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<\/h3>\n<\/h3>\nDietary supplements and food products are subject to different FDA registration regimes, with the main differences being registration targets, labeling requirements, and inspection standards. Dietary supplements are subject to facility registration and product labeling notification, while general foods are subject to facility registration and prior notification.<\/p>\n
Under the FDA system, the classification of Dietary Supplement and Conventional Food is based on the use of the product and the form of the ingredients.<\/p>\n
Dietary supplements are usually supplied in the form of capsules, lozenges, powders or liquids, labeled as \"Supplement Facts\" and must not claim to treat or prevent disease. General food products are intended for daily consumption and are labeled as \"Nutrition Facts\" and can be in solid or liquid form.<\/p>\n
If a product meets the characteristics of both a food and a dietary supplement, the category of applicability must be determined by the primary use and labeling.<\/p>\n
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(This chart illustrates the major differences in the registration process and target audience between dietary supplements and general food products)<\/p>\n
Dietary supplements require two processes: Facility Registration and Label Notification. Facility Registration is for establishments that manufacture, package or hold dietary supplements, and Label Notification must be completed before the product can be marketed.<\/p>\n
General food products are also subject to facility registration, but product labeling is not mandatory. For imported products, a Prior Notice must be submitted prior to the arrival of the shipment, stating the contents of the product, the source and the scheduled time of arrival.<\/p>\n
Taiwan sellers who ship through third-party logistics or agents need to confirm the responsibility of facility registration to avoid customs clearance due to incomplete registration.<\/p>\n
Dietary supplement labeling must comply with the \"Supplement Facts\" format, listing the amount per serving, the recommended daily intake percentage, and labeled with disclaimers such as \"This statement has not been evaluated by the FDA\".<\/p>\n
General food labels use the \"Nutrition Facts\" format, which must list nutrients such as calories, fat, carbohydrates, etc., and comply with the FDA's requirements for allergen labeling.<\/p>\n
Incorrect labeling or mixing of two formats may be considered as labeling inconsistency, which may result in the product not being able to clear customs or being asked to be removed from the shelves.<\/p>\n
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(This chart illustrates the major differences in testing standards and risk types between dietary supplements and general food products)<\/p>\n
Dietary supplement testing focuses on ingredient compliance, labeling integrity and GMP (Good Manufacturing Practice) compliance. If the product contains unapproved New Dietary Ingredient (NDI), a safety assessment report must be submitted in advance.<\/p>\n
General food inspections focus on microbiological testing, allergen labeling, and prior notification accuracy. If the product is canned or low-acid, it must additionally comply with FDA process control requirements.<\/p>\n
Taiwan sellers are advised to check with the FDA or a professional consultant beforehand if the classification of their products is not clear, in order to avoid misclassification that may lead to non-compliance with inspection or product recalls.<\/p>\n