Medical Foods: Between a Rock and a Hard Place

Not a drug, but administered under medical supervision; not a fortified food, but containing added ingredients to make a food healthier. Medical foods lie somewhere in between. FDA regulation of medical foods also lies between the stricter rules for drugs and the more lenient (yet still rigorous) guidelines for dietary supplements.

The concept of a "medical food" is a relatively recent one. Products now regarded as medical foods were regulated as drugs by FDA until 1972, when the agency issued an advance notice of proposed rulemaking (ANPR), which it has since withdrawn. In 1988, Congress established the legal category of medical foods in the Orphan Drug Amendment, which states medical foods are those designed to be orally consumed, administered under the supervision of a physician, specially formulated and processed (i.e., not naturally occurring), and intended for the specific dietary management of a disease or condition that has distinctive nutritional requirements. That definition was subsequently incorporated into the Nutrition Labeling and Education Act of 1990 (NLEA), where Congress exempted medical foods from the nutrition labeling, health claim and nutrient disclosure requirements applied to most other foods.

According to FDA, medical foods are “intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.” Further, in the Compliance Program, FDA asserts a medical food must be primarily, but not exclusively, sold to hospitals, clinics and other medical facilities.

Deanna Minich, Ph.D., FACN, CNS, Metagenics’ vice president of R&D communications, further explained, “They’re intended to support specific conditions and contain combinations of macro- and micronutrients in ratios that have known biochemical rationale and are effective in nutritionally managing a disease state.”

Continued Tomorrow

http://www.naturalproductsinsider.com/articles/2010/10/medical-foods-between-a-rock-and-a-hard-place.aspx

http://www.depsyl.com/ 

http://back2basicnutrition.com/

http://bionutritionalresearch.olhblogspace.com/