chapter 2 Flashcards
(59 cards)
The Pure Food and Drug Act prohibited the
adulteration and misbranding of Foods and Drugs. IT DID NOT REGULATE the adulteration and misbranding of devices and cosmetics.
The Pure Food and Drug Act only prevented false statements on a drugs ____
Identity ( strength, quality, and purity). IT DIDN’T prevent false or misleading efficacy claims. IT didn’t include list of ingredients, directions for use or provide warnings.
The Food Drug and Cosmetic Act provides for the comprehensive regulation of all drugs introduced into interstate commerce. The intent of this law is to protect consumers from adulterated or misbranded _____, _____, _____ or ______. It also said NO NEW DRUG can be marketed and sold unless ______
foods, drugs, cosmetics, and devices
it has been proved to be both safe and effective for its intended use, described on the label and approved by the FDA.
The Food Drug and Cosmetics act also expanded on the definitions of ____ and ____ requiring that labels must also contain _______ and ______ about the habit forming properties of certain drugs.
misbranding and adulteration
adequate directions for use
warnings
The FDA is a component of the _____ and has actual authority for administering the _____
Department of Health and Human Services (DHHS)
Food Drug and Cosmetic Act (FDCA)
The Office of Medical Products and Tobacco: coordinates and leads the scientific and regulatory evaluations and interpretations for ______.
Drugs, Biologics, Medical Devices, and Tobacco Products
The FDA interprets the FDCA through both _____ and ______
rulemaking (regulations) AND
by the means of guidance documents
The term “drug” means _______ (under section A)
articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them
The term “drug” means ________ (under section B)
articles intended for use in the diagnosis, cure, mitigation, treatment, or other prevention of disease in man or other animals
The term “drug” means _____- (under section C)
articles (other than food) intended to affect the structure or any function of the body of man or other animals
The Office of Medical Products and Tobacco - coordinates and leads scientific and regulatory evaluations and interpretation for _____
Drugs
Biologics
Devices
Tobacco
The Food Drug Cosmetic Act, once passed in 1938 required that no new drug can be marketed unless it is proven to be _____. It didn’t initially require a drug be _____ until the _______ came into legislation.
safe
effective
Kefauver-Harris Amendment
The Food Drug Cosmetic Act created 2 special categories of foods _____ and _____.
Special Dietary foods
Medical foods
TRUE or FALSE
Special dietary foods and Medical foods are not considered drugs
True
TRUE or FALSE
Special dietary foods and medical foods can make therapeutic health claims
True
The Dietary Supplement and Education Act (DSHEA) - created a new special category of foods called ____
dietary supplements
The Dietary Supplement Health and Education Act mandates that the FDA regulates dietary supplements more as a _________ rather than ______
special type of food
rather than a drug
A dietary supplement is defined as a _____, _____, _______ or other ______, ______, or substance used to supplement the diet by increasing total dietary intake.
vitamin mineral herb botanical amino acid
TRUE or FALSE
Dietary supplements require premarket approval
False
they do not require
TRUE or FALSE
The DSHEA altered the FDA’s authority to regulate dietary supplements
True
prior to the DSHEA amendment the FDA had regulated dietary supplements as drugs
The DSHEA permits(allows) four types of nutritional support claims to be made:
1-benefitting a classical nutrient deficiency disease
2-describing role of the dietary supplement in affecting the structure/function of the body (as long as NOT making a health or therapeutic claim)
3-characterizing the mechanism by which a DS acts to maintain the structure or function
4-statements of general well-being
-claims must be substantiated as truthful and not misleading
-the label must contain a disclaimer
True or False
The Dietary Supplement Health and Education Act excludes an article as a dietary supplement if it was approved as a drug prior to being marketed as a dietary supplement.
True
Infant formulas, artificial sweeteners and caloric supplements are examples of ______
special dietary foods
Define Medical Foods
are foods formulated for oral or external use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation.
