dietary supplements and natural products

OTC exam 4

what is the FDA definition of dietary supplements

vitamins, minerals, herbs, or other botanicals, and amino acids

dietary substances used to supplement the diet by increasing dietary intake or concentrations, metabolites, constituents, and extracts

what is complementary and integrative/alternative medicine

broad domain of healing philosophies, diagnostic approaches, and therapeutic interventions that are not typically considered part of the conventional western health system

what are the most commonly used dietary supplements in adults

fish oil, glucosamine and/or chondroitin, pre or probiotics, melatonin, and CoQ10

what are the most commonly used dietary supplements in children

fish oil, melatonin, pre and probiotics, echinacea, and garlic

what is the dietary supplement health and education act of 1994

supplements are regulated under food preparation standards — not purity and potency standards like drugs

must be safe, does not have to efficacious

clinical trials not required to demonstrate evidence of safety/efficacy

FDA — postmarketing surveillance role

what are the current good manufacturing practice standards for dietary supplements

manufactured in a quality manner without adulterations or impurities

labeled accurately

raw material evaluated by manufacturer

what are the FDA labeling requirements for dietary supplements

name of the product and “dietary supplement”

net quantity of contents

manufacturer’s, packer’s, or distributor’s name and place of business

directions for use

supplement facts panel

scientific name if plant based

what has the primary responsibility for regulating dietary supplement labeling

FDA

what has the primary responsibility of advertising and direct marketing materials of dietary supplements

federal trade commission

what are the three types of claims for dietary supplements

health claims

nutrient content claim

structure-function claim

what is a health claim

describes the relationship of food, food-component, or dietary supplement ingredient and the resulting risk reduction of a disease or health-related condition

what is a nutrient content claim

describes the relative amount of a nutrient or dietary substance in a product

what is a structure-function claim

describes how a product may maintain the normal healthy structure or function of the body without discussing a specific disease state

what is the USP dietary supplements verification program

voluntary program to certify that products contain listed ingredients in the indicated amount/potency, are bioavailable and free of contaminants, are manufactured and under appropriate sanitary and well-controlled conditions, and USP verified mark is found on label

what are the “clearly problematic” categories of dietary supplements provided by FDA

treatments of potentially life threatening disease

weight loss products

chelation products

treatments for behavioral disorders

colloidal minerals and other silver products

supplements for addiction

supplements for body building/performance enhancing

supplements for sexual enhancement

what can overuse of colloidal silver lead to

irreversible blue-gray skin discoloration

what are the four main areas of safety concerns for dietary supplements

drug interactions

bleeding risk

cardiotoxicity

hepatotoxicity

what are the 4 G’s that increase bleeding risk

garlic, ginger, ginkgo, ginseng

what dietary supplements can have antiplatelet effects

higher dose fish oil, vitamin E, and willow bark

what dietary supplements can cause cardiotoxicity

ephedra

bitter orange

guarana

pre-workout supplements with large amounts of caffeine

dimethylamylamine

what dietary supplements can cause hepatotoxicity

black cohosh

kava kava

garcinia cambogia

hydroxycitric acid

what are general counseling points for dietary supplements

self-care should be for a limited time

inform providers before taking supplements

FDA does not require demonstration of efficacy or safety before marketing

quality and consistency of DS products remain a concern

what natural products are commonly used in relation to the CV system

CoQ10

fish oil

garlic

red yeast rice

resveratrol

what natural products are used in relation to the CNS

butterbur

feverfew

ginkgo

melatonin

st john’s wart

valerian

what natural products are used in relation to the digestive system

ginger

milk thistle

peppermint

what natural products are used in relation to the endocrine system

alpha lipoic acid

cinnamon

berberine

what natural products are used as immune modulators

echinacea

elderberry

what natural products are physical and mental performance enhancers

eleuthero

asian ginseng

green tea

what natural products are used for the kidney, urinary tract, and prostate

african plum

cranberry

DHEA

saw palmetto

what natural products are used for the musculoskeletal system

glucosamine and chondroitin

MSM
SAMe

tumeric/curcumin

what natural products are used for skin conditions

aloe vera

tea tree oil

what natural products are used for women’s health

black cohosh

chaste tree berry

evening primrose oil

fenugreek

phytoestrogens