Frequently Asked Questions

Below are some of the frequently asked questions about Medical Food products. If you have additional questions you can contact us via email or telephone. (link to contact page)

1. Do Medical Food products require a prescription?
2. Why have I not heard about Medical Food products?
3. Are Medical Foods safe?
4. Are Medical Food products effective?
5. Do Medical Food products contain a specific class of ingredients?
6. Are Medical Food products regulated by FDA?
7. What are Medical Foods?
8. What are the differences between Medical Foods and dietary supplements?
9. Are there clinical data supporting Medical Food products?
10. What side effects have been observed in clinical practice?
11. Which patients should not use Medical Food products?
12. Have there been any adverse interactions between Medical Foods and drugs?
13. How are Medical Foods manufactured?
14. Are Medical Foods reimbursed?
15. How can my patients obtain Medical Food products?
16. What is the difference between a Medical Food and Rx Drug?
17. Are there on-going clinical studies on Medical Food products?
18. What are other examples of medical food products?
19. How does the physician determine the nutritional requirements of a disease state?
20. Should Medical Foods be taken with or without other foods?

1. Question: Do Medical Food Products Require A Prescription?

Answer: Yes, Medical Food products require a prescription because they are designed to be used in patient populations with disease states. Medical Food products are sold as Rx only products. The Medical Food FDA regulatory class requires that the products be used while a patient is under the ongoing supervision of a physician. The Rx only label insures ongoing physician supervision. Medical Food products are distributed through physician’s offices and retail pharmacies.

2. Question: Why Have I Not Heard About Medical Food Products?

Answer: Although Medical Foods have been used in the United States for decades, they are poorly understood as a product category. Confusion about their classification and regulation derives in part from the fact that these products were regulated as drugs prior to 1988. The word "food" in "Medical Food" may contribute further to category confusion.

3. Question: Are Medical Food Products Safe?

Answer: All Medical Food product ingredients have been designated as GRAS (Generally Recognized As Safe) according to strict FDA (Food and Drug Administration) standards. The standards for an ingredient to achieve GRAS status require not only technical demonstration of non-toxicity and safety, but also general recognition and agreement on that safety by experts in the field. Ingredients in conventional foods in the U.S. also hold GRAS status and are therefore considered safe for public consumption. Many supplement and food ingredients with widely accepted therapeutic benefits have been approved as GRAS ingredients, such as Folic acid, Vitamin C and Calcium. The GRAS status of each ingredient also evidences safety, as determined by consumption by wide geographic and demographic populations over long periods of time.

In clinical experience over a five year period, Physician Therapeutics’ Medical Food products have been shown to have an extremely low side effect rate. To date, the number of side effects reported by physicians and patients that might have been related to our Medical Food products has been less than 0.1% , exceptionally low compared to most other prescription products.

4. Question: Are Medical Food Products Effective?

Answer: The effectiveness of our Medical Food products has been validated using a variety of methods. The original formulas are created using an extensive review of the peer-reviewed, published literature. Prototype products are subject to physiologic and clinical testing using a crossover study design. Final product formulas are validated for efficacy using double-blind controlled trials. Placebo controlled trials are performed where ethical.

5. Question: Do Medical Food Products Contain A Recognized Class Of Ingredients?

Answer: The Company's products are fundamentally based on neurotransmitter science. Cell communication particularly nerve cells depend on the release and reuptake of neurotransmitters. The most important neurotransmitters include acetylcholine, serotonin, nitric oxide, norepinephrine and dopamine. Each of these neurotransmitters is produced by conversion of an essential amino acid into the neurotransmitter. Acetylcholine is produced from choline. Serotonin is produced from tryptophan. Nitric oxide is produced from arginine. Dopamine and norepinephrine are produced from tyrosine.

The company's products are based on these essential amino acids. Amino acids are the building blocks of blocks of proteins and are the foundation of life, health, and cognition. The Company's products are based on this class of ingredients.

