Todd Harrison04.01.06
Revisiting Medical Foods
The rising interest in medical foods today warrants another look at the regulations.
By Todd Harrison
From time to time, it is good to review the regulatory status of medical foods. Medical foods is an intriguing category that permits more aggressive disease-like claims if the scientific literature truly justifies their use as a means of managing a disease through dietary management.
Medical foods have been around since the early 1970’s, and were initially regulated by FDA on a case-by-case basis. At that time, there were only a limited number of products that would have been considered medical foods, such as the infant formula Lofenalac, a product de-signed for use in the dietary management of a rare genetic condition known as phenylketonuria (PKU). These early medical foods, like the infant formula, were regulated as drugs under the Food Drug and Cosmetic Act (FDCA) and FDA’s drug regulations because of their role in mitigating serious adverse effects of the underlying diseases.
In 1988, as part of the Orphan Drug Act amendments, Congress attempted to codify FDA’s policy regarding medical foods by adopting a definition of medical foods. In addition, under the Nutrition Labeling and Education Act
of 1990 (NLEA), Congress exempted medical foods from the nutrition labeling, health claim, and nutrient content claim requirements applicable to most other foods. Moreover, neither the FDCA nor the Orphan Drug Act re-quired medical foods or their ingredients to be approved for use by FDA before marketing.
Recognizing this unique situation in which medical food products, which are intended for use by sick people, were subject to less scrutiny than virtually all other foods, FDA issued an advanced notice of proposed rulemaking (ANPR) in 1996 to re-evaluate its policy for regulating these products. Of most concern to FDA was the assurance of the safety and effectiveness of a medical food (i.e., establishment of a standard to determine the safety of a medical food; developing a standard for the quality and quantity of scientific evidence to support the validity of claims made for medical foods; and determining what information should be included on the label).
In the preamble to the ANPR, FDA explained that it had not undertaken a comprehensive review of the claims being made for products that purport to be medical foods but rather had been evaluating claims on a case-by-case basis (this is likely to be FDA’s continued course of enforcement in this area) based on the following principles: (1) products marketed as a medical food for the diet-ary management of a disease or condition should have characteristics that are based on scientifically validated dis-
tinctive nutritional requirements of the disease or condition; (2) there should be a scientific basis for the formulation of the product and the claims made for the product; and (3) there should be sound, scientifically defensible evidence that the product does what it claims to do. Currently, no further regulatory action has been taken to finalize this rule.
In laying the groundwork for regulating medical foods, FDA said that a medical food must address the “distinctive nutritional requirements” of a disease or condition, and thus, a medical food is suitable only for use by patients with that disease or condition. Historically,
an example of a medical food would be low nitrogen foods fed to a patient through a feeding tube due to impairedkidney function. However, with the rapid development of nutritional
science, the ability to pursue a product as a medical food has significantly increased. A recent example of a med-ical food is Metagenics Inc.’s Bariatric Meal. Other examples of recent medical foods include:
(1) Elecare: A nutritionally-complete amino acid-based medical food that is used for meeting the nutritional needs of children 1 year of age and older, who need an amino acid-based medical food or who cannot tolerate intact protein; for the dietary management of maldigestion, malabsorption, severe food allergies, GI tract impairment, or other conditions in which an elemental (amino acid-based) diet is required.
(2) AlitraQ: An elemental formula specifically designed for metabolically stressed patients with impaired GI function. It helps maintain nutritional status and provides supplemental glutamine
to nourish the GI tract and help restore glutamine depleted during catabolic states. It is designed for patients with impaired GI function due to injury from severe multiple trauma, inflammatory bowel disease (IBO), GI surgery, severe burns and injury due to chemotherapy or radiation therapy.
(3) Pulmocare: A low-carbohydrate formula specifically designed to help reduce carbon dioxide production, thereby minimizing CO2 retention resulting from chronic obstructive pulmonary disease, cystic fibrosis or respiratory failure.
In the meantime, FDA’s policy in regulating medical foods is based on the principle that, unlike certain conventional foods and dietary supplements, “[m]edical foods are not those foods included within a healthy diet intend-ed to decrease the risk of disease.” Accordingly, medical foods are intended for the dietary management of a patient who has a disease or condition.
In order for a product to be considered a “medical food” it must meet the following statutory and regulatory criteria.
• To make any disease treatment claims for a medical food, the product must be used under the supervision of a physician.
• The substance must be recognized as
a “food.”
• The product must be a food that is specifically formulated to be consumed enterally (taken by mouth).
• The product is solely 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.”
According to FDA’s regulations, medical foods assist the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to consume ordinary foodstuffs or certain nutrients (i.e., unable to digest, absorb or metabolize certain nutrients), or who has special nutrient requirements. Accordingly, medical foods are necessary where modification of diet alone will not achieve the desired result.
FDA’s regulations require medical supervision of treatment with medical foods. Specifically, similar to prescription drug products, patients should use medical foods under a physician’s supervision and patients should also receive frequent and continual medical supervision on a recurring basis for instructions on the use of a medical food.
FDA explains that, generally, med-ical foods are not intended for use by the general public and should not be readily available at drug stores or supermarkets. While FDA may wish for the latter, there is no statutory requirement that the availability of medical foods be so limited. However, if a company is seeking to limit its regulatory exposure, the company should, at least initially, consider only marketing to healthcare practitioners.
Medical foods is a category that has many intriguing possibilities. However, its regulatory picture remains unclear. NW