- What Is a Medical Food?
- How to Explain Medical Foods to Your Patients
- What is medical food?
- Medical Foods over the years
- Who pays for medical foods?
- How to best explain it to patients
- Why would a medical food be best when combating eye-related problems?
- Medical Foods – Natural Products Association
- NPA Position
- Everything You Need to Know About Medical Food
- Food and Drug Administration Definition
- Main Types
- The FDA Paradox
- The Truth About Medical Foods
- Making Sense of Medical Foods
- These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods | News & Insights | Arnall Golden Gregory LLP
What Is a Medical Food?
What is the difference between a medical food, a dietary supplement, and a functional food?
|Response from Gayle Nicholas Scott, PharmD Assistant Professor, Eastern Virginia Medical School, Norfolk, Virginia; Clinical Pharmacist, Chesapeake Regional Medical Center, Chesapeake, Virginia|
Prior to 1972, medical foods were primarily formulas designed for the unique nutritional needs of patients with inherited metabolic disorders. These products were regulated as drugs, usually as orphan products.
In 1972, the US Food and Drug Administration (FDA) created the classification “medical food” to enhance product development and availability.
In the nearly 4 decades since this classification change, products marketed as medical foods have strayed widely from the original narrow use in rare metabolic conditions.
The FDA specifies that medical foods are foods specifically formulated for dietary management of diseases or conditions with distinctive nutritional needs that cannot be met by diet alone. Generally, a product must meet the following criteria to be labeled a “medical food”[1,2]:
- A specific formulation (as opposed to a naturally occurring foodstuff in its natural state) for oral or tube feeding;
- Labeled for the dietary management of a specific medical disorder, disease, or condition with distinctive nutritional requirements;
- Intended for use under medical supervision; and
- Intended only for a patient receiving active and ongoing medical supervision for a condition requiring medical care on a recurring basis so that instructions on the use of the medical food can be provided.
Think of medical foods as hybrids of prescription drugs and dietary supplements, more closely resembling dietary supplements in terms of regulation. Packaging for medical foods is similar to prescription products with package inserts, National Drug Code (NDC) numbers, and usually “Rx only” on the labels.
However, dietary supplements, medical foods have not been evaluated for safety or efficacy, and the FDA does not require approval before marketing. “Caution: Federal law prohibits dispensing without prescription” is not required on product labeling.
The FDA specifies only that these products are for use with medical supervision; however, a medical food manufacturer may market a product to be dispensed only on physician request.
Un dietary supplements, medical foods can be labeled for medical conditions such as Alzheimer disease.
Dietary supplements must be labeled for so-called “structure and function claims” and cannot make claims to treat or prevent disease.
 For example, ginkgo may be labeled “supports memory function” but not “for treatment of dementia.” A drug or medical food could be labeled “for treatment of dementia associated with Alzheimer disease.”
Medical foods that more closely align with the FDA's historic intent are infant formulas such as Phenyl-Free® 1,aphenylalanine-free formula for babies with phenylketonuria, and Ketonex®-1, a branched-chain amino acid-free formula for babies with maple syrup urine disease — both rare disorders.
Some manufacturers use the loopholes in the medical foods law to market products for disease indication claims that would not be allowed if marketed as dietary supplements. The following are examples of medical foods:
- Axona® (caprylic triglyceride) is marketed as for dietary management of Alzheimer disease. Caprylic triglyceride is a medium-chain triglyceride found in coconut oil.
- Limbrel® (flavocoxid™) is marketed for osteoarthritis. Flavocoxid, which sounds remarkably similar to cyclooxygenase (COX)-2 inhibitors such as celecoxib, is a proprietary blend of flavonoids such as baicalin and catechin.
- Foltx® (folic acid 2.5 mg, pyridoxine 25 mg, cyanocobalamin 2 mg) is marketed for hyperhomocysteinemia, which has been linked to cardiovascular disease.
In terms of drug interactions, adverse effects, and safety, credible research about medical foods is similar to dietary supplements.
Manufacturers are not required to prove efficacy or safety before marketing medical foods or dietary supplements.