6. Question: Are Medical Food products regulated by FDA?

Answer: Yes, Medical Food products are regulated by FDA. Physician Therapeutics products meet the standards and requirements set forth by FDA to define its regulatory product class, Medical Foods. All products are also subject to manufacturing facility inspections, including product and label reviews by FDA.

7. Question: What are Medical Foods?

Answer: Medical Foods are a specific category of therapeutic agents created under the Orphan Drug Act of 1988, which separated medical foods from drugs for regulatory purposes. Products in this category share the requirements that they are intended for the nutritional management of a specific disease, are used under the supervision of a physician, and contain ingredients that are generally recognized as safe (GRAS). An example of Medical Foods is formulations intended to manage patients with inborn errors in amino acid metabolism. Newer medical foods are designed to manage hyperhomocysteinemia, pancreatic exocrine insufficiency, inflammatory conditions, cancer cachexia, and other diseases.

8. Question: What Are The Differences Between Medical Food And Dietary Supplements?

Answer: Medical Food products are NOT dietary supplements. Relatively few medical professionals are familiar with the actual statutory definition of Medical Foods Perhaps most importantly, Medical Food products must be used while the patient is under physician supervision whereas dietary supplements are consumer products. From a medical perspective, the differences between medical food and dietary supplement product classifications are as follows:

	MEDICAL FOODS	DIETARY SUPPLEMENTS
INTENDED USE	Nutritional or dietary management of a specific disease (e.g., sleep disorders).	To support the structure and function of normal, healthy physiology (e.g., maintain restful sleep).
SAFETY	Ingredients must be GRAS (Generally Recognized As Safe)	Ingredients are considered safe as evidenced by having been sold or widely used in the U.S. market prior to October, 1994.
CATEGORY OF USER	A patient who is under the care of a physician and has distinctive nutritional requirements of a specific as assessed by medical evaluation and determination.	Normal, healthy adult
EFFICACY & CLINICAL and/or SCIENTIFIC SUPPORT	The distinctive nutritional requirements of the specific disease and its response to the Medical Food product must be assessed by medical evaluation and determination.	No requirements for pre-market approval.
MEDICAL CARE	Must be used while the patient is under the ongoing care and supervision of a physician.	No requirements for medical care. Products are sold directly to consumers.

9. Question: Are There Clinical Data Supporting Medical Food Products?

Answer: Yes, strong clinical and scientific data support the Physician Therapeutics Medical Foods products. Clinical trials include crossover trials using clinical scales or physiologic endpoints, open label clinical studies and double-blind placebo-controlled trials. These studies for individual products are available upon request.

10. Question: What Side Effects Have Been Observed In Clinical Practice?

Answer: The side effect profile of Physician Therapeutics Medical Food products is comparable to the rate of food intolerance in the community. The product ingredients are derived from nutrient based compounds found in the normal food chain. Food intolerance is an adverse reaction to food that does not involve the body's immune system.

When first starting any therapeutic regime containing amino acids, some people complain of mild headaches, nausea, or mouth dryness. These symptoms are mild and temporary and can be managed by drinking plenty of fluids and carefully adjusting the dose. These side effects are relieved by lowering the dose initially and slowly increasing until reaching the recommended dosing level.

11. Question: Which Patients Should Not Use Medical Food products?

Answer: Patients who have a know allergy to any of the product ingredients should not take these products. Patients who are on MAO inhibitor drugs should avoid products containing tyrosine.

12. Question: Have There Been Any Drug Interactions with Medical Food products?

Answer: The Company’s Medical Food products do not alter the pharmacokinetics of drugs. No adverse drug interactions have been observed.

13. Question: How Are Medical Food Products Manufactured?

Answer: Physician Medical Foods products are manufactured to FDA’s cGMP (current Good Manufacturing Practices) as required by FDA regulation.

14. Question: Are Medical Foods Reimbursed?

Answer: Medical Foods and Convenience Packed Medical Foods with generic drugs are covered by many major health care plans, such as Aetna, United, Humana, Cigna Wellpoint, numerous Blue Cross/Blue Shields and many others.

15. Question: How Can My Patients Obtain Medical Food Products?

Answer: The Company's Medical Food and Convenience Packed Pharmaceuticals products are available through physicians’ offices or selected retail pharmacies.

