| | Tahiti | | | | CHK Nutrition | | Medical Foods Home Page | |
The FDA registered Medical Foods
of CHK were developed by | |
medical doctors while caring for their patients in clinics. | | | | The FDA definition of Medical Foods. | In the Federal Register of January 6, 1993, FDA published several final rules implementing the 1990 amendments. The final rule on mandatory nutrition labeling (58 FR 2079 at 2151, January 6, 1993) exempted medical foods from the nutrition labeling requirements and incorporated the statutory definition of a medical food into the agency's regulations at 101.9(j)(8)(21 CFR 101.9(j)(8). In this regulation, FDA enumerated criteria that were intended to clarify the characteristics of medical foods. The regulation provides that a food may claim the exemption from nutrition labeling requirements only if it meets the following criteria in 101.9(j)(8): |
| | | 1. It is specially formulated and processed product (as opposed to a naturally occurring foodstuff used in it natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube; |
| | | 2. 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 normal diet alone; |
| | | 3. It provides nutritional support specifically modified for the management of the unique (distinctive) nutrient needs that result from the specific disease or condition, as determined by medical evaluation; |
| | | | 4. It is intended to be used under medical supervision; and, |
| | | 5. 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. (958 FR 2079 AT 2185) |
| | | In the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), Congress incorporated the definition of medical foods contained in the Orphan Drug Amendments of 1988 into section 403(q)(5)(A)(iv) of the act (21 U.S.C. 343(q)(5)(A)(iv) and exempted medical foods from the nutrition labeling, health claim, and nutrient claim requirements applicable to most other foods. The Federal Register of Nov 27 1991 (56 FR 60366 at 60377), FDA published a proposal to implement the mandatory nutrition labeling provisions of the 1990 amendments. This proposal discussed the statutory exemption for medical foods and advised that the agency considered the statutorydefinition of medical foods to "narrowly constrain the types of products that can be considered to fall within this exemption." |
| | | In establishing the recommended dietary allowances for general, healthy population, the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences recognized that different or distinctive physiologic requirements may exist for certain persons with "special nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth, other medical conditions and drug therapies (Ref 9). Thus, the distinctive nutritional needs associated with a disease reflect the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism and excretion. These distinctive nutritional requirements may be greater than, less than, or in a narrower range of tolerance that for an otherwise healthy individual. |
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| | | | Under FDA guidelines Medical Food is used only under the supervision of a physician. |
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| | | | | | CHK Nutrition | | 8721 Falcon St | | Duluth, MN, 55808 | | 877-538-8388 | | CHK@CHKnutrition.com | | |
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