Explain to patients who want to try a medical food that these products have not been evaluated by the FDA, despite the trappings of prescription drugs.
Finally, “functional foods” is simply a lay term, “nutraceutical.” The FDA has no formal definition for functional foods but does regulate safety and labeling as it does for all food products.
Functional foods are foods marketed for purposes other than nourishment. For example, Activia® is a probiotic yogurt marketed to help “regulate your digestive system.
” It contains a subspecies strain of Bifidobacterium animalis, which is marketed as Bifidus Regularis®.
Another example is DanActive® dairy drink that contains a strain of Lactobacillus casei marketed as L casei immunitas® and is labeled to help “support your immune system.”
The Federal Trade Commission recently charged Dannon with deceptive advertising. Dannon agreed to drop claims that allegedly exaggerated the health benefits of Activia (relieves irregularity) and DanActive (protects against cold and flu).
For products marketed as medical foods for common indications, clinicians should advise patients that these products are dietary supplements in terms of FDA oversight. Safety and efficacy are unproven.
Functional foods, which are undefined by the FDA, are simply products of marketing strategy. dietary supplements, functional foods are not required to undergo safety and efficacy testing prior to marketing.
Medscape Pharmacists © 2011 WebMD, LLC
Cite this: Gayle Nicholas Scott. What Is a Medical Food? – Medscape – Jun 13, 2011.
How to Explain Medical Foods to Your Patients
Today, there is growing enthusiasm around the subject of medical foods. “Medical food” is not just simply food recommended by doctors as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition. It is specially formulated and distinguished from the broader category of specially formulated food products (foods for special dietary use [FSDU]).
What is medical food?
Medical food products have three primary characteristics—meets distinctive nutritional requirements of a disease or condition that cannot be satisfied by a typical diet, administered/prescribed under medical supervision, and intended for the specific dietary management of a disease or condition (e.g., Alzheimer disease or type 2 diabetes mellitus).
It is important to note that medical foods cannot prevent or cure illness; they are meant only to manage the course of a disease or condition, usually in an effort to avoid development or progression of a pre-existing disease or condition. The majority of medical foods are part of the life-long management of a disease or condition through dietary means.
Medical Foods over the years
Debuting in the late 1960s, Lofenalac was the first commercially developed of the medical foods. Prior to 1972, medical foods were primarily formulas designed for the unique nutritional needs of patients with inborn errors of metabolism (e.g., phenylketonuria [PKU] or maple syrup urine disease), which are usually rare genetic disorders.
Today, medical foods have been developed for patients with macular degeneration (e.g., Lumega-Z™), malabsorption caused by inflammatory bowel disease (i.e.
, Crohn disease and ulcerative colitis), gastroesophageal reflux disease (GERD), chronic intestinal pseudo-obstruction, insomnia, attention deficit hyperactivity disorder (ADHD), and inherited diseases of amino and organic acids.
The difference between medical foods and dietary supplements and the role of the FDA
Medical food products often are confused with dietary supplements. Medical foods and dietary supplements have separate United States Food and Drug Administration (FDA) regulatory classifications.
According to the FDA, “A dietary supplement is a product intended for ingestion that contains a ‘dietary ingredient’ intended to add further nutritional value to (supplement) the diet.
A ‘dietary ingredient’ may be one, or any combination, of the following substances: a vitamin, a mineral, an herb, or other botanical.” The goal of dietary supplements is to augment wellness among healthy individuals.
In contrast, according to the FDA, “medical food” is “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, recognized scientific principles, are established by medical evaluation.” The FDA has written guidance documents on the topic of medical foods. But it should be made clear that medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs. In the guidance, the FDA indicates its definition is meant to “narrowly constrain” this category of food products and distinguishes medical foods from what it considers to be a broader category of specially formulated food products, FSDU.
The key difference between the two (dietary supplement vs. medical food) is that a medical food can make a medical claim such as this product can be ‘used for the treatment of Alzheimer disease,’ while the dietary supplement would say something ‘supports healthy dopamine levels.