16. Question: What Is The Difference Between A Medical Food And An Rx Drug?

	MEDICAL FOODS	Rx DRUG
INTENDED USE	For the dietary management of the metabolic process of a specific disease	To cure, treat, prevent or mitigate a specific disease or symptoms of disease.
SAFETY	Ingredients must be GRAS (Generally Recognized As Safe)	Drug ingredients do not have to be GRAS listed. All drugs must be pre-approved by FDA for safety
EFFICACY & CLINICAL and/or SCIENTIFIC SUPPORT	The distinctive nutritional requirements of the specific disease and its response to the Medical Food product must be assessed by medical evaluation and determination.	The efficacy and disease specific claims must be supported by clinical/scientific studies and pre-approved by the FDA
PRESCRIBING & DISPENSING	Must be used under a physician’s supervision.	Must be used under a physician’s supervision.
MANUFACTURING	FDA Good Manufacturing Practices for foods are required.	FDA Good Manufacturing Practices for drugs.

17. Question: Are There On-Going Clinical Studies On Medical Foods?

Answer: Several clinical studies are in progress on the Company's Medical Food and Convenience Packed Medical Food and generic drug products.

18. Question: What Are Other Examples Of Medical Food Products?

Answer: Medical Food products are not new. They have been widely used in hospitals, but have had relatively low awareness as a class of products among physicians, until recently.

EXAMPLES OF PRESCRIPTION MEDICAL FOODS
PRODUCT	USES	KEY INGREDIENTS	FORM
Ultrase MT® NDC 5814-045-10 Axcan Pharma www.axcan.comm	Exocrine pancreatic insufficiency caused by cystic fibrosis, chronic pancreatitis, steatorrhea	Lipase Protease Amylase	Enteric coated capsules
Conison™ Capsules NDC 58177-0044-03 Ethex (KV Pharm) www.ethex.com	Pernicious anemia, megaloblastic anemias	Intrinsic factor Vitamins B12 & C Folic acid Iron fumarate	Capsules
Renax® NDC 0642-2746-90 Everett Labs www.everettlabs	End stage renal disease, renal insufficiency	Chromium Selenium Zinc Vitamin E Folic acid Cyanocobalamin (B12) Pyridoxine (B6)	Caplets
Folgard RX 2.2 NDC 0245-0016-11 Upsher-Smith www.upsher-smith.com	Elevated homocysteine	Folic acid Cyanocobalamin (B12) Pyridoxine (B6)	Tablets
Cerefolin™ NDC 0525-0503-90 Pan American Laboratories www.cerefolin.com	Mild to moderate cognitive impairment, vascular dementia, Alzheimer’s disease	L-mehtylfolate Riboflavin (B2) Pyridoxine (B6) Cyanocobalamin (B12)	Tablets
BCAD 2 NDC 0087-008341 Mead Johnson www.meadjohnson.com	MSUD, other errors of branched-chain amino acid metabolism.	Hydrolyzed guar gum Soy lethicin Potassium Calcium Magnesium Vitamin E Folic acid Niacin	Powder

19. Question: How Does The Physician Determine The Metabolic Requirements Of A Specific Disease State?

Answer: The distinctive nutritional requirements of disease are medically determined. The physician uses either a clinical endpoint validated by an approved clinical scale or by a physiologic endpoint. For example, the pain of low back pain is validated using either a visual analogue scale, Likert scale, or a Randall Morris scale. Hypertension is evaluated by measurement of blood pressure. Asthma is evaluated by the measurement of FEV1. Sleep disorders are evaluated by either visual analogue scales or Likert scales. In addition, physicians can directly measure the amino acid concentrations in blood. The blood of evaluation of arginine, tryptophan and choline levels is particularly effective.

20. Question: Should Medical Food Products Be Taken With Or Without Other Foods?

Answer: Medical Foods are most effective when take one hour before or after meals, or between meals, to help increase the absorption of key ingredients into the blood. See Prescribing Information for specific administration and dosing recommendations.