What is a medical food? According to FDA’s Web site and section 5(b) of the Orphan Drug Act, “the term ‘medical food’ means 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.”
Sandy Bigelow, Ph.D., principal at Vanguard Global Associates, said, “Medical foods are supposed to be developed for the dietary management of a disease; they need to provide nutritional sustenance, necessary macro and micronutrients, and vitamins and minerals.”
Esra Ogru, Ph.D., chief operating officer, and Jeremy Cottrell, Ph.D., research scientist, Phosphagenics, said: “Medical foods differ from normal foods in that they have substantiated health-promoting or disease-preventing benefits beyond the basic delivery of nutrients. And, they differ from nutritional supplements in that they are not designed for use by healthy people, but rather as a therapy for a particular medical condition under the guidance of a medical practitioner.”
Marshall Fong, vice president of marketing at Ganeden Biotech, added, “These products [medical foods] must be specially formulated and processed instead of being a naturally occurring food.”
Original medical foods formulas were engineered for those with genetic diseases that could not handle certain nutrients. For example, patients with phenylketonuria (PKU) cannot metabolize the amino acid phenylalanine. “In the 1950s, formulas were developed for those who couldn’t metabolize more than 100 to 150 mg/d of phenylalanine,” Bigelow said. “PKU warnings on soda cans and other products are often necessary due to phenylalanine’s use in aspartame. Where history collides: one of the first formulas produced as a medical food was in the 1950s by Mead Johnson Nutrition so people with PKU could eat and sustain their lives. In the beginning, FDA regulated them as drugs because they were for diseases, but later switched them as regulated food products.” However, Bigelow noted FDA found it untenable to regulate these products as drugs because, as such, they would have to assure the active ingredients were produced in the product at a particular level, which is difficult to do for nutrition formulas; so, in turn, FDA created a new category (in the regulatory sense) and regulated them as foods. And, in 1988 Congress defined what a medical food was in the Orphan Drug Act.
Sheila M. Campbell, Ph.D., R.D., in her paper, “History of Tube Feeding”, (Nutrition in Clinical Practice 2006;21:411-15), said, “The first commercially available [enteral] formulas were elemental. They came on the market in the late 1960s. The formulas were tested by U.S. National Aeronautics and Space Administration (NASA) in an attempt to develop a residue-free formula for use by astronauts.” An elemental formula’s macronutrients are in simple forms, so little or no digestion is needed before absorption. NASA was looking for ways to eliminate the issue of disposing of human waste in outer space, but the formulas were not used due to their poor taste profile.
“As medical foods are used the treat a specific medical condition, they are administered with oversight from a health care professional,” Ogru and Cottrell said. “This could be intensively as part of hospitalized treatment, even via a nasogastric tube, but typically, medical foods will be consumed orally.”
Ensure was introduced in 1973 by a division of Abbott Nutrition, Ross Products. It was, “the first intact-nutrient, lactose-free, ready-to-use adult medical nutrition product in the United States. It was an ‘all-purpose’ product, designed for tube feeding and oral supplementation,” Campbell noted in her 2006 paper. Glucerna® was the first enteral formula to be patented and was developed in 1989 by Ross Products for patients with diabetes, and Pedialyte® was one of the first retail medical foods for children.
