Nationwide Medical Foods | Requirements for Physician Distribution of Products

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Medical Supervision and Regulations

Welcome to Nationwide Medical Foods Group and prescription based Medical Foods dispensing. This overview is designed to provide the practicing physician and others with background information regarding the category known as Medical Foods.

Medical Foods are not new, but because they have been predominately used in hospitals and other institutional settings many physicians have limited understanding of these products.

According to the Orphan Drug Act Amendments of 1988, the FDA category known as “Medical Foods” is defined, at 21 U.S.C. section 360ee (b) 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 management of a disease or condition for which distinctive nutritional requirements based on scientific principles are established by Medical evaluation.

Theramine™ is a prescription Medical Food product for the daily nutritional management of the metabolic aspects of pain and inflammation

Sentra AM™ is a prescription Medical Food product for the daily nutritional management of the metabolic aspects of Cognitive Disorders

Sentra PM™ is a prescription Medical Food product for the daily nutritional management of the metabolic aspects of Sleep Disorders associated with Depression

GABAdone™ is a prescription Medical Food product for the daily nutritional management of the metabolic aspects of Sleep Disorders associated with Anxiety

AppTrim™ and AppTrim D™ are prescription Medical Food products for the daily nutritional management of the metabolic aspects of Obesity Management

Hypertensa™ is a prescription Medical Food product for the daily nutritional management of the metabolic aspects of Vascular Function

Pulmona™ is a prescription Medical Food product for the daily nutritional management of the metabolic aspects of Pulmonary Function

MEDICAL FOODS MUST MAKE DIETARY MANAGEMENT CLAIMS

By statutory and regulatory definition, product claims must be explicitly DIFFERENT for Medical Foods vs. drugs vs. dietary supplements.

Generally speaking, Medical Foods claims reference the “dietary management” or “distinctive nutritional requirements” of a particular disease or the metabolic processes of that disease, where as drug claims reference “curing, treating, preventing or mitigating” the effects or symptoms of a particular disease, while dietary supplement claims reference “supporting” healthy function of the body or particular body organ or system.

Claims for both Medical Foods and drugs must be supported by solid laboratory and clinic data. But, by contrast, for a drug, the safety of the product and both the therapeutic claims and the ingredients must be pre-approved by the FDA through extensive clinical testing. Medical Foods have up-front safety obtained through the GRAS (Generally Recognized As Safe) status of the ingredients, including use of the Food or Food additive or component in perhaps millions of people, whereas drugs have unproven safety that must first be shown in animals and then be tested in human clinical trials, which typically exclude wider populations with various health problems.

Medical Food ingredients have GRAS designation, the highest FDA standard of safety given to Food. Most Medical Foods are also tested in clinical trials to confirm their “traditional use” safety.

The use of Medical Foods is regulated by the FDA, which represents an entirely different approach to managing diseases. For example, unlike drugs, Theramine does not treat or mask symptoms of pain and inflammation. Instead, Theramine manages the underlying metabolic process of pain and inflammation to restore the proper metabolic balance of inflammatory metabolites at the cellular level, and thereby promotes normal physiologic function.

MEDICAL FOODS ARE NOT DIETARY SUPPLEMENTS

A common mistake made by those not familiar with Medical Foods is to confuse them with dietary supplements, because both types of product have nutritional ingredients. Medical Foods and Dietary Supplements are NOT interchangeable.

Medical Foods and Dietary Supplements are discrete FDA regulatory classifications, as defined by the Orphan Drug Act for Medical Foods while Dietary Supplements are covered by the Dietary Supplement Health and Education Act (DSHEA) for Supplements.

Medical Foods require physician supervision (and thus institutional administration or a prescription or close outpatient monitoring). Whereas dietary supplements are sold Over-the-counter and are self-administered by the consumer.

Medical Foods are specifically formulated for the diseased patient population, whereas dietary supplements are intended for a healthy consumer population.

Medical Foods make Medical claims (i.e. to nutritionally manage the disease) whereas dietary supplements make structure/function claims (i.e., to support the healthy function of the particular body part or system) and are FORBIDDEN to make disease claims and drug claims.

Medical Foods ingredients have a higher standard of safety (GRAS-Generally Recognized As Safe per FDA standards) whereas Congress exempted dietary ingredients from the GRAS standard, requiring only that their ingredients either have a mere presumption of safety (i.e., were on the market as Foods or supplements prior to the passage of DSHEA in 1994), or a reasonable expectation of safety (shown through scientific evidence submitted 75 days pre-market).

Medical Foods must be first be shown, by Medical evaluation, to meet the distinctive nutritional needs of a particular patient population before they may be marketed, whereas supplements a) may not be intended, promoted or sold for a disease, and b) require no efficacy tests or trials pre-market.

While dietary supplements are governed by meticulous labeling regulations, including a detailed Supplement Facts box, there are virtually no labeling regulations for Medical Foods, and they are exempt from the nutrition labeling regulations required for conventional Foods.

While supplements and Medical Foods are both regulated by the FDA and the FTC, Medical Foods must be administered under physician supervision whereas dietary supplements have no such requirement.

MEDICAL FOODS AND THE Rx STATUS

Both the Federal Food and Cosmetic Act (“FDCA”) and FDA regulations require Medical physician’s supervision of the patient taking Medical Foods, 21 U.S.C. section 360eee(b)(3); 21 C.F.R. section 1010.0(j)(8)(iv)-(v). Specifically, similar to administration and consumption of prescription drug products, patients must use Medical Foods under a physician’s supervision, and patients should also receive frequent and continual use of the Medical Food or Foods prescribed by their physician.

Prescription status ensures the required physician supervision.

Given the multiple federal and state requirements, as well as Nationwide’s desire to market its Medical Foods products as ethical Medical Foods based on recognized laboratory and clinical science, a prescription is required to purchase our Medical Foods products.

Lastly, federal law requires Medical Foods such as Theramine and those listed above must be administered to a diseased patient population under physician supervision, which is the basis of prescription distribution and our Medical Foods.

MEDICAL FOODS vs. DRUG CLAIMS

By statutory and regulatory definition, product claims must be explicitly different for Medical Foods versus drugs.

Generally speaking, Medical Foods claims reference the “dietary management” or “distinctive nutritional requirements” of a particular disease, whereas drug claims reference “dosing, treating, preventing or mitigating” a disease or the effects or symptoms of a particular disease. For example, a Medical Food may claim the dietary management of the metabolic processes of pain and inflammation, where as a drug may claim the reduction of lower back pain.

A Medical Food must meet the distinctive nutritional requirements of a disease through dietary management, whereas a drug may address any aspect of a disease or its treatment or prevention.

Claims for both Medical Foods and drugs must be supported by solid scientific and clinical data. Their formulas and efficacy must be established by Medical determination.

For more information on how you can become a physician who dispenses Medical Foods in your practice, please contact us at 866-693-9593 or info@MedicalFoods.com.

Nationwide Medical Foods Group is a leading distributor of Medical Foods products and physician dispensing. We provide physicians with turnkey in-office Medical Foods and Generic Medication and Convenience packaged Medical Foods dispensing programs designed to benefit both the patient and the practicing physician community.