Prior to 1972, medical foods were primarily formulas designed for
the unique nutritional needs of patients with inherited metabolic disorders.
These products were regulated as drugs, usually as orphan products. In 1972,
the US Food and Drug Administration (FDA) created the classification
"medical food" to enhance product development and availability. In
the nearly 4 decades since this classification change, products marketed as
medical foods have strayed widely from the original narrow use in rare
metabolic conditions.
The FDA specifies that medical foods are foods specifically
formulated for dietary management of diseases or conditions with distinctive nutritional
needs that cannot be met by diet alone. Generally, a product must meet the
following criteria to be labeled a "medical food:
- A specific formulation (as opposed to a naturally occurring
foodstuff in its natural state) for oral or tube feeding;
- Labeled for the dietary management of a specific
medical disorder, disease, or condition with distinctive nutritional
requirements;
- Intended for use under medical supervision; and
- Intended only for a patient receiving active and
ongoing medical supervision for a condition requiring medical care on a
recurring basis so that instructions on the use of the medical food can be
provided.
Think of medical foods as hybrids of prescription drugs and
dietary supplements, more closely resembling dietary supplements in terms of
regulation. Packaging for medical foods is similar to prescription products
with package inserts, National Drug Code (NDC) numbers, and usually "Rx
only" on the labels. However, like dietary supplements, medical foods have
not been evaluated for safety or efficacy, and the FDA does not require
approval before marketing. "Caution: Federal law prohibits dispensing
without prescription" is not required on product labeling. The FDA specifies
only that these products are for use with medical supervision; however, a medical food manufacturer may
market a product to be dispensed only on physician request.
Unlike dietary supplements, medical foods can be labeled for
medical conditions such as Alzheimer disease. Dietary supplements must be
labeled for so-called "structure and function claims" and cannot make
claims to treat or prevent disease.[4] For example, ginkgo may be labeled
"supports memory function" but not "for treatment of
dementia." A drug or medical food could be labeled "for treatment of
dementia associated with Alzheimer disease."
Medical foods that more closely align with the FDA's historic
intent are infant formulas such as Phenyl-Free® 1,aphenylalanine-free formula
for babies with phenylketonuria, and Ketonex®-1, a branched-chain amino
acid-free formula for babies with maple syrup urine disease -- both rare
disorders.
Some manufacturers use the loopholes in the medical foods law to
market products for disease indication claims that would not be allowed if
marketed as dietary supplements. The following are examples of medical foods:
- Axona® (caprylic triglyceride) is marketed as for
dietary management of Alzheimer disease. Caprylic triglyceride is a
medium-chain triglyceride found in coconut oil.
- Limbrel® (flavocoxid™) is marketed for osteoarthritis.
Flavocoxid, which sounds remarkably similar to cyclooxygenase (COX)-2
inhibitors such as celecoxib, is a proprietary blend of flavonoids such as
baicalin and catechin.
- Foltx® (folic acid 2.5 mg, pyridoxine 25 mg, cyanocobalamin
2 mg) is marketed for hyperhomocysteinemia, which has been linked to
cardiovascular disease.
In terms of drug interactions, adverse effects, and safety,
credible research about medical foods is similar to dietary supplements.
Manufacturers are not required to prove efficacy or safety before marketing
medical foods or dietary supplements. Explain to patients who want to try a
medical food that these products have not been evaluated by the FDA, despite
the trappings of prescription drugs.
Finally, "functional foods" is simply a lay term, like
"nutraceutical." The FDA has no formal definition for functional
foods but does regulate safety and labeling as it does for all food products.
Functional foods are foods marketed for purposes other than
nourishment. For example, Activia® is a probiotic yogurt marketed to help
"regulate your digestive system." It contains a subspecies strain of Bifidobacterium animalis, which is marketed as Bifidus Regularis®. Another example is DanActive® dairy drink
that contains a strain of Lactobacillus casei marketed as L casei immunitas® and is labeled to help "support your immune system."
The Federal Trade Commission recently charged Dannon with
deceptive advertising. Dannon agreed to drop claims that allegedly exaggerated
the health benefits of Activia (relieves irregularity) and DanActive (protects
against cold and flu).[
For products marketed as medical foods for common indications,
clinicians should advise patients that these products are like dietary
supplements in terms of FDA oversight. Safety and efficacy are unproven.
Functional foods, which are undefined by the FDA, are simply products of marketing
strategy. Like dietary supplements, functional foods are not required to
undergo safety and efficacy testing prior to marketing.
by
Gayle
Nicholas Scott, PharmD
Assistant Professor, Eastern Virginia Medical School, Norfolk, Virginia;
Clinical Pharmacist, Chesapeake Regional Medical Center, Chesapeake, Virginia
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