Medical Foods and Dietary Supplements
For the benefit of the pharmacists, physicians and other health care practitioners who are interested in learning more about this unique nutrient delivery system, we asked Ralph Fucetola JD, also known as The VitaminLawyer.com, to tell us about the new regulatory category created in 2005, Medical Foods, and how this category compares to Dietary Supplements.
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A Medical Food 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....” Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))
The FDA tells us, "Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods
a. be intended to meet distinctive nutritional requirements of a disease or condition,
b. used under medical supervision and
c. intended for the specific dietary management of a disease or condition."
The FDA FAQs further inform us, "The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality."
And the agency concludes: "In general, to be considered a medical food, a product must, at a minimum, meet the following criteria:
a. the product must be a food for oral or tube feeding;
b. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and
c. the product must be intended to be used under medical supervision..."
I can conclude from this exposition by the agency several points of note: (1) the agency has not yet prepared comprehensive regulations regarding Medical Foods; (2) products protected under the Dietary Supplement Health and Education Act of 1994 (DSHEA) can be considered Medical Foods, and (3) it is appropriate for health care providers to recommend dietary management of various nutritional and metabolic syndromes that are being identified by advanced heath care practitioners.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/default.htm
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A Medical Food 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....” Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))
The FDA tells us, "Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods
a. be intended to meet distinctive nutritional requirements of a disease or condition,
b. used under medical supervision and
c. intended for the specific dietary management of a disease or condition."
The FDA FAQs further inform us, "The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality."
And the agency concludes: "In general, to be considered a medical food, a product must, at a minimum, meet the following criteria:
a. the product must be a food for oral or tube feeding;
b. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and
c. the product must be intended to be used under medical supervision..."
I can conclude from this exposition by the agency several points of note: (1) the agency has not yet prepared comprehensive regulations regarding Medical Foods; (2) products protected under the Dietary Supplement Health and Education Act of 1994 (DSHEA) can be considered Medical Foods, and (3) it is appropriate for health care providers to recommend dietary management of various nutritional and metabolic syndromes that are being identified by advanced heath care practitioners.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/default.htm