The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is “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.”
A physician’s supervision of patients taking medical foods (MF) is required by both the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations (See 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(j)(8)(iv)-(v)). Specifically, the administration and consumption of medical foods are similar to prescription drug products, in that patients must obtain instructions from their physician on the use of MF on a recurring basis and should also be under frequent and continual medical supervision with regard to their use of the MF.
Although the FDA does not mandate that patients obtain a prescription for medical foods, Sigma-Tau Healthscience requires a prescription for VSL#3 DS. We are dedicated to the safety, health and wellness of our patients. As a high potency probiotic medical food, VSL#3 manages the serious digestive disorders of IBS, ulcerative colitis and an ileal pouch and is intended to be used under medical supervision as per the FDA’s criteria.
Sigma-Tau Healthscience believes that obtaining a prescription and complying with their physician’s instructions will ensure that patients achieve the best possible outcome and will help to prevent any self-diagnosis, self-medicating, confusion in consumption and dosage, and infrequent follow up with a medical professional.
There are 7 key reasons why VSL#3 is classified as a medical food requiring medical supervision.
|Criteria||Medical Foods||Dietary Supplements|
|Formulated and processed to be consumed orally or administered enterally||√||√|
|Intended to be used only for the specific dietary management of a medical condition or disease, which cannot be managed by modifying the normal diet alone||√||×|
|Formulated to provide distinctive nutritional requirements established by a medical condition or disease||√||×|
|Nutritional requirements are based on recognized scientific principles||√||×|
|Intended to be used under medical supervision||√||×|
|Ingredients should be Generally Recognized as Safe (GRAS) by qualified experts under the conditions of their intedned use||√||×|
|Intended for patients requiring medical care on a recurring basis||√||x|
Note: The above criteria may not be an all-inclusive list of what FDA considers the statutory
definition of “medical food” to be.