Medical Food Formulations


CortControl Blog

Medical Foods: The Essentials

By Jim Daniels, CEO, CortControl LLC

When I use the term “medical foods,” I often get perplexed looks followed by questions such as: “Oh, do you mean health foods?” “So, are we talking herbal remedies?” or “Vitamin supplements—right?”

Well—no. The correct answer is “none of the above.” 

This confusion is quite understandable. Although the FDA first defined the term “medical foods” 27 years ago, it has only been two years since the agency established separate guidelines for this disease management category. For science and commerce, medical foods represent a relatively new frontier. Many people simply don’t know much about medical foods or about the opportunities they offer. Hundreds of millions of potential users stand to benefit. Health care providers stand to acquire additional and more effective treatment options. Pharmaceutical companies stand to profit from broadening their product portfolios and market reach.

Specifically, what do we mean when we say “medical foods?” Why are they important? And who can benefit from their widespread use?

Let’s look at these subjects individually:

  •  What Medical Foods Are

First defined in the 1988 amendments to the FDA’s Orphan Drug Act, a medical food is a food “intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” 

"Medical foods" represent an acknowledgement by the FDA that foods have healing properties and are now seen as more than basic proteins, fats, and carbohydrates. 

Grassroots public pressure led to their introduction. For example, 95% of consumers believe that “certain foods have health benefits that go beyond basic nutrition and may reduce the risk of disease or other health concerns." In fact, more than 50% of consumers believe that foods can replace the use of drugs.

Administered orally, medical foods are dietary products developed specifically for the management of diseases and other health conditions. They are not intended to be substitutes for drugs and other traditional medical treatments. Instead, they part of an integrative medical strategy to safely and effectively address diseases and other conditions. Finally, they may be used only under the supervision of an MD, nutritionist, dietitian, or other qualified health care professional.

For those who wish to learn more about the FDA’s perspective on medical foods, the Medical Foods Guidance Documents and Regulatory Information page on the agency’s website offers a comprehensive overview.

  •  Why Medical Foods Are Important

Medical foods offer doctors and other health care providers an additional treatment option that can greatly enrich an integrative medicine strategy. Safe and effective, medical foods do not have the side effects the come with many drugs. Proof of effectiveness is based on recognized scientific testing principles. Unlike health-food-store products, medical foods are not introduced into the market until effectiveness has been demonstrated to the FDA.  

Numerous papers have already been written on the effectiveness of certain medical foods in addressing a wide variety of diseases and conditions from diabetes and breast cancer to infertility and depression. For more information about these and other medical food-related subjects, visit the website Medical Foods.

  •  Who Benefits from Medical Foods

The short answer is: everyone. Doctors and other health care professionals offer people living with a multitude of diseases and conditions a richer, more effective integrative medicine strategy. Pharmaceutical companies seeking to broaden their product portfolios and increase revenues will also be big winners. With medical foods still in their infancy, high growth and profits are projected. 

“When you’re through changing,” the old adage goes, “you’re through.” And for both health care professionals and pharmaceutical companies, medical foods represent a major change. Yes, change can be risky. But, considering the potential upside, the risk of doing nothing in today’s fiercely competitive pharmaceutical marketplace is even greater.

James Daniels is the CEO of CortControl, which develops and markets GlutrasolTM, a patent-pending medical food for the treatment of such indications as infertility, vaccine enhancement, diabetes, depression, breast cancer, heart disease, sleep disorders, and Alzheimer's disease.


Laura CoxComment