law 4

what does DSHEA stand for

dietary supplement health and education act

FDA requires that all non-prescription otc drug labels to have detailed usage and warning info in _____section so that consumers can properly chose and use otc rugs

drug facts

pursuant to its application and interpretation of the law, the fda issued a final regulation in 2004 banning all ____

ephedrine alkaloid dietary supplement (eds) products

regulation of advertising and labeling of cosmetics basically falls under the jurisdiction of the ___

federal trade commision (ftc)

DSHEA places dietary supplements in a special category under the general umbrella of _______and requires that every supplement be labeled ____

foods; a dietary supplement

medical foods include foods ___

formulated for oral/enteral use under the supervision of a physician are are intended for the specific dietary management of a disease or condition

all nonprescription otc medicine labels must have the following detailed usage and warning info:

1. active ingredient 2. uses 3. warnings 4. inactive ingredients 5. purpose 6. directions 7. other info eg. storing

the label will also identify:

1. expiration date 2. lot or batch code 3. name and address of manufacturer, packer or distributor 4. net quantity of contents 5. what to do if an overdose occurs

DSHEA allows manufacturers to make 3 types of claims for their dietary supplement products:

1. health claims 2. structure/function claims 3. nutrient content claims

critics have 3 major concerns about DSHEA:

1. prevents the FDA from acting aggressively enough to protect the public 2. a lack of consumer info about the dangers of taking many dietary supplements with certain OTC and prescription medications 3. lack quality standards for strength and purity because manufacturers are not require to register themselves of their products with the FDA prior to marketing them and no manufactring standards exist for dietary supplements

DSHEA allows dietary supplement suppliers to make 4 types of nutritional support statements:

1. product will benefit a classical nutrient deficiency disease 2. role in affecting the structure or function of the body (xyz may reduce risk of abc) 3. product may maintain structure or function 4. general well-being from consumption of product (energize, relaxant)

OTC status is granted to drugs that have been shown to be :

1. safe for use without a physician's supervision 2. conditions suitable for self-diagnosis 3. must have "adequate directions for use" on their label

under DSHEA, a dietary supplement is defined as ____

a product (other than tobacco) that is intended for ingestion, is intended to supplement the diet and contains on or more of the following: a vitamin, mineral, herb or other botanical, an amino acid

dietary supplements containing contaminants or lacking the ingredient they represent would be ____

adulterated or misbranded

in response to concerns over quality standards, the FDA issued a final rule in june 2007 requirng that dietary supplement manufacturers ...

comply with current good manufacturing practices (cgmp) in such a manner that the products will not be adulterated or misbranded

the overriding factor in determining a product's status might not be its _____, but rather the _____

ingredients; manufacturer's claims

are there provisions in the law for FDA to approve dietary supplements for safety or effectiveness before they reach the consumer

no

can the FDA require premarket approval of dietary supplements?

no

do cosmetics have to be tested for safety like drugs do?

no

do cosmetic manufacturers have to meet FDA good manufacturing practices ?

no. ( but they still must be manufactured under sanitary conditions

do cosmetics require premarketing approval from the FDA?

no. do not require (exception of color additives)

DSHEA thus exempts dietary supplements from part C of the FDCA drug definition by ___

permitting structure/function claims

because dietary supplements are regulated much as foods rather than drugs, the FDA can only remove a dietary supplement from the market on the basis of ____

public safety if the agency can prove the product is adulterated

DSHEA provides that a dietary supplement is adulterated if it presents a

significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling

the FDCA has created at least 2 special categories of foods including

special dietary foods and medical foods

essentially, DSHEA mandates that the FDA regulate dietary supplements more as a ______

special type of food than as drugs

special dietary foods under the FDCA include those ___

supplying a special dietary need that exists because of a physical, physiological, pathological or other condition

congress passed DSHEA in 1994, further ammended the FDCA by legally creating ____

the category of dietary supplements and significantly altering the FDA's authority to regulate the safety and labeling of dietary supplements

what act amended the FDCA and required the manufacturer, packer or distributor whose name appears on the label of a dietary supplement marketed in the US to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the US within 15 days via the medwatch program?

the dietary supplement and nonprescription drug consumer protection act

under DSHEA, who is responsible for determining that the dietary supplements it manufacturers or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading?

the manufacturer (and not the FDA)

to make any of the 4 nutritional support statements, the manufacturer must have substantiation that they are truthful and not misleading and the label must contain the disclaim: "..."

this statement has not been evaluated by the food and drug administration. this product is not intended to diagnose, treat, cure or prevent any disease

true or false DSHEA has proven thus far to be an extremely controversial law

true

DSHEA stripped the FDA of premarket approval authority. under DSHEA, the FDA must prove that a dietary supplement is ______before it can restrict or remove the product from the market

unsafe (FTC, not FDA, regulates advertising and therefore monitors for misleading claims)

what is the crucial distinction of whether a product is a drug?

whether the supplier made a therapeutic or claim or a structure/function claim

is the manufacturer and distributor require to submit to FDA all serious adverse event reported associated with use of the dietary supplement in the US ?

yes (as of 2007); require to report within 15 days via the medwatch program