Medical foods are formulated to be consumed or administered internally while under the supervision of a physician. Medical foods may be in the form of infant formulas, edible bars, modified low-protein foods, and specialized nutritional products, such as high doses of vitamins and amino acids formulated as tablets and/or capsules. Medical foods are distinguished from conventional foods, foods for special dietary use, and dietary supplements by the fact that they can lawfully make disease-related claims.
Many medical foods are designed to treat inborn errors of metabolism, such as phenylketonuria (PKU), in which the body cannot metabolize the amino acid phenylalanine, or maple syrup urine disease, in which branched-chain amino acids cannot be metabolized. Medical foods have also been developed for Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease, chronic intestinal pseudo-obstruction, insomnia, ADHD, and inherited diseases of amino acids and organic acids.
There are three main types of medical foods. The first is products that omit the substance that must be avoided but otherwise contain a full complement of nutrients, such as Lofenalac, Ketonex-2, and Propimex. The second includes modular products, such as GlutarAde and Foltx. The third type includes low-protein foods, used to meet energy requirements in patients with inborn errors of metabolism that need protein-restricted diets. Some medical foods are formulated to address metabolic deficiencies that result from the physiologic stress of chronic diseases. Drug-induced nutrient depletion, which can occur with chronic use of certain prescription medications, may also be treated with some medical foods. Medical foods cannot be labeled or marketed for diseases that can be treated with regular modifications to diet, such as diabetes, obesity, or nutrient deficiencies like scurvy or pellagra.
Vayarin, manufactured by VAYA Pharma, is a capsule containing phosphatidylserine and omega-3s.
Vayacog, manufactured by VAYA Pharma, is a capsule for the management of complex lipid imbalances in early memory impairment containing phosphotidylserine and omega-3s.
Foltx, manufactured by Pamlab, is a tablet containing folic acid, pyridoxine, and cyanocobalamin, and is marketed for hyperhomocysteinemia, which is linked to cardiovascular disease.
Deplin (Pamlab) is for the dietary management of suboptimal L-methylfolate levels in patients with depression. When taken with an antidepressant at the start of treatment, patients with major depressive disorder showed a greater improvement in depression symptoms in a shorter period of time.
Enterade, manufactured by Entrinsic Health Solutions, is a liquid formula for individuals with occasional diarrhea, cramping, dehydration, nausea, and malnutrition, such as when undergoing cancer treatment and those diagnosed with inflammatory bowel disease (Crohn’s and colitis), irritable bowel syndrome, and celiac disease.
IBgard contains I-Menthol, the main component in peppermint oil, and is developed by IM HealthScience to treat irritable bowel syndrome; it is a capsule that releases ultra-purified peppermint oil in the small intestine.
FDgard, developed by IM HealthScience, contains peppermint oil and caraway oil released from microspheres in the upper digestive tract to treat functional dyspepsia.
KetoVie Peptide, manufactured by Cambrooke Therapeutics, is composed of a 4:1 ratio of fat:net carbohydrate + protein in a nutritionally complete hydrolyzed whey protein-based enteral ketogenic formula for children with impaired gastrointestinal function and/or intolerance to intact proteins.
VSL#3, developed and manufactured in Italy and distributed by Sigma-Tau Healthscience USA and VSL Pharmaceuticals, is a probiotic that treats IBS, ulcerative colitis, and patients with an ileal pouch. Capsules contain eight live, freeze-dried bacteria, which normally reside in the human gastrointestinal tract.
GlutarAde, manufactured by Nutricia, is a drink mix for children, teens, and adults.
Calcilo XD, manufactured by Abbott Nutrition, is a powdered formula to support infants with hypercalcemia due to Williams syndrome, osteopetrosis, and primary neonatal hyperparathyroidism and when low-calcium, vitamin D-free formula is needed.
Carbzero, manufactured by Nestle Health Science, is an emulsion of long-chain triglycerides (LCTs) for children three years old and older. The product is for use in the Ketogenic diet for patients with intractable seizures, glucose transport protein defect, or pyruvate dehydrogenase deficiency. The ketogenic diet for the treatment of epilepsy is a high-fat, low-carbohydrate, and normal-protein diet and was first described by pediatrician Hugh Conklin in the 1920s.
BCAD 1, manufactured by Mead Johnson, is an iron-fortified infant formula and medical food powder free of branched chain amino acids, isoleucine, leucine, and valine. The product provides all other essential and nonessential amino acids, carbohydrates, fats, essential fatty acids, vitamins, and minerals.
Ketonex-2, manufactured by Abbott Nutrition, is a powdered formula for children and adults that is isoleucine-, leucine-, and valine-free.
Cambrooke Therapeutics manufactures low-protein portabella and spinach ravioli and other low-protein foods.