’ Furthermore, medical foods require medical supervision, which is why manufacturers of medical foods require a product to be dispensed only upon a doctor’s request.
One author put it best by saying, “Think of medical foods as hybrids of prescription drugs and dietary supplements, more closely resembling dietary supplements in terms of regulation.”
In terms of drug-drug interactions, side effects, and safety, trustworthy research about medical foods is similar to that of dietary supplements. Manufacturers are not required to prove efficacy or safety before marketing medical foods or dietary supplements.
Dietary supplements have strict labeling guidelines, while medical foods have virtually no labeling regulations.
In contrast, packaging for medical foods is similar to prescription medications with package inserts, National Drug Code (NDC) numbers, and usually “Rx only” on the labels.
Additionally, medical foods are tested for effectiveness in clinical trials and deemed safe by panels of experts before they are brought to the marketplace and consumers. All ingredients in a medical food must be on the FDA’s “Generally Recognized as Safe” list.
Who pays for medical foods?
Private health insurance coverage for medical foods is not uniform across all states. As a result, some patients end up receiving very good coverage, whereas others receive poor to no coverage. State legislation for coverage of medical foods is highly variable.
For example, 33 50 states have provisions related to private insurance coverage requirements for medical foods to treat disorders identified through newborn screening.
No private insurance requirements were found in Alabama, District of Columbia, Georgia, Idaho, Illinois, Iowa, Kansas, Michigan, Mississippi, Nebraska, North Carolina, Ohio, Oklahoma, South Carolina, Virginia, West Virginia, Wisconsin, and Wyoming.
Requirements range from mandates for private health insurers to provide medical food for one specified metabolic condition (e.g.
, PKU in Alaska and California) with those that require private health insurers to provide coverage for modified low protein foods (one form of prescribed solid modified foods) to treat any newborn screening disorder identified by the state program (e.g., Arizona). Typically, FDA approval for an agent translates into insurance reimbursement, which is a major problem since medical foods are not regulated by the FDA and therefore cannot receive approval. Therefore, patients/parents are required to work with their insurance carrier to educate them about the nature and necessity of the medical foods to have any hope of obtaining coverage and/or reimbursement.
How to best explain it to patients
Doctors who are practitioners of evidence-based medicine should keep in mind and emphasize the following to their patients when recommending and supervising medical foods:
- Medical foods are specially formulated and indicated for the management/treatment of your
- Medical foods require medical supervision, which is why you need to procure a doctor authorization code (DAC) that will be validated in order to receive the appropriate food (a “prescription” of sorts). In addition, you will be scheduled for a follow-up appointment.
- Medical foods are not dietary supplements or prescription medications.
- Medical foods are not regulated by the FDA, but are usually backed by scientifically credible evidence for their use.
- Medical foods are not always covered by health insurance.
Why would a medical food be best when combating eye-related problems?
Today, retinal disease is all too common and macular degeneration is the leading cause of vision loss/blindness in individuals over the age of 55. Researchers at Guardion Health Sciences offer Lumega-Z, the only vision-specific medical food created to replenish, restore, and maintain the macular pigment.
Previous studies have shown that the depletion of the macular pigment increases the risk of developing eye diseases such as macular degeneration.
Lumega-Z contains all three critical macular carotenoids (which comprise the macular pigment)—lutein, zeaxanthin, and meso-zeaxanthin—as well as a robust complex of 35 critical micronutrients with potent antioxidant activity.
Humans can neither synthesize nor obtain enough of the three critical carotenoids in a normal diet to maintain the macular pigment, which is why supplementation with Lumega-Z can effectively replenish the protective macular pigment and has the potential to prevent or alter the course of a disease such as macular degeneration.
Medical Foods – Natural Products Association
The Food and Drug Administration’s (FDA) Center for Food Science and Applied Nutrition regulates medical foods as a distinct category of food under the Orphan Drug Act. Medical foods contain highly purified, food-based therapeutic ingredients specially formulated for dietary management of specific diseases and/or conditions.
A “medical food” is “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, recognized scientific principles, are established by medical evaluation.
