The US Food and Drug Administration has finalised guidance for the industry on the definition and labelling requirements for “medical foods”.
According to the regulator, medical foods are products “specially formulated and processed” for a patient who has a “limited or impaired capacity to ingest, digest, absorb, or metabolise ordinary food or certain nutrients”, or who has “other special medically determined nutrient requirements” that cannot be met by modification of a normal diet alone.
Go deeper with GlobalData
These foods should be consumed “under the supervision of a physician”, the FDA noted. However, medical foods are not those foods recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, the FDA noted.
The labelling of medical foods must comply with applicable food labelling requirements and include a statement of identity, a statement of net quantity, the name of manufacturer and a complete ingredient list. Products defined as medical foods are exempt from the labelling requirements for health claims under the Nutrition Labeling and Education Act.
The final guidance represents the FDA’s current thinking on medical foods and finalises draft guidance, issued in August 2013.
To view the FDA’s full guidance notes, click here.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
