FDA Regulation & Required Safety of Medical Foods



so the medical food category has very strict requirements they are for nutritional support there is the requirement for physician involvement in their dosing and monitoring of their use this is to assure that there are no side effects they are on medications these are diseased individuals so these are not healthy people you give medical foods to for patients who can't process food properly so you can have medical foods for people who can't chew macerate their food or swallow properly so they could be fed by an Terrell Nutrition also in the GI realm medical foods are perfectly suited because a lot of Interop with these patients don't absorb and metabolize nutrients properly they have to be highly processed our product sb id serum derive bovine immunoglobin protein isolate its equivalent about 40 gallons of milk per day in its immunoglobulin content and about 80 raw 8 ounce steaks so if you like to eat a lot of beef and drink a lot of milk 1 packet of SBI its equivalent to those amounts of foods so I don't think any of us could sustain that and they have to be delivered orally or entirely so they have to reach the intestinal tract in some manner the big requirement for medical foods is safety they have to have food safety and there's something called generally recognized as safe this doesn't mean like oh they're generally safe it means they are literally safe for everyone to consume this is a long-standing safety endorsement by the FDA started in 1958 you literally have a list at the FDA with every food item in the American diet the original list was composed of dangerous things like orange juice roast beef broccoli cauliflower then you started to have food technology where you had new foods in the form of TV dinners which I grew up during the 60s and 70s eating and even now the grass list is being added to and there you can actually search this list on the FDA's website and find our product as well so this is the grass review that was done by the FDA and this is their final conclusion we did what's called the self-affirmation with an expert panel review of all our toxicology data submitted it to the FDA ProLiant is our sister company that did the submission at the time and essentially they had no questions were guarding the conclusion that bovine globulin is grass under the intended conditions of use so this is not an approval process but the FDA has reviewed our product for safety

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