Biochemical Nutrition Module 3 Study #3

How are dietary supplements different from drugs?

• Drug

  • A drug is intended to diagnose, cure, mitigate, treat, or prevent disease; a supplement is not

  • Both are intended to affect the structure and function of the body

    • Drug must undergo FDA approval after clinical studies to determine effectiveness and safety. Dietary supplements do not require pre-market testing

How are Dietary Supplements different from foods?

• Food

  • Foods are not intended to affect structure and function

  • Dietary supplement intended only to supplement diet

    • Not represented for us as conventional food

      • Not intended as the sole item of a meal or diet

Herbs and Botanicals considered ‘__________________’, was deemed to be a _______________.

Dietary supplements; controversial decision

____________ are deemed appropriate under 2 conditions only;

1. Early stage of treating a nutritional deficiency disease

2. As a drug to treat disease (when supported by research)

Megadoses

Law passed by congress in 1938 giving authority to FDA to oversee safety of food, drugs, and cosmetics

US Federal Food, Drug and cosmetic Act (1938)

Delaney Clause of 1958: 1

No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal

Delaney Clause of 1958: 2

Every new additive must be tested for safety in several species of animals, including one non-rodent mammal, for a specified period of time

Delaney Clause of 1958: 3

GRAS ( generally recognized as safe): refers to> 700 additives in use before the passage of this clause (long history of use in food) or shown scientifically to be “safe”