Week 2 Flashcards
CFR FDA
Title 21
Cabinets & Agencies
Health + human services (FDA, CDC)
Agriculture/USDA (FSIS)
EPA
Homeland security (Customs)
Treasury (TTB)
FTC
Commerce (NMFS)
CFR USDA
Titles 7, 9
Food
Articles used for food or drink for man or other animals.
Chewing gum
Articles used for components of any other such article
Drug
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
Device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article
Cosmetic
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…
for cleansing, beautifying, promoting attractiveness, or altering the appearance
Food Additive
Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food
Intended use
An article can be either a food, drug, or a supplement, but not more than 1
Food vs drug guidelines
1: Is the product a common sense food?
2: If not, is it consumed primarily for taste, aroma, or nutrition?
3: If no to either, probably not a food.
Health claims
Health claims were originally only permitted on drugs
FDA approved health claims are now allowed (structure-function claims)
Regulatory effort categories
Pre market approval
Post market surveillence
USDA/FSIS area
USDA to conduct continuous inspections of all
domestic meat intended for human consumption except
poultry
FSIS
FSIS ensures all regulated foods are slaughtered and
processed using approved processes (sanitary
conditions)
FSIS responsibilities
FSIS personnel inspect all meat and poultry at slaughter
Minimum 1 federal inspector per line during all hours
plant is operating
At processing plants, inspectors are on-site, but not
overseeing each process or product
