FDA Posts Updated Guidance on Medical Foods
The Food and Drug Administration issued a new edition of its guidance document on medical foods (here). The second edition of its guidance titled “Frequently Asked Questions About Medical Foods” gives “responses to additional questions about the definition and labeling…
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of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance,” said FDA in its announcement of the new guidance (here). Medical foods are “specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize 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,” said FDA.