Lifecycle Nutrition Exam 1

FDA (Federal Drug Administration) and the FTC (Federal Trade Commission)

Dietary Supplement Health Education Act of 1994 keeps supplements available and keeps them more safe

Gives FDA authority to recall supplements and requires the manufacturer to register with the FDA and provide the FDA with the list of ingredients

Amends the FFDCA1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured; and(2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days.

Intended to supplement the diet, cannot be represented as a food, comes in teh form of a pill-capsule-gel-powder-etc, and the standard product label must have a disclaimer, not intended to treat, prevent, diagnose, or cure dieseases

Quantifies the amount of active ingredient in a (herbal) dietary supplement-assumes the active ingredient is known and depends on the Good Manufacturing Practices (clean facility, keep records)-useful in determining effective doseage

Structure function claims, claims related to lifecycle stages for health maintenance, and approved disease claims

Promote, maintain or help with XYZ..-must notify FDA withing 30 days of marketing

Claims for common symptoms related to life changes such as hot flashes during menopause, balding, menstruation

Calcium is proven to help with osteoporosis and strong bones

Drugs are intended to treat disease and have extensive precautionary information and require adverse event reporting whereas supplements are not intended to treat prevent diagnose or cure and usually only report cautionary information for pregnant women and it is mandatory to report adverse effects. Drugs are available in fewer forms and supplements are easier to obtain

-potential drug interactions-potential adverse effects-may not be safe for all persons-contamination/adulteration-may not be legal for athletes-lack of consistent formulation or quality

-those with high blood pressure-those with heart diesease-diabetics-pregnant or lactating women-those taking prescription meds-children

S-safety has it been studiedT-tolerability what are the side effectsE-efficacy does it work?P-price how much will it costS-simplicity how easy is it to do

-establish target dose according to the amount recommended by the DRI, WHO, a health professional-be aware of the % of active ingredient for herbs-how many capsules will it take to get the adequate dose and how many doses will you need each day-how many doses does the bottle actually contain