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The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "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." FDA Medical Foods Guidance Documents & Regulatory Information
Low protein foods are indicated for those patients diagnosed with an inborn error of metabolism (IEM). Phenylketonuria (PKU), Tyrosinemia (TYR), and Maple Syrup Urine Disease (MSUD) are a few of the IEM's that are managed with the use of medical foods.
Some private insurance companies and many states provide reimbursement for low protein foods to manage the numerous IEM's.
ZOIA Pharma can assist you with insurance reimbursement or provide you with very affordable options to purchase products direct. There is no need to make multiple phone calls or place several orders with three or four manufacturers when ZOIA carries products from manufacturers in one place. Take a moment to check out our marketplace and feel free to call with any other requests. We are constantly adding products to the marketplace and look forward to serving your families medical needs.