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Have you heard of phenylketonuria? No?

Well, it’s the most common amino acid metabolism disorder—in which the body is unable to process phenylalanine, an essential amino acid found in many different foods. Nearly 19,000 American people experience phenylketonuria (PKU), a small fraction among millions in the population who suffer from some sort of metabolic disease.

There are many ways to treat disorders such as these ones: diet, over-the-counter medicines, pills, supplements, and more. Disorders including ulcerative colitis, insomnia, Chron’s disease, ADHD, and PKU can all be treated with these methods. But there is one more option for those suffering with essential medical problems: medical foods.

Chances are, if you or someone in your life does not have an uncommon nutritional defect, you would never come across the often-ambiguous world of medical foods.

You may recognize some medical foods, like Lipisorb® (for malabsorption, common among those suffering from AIDS) or Folgard Rx® (for folic acid supplementation). Medical foods can be used via oral ingestion or tube feeding. Unlike probiotics, there are only a few ways to categorize medical foods: nutritionally complete or incomplete, formulas for metabolic disorders, and oral rehydration products.

According to the Orphan Drug Act, the definition of a medical food is as follows: "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is 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."

 


There are probably many medical foods that you’ve never heard of: there are at least 37,000 patented, and the list is ever-growing. There are foods containing essential botanicals, vitamins, bacteria, minerals, hormones, or a combination of these. They can target asthma, liver problems, skin problems, metabolic disorders, digestive diseases and more. Some medical foods contain one targeted nutrient, and some include multiple for stabilization or enhanced potency.

While many of the supplementary material in medical foods can be found in standalone supplements, the type of food and delivery form of the remedial material in a medical food are often carefully formulated to maximize its efficacy.

It is very important to distinguish medical foods as their own category apart from supplements, however. Supplements, while important for improved health, can be variable. They are a less targeted, and a more regulated, industry. And nutraceuticals, although related to medical foods, are in some ways more elevated. While medical foods are intended solely to manage diseases and deficiencies, nutraceuticals are formulated for health benefit and disease fighting.

Medical foods are the gray area between a prescription drug and a dietary supplement, and suggested much more rarely by a doctor. Although medical foods do not require a prescription, they must be overseen by a physician and are often utilized by dieticians. It is not uncommon for those taking a medical food to be either in a health care facility or an outpatient program.

Medical foods first emerged in the 1940s for the treatment of elderly people in hospitals and nursing homes. The first medical foods contained important lipids, carbohydrates, and whey protein for the fortification of bodies which were failing at performing some essential health processes.

The next commercially available medical food, Lofenalac®, debuted in the 1960s as a treatment for PKU in infants. Lofenalac® is cited as having an offensive taste to the adult palate, and it can be quite expensive – nobody chooses to take it unless they really have to!

Medical foods create a pharmaceutical dilemma in that they are considered to be over-the-counter drugs, and yet there is no over-the-counter substitution for a medical food. Those who need them often must pay out-of-pocket. That’s an unfortunate predicament for people with essential health problems.

Some diseases caused by a lack of essential nutrients – such as scurvy or pellagra, can be remediated by a balanced diet and not a medical food. So what warrants its use?

Medical foods came to be as a result of a demand for the management of serious and specific diseases/disorders with a nutritional association. Medical foods can also offer an important alternative to bodily pain treatment with narcotics, thereby reducing chances of addiction to prescription drugs.

The labeling of medical foods are limited by the requirements of the Federal Food, Drug, and Cosmetic Act of 1938. All medical foods require some sort of medical claim and a comprehensive ingredients list.

Despite a lack of oversight in comparison to pharmaceutical drugs, the claim process for medical foods is rather rigorous, unusual, and high-stakes. This due to the seriousness and rarity of the deficiencies which medical foods are able to treat or remediate.

Even so, medical foods are not reviewed by the FDA or subject to the Nutrition Labeling and Education Act before entering the market, as “regular” foods are. The processing, packaging, and holding of medical foods, however, requires registration with the FDA.

All medical foods must be considered GRAS, or Generally Regarded As Safe. This means that the producer demonstrates “adequate” safety relating to the way that the food is intended to be used, as demanded by the FDA. Usually, proof of GRAS requires published lab trials and data.

Despite the important role of medical foods, there is still a lot of work to do in order to increase the quality of their treatments. Additionally, recognition by health insurance companies will offer a new level of accessibility for those in need. Medical foods require more time, money and visibility in order to be maximally safe and effective – diminishing the gray space between supplements and drugs will help those with life-threatening conditions that require treatment via medical food. A simple exploration by Gregory Stephens of what is lacking in the medical food category is available here.

 

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