It should be noted that not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods.
FDA states that the distinguishing aspect of a medical food from foods for special dietary use is the requirement that a medical food be intended to meet the distinctive nutritional requirements of a disease or condition.
FDA explains that “medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition,” but, instead, are a specially formulated food product for patients who require that product as part of a disease or condition’s dietary management.
Characteristics of a medical food as set forth by FDA include:
- It is specially formulated and processed, as opposed to a naturally occurring foodstuff used in its natural state, for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube (tube or catheter that delivers nutrients beyond the oral cavity into the stomach or small intestine);
- It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has 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;
- It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
- It is intended to be used under medical supervision; and
- It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
Finally, the claims on medical foods must be supported by competent and reliable scientific evidence.
In its finalized guidance on medical foods in May 2016, FDA stated that it “narrowly constrain(s)” this category of products. FDA’s medical food definition is so narrow that it only considers the following products as medical foods:
- Nutritionally complete or incomplete formulas
- Formulas for metabolic (genetic) disorders in patients over 12 months of age (ie. Phenylalanine-free formulations for phenylketonuria patients); or
- Oral rehydration products
FDA’s guidance also eliminates the potential use of medical foods for the dietary management of conditions pregnancy and diabetes. FDA believes that while there are nutrient requirements associated with these 2 states, they do not impose distinctive nutritional requirements.
Physicians use probiotics off-label at CFU quantities in the trillions for antibiotic associated diarrhea to prevent Clostridium difficile colitis. These are not considered medical foods, but yet they are probiotics found in dietary supplements and other foods.
Furthermore, these probiotics can’t be obtained and ingested by modification of the normal diet because one needs high quantities of a single or combination of probiotics.
These probiotics can only be ingested when manufactured and specially formulated to maintain their long-term viability.
NPA is committed to working with Congress and the Trump Administration in developing a broader and more transparent definition for medical foods with more examples. NPA believes the main goal should be for FDA to establish a clear path to market for this food commodity while utilizing the current state of nutritional science to benefit the health of all Americans.
NPA believes there is considerable science to substantiate the use of many dietary ingredients for disease conditions, and the population would benefit greatly.
Probiotics for antibiotic associated diarrhea is just one example where dietary ingredients can be used in a medical food to benefit patients, as long as the intended use and medical food claims can be substantiated in clinical trials.
Everything You Need to Know About Medical Food
(Photo : photo by Google)
Did you know that the concept of medical food has been around for years? Did you also know there are four main types, each with their own specific use? It's time to take the mystery medical food with our handy guide!
Food and Drug Administration Definition
The first thing to do in order to get a better understanding of what medical food actually is is to take a look at the FDA. The organization is responsible, in the US, for maintaining safety standards with regards to human and animal drugs, medical devices, and biological products. They also check cosmetics, food, and any products that emit radiation.
According to their Orphan Drug Act (orphan drugs being the name for medication related to drugs for rare or unusual diseases), medical food is specially processed food that's intended to meet specific nutritional requirements of a disease or condition.
As such, it has to be prescribed by your doctor – it cannot be bought over the counter. It's also different from dietary needs-related food, such as gluten-free products, as it's typically created to a strict and distinctive chemical formula.
Now we have a better understanding of the actual definition, let's look at the four main categories available.
Medical food can be:
1) a formula used as the sole form of nutrition for an individual
2) a “nutritionally incomplete” formula, which means it's missing an ingredient (e.g. protein) that a person's body is currently unable to process
3) oral rehydration products, which are medical equivalents to sports drinks that replace electrolytes.
4) formulas specifically designed to help manage particular medical conditions/diseases
Many, if not most, types of medical food are marketed under brand names that in some way, reflect the active ingredients. These are a few of the most common, and what they're typically used for.
Specially designed for people suffering from fat malabsorption (e.g., inflammatory bowel disease, cystic fibrosis, HIV infection). This is a nutritionally complete liquid that provides a patient with an easily absorbed fat blend of vitamins and minerals. This product is known by different names outside the US.
