To Whomever in Need

Excerpts of Regulations and Information on

Medical Food Products

to which our Product Series Apply

 

‘Providence Medical Food’ is formulated and processed in conformity to the following criteria that clarify the statutory definition of a medical food in FDA’s regulations at 21 CFR 101.9(j)(8) below：

a. It is a specially formulated and processed product (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, meaning a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine;

b. 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;

c. 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;

d. It is intended to be used under medical supervision; and

e. 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.

 

Q. How does FDA interpret

“under the supervision of a physician”?

1. FDA considers the requirement that a medical food be

formulated to be consumed or administered enterally under the supervision of a physician to mean that the intended use of a medical food is for the dietary management of a patient receiving active and ongoing medical supervision (e.g., in a health care facility or as an outpatient) by a physician who has determined that the medical food is necessary to the patient’s overall medical care. The patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food as part of the dietary management of a given disease or condition.

 

Q. What is IEMs?

What is the expected role of the medical diet for those diseases and conditions ?

 

1. FDA generally considers IEMs to be diseases or

conditions that a medical food could be used to manage.

As well as IEMs which are inherited biochemical disorders, errors of metabolism are a specific enzyme defect interferes with the normal metabolism of protein, fat, or carbohydrate. As a result of diminished or absent enzyme activity in these disorders, certain compounds accumulate in the body to toxic levels, and levels of other compounds that the body normally makes may become deficient (Ref. 1). Without appropriate and accessible management, these metabolic disturbances can lead to a host of medical and developmental consequences ranging from intellectual disability to severe cognitive impairment and even death (Ref. 1). Management may include one or a combination of the following: drug therapy, modification of the normal diet, or use of a medical food.6

Some of these disorders can be managed with modification of the normal diet alone (e.g., reduction of galactose and lactose for galactosemia). However, others cannot be managed solely with diet modification.

However, these conditions primarily require significant restriction and/or facilitation of particular amino acids and/or total protein.

For these IEMs and metabolic errors, a medical food is required in addition to a specific dietary modification in order to obtain adequate levels of essential nutrients (e.g., essential amino acids, essential fatty acids). In this regard, medical foods become indispensable for individuals with these IEMs and metabolic disorders to meet the daily requirements of essential nutrients and to limit the metabolic disturbances associated with the particular IEM and errors in metabolism.  (e.g., see question 21).

 

Conclusion 

And as provided herein, is our medical food, in hope of its effects in some of those specific diseases that involve amino acid/protein metabolism.

 

Note：“This product may mitigate a specific disease or diseases, but is not intended to diagnose, treat, cure, or prevent any disease.”