• A Unique FDA Category
• Common Medical Foods
• Not a Supplement
• GRAS Ingredients Explained
• Medical Food Claims
• Prescription Status
• FDA Medical Food Status

LacPro Products Medical Foods Antibiotic Assist™ is a 8-oz. drinkable, highly active probiotic medical food that is specially formulated and processed for the dietary management of Clostridium difficile Infection (CDI). Antibiotic Assist™ is intended to be used under the supervision of a physician.

Therapeutic, Probiotic Nutrition for Clostridium difficile Infection Antibiotic Assist™ is a ready-to-drink medical food for patients and residents who need dietary management of Clostridium difficile Infection. For tube or oral feeding - may be diluted with normal saline For supplemental or sole-source nutrition (especially as a breakfast meal replacement) Not for parenteral use Use under medical supervision For Real Patients - 7g protein, 132mg Sodium, 356mg potassium per 8oz bottle. Features No side effects Lactose Reduced - Less than 0.05% per 8 OZ bottle. Safe for the lactose intollerant not. Not for use by individuals with a true milk allergy. Low carb - 19g per 8 OZ Contains at least 35 billion units of Lactobacillus delbrueckii spp. bulgaricus B-30892 (LDB B-30892) at the time of consumption.  LDB B-30892 is toxigenic to Clostridium difficile and it helps modulate inflammation and support immune function.

Nutrition Information Nutrition Information for 8 FL OZ Antibiotic Assist™ Ingredients Vanilla Cultured Reduced Fat Milk (Pasteurized Grade A Reduced Fat Milk, Non Fat Dry Milk, Modified Food Starch, Pectin, Dextrose, Lactase Enzyme (to reduce Lactose), Live bacterial cultures*), Flavor Base (Crystalline fructose, modified food starch, natural and artificial flavors and colors, potassium sorbate and sodium benzoate (as preservatives), sucralose and sodium citrate). *Contains live and active Lactobacillus delbrueckii B-30892 and Streptococcus thermophilus. Contains at least 35 billion units of LDB B-30892 at the end of shelf life.   Contains dairy (milk and milk products such as non fat dry milk).

Medical foods are not new but because medical food products have been predominantly used in hospitals and other institutional care settings as enteral nutrition products, many health care professionals have a limited understanding of the term “Medical Food.” As created by the Orphan Drug Act Amendments of 1988, the FDA category “Medical food” is defined, at 21 U.S.C. §360ee (b)(3), as “a food - which is specially 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.”

Antibiotic Assist™ is a Medical food for the dietary management of Clostridium difficile Infection (CDI), also called Clostridium difficile associated disease (CDAD).  Antibiotic Assist™ is neither a drug, nor a dietary supplement.

By statutory and regulatory definition, product claims must be explicitly different for Medical Foods as compared with foods, dietary supplements, or drugs. Generally, Medical Food claims reference the “dietary management” or “distinctive nutritional requirements” of a particular disease, whereas drug claims reference “curing, treating, preventing or mitigating” a particular disease, while food or dietary supplement structure/function claims reference “supporting” healthy function of the body or particular body organ or system.

Patients with CDI are shown to have distinctive nutritional requirements as a result of the change in their normal flora which cannot be met with a normal food, i.e., the need for a special formulation or process of a food. A Medical Food may claim the dietary management of CDI, whereas a drug may claim the prevention or treatment of CDI, while a food or a dietary supplement may claim the support of intestinal health. A Medical Food must meet the distinctive nutritional requirements of a disease through dietary management, whereas a drug may address the symptoms of a disease or its treatment or prevention of the disease.

Claims for both Medical Foods and drugs must be supported by solid laboratory and clinical 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 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.

The use of Medical Food, regulated by the FDA, represents an entirely different approach to managing diseases. For example, unlike drugs that often have associated toxic side effects, a Medical Food – that is a specially formulated food – is a safe way, void of side effects, to provide the dietary management of a disease.

A Medical Food is intended to be used under physician supervision for a patient with special medical nutritional needs, in order to manage a disease or health condition, through dietary or nutritional means and when the patient is under the physician’s ongoing care. Medical Foods are not meant to be used by the general public, or by normal healthy adults, and may not be available in stores or supermarkets. Medical Foods are not those foods included within a healthy diet intended to decrease the risk of disease, such as reduced-fat foods or low-sodium foods, nor are they weight loss products*.

Also note that in this simple explanation below, from the FDA’s regulation, the Agency states explicitly that “for the dietary management of disease” must be printed on the label. See reference below. The FDA’s Compliance Program Guidance Manual recognizes four major categories of medical foods:

1. 1. Nutritionally complete products


2. 2. Nutritionally incomplete formulas


3. 3. Oral rehydration products


4. 4. Formulas for metabolic disorders (FDA, 1999).

Indeed, a wide range of Medical Foods are used for medical management of various conditions, such as prevention of loss of body mass, to provide proper nutrition for special population groups, and to prevent, control, and/or alleviate acute, genetic, and chronic diseases. As such, CDI qualifies as an acute disease with distinct nutritional needs. In addition, the nutritional requirements of individuals with CDI change as a result of age, poor diet, oral health and gastrointestinal function, all of which can result in the need for special nutrients to manage or to balance the disrupted intestinal flora that is a hallmark of CDI. Medical Foods were designated to meet this need. They are a unique regulatory class with certain special requirements.

