| Food Ingredients with a health benefit | Food and Beverage Products | Drug | ||||||
| Food/Beverage | Dietary Supplement | Food For Special Dietary Use (FSDU) | Medical Food | |||||
| Nutraceutical | ||||||||
| Food Additives and Ingredients • Significant safety evidence required • Documented safe only for an intended use • Food Additive Petitions (FAPs): - 2-12 years for approval - Petition for approval required for compounds foreign to the human body • Gras Ingredient (Generally Recognized As Safe): - Evaluation undertaken for substances expected to be safe - Independent Expert Panel Review for Safety - GRAS notification process can be much shorter than for FAPs - Can self-affirm GRAS status in some circumstances | NLEA Nutrition Labelling and Education Act of 1990 • Nutrition Labelling required for any nutrient or health-related claim • Nutrition Facts box required on label | DSHEA Dietary Supplement Health and Education Act of 1994 • May take form of pill, bar or liquid • Supplement Facts box required on label • Composition defined by status | FSDU • Foods used to supply particular dietary needs that exist because of a physical, physiological or pathological condition • Fall under NLEA regulations • Examples are - Hypoallergenic foods - Infant foods - Meal replacements for weight management | Medical Food • For managing diseases that have specific nutritional requirements • For use with medical supervision • Exempt from NLEA labelling • Insurance covers cost if given by feeding tube • Few regulations because market “regulate” itself regarding product composition and claim | OTC/RX • Musst meet FDA premarket approval requirements • Substantial safety and efficacy data required • May claim to diagnose, cure, mitigate, treat or prevent disease • High investment and strong scientific core competencies required • Long time to develop New Drug Application (NDA) • Approval process of qualified NDAs in 2 years or less | |||
| Claims • Nutrient content claims • FDAMA claims, from an authoritative scientific source (usually gov’t) - Food And Drug Administration Modernization Act 1997 • Structure/function claims require no formal approval, but FDA has indicated which they will accept • Claims obtained by petition: - Non-qualified health claims must meet significant scientific agreement standard - Qualified Health claims have statements indicating the level of inconclusive scientific support behind them | ||||||||