Strategic Implementation of US Medical Foods Regulations for Ensuring Safety and Efficacy in the Treatment
One of the recurring themes in US medical forums is the "definition" of what constitutes a medical food. The FDA requires that these products be for a condition that has "distinctive nutritional requirements" which cannot be met by simply modifying a normal diet.
This excludes conditions like common diabetes, which can be managed through standard dietary changes, but includes rare metabolic disorders. Discussions often turn to the manufacturing standards, as these products must be produced in facilities that adhere to "Good Manufacturing Practices" (GMP) to ensure purity and consistency.
8 Views