From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 44
According to the US Food and Drug Administration (FDA), medical foods must be
prescribed by a physician to meet a patient’s nutritional needs in managing a disease
or health condition.1 The patient must be under the physician’s ongoing care. A medi-
cal food’s label must clearly state that the product is intended to be used in managing
a specific medical disorder or condition. Medical foods are not meant to be used by the
general public and may not be available in stores or supermarkets. Prior to 1972, many of
the dietary items for use under a physician’s care were classified as drugs. In 1972, many
of these drug items were reclassified as foods for special dietary users and placed under
the jurisdiction of FDA’s Bureau of Foods (now the Center for Food Safety and Applied
Nutrition, CFSAN).2 The regulations are administered under 21 CFR Part 105.
The definition of a medical food initially was included as part of the Orphan Drug
Amendments of 1988.3 It can be found in 21 CFR 101.9(j)(8) and reads as follows: “a food
which is formulated to be consumed or administered enterally (within the intestines,
as distinguished from parenterally) under the supervision of a physician and which is
intended for the specific dietary management of a disease or condition for which distinc-
tive nutritional requirements, based on recognized scientific principles, are established by
medical evaluation.”
Even though there was a statutory definition, the amendments did not provide any
further information regarding the product types the definition was intended to regulate.
In the Nutritional Labeling and Education Act of 1990 (NLEA), Congress incorporated the
medical foods’ definition and exempted them from the nutritional labeling, health claims
and nutrient content requirements applicable to most other foods.4 According to a Medical
Foods Task Force Report issued 4 August 1992, the exemption created a medical foods
paradox without specific requirements for regulating them. These products, which have
both food and drug characteristics, are used under a physician’s supervision to mitigate
disease in sick patients, yet their safety is not regulated as closely as that of either drugs
or infant formulas, and their labeling provides less information than required for ordinary
foods under the NLEA. No specific regulations have been issued since that report.
Medical Foods and Foods for Special Dietary Purposes
Medical foods were deemed to be different from foods for special dietary uses, which
according to the Food, Drug, and Cosmetic Act means foods that supply a special dietary need
that exists by reason of a physical, physiological, pathological or other condition. These con-
ditions include, but are not limited to, disease, convalescence, pregnancy, lactation, infancy,
allergic hypersensitivity to food, underweight, overweight or the need to control the intake
of sodium. Foods for a special dietary need also supply a vitamin, mineral or other ingredi-
ent that allow man to supplement his diet by increasing the total dietary intake or supply a
special dietary need by reason of being a food for use as the sole item of the diet.5
There is no exemption for foods for special dietary uses in terms of nutritional label-
ing requirements or requirements for health and nutrient content claims. Health claims
may be used on labeling in one of three ways:
• complying with the 1990 NLEA that authorized FDA to issue regulations after
carefully reviewing scientific evidence submitted in health claim petitions
• utilizing the 1997 Food and Drug Administration Modernization Act provision for
health claims based upon an authoritative statement of a scientific body of the US
government or the National Academy of Sciences, and health claims of a health
claim notification submitted to FDA
• exercising the 2003 FDA Consumer Health Information for Better Nutrition
Initiative provision for qualified health claims where the quality and strength of
the scientific evidence falls below that required for FDA to issue an authorizing
regulation (must include qualifying language as part of the claim to indicate that
evidence supporting the claim is limited)
According to the US Food and Drug Administration (FDA), medical foods must be
prescribed by a physician to meet a patient’s nutritional needs in managing a disease
or health condition.1 The patient must be under the physician’s ongoing care. A medi-
cal food’s label must clearly state that the product is intended to be used in managing
a specific medical disorder or condition. Medical foods are not meant to be used by the
general public and may not be available in stores or supermarkets. Prior to 1972, many of
the dietary items for use under a physician’s care were classified as drugs. In 1972, many
of these drug items were reclassified as foods for special dietary users and placed under
the jurisdiction of FDA’s Bureau of Foods (now the Center for Food Safety and Applied
Nutrition, CFSAN).2 The regulations are administered under 21 CFR Part 105.
The definition of a medical food initially was included as part of the Orphan Drug
Amendments of 1988.3 It can be found in 21 CFR 101.9(j)(8) and reads as follows: “a food
which is formulated to be consumed or administered enterally (within the intestines,
as distinguished from parenterally) under the supervision of a physician and which is
intended for the specific dietary management of a disease or condition for which distinc-
tive nutritional requirements, based on recognized scientific principles, are established by
medical evaluation.”
Even though there was a statutory definition, the amendments did not provide any
further information regarding the product types the definition was intended to regulate.
In the Nutritional Labeling and Education Act of 1990 (NLEA), Congress incorporated the
medical foods’ definition and exempted them from the nutritional labeling, health claims
and nutrient content requirements applicable to most other foods.4 According to a Medical
Foods Task Force Report issued 4 August 1992, the exemption created a medical foods
paradox without specific requirements for regulating them. These products, which have
both food and drug characteristics, are used under a physician’s supervision to mitigate
disease in sick patients, yet their safety is not regulated as closely as that of either drugs
or infant formulas, and their labeling provides less information than required for ordinary
foods under the NLEA. No specific regulations have been issued since that report.
Medical Foods and Foods for Special Dietary Purposes
Medical foods were deemed to be different from foods for special dietary uses, which
according to the Food, Drug, and Cosmetic Act means foods that supply a special dietary need
that exists by reason of a physical, physiological, pathological or other condition. These con-
ditions include, but are not limited to, disease, convalescence, pregnancy, lactation, infancy,
allergic hypersensitivity to food, underweight, overweight or the need to control the intake
of sodium. Foods for a special dietary need also supply a vitamin, mineral or other ingredi-
ent that allow man to supplement his diet by increasing the total dietary intake or supply a
special dietary need by reason of being a food for use as the sole item of the diet.5
There is no exemption for foods for special dietary uses in terms of nutritional label-
ing requirements or requirements for health and nutrient content claims. Health claims
may be used on labeling in one of three ways:
• complying with the 1990 NLEA that authorized FDA to issue regulations after
carefully reviewing scientific evidence submitted in health claim petitions
• utilizing the 1997 Food and Drug Administration Modernization Act provision for
health claims based upon an authoritative statement of a scientific body of the US
government or the National Academy of Sciences, and health claims of a health
claim notification submitted to FDA
• exercising the 2003 FDA Consumer Health Information for Better Nutrition
Initiative provision for qualified health claims where the quality and strength of
the scientific evidence falls below that required for FDA to issue an authorizing
regulation (must include qualifying language as part of the claim to indicate that
evidence supporting the claim is limited)