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One of the first medical foods to be developed was the infant formula. Lofenalac, product that was designed for use in the dietary management of a rare genetic condition known as Phenylketonuria (PKU). This product contains only a very limited amount of the essential amino acid phenylalanine because the individuals with this condition have an impaired ability to metabolize this amino acid. If infants with PKU consume foods that contain phenylalanine, harmful end products of phenylalanine metabolism accumulate in the body and can cause severe, irreversible mental retardation. Dietary management to carefully limit phenylalanine intake (for example, by using a formula that provides only a limited, minimal amount of this essential amino acid) can result in normal growth and development and avoid mental retardation. Before 1972, FDA regulated products like the infant formula Lofenalac as drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act. The FDA saw that it was important to differentiate these products from foods for general use. As a result, in 1972, FDA stated that the PKU product described above would no longer be regulated as a drug but rather as a "food for special dietary use". (37 FR 18229 at 18230, Sep 8 1972). In addition, the agency began to follow a policy of regulating similar types of products as foods for special dietary use. Medical foods are used under the supervision of a physician when such distinctive nutritional requirements cannot be met with a conventional diet. These characteristics have led the agency to exempt medical foods from many of the requirements that apply to conventional foods. The 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): i. 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; ii. 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; iii. 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; iv. It is intended to be used under medical supervision; and, v. 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) Enteral nutrition is nutrition provided through the gastrointestinal tract, taken by mouth or provided through a tube or catheter that delivers nutrients beyond the oral cavity (i.e., directly to the stomach or small intestine). This document uses the term "enteral nutrition products" to refer to products that have been marketed as medical foods; The labeling of such products frequently bears claims related to an intended use of the product in the management of a disease or condition, e.g., in alleviating specific symptoms and clinical manifestations of a particular disease. Claims and the Potential for Economic Fraud. FDA has not, to date, undertaken a comprehensive review of the claims being made for products that purport to be medical foods but rather has evaluated claims for a small number of these products on a case-by-case basis, applying the following general principles: A product marketed for use as a medical food in the dietary management of a disease or condition should have characteristics that are based on scientifically validated distinctive nutritional requirements of the disease or condition. There should be a scientific basis for the formulation of the product and the claims made for the product. There should be sound, scientifically defensible evidence that the product does what it claims to do. “Under the Supervision of a Physician” The second element of the medical food definition that distinguishes a medical food from a food for special dietary use is the statutory requirement that a medical food be "formulated to be consumed or administered internally under the supervision of a physician." As stated in the preamble to the proposed rule implementing the nutrition labeling requirements of the 1990 amendments (56 FR 60366 at 60377). "under the supervision of a physician means 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). The physician determines that the medical food is necessary to the patient's overall medical care, and the patient consults the physician on a recurring basis. Medical foods are intended for the dietary management of patients who have a short-term or long-term medical need for a particular nutrient or combination of nutrients to meet distinctive nutritional requirements. The use of a medical food requires ongoing physician oversight to ensure that the food effectively meets the distinctive nutritional requirements of the patient's disease or condition, and that the use of an enteral medical food is the appropriate means (i.e., as opposed to a patient requiring a parenteral nutrition product) to meet the patient's distinctive nutritional requirements. Therefore, medical foods are foods that are an integral component of the clinical management of a patient.
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