Hominex-2, manufactured by Abbott Nutrition, is a powdered methionine-free formula for children and adults with vitamin B6-non-responsive homocystinuria and hypermethioninemia, conditions that result in an excess of the amino acid methionine.
Limbrel (Flavocoxid), manufactured by Primus Pharmaceuticals, is a capsule containing a blend of flavonoids, such as baicalin and catechin.
Percura (Physician Therapeutics) consists of a proprietary blend of amino acids for dietary management of metabolic processes associated with pain, inflammation, and loss of sensation due to peripheral neuropathy. Peripheral neuropathy is weakness, numbness, and pain that results from damage to nerves outside of the brain and spinal cord and can result from traumatic injuries, infections, metabolic problems, inherited diseases, exposure to toxins, and diabetes.
Propimex-1 and Propimex-2, manufactured by Abbott Nutrition, are powdered formulas for infants/toddlers and children/adults respectively, that are methionine-free, valine-free, and have low isoleucine and threonine.
The US Orphan Drug Act defines medical food as “a food that 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,” from (Section 5(b) of Orphan Drug Act (21 U.S.C. 360ee (b) (3)).
In Canada, food that is specially processed or formulated to meet the particular requirements of a person with a physical or physiological condition by controlled intake to have a particular effect is defined as “food for special dietary use” under Food and Drug Regulations (9.9 Foods for Special Dietary Use [Division 24, FDR]).
"Foods for special medical purposes" are regulated in the European Union Commission Directive 1999/21/EC. New compositional and labeling rules by Commission-delegated Regulation 2016/128 were adopted on September 25, 2015, and were set to be applied on February 22, 2019. Foods for special medical purposes are defined as foods intended for exclusive or partial feeding; for dietary management; and under medical supervision for individuals with certain diseases, disorders, or medical conditions when nutritional requirements that cannot be met by normal foods.
Codex Alimentarius was created by FAO and WHO to develop food standards and guidelines in 1963. The Codex Committee on Foods for Special Dietary Uses developed a standard for labeling medical foods in 1987, using the term “foods for special medical purposes.” It was determined that labels should include essential information for health professionals. Some required provisions include energy value, content of protein, fat, carbohydrates, vitamins and minerals, and amino acids or essential fatty acids if applicable. In some cases, osmolality and acid-base balance must be on the label.
In the US, medical foods are designed to be used under physician supervision; however, they are not allowed to be labeled prescription-only, and some medical products available online do not need physician approval. Nevertheless, many products are marketed as prescription-only medical foods, such as Metanx to treat diabetic nerve damage.
Medical foods are not classified as drugs and do not require clinical testing for efficacy, premarket review, and FDA approval. The ingredients are required to be FDA Generally Recognized as Safe. The FDA does not evaluate medical foods. However, facilities that manufacture, process, pack, or hold medical foods for consumption in the United States must register with the FDA.
Functional foods, dietary supplements, and nutraceuticals are not medical foods. The term functional food is considered to be primarily a marketing term. The Academy of Nutrition and Dietetics defines functional foods as “whole foods along with fortified, enriched, or enhanced foods that have a potentially beneficial effect on health when consumed as part of a varied diet on a regular basis at effective levels.” Dietary supplements are products that contain a dietary ingredient that adds further nutritional value to the diet. According to FDA guidelines, a dietary supplement may be marketed in food form if it is not represented to the public as conventional food and is clearly labeled as a dietary supplement. Nutraceuticals are whole foods or parts of foods that contain bioactive components that deliver a purported health benefit. Nutraceuticals are commonly marketed as oral dosage forms, such as tablets, capsules, and gummies.
The US FDA does not consider DM to be a disease for which medical foods can be labeled or marketed, due to the following lines of reasoning:
“There are no distinctive nutritional requirements associated with the management of diabetes mellitus” and “A regular diet can be modified to meet the needs of an individual affected by DM ( along with appropriate drug therapy if necessary).”
“Under 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.” The FDA’s stance is perceived as a reaction to companies selling dietary supplements disguised as medical foods.
Not considered a medical food by the US FDA, NiteBite, manufactured previously by ICN Pharmaceuticals and now by Optim Nutrition, is a snack bar designed to prevent hypoglycemia and contains three sources of glucose that are absorbed at different times. The US FDA does not consider products, such as those that aid in the management of blood sugar as medical foods since “There are no distinctive nutritional requirements associated with the management of diabetes mellitus” and “A regular diet can be modified to meet the needs of an individual affected by DM (along with appropriate drug therapy if necessary).”
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Frequently Asked Questions About Medical Foods; Second Edition Guidance for Industry
Top Medical foods companies | VentureRadar