The FDA defines a medical food 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, based on recognized scientific principles, are established by medical evaluation."1
The FDA goes on to say "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."1
A medical food therefore, must be given under the supervision of a medial provider for a specific disease process.
Medical foods are not drugs and are not under the same guidelines as a pharmaceutical. They are treated more like a dietary supplement.
There are strict label requirements including:
Name of product
Complete List of ingredients in descending order of predominance
Name and location of business
,Medical foods also must comply with all the manufacturing guideline of any foods in the United States. This includes an FDA registered facility, current good manufacturing practices, and proper packaging.
What about a prescription?
This is an excellent question that comes up a lot especially for our products UreaAide packets and UreaAide unflavored. As these are medical foods and not drugs, a prescriptions is not necessary to purchase. We sell direct to consumers which actually saves money by cutting out the middle man (pharmacies). Having said that this also means getting medical foods covered by insurance can be difficult. Often, if covered, this would be under the medical benefit and not the pharmaceutical benefit.
Are medical foods a qualified Medical expense? Will my HSA/FSA/MSA cover it?
Medical foods are a tax deductible qualified medical expense with any tax differed health account. This is discussed in the publication 502 by the IRS.2
Herein they state the following criteria to meet coverage:
1. The food doesn't satisfy normal nutritional needs
2. The food alleviates, or treats an illness
3. The need for a food is substantiated by a physician
This is by definition a medical food such as UreaAide for the management of Hyponatremia (low sodium).
What about a National Drug Code number (NDC)?
This is interesting, the FDA actually states medical foods should NOT have a NDC number as this could be considered misleading to consumers, as they are not drugs.1
They go on to say:
"The presence of an NDC number on a food product that is not a drug misbrands the product under section 403(a)(1) of the FD&C Act. In addition, any representation that creates an impression of official FDA approval through the use of an NDC number in labeling constitutes misbranding.1
In closing medical foods are non-prescription supplements that can be purchased directly. They should be taken only under the supervision of a medical provider but must have certain labeling and manufacturing requirements. Medical foods are qualified medical expenses and any health saving account may be used to purchase. Medical foods may be covered by insurance companies but not typically. If they are covered it would usually be under the medical benefit and not the pharmaceutical benefit.
1. FAQ about medical foods second edition. FDA.
2. Publication 502. IRS. Qualified Medical Expenses
Reset osmostat is a sub-type of SIADH (type C in the nephrology literature). It is essentially your body having a higher threshold for low sodium. In other words your body will allow the sodium to run lower, to a lower set point than what is typical1. As you drink water, under normal circumstances, the body will suppress ADH and your kidneys will release that water, keeping blood sodium levels in a narrow range. In SIADH this does not occur and high water intake dilutes the sodium. In reset osmostat only as the sodium tracks closer to normal does that secretion of ADH take hold. Due to this those with reset osmostat tend to stay consistently in the 125-135 mEq/L serum sodium range. This is a new normal for that individual patient, and the system is still intact just at a lower set point. This phenomenon is actually a normal occurrence in pregnancy. Some clinical clues to the diagnoses of Reset Osmostat include1,2:
•Sodium in the 125-134 range for several days despite varying water and salt intake
•Fractional Excretion of Uric Acid in the normal 4-11% range
•Rule out primary polydypsia
•Greater than 80% of a water load (20 ml/kg) excreted in a 4 hour period (low urine osm)
The idea is this is asymptomatic and no definitive treatment is absolutely indicated. However most clinicians would still try to correct the sodium based on the fact that even mild Hyponatremia is correlated with significant morbidity and mortality.
1. Indian J Nephrol. 2019 Jul-Aug; 29(4): 232–234.
2. Ten common pitfalls in the evaluation of patients with hyponatremia Filippatos, T.D. et al.European Journal of Internal Medicine, Volume 29, 22 - 25
We realized we could really bring the cost down if we sold our same USP grade Urea but just left it unflavored.
Before KidneyAide there was only one company making one Urea in the entire US. We loved how well Urea worked to bring sodium levels up, but didn’t love the cost for our patients. This backdrop is the reason for our existence. Could we lower the cost and still provide a high quality product?
We were able to accomplish this goal with our UreaAide 15 gram premium natural mint flavored packets. We cut the cost to the consumer by 30%.
The hard part, however, is that for many that is still quite a bit of money as insurance often will not cover the cost. Given our simple mission to help lower the cost of Urea, we had to do more.
Recently we were testing some new flavors, mixing Urea with berry, chocolate and even coffee. We had some blue Gatorade powder and thought, wonder if we simply mixed Urea powder with Gatorade powder. The same kind you can buy at Walmart or Target. Well we had to admit, this tasted pretty darn good. We were impressed and realized, we could really bring the cost down if we sold our same USP grade Urea and just left it unflavored. When we asked our customers and showed them the over 60% cost savings plus they can chose any flavor they like, people were excited. UreaAide unflavored was born. 30 doses per bag with easy 15 gram dosing scoop. The Urea won’t clump as they are in microspheres not crystal form. The bag is aluminum Mylar, easy-open and resealable, making it durable and long lasting. UreaAide unflavored, just like UreaAide packets are made in an FDA registered, cGMP facility in the United States.
So check us out and get out of the low salt brain fog. As we like to say: “Fix your sodium simply, safely, and effectively for less with UreaAide unflavored Urea.”