Created using Palmitoylethanolamide (PEA), which is a fatty acid usually created by the human body. It can be used by people whose bodies either don't produce enough PEA naturally or suffer from chronic/neuropathic inflammation and pain. Look here for further info on its myriad of uses.
Typically used by those suffering renal failure. Renax is a nutritionally incomplete formula with the primary aim to replace and replenish vitamin and mineral deficiency in a patient. It's also linked with ergocalciferol, a form of vitamin D2.
A calorically dense liquid formula (i.e. has a very high-calorie count) most often used to treat inflammation in patients with severely limited food intake. Chiefly for the critically ill or mechanically ventilated patients. The most common conditions Oxepa can be used to treat include SIRS (systemic inflammatory response syndrome and ARDS (acute respiratory distress syndrome).
The FDA Paradox
Despite the fact that the FDA has a precise classification for what constitutes as a medical food, they don't actually regulate them; they're not technically a drug, since many incorporate natural products in their formula.
Instead, they're graded many food additives (including pepper, vinegar, and chemical preservatives) as to whether they're Generally Recognized as Safe (GRAS). For the FDA to grant this classification, the producer of the additive/medical food has to put the ingredient through similar safety tests as drugs (e.g. to make sure it won't cause awful side effects).
For this reason, medical food falls into a kind of gray area, wherein a physician should prescribe it, but you may encounter related products (e.g. isotonic sports drinks) in your local supermarket. This is why you may notice such products are often labeled with disclaimers along the lines of consulting a medical professional if you intend to use the product therapeutically.
Medical food should only be used if it's been prescribed to you.
There are cheap alternatives to many of the products mentioned here, but as a general piece of advice, they should be avoided (they may not be classified as GRAS).
Finally, it's not an actual cure for anything; instead, it's designed to help alleviate pain or make a disease/condition more manageable to live with.
See Now: What Republicans Don't Want You To Know About Obamacare
The Truth About Medical Foods
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Have you ever looked at a label and noticed the term medical food? Although medical foods have been around for decades, many healthcare professionals may not recognize this term, as it was not part of our standard medical training.
In addition, the medical food category is one that is growing.
As these therapeutic medical foods become more and more popular it is our responsibility as healthcare professionals to understand what they are, their significance, and how they compare to functional foods.
According to the U.S.
Food and Drug Administration (FDA), a medical food is defined in the Orphan Drug Act as “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, recognized scientific principles, are established by medical evaluation.” In other words, a medical food must be labeled for a specific medical disease or condition that has distinctive nutritional requirements. Inherent in this definition is the fact that medical foods are not meant for use by a healthy person and their use is intended to be under medical supervision. In addition to these requirements, all medical food ingredients must be considered Generally Recognized as Safe (GRAS), which provides a standard of safety through qualified expert evaluation, published research, and corroboration from other data sources. Medical foods therefore have undergone toxicology studies and multiple human clinical trials in order to prove efficacy and safety.
Although functional foods can be beneficial and easy for people to obtain and sustain, they do not require the same rigor in efficacy-based research and safety studies as do medical foods.
As integrative practitioners, we all recommend the use of food in its natural state to support specific conditions, and so you may be wondering, “What’s the big deal about a medical food?” A medical food is specifically formulated for ill patients who require the food as a major part of their treatment. In certain circumstances it may be best to recommend a food in its natural state, for example when offering lifestyle preventative counseling. Although constructing a therapeutic diet for patients is a vital part of most treatment protocols, this alone may not be enough for some people with a serious illnesses. Whenever a patient’s condition requires nutritional nourishment that extends beyond the capacity of their diet, the addition of a medical food with its additional macro and micronutrients, vitamins, and minerals may be indicated.
Another term commonly mentioned in the healthcare industry is “functional foods.” This is an industry term, as there is not a defined set of regulations specific to functional foods. So-called functional foods are regulated as a food.
Functional foods are essentially foods fortified with vitamins, minerals, macro and micro nutrients (eg, vitamin D-fortified milk, probiotic-fortified yogurt). Although functional foods can be beneficial and easy for people to obtain and sustain,they do not require the same rigor in efficacy-based research and safety studies as do medical foods.
