Definitions

Question 1

1. Articles used for food or drink for man or other animals
2. Chewing gum
3. Articles used for components of any such article

Answer 1

Food

Question 2

A. Articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the US, or official National Formulary, or any supplement to any of them
B. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in man or other animals
C. Articles (other than food) intended to affect the structure or any function of the body of man or other animals
D. Articles intended for use as a component of any articles specified in clause A, B, or C

Answer 2

Drug

Question 3

A drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.

Answer 3

Counterfeit drug

Question 4

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is

1. Recognized in the official National Formulary, or the USP, or any supplement to them
2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
3. Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes

Answer 4

Device

Question 5

1. Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, AND
2. Articles intended for use as a component of any such articles; except that such term shall not include soap.

Answer 5

Cosmetic

Question 6

A product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients:
A. a vitamin
B. a mineral
C. an herb or other botanical
D. an amino acid
E. a dietary substance for use by man to supplement the diet by increasing the total dietary intake, OR
F. a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clauses A, B, C, D, or E

Answer 6

Dietary supplement

Question 7

A display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appearing shall not be considered to be complied with unless that same information also appears on the outside container or wrapper, if any there be of the retail package of such article or is easily legible through the outside container or wrapper

Answer 7

Label

Question 8

Any and all labels and other written, printed, or graphic matter

1. Upon any article or any of its containers or wrappers, OR
2. Accompanying the article (written materials part of an integrated distribution program, have a common origin and destination, and explain the drug)

Answer 8

Labeling