Medical Foods

Continued from Yesterday

Medical Foods: Between a Rock and a Hard Place

Those who suffer from certain aliments may experience inadequate ingestion of nutrients, malabsorption, impaired metabolism, loss of nutrients due to diarrhea, increased nutritional turnover inherent in certain diseases or inadequate ingestion due to a drug therapy. Medical foods can offer these patients a therapy to use with or without prescription drugs and lifestyle changes. For instance, pancreatic insufficiency is associated with reduced enzyme production; renal insufficiency drives patients to minimize uremic toxicity by following a low-protein diet and reducing phosphorus intake; Alzheimer’s patients can benefit from medium-chain triglycerides (MCTs) that produce ketones, offering alternative energy sources for brain cells’ depression can deplete folate levels; those with bone disease could benefit from additional vitamin D and calcium; and short-bowel syndrome requires nutrients that can be absorbed elsewhere in the body. All of these conditions and more can be addressed by specifically formulating foods with additional healthful ingredients.

Medical foods, unlike dietary supplements, are required to undergo pre-market scientific testing (results need to be based on recognized scientific principles, but not necessarily from clinical trials); but, like supplements, do not require pre-market FDA approval. Whereas medical foods are formulated for specific disease populations, supplements are intended for healthy adults. Medical foods cannot make therapeutic claims for treating, preventing or mitigating specific diseases like drugs can; but, they can go beyond the structure/function claims of supplements to make medical claims for dietary management of a specific disease. Also, like drugs, patients’ private insurance companies often cover some of the costs of medical foods. They are also covered under the Worker’s Compensation Insurance plans and Medicare Part D.

All ingredients of medical foods must also be GRAS (generally recognized as safe) or approved food additives. While many more fortified-food ingredients have achieved GRAS status, it is not required for those products. “A medical food by definition must contain GRAS ingredients, and this status is not given easily and widely to all so-called natural ingredients,” said Pierre Lemieux, COO, Acasti Pharma Inc., a subsidiary of Neptune Technologies & Bioressources Inc. “Ingredients have to go through a thorough process in which all the intended uses and dosages have to be defined and presented, and backed up with appropriate safety and toxicology data.”

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/