Fda Regulation of 'Medical Foods' — An Industry Perspective
| Autor: | Stephen H. McNamara |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Pharmacology
Medical food medicine.medical_specialty business.industry Diet therapy digestive oral and skin physiology Dietary management Alternative medicine Pharmaceutical Science Legislation Statutory law Medicine Pharmacology (medical) Food science Product (category theory) Marketing Medical prescription business |
| Zdroj: | Clinical Research and Regulatory Affairs. 14:15-31 |
| ISSN: | 1532-2521 1060-1333 |
| DOI: | 10.3109/10601339709019436 |
| Popis: | Since the early 1970s, the Food and Drug Administration (FDA) has accepted the premise that a nutrient formulation could be represented as meeting the special nutritional needs of a person with a disease or a medical condition, without triggering drug status for the product, and has subsequently defined and refined the concept of special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions. The tenn medical food refers to 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. As the number and diversity of products marketed under the medical food category has increased, the FDA has attempted to clarify what products qualify under the category. Classification as a medical food confers significant advantages on a product, exempting it from various FDA labeling requirements that apply to conventional foods. Because the statutory guidelines are so sparse, developers of medical foods are looking to correspondence between FDA inspectors and medical foods manufacturers, to clarify the regulatory status of their products. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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