In addition, functional foods cannot make specific substantiated condition and disease claims as can medical foods.
Medical foods can come in a variety of forms, such as powders, liquids, and even gum.
Although medical foods can be used as an acute critical care therapy, such as enterally administered lifesaving nutrients during an inpatient visit, they are more commonly used to slow the advance of chronic conditions and diseases through long-term use in an outpatient setting. As medical food manufacturers continue to expand their offerings it is important for us to expand our knowledge of their potential in our practices.
* I would to acknowledge the significant help of Christine Toomasi, ND, in researching and writing this article.
Making Sense of Medical Foods
April 2017 Issue
Making Sense of Medical Foods
By Densie Webb, PhD, RD
Vol. 19, No. 6, P. 40
Learn about what they are, the different types for various diseases, and how they're regulated.
Hear the term “medical foods” and you're ly to think of special formulas for those with inborn errors of metabolism, such as phenylketonuria (PKU), an inherited condition in which the body can't metabolize the amino acid phenylalanine, or maple syrup urine disease, in which the body can't metabolize branched-chain amino acids. To be sure, formulas for such conditions are a large part of the medical foods category, but the category has expanded and changed far beyond what it was in 1958 when Lofenalac, Mead Johnson's infant formula for infants born with PKU, was introduced as a drug.
Today, medical foods have been developed for patients with malabsorption caused by Crohn's disease, ulcerative colitis, gastroesophageal reflux disease, chronic intestinal pseudo-obstruction, insomnia, ADHD, or inherited diseases of amino acids and organic acids.
Medical foods are considered neither drugs nor dietary supplements and aren't regulated as either one.
They are their own category of products and since 1988 have been defined by the FDA as “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, recognized scientific principles, are established by medical evaluation.” They aren't simply foods recommended by a physician as part of an overall diet to manage symptoms or reduce the risk of a disease or condition. New industry guidance addressing medical foods was published in May 2016 reestablishing this as the definition.1
Medical foods generally fall into one of the following three categories:
• products with a full complement of nutrients except the offending nutrient (eg, phenylalanine or tyrosine), including Lofenalac, Ketonex-2, or Propimex; • modular products, such as ready-to-drink beverages, tablets, and amino acid mixtures, including GlutarAde and Foltx; and
• low-protein foods that range from baked goods, pasta, and rice, to meat and cheese substitutes as well as snack foods.
Chronic illnesses, such as diabetes or obesity, or diseases that result from nutrient deficiencies, such as scurvy or pellagra, for which modifications in a regular diet can treat the disease, aren't considered conditions for which medical foods can be labeled and marketed.
The regulation of medical foods is a hybrid of that for prescription drugs and dietary supplements, though it's much closer to supplements than drugs. Medical foods are exempt from federal nutrition labeling requirements and those for health claims.
Although medical foods are designed to be used only under the supervision of a physician, and can be labeled as such, labeling them as “Rx only” isn't allowed.
Despite their similarity to prescription drugs, they aren't classified as drugs and aren't subject to drug approval requirements, such as clinical testing for efficacy, premarket review, and FDA approval. Instead, all ingredients in a medical food must be on the FDA's Generally Recognized as Safe list.
On the other hand, according to Kathryn Camp, MS, RD, CSP, former senior scientific policy analyst and scientific policy analyst to the Office of Dietary Supplements at the National Institutes of Health, infant formulas for inborn errors of metabolism are considered medical foods, but are regulated as infant formulas. Per the FDA's Office of Food Labeling and Nutrition, there's no federal requirement that prevents medical foods from being in pill or capsule form. Neither does the FDA maintain a comprehensive list of medical food products on the market. However, any facility that manufactures, processes, packs, or holds medical foods intended for consumption in the United States must register with the FDA and follow current good manufacturing practice regulations, which are enforced by the FDA.
