Present scenario of medical food with specific emphasis on its registration procedure in US and Australia

摘要

A food that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone is known as medical food. Medical food is newly developed products for mostly genetic disease and have advantage over allopathic medicines as they have lesser side effects and easily acceptable by patients. Now a days Medical food is growing industry and have a wide opportunity in pharmaceutical industry because of low cost compare to allopathic medicines as it do not require pre-market approval. It is also known as alternative medicines. In different countries medical food is regulated under different name like in US it is regulated under Medical food while in Australia it is regulated under name of food for special dietary use. Medical food must meet distinctive nutritional requirement for particular disease state and administered under the supervision of physician and contain ingredient that are generally consider as a safe as per GRAS(generally recognized as safe).Medical food regulation is required to because it is newly developed therapy. This article includes general information of medical food, how it differ from drug and dietary supplements, its concept, general regulatory requirements, current marketing scenario and labeling requirements in US and Australia. In US medical food is regulated by FDA (food and drug administration) and in Australia it is regulated by FSANZ(food standard Australia and New Zealand).