Definitions

Question 1

Drug

Answer 1

A. Article is recognized in USP National Formulary or in official Homeopathic Pharmacopoiea of US or any reference supplements
B. Article is intended for us in diagnosis, cure, mitigation, treatment, prevention of disease in humans or animals
C. Article is intended to affect the structure or function in body of humans or animals (food excluded)
D. Article intended for use as a component of any articles specified above but not including devices, their components/parts/accessories

Question 2

Food

Answer 2

Articles used for food/drink by humans or animals, gum, and components of any such article

Question 3

Special Dietary Foods

Answer 3

Food that supplies a special dietary need for physical/psych/pathological/other conditions like disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity, underweight, control of sodium

Question 4

Medical Food

Answer 4

Foods formulated to be consumed/administered enterally under supervision of physician and are intended for specific dietary management of dz or condition for which distinct nutritional requirements based on recognized scientific principles are established by medical evaluation

Question 5

Cosmetic

Answer 5

• Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to body for cleansing, beautifying, altering appearance and articles that are components of such articles. Soap not included.
• FDA doesn’t have premarket approval for cosmetics and manufacturers do not have to register with FDA or follow GMPs.
• Cosmetic label must list ingredients in descending order
• Required Warnings:
  1. inhaling contents under pressure may be harmful/fatal
  2. product safety not been determined
  3. presence of coal tar in hair dye
• FDA may remove adulterated or misbranded or health hazard products
• Cosmetics must conform to Poison Prevention Packaging Act (PPPA) or they are misbranded
• Cosmetic can be considered a drug if it claims to treat a condition (dandruff shampoo is considered both)

Question 6

Dietary Supplement

Answer 6

• Product intended for ingestion, to supplement the diet, contains one or more: vitamin, mineral, herb, botanical, amino acid, dietary substance supplementing/increasing intake in diet, a concentrate, metabolite, constituent, extract, or combination
• FDA regs less strictly but claims about treatment etc can bring a product under drug regulation

Question 7

Medical Device

Answer 7

Instrument, apparatus, implement, machine, contrivance, implant, in reagent, or other including components that is
1. recognized in USP/NF + supplements
2. intended for use in diagnosis, cure, treatment, mitigation, or prevention of dz in humans/animals
3. intended to affect structure or function
AND does not achieve its primary purpose via chem rxn in or on the body and doesn’t depend on metabolism
*Intrauterine device is device that delivers hormones is both but is treated as a drug

Question 8

Tamper Evident Packaging

Answer 8

• Barrier that exhibits visible evidence of disturbance

- Directions to consumer to determine if tampering occurred