ANH-USA has released a ground-breaking Strategic Roadmap and Action Plan exposing how outdated FDA rules are blocking access to medical foods—science-based nutrition therapies that could help millions of Americans prevent, manage, and even reverse chronic disease. Our Action Plan shows how we’re going to fix it. It’s time to educate Congress: sign our Action Alert now!
THE TOPLINE
- America is facing a chronic disease crisis, yet FDA rules restrict access to medical foods—nutrition-based therapies designed to meet the special dietary needs of people with diagnosed health conditions.
- By treating these foods like drugs, FDA policy has stifled innovation, discouraged research, and cut off patients from affordable, safe, and effective nutrition-based care.
- ANH-USA’s roadmap lays out how to modernize medical food policy, broaden access, and bring the “food is medicine” vision to life.
A Healthcare System That’s Failing Us
Despite spending over 16% of our GDP on healthcare—more than any other country—the United States ranks a shocking 80th in healthy life expectancy, projected to fall even further by 2050. Today, 133 million Americans live with at least one chronic disease, and 42% have two or more.
How can a nation that spends so much on health be so sick? Because we’ve built a healthcare system that waits for people to get sick—and then treats them with drugs that are expensive, dangerous, and do not address the root cause of illness in the first place.
There’s a better way.
>>>Download ANH-USA Strategic Roadmap and Action Plan, Medical Foods: Unlocking Access and Value
The Untapped Power of Medical Foods
Medical foods (MFs) are specially formulated products that provide targeted nutrition for people whose dietary needs cannot be met by regular foods alone. They’re used in hospitals every day, often in the form of shakes, powders, or enteral (feeding tube) formulas for patients recovering from surgery, living with metabolic disorders, or managing chronic disease.
Medical foods can help underserved populations reduce age-related disease and chronic conditions like diabetes, cardiovascular disease, and arthritis, improving health while reducing healthcare costs. They’re safe, effective, and far less expensive than many branded drugs.
So why don’t more Americans have access to them?
The Problem: A System Rigged Against Nutrition
Medical foods are trapped inside an outdated legal framework. In 1988, Congress created the medical food category in the Orphan Drug Act—a law meant to encourage the development of drugs for rare diseases.
Current rules say medical foods can only be used under a doctor’s supervision—even though most physicians receive very little training in nutrition. Meanwhile, qualified nutrition professionals like Certified Nutrition Specialists and Registered Dietitians are shut out from helping patients access these lifesaving foods.
The FDA’s interpretation of the law is so narrow that medical foods are completely shut out from addressing common chronic conditions like diabetes, heart disease, and metabolic syndrome, even though nutrition is central to their management. In its guidance document, for example, the FDA states, “There are no distinctive nutritional requirements associated with the management of [diabetes],” so medical foods cannot target diabetes.
Making matters worse, medical foods are often denied insurance reimbursement because FDA policy has left their prescription status in limbo. This is critical: our healthcare system mostly runs on insurance reimbursement. But because of the FDA’s restrictive rules, medical foods are left out of that system. As a result, most doctors and patients don’t even know these products exist—and when they do ask for them, insurance almost always refuses to cover the cost. By effectively hiding a whole category of safe, affordable nutrition-based treatments, the system blocks competition and discourages companies from investing in this promising area of medical science.
>>>Download ANH-USA Strategic Roadmap and Action Plan, Medical Foods: Unlocking Access and Value
In short: the FDA has put medical foods in handcuffs for decades while we’ve been seeing increasing rates of chronic disease that are nutrition and lifestyle related. This is crony medicine at its finest: shut out natural, nutrition-based interventions in favor of pharmaceutical monopolies over disease treatment.
Our Solution: A Roadmap for Reform
ANH-USA’s Strategic Roadmap and Action Plan offers a clear, actionable plan to fix this broken system. We’re calling for a modern framework that empowers innovation and restores nutrition to its rightful place in medicine.
Key recommendations include:
- Modernize the definition. Update the statutory language so medical foods can address common chronic diseases, not just rare ones.
- Expand access and supervision. Allow qualified nutrition professionals—not just doctors—to oversee medical food use.
- Clarify prescription status and enable reimbursement. Give medical foods a clear path to coverage through Medicare, Medicaid, the Veterans Administration, and private insurers.
- Replace regulatory intimidation with guidance. End the warning-letter culture and provide transparent, science-based rules for innovation.
- Educate healthcare professionals. Integrate medical nutrition training into medical, nursing, dietetic, and pharmacy schools nationwide.
These changes would unleash innovation, bring competition and lower prices, and expand patient access to safe, proven, food-based therapies.
Why It Matters
Medical foods won’t replace drugs—but they can reduce the need for them. By addressing the nutritional roots of disease, medical foods can help people stay healthier, longer, while saving billions in healthcare costs.
It’s time to bring “food as medicine” from rhetoric to reality.