And while medical foods aren't considered drugs, most labels on medical foods state, “must be used under the supervision of a physician,” but the statement isn't required and, paradoxically, a physician's approval for use isn't required for some online products labeled as “medical foods.”
Just as complex as the definition and regulatory oversight, or lack thereof, of medical foods is insurance coverage for patients.
“Insurance coverage is probably the biggest challenge for patients needing medical foods because reimbursement is highly variable,” says Marina Chaparro, MPH, RD, CDE, a pediatric dietitian and spokesperson for the Academy of Nutrition and Dietetics. “Currently, there are no federal laws to mandate consistent coverage for medically necessary foods.
Some insurance policies will cover a medical food only if it's demonstrated to provide 50% of total energy needs.
” Generally, however, while a physician's order isn't necessary to purchase a medical food, a physician must issue a written order that a medical food or formula is medically necessary for treatment for it to be covered by a health insurance policy.
Even when covered, essential medical foods are sometimes categorized as “second-” or “third-tier” drugs and have high out-of-pocket costs. However, several states have passed legislation mandating a limit on out-of-pocket costs for specialty medications such as these. These limits range from $100 to $500 per month per medication, depending on the type of plan. Insurance companies are more ly to cover medical foods for inborn errors of metabolism than for, say, medical foods for sleep or ADHD.
In a 2013 survey, families requiring medical foods reported purchasing them primarily from pharmacies (34%), hospitals/clinics (18%), health departments (14%), and medical supply companies (12%). The survey also found that insurance companies often terminated coverage for these specialized products at age 21. In addition, Medicare Part D excluded the coverage of amino acid supplements.2
According to Camp, “While medical food companies have a history of providing products in critical situations (eg, during pregnancy and for newly diagnosed patients), this practice is primarily a stopgap measure until coverage can be established.
” Health insurance has changed dramatically since 2013 and is predicted to undergo another sea change in the near future, making it difficult to counsel clients on how to obtain and pay for these specialized products.
Annual costs for medical foods for an individual can range from $3,600 for an infant requiring infant formula to more than $26,000 for an adult male or a pregnant woman.3 Some companies, such as Cambrooke Therapeutics, have dedicated teams to help customers obtain insurance reimbursement coverage.
Where to Get Help
“Manufacturing companies of specialized formulas, such as Nestlé, Abbott, Nutricia, and others, offer assistance programs that teach parents how to advocate and obtain insurance coverage,” Chaparro says. Nonprofit organizations such as the Oley Foundation, provide donated supplies and specialized formulas to children and families in need of specialized enteral supplies for medical foods.
The Center for Advancing Health Policy and Practice at Boston University's School of Public Health provides a state-by-state listing of mandates for coverage that was current as of November 2016.
Extensive state-to-state differences exist in diagnoses covered, types of products and supplies covered, age and benefit limits, and individual mandates for private insurance coverage.
Findings include the following:
• Six states have legislation specifically for medical foods required for children with PKU; five Medicaid programs only cover PKU, and two WIC programs and three Title V programs (federal/state programs to improve the health and well-being of women, particularly mothers, and children) cover only PKU;
• 35 states have legislative mandates for employer-sponsored insurance coverage of medical foods for genetic inborn errors of metabolism such as PKU, galactosemia, and maple syrup urine disease;
• 34 states provide coverage of medical foods through their Title V/CSHCN (Child with Special Health Care Needs) or other programs; and
• the language and vocabulary used in state statutes and legislation is highly variable and doesn't always conform to clinical norms.
NORD, the National Organization for Rare Disorders, provides up-to-date information on where individual states stand on coverage of medical foods and provides links and information on getting involved with advocacy.
For dietitians who counsel clients and patients, especially those who are newly diagnosed or have children who are newly diagnosed, it's important to be aware of and to understand the complex network of products, insurance providers, and nonprofits that are there to offer assistance. For many people, medical foods are a lifeline; doing without them isn't an option. It's also important to recognize and understand that not all products labeled as “medical foods” fall into the same category of need and to know the difference.
— Densie Webb, PhD, RD, is a freelance writer, editor, and industry consultant based in Austin, Texas.
