regulations

• Delete "nutritive value" requirement in 21 CFR §101.14

• Streamline petition process with mandatory timelines

• Expand 21 CFR §101.93 to cover conventional foods

• Include chronic diseases in medical foods definition

CMS Policies

• Cover preventive services for pre-disease populations

• Launch pre-chronic payment pilots

• Count prevention spending toward medical loss ratios

• Eliminate prior authorization for preventive care

The Friction We Must Eliminate

From broad barriers to paralyzing minutiae, we must address:

Financial Friction

• Employer tax bias toward treatment over prevention

• Reimbursement only after diagnosis

• Lack of prevention ROI recognition

Regulatory Burden

• Years-long health claim approvals

• State-by-state telehealth licensing

• Prior authorization for prevention

• Treating wellness as medical devices

Cultural Barriers

• Healthcare profits from sickness

• Food and health in separate silos

• Innovation happens despite, not because of, regulation

The Call to Action

This isn't about choosing between food reform OR pre-chronic prevention. We need both, simultaneously, to create the systemic change required.

Every day we delay means:

• More Americans progressing from pre-diabetic to diabetic

• More food innovations trapped in regulatory limbo

• More healthcare dollars spent on preventable disease

• More lives shortened by metabolic dysfunction

The companies are ready. Brightseed, One Bio, Holobiome, and Bonumose represent just the tip of the innovation iceberg. Forward-thinking healthcare companies are already serving the pre-chronic population. Consumers are voting with their wallets for prevention.

What's missing is regulatory courage to embrace a new paradigm.

Join the Movement

This RFI response represents our best shot at systemic reform in a generation. We're not asking for deregulation that compromises safety. We're asking for smart regulation that recognizes the difference between keeping people healthy and treating them once they're sick.

If you support this two-front battle to Make America Healthy Again, add your name to our submission. Whether you're a food innovator frustrated by health claim barriers, a healthcare disruptor serving the pre-chronic population, or simply someone who believes we can do better than spending $3.6 trillion to manage preventable disease - your voice matters.

The deadline is Monday, July 14th at 11:59pm ET.

Let's not just move deck chairs on the Titanic. Let's build a new ship entirely.

Together, we can create a future where food is recognized as medicine, prevention is profitable, and staying healthy is easier than getting sick.

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To add your name and organization to this RFI response, representing both food regulatory reform and pre-chronic prevention framework, please reach out immediately. Time is running out to make our collective voice heard.