FDA Application and GMP Consulting
Food, Additives, Dietary Supplements...
Definition of Food
Dietary Supplement
Product intended to supplement the diet which is taken by mouth and contains dietary ingredients including vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, metabolites, concentrates, or extracts. A component in a dietary supplement that was not sold in the U.S. before October 15, 1994 is considered a new dietary ingredient (NDI) subject to pre-market approval by the U.S. FDA.
Food Labeling
Export into U.S.
Services
BBC Training
Released courses on FDA application training and GMP training for dietary supplement and food:
Food/Color Additives and Packaging
Food and Color Additives
All new food and color additives, including antimicrobial food additives, require pre-market approval by the U.S. FDA through food additive petition (FAP) or color additive petition (CAP) unless its use is generally recognized as safe (GRAS).
Materials Needed for Review
Genetically Modified Foods
Proposed rule of the U.S. FDA require that developers submit a scientific and regulatory assessment of genetically modified food through biotechnology notification file (BNF) 120 days before marketing.
GRAS Program
A GRAS status of a substance may be established by history of common use or by scientific procedures through GRAS notification (GRN) to the U.S. FDA.
Food Contact Substances
The U.S. FDA requires reviewing a food contact notification (FCN) for any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.
Services