1. US Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition. Frequently asked questions about medical foods; second edition — guidance for industry. https://www.fda.gov/downloads/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/UCM500094.pdf. Published May 2016.
2. Berry SA, Kenney MK, Harris KB, et al. Insurance coverage of medical foods for treatment of inherited metabolic disorders. Genet Med. 2013;15(12):978-982.
3. Therrell BL Jr, Lloyd-Puryear MA, Camp KM, Mann MY. Inborn errors of metabolism identified via newborn screening: ten-year incidence data and costs of nutritional interventions for research agenda planning. Mol Genet Metab. 2014;113(1-2):14-26.
These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods | News & Insights | Arnall Golden Gregory LLP
FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
The violations were discovered during FDA’s inspection of the facility.
FDA said that four of the manufacturer’s products did not meet the definition of a medical food and were instead unapproved new drugs, misbranded conventional foods, and misbranded dietary supplements.
A medical food is defined under the Orphan Drug Act as:
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, recognized scientific principles, are established by medical evaluation
FDA’s regulations also provide criteria that a product must meet in order to be considered a medical food. FDA considers the medical food definition to be very narrow. The product must be:
- Specially formulated and processed, rather than a naturally occurring food;
- Consumed by oral intake or via feeding tube; and,
- Intended to be used under medical supervision (note: this does not mean medical foods can only be dispensed under a prescription, although many are).
Most importantly, a medical food must be intended for the dietary management of a specific disease or condition, the dietary management of which cannot be achieved by the modification of the normal diet alone. In order to meet this requirement, the product must:
- Be intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements; and
- Provide nutritional support specifically modified for management of the unique dietary needs of a particular disease or condition.
The Warning Letter
The products at issue are nutritional flakes, liquid protein, and liquid fiber that are promoted as medical foods for use by persons with numerous conditions, including combinations of: pressure ulcers, hypoalbuminemia, protein calorie malnutrition, poor appetite, trauma, muscle wasting associated with cancer and AIDS, immune dysfunction, dialysis, bariatric surgery, chronic constipation, bowel irregularity, irritable bowel syndrome, diverticulitis, and diarrhea. FDA stated it was “not aware of any distinctive nutritional requirements” for individuals suffering from these conditions, meaning the products as promoted did not meet the definition of a medical food.
FDA also stated that the four products included claims that the products were intended for use in the cure, mitigation, treatment, or prevention of disease, which are drug claims, and because the products are not generally recognized as safe and effective for treating these conditions, they are considered unapproved new drugs under the FDCA. Additionally, FDA said they are misbranded because they do not bear adequate direction for use.
The claims FDA pointed to as drug claims include:
- “Helps to relieve chronic constipation, bowel irregularity, irritable bowel syndrome, and diverticulitis”
- “Helps against Hemorrhoids, Diverticulitis, IBS, and lowers Cholesterol”
- “Shorten and Control Diarrhea from the Start”
FDA goes further and states that even if three of the four products were not unapproved new drugs, they would still be misbranded conventional foods.
Those three products were labeled with inaccurate nutrition facts, including inaccurately calculated calorie information and an improper use of the “Sugar Free” nutrient claim.
FDA went on to provide numerous comments outlining what the manufacturer should change in order to market these products as conventional foods. The fourth product, FDA stated, is a misbranded dietary supplement because it fails to comply with numerous Supplement Facts labeling requirements.
- FDA has made it clear in this warning letter that it intends to enforce a narrow reading of the definition of medical food. Manufacturers should keep in mind that general nutrition or health claims will not fulfill the requirement that there be a specific dietary need of a particular disease or condition that the medical food is intended to meet. Similarly, foods that are recommended as part of an overall diet to manage symptoms or reduce the risk of disease would not meet the definition of a medical food.
- Medical foods fall under FDA’s food regulations, rather than the drug regulations. However, medical food manufacturers should be aware that if there is an insufficient connection between their product and the specific nutritional requirements of a specific disease, the claims may lead to the product being considered an unapproved new drug that is also misbranded.
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