*Medical Foods, from Office of Special Nutritionals, May 1997

Some examples of Medical Foods are: special infant formulas, formulations for metabolic disorders, oral rehydration products or products for chronic diarrhea, and special nutritional formulas for patients with diabetes, AIDS, kidney disease, or inborn errors in metabolism. Traditional Medical Foods are typically in the form of liquids or powdered drink mixes.

Below are just a few examples of traditional Medical Food products currently on the market:
Enlive!® - clear liquid nutrition that contains high-quality protein and essential nutrients for diverticulitis and Irritable Bowel Syndrome.  (Abbott Nutrition)

Ensure® - for Irritable Bowel Syndrome.  (Abbott Nutrition)

Optimental® - ready-to-feed formula for the dietary management of stress/trauma, Crohn’s disease, and malabsorptive conditions requiring elemental diets, and for patients who can benefit from supplemental arginine.  (Abbott Nutrition)

Peptamen® - for the dietary management of those with impaired gastrointestinal function. (Nestle Nutrition)

IMPACT® - medical nutrition for surgical and trauma patients. (Nestle Nutrition)

VSL#3® – a probiotic medical food for the dietary management of patients with ulcerative colitis (UC), an ileal pouch (IP), and irritable bowel syndrome (IBS).  (VSL Pharmaceuticals, Inc.)

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

• Medical Foods & Dietary Supplements are discrete FDA regulatory classifications, as defined by the Orphan Drug Act for Medical Foods and 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 OTC and are self-administered by the consumer.

• Medical Foods are specially formulated for a 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 Food 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.
  
  
• Medical Foods may be the sole nutrient or food of a patient group, e.g., terminal AIDS patients, whereas supplements may not be a meal replacement.
  
  
• Supplements as well as selected conventional foods are eligible to make certain qualified health claims (FDA pre-approved claims that a substance prevents or lowers the risk of a disease), whereas medical foods are not, given that they are intended for dietary management of an existing disease.

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. However, because Antibiotic Assist™ is a food, LacPro provides a complete ingredient declaration and a nutrition facts box on the product label.

The FDA prefers that Medical Foods be foods, as opposed to a supplement.  Thus, at a fundamental level, a Medical Food is as safe as a regulated food.  Antibiotic Assist™, a Medical Food, is a food with regulated food ingredients that are Generally Recognized As Safe (GRAS).

The category that describes all edible foods as GRAS was established in 1958 by the FDA as Food, Drug, and Cosmetic Act of 1938. The original GRAS list contained over 700 foods and food additives that had stood the test of time and of public consumption, and were believed to be harmless. Any food item in common use in the U.S. before 1958 is “grandfathered” in as GRAS. Understanding the GRAS status of Antibiotic Assist’s ingredients is important since this is a major qualification to be considered a safe and consumable Medical Food.

Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 CFR Sections 182, 184 and 186. Other ingredients may achieve self-affirmed GRAS status via a panel of experts who co-author a GRAS Report. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition and agreement on that safety by experts in the field.

Some experts believe achieving FDA recognized GRAS status is an even higher standard of safety than the standard applied to drug products where a given compound is considered safe for a particular indication in a particular patient population at a particular dose for a specified duration of use. While considered safe under these or similar limitations, most prescription drugs are not considered safe on a general (i.e., GRAS) basis. GRAS denotes safe use by sometimes millions of people, as food ingredients.

It is well-recognized that all drugs have some side-effects for some percentage of the population, and the concept of “safety” for pharmaceuticals is a relative assessment based on a risk/benefit analysis, such that a harmful drug for terminal cancer patients, for example, may still be approved. As such, drugs and drug ingredients are not GRAS, whereas Medical Foods have up-front inherent safety due to the GRAS requirement for all ingredients, and in some cases also based on centuries of traditional use of certain ingredients.  The ingredients in Antibiotic Assist™ meet the FDA’s standard of definition for a yogurt: a Lactobacillus bulgaricus and a Streptococcus thermophilus.  The particular strain and the specific formulation and processing of Antibiotic Assist™ are what make it a Medical Food but with ingredients that are GRAS and safe for your patients and residents.

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

Generally, foods and dietary supplements are limited to structure/function claims for normal body functions, e.g., maintain intestinal health.  Medical Food claims reference the “dietary management” or “distinctive nutritional requirements” of a particular disease, whereas drug claims reference “curing, treating, preventing or mitigating a disease. For example, a Medical Food may claim the dietary management of the CDI, whereas a drug may claim the prevention or treatment of CDI.

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 foods and dietary supplements must be supported by a substantiation file of scientific and clinical data.  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.

Both the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations require a medical physician’s supervision of the patient taking Medical Foods. 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(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 medical supervision on a recurring basis for instructions on the use of the Medical Food.

In a simple description of this category, on the FDA’s own website, “A Medical Food is prescribed by a physician when a patient has special nutrient needs in order to manage a disease or health condition, and the patient is under the physician's ongoing care.” In addition, the FDA states that generally, Medical Foods are not intended for use by the general public and should not be readily available at drug stores or supermarkets (FDA Medical Foods, 1997). This is why many Medical Food companies only offer their Medical Foods through prescription distribution. Additionally, over a dozen states have state laws which require prescription status for Medical Foods.

Given multiple federal and state requirements, as well as LacPro’s desire to market Antibiotic Assist™ as an ethical medical food based on recognized laboratory and clinical science, a prescription may be required to purchase Antibiotic Assist™. Importantly, federal law requires Medical Foods such as Antibiotic Assist™ to be administered to a diseased patient population under physician supervision, and by definition patients or residents of acute or long-term care facilities are under physician supervision.

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