Chapter 19: Dietary Supplements

Question 1

Define ‘dietary supplement.’

Answer 1

Legal definition, set by Congress included in DSHEA is board and includes products taken by mouth that contain one or more of the following “dietary ingredients:”

• Vitamin
• Mineral
• An herb or other botanical
• AA
• Dietary substance for use by humans to supplement the diet by increasing the total dietary intake, OR
• A concentrate, metabolite, constituent, extract, or combination of any ingredients above.

Question 2

FDCA

Answer 2

Federal Food, Drug and Cosmetic Act

Question 3

DSHEA

Answer 3

Dietary Supplement Health Education Act (of 1994) amended the FDA authority under the FDCA

Question 4

Define ‘supplement’

Answer 4

Means that the product is not represented for use as a conventional food or as a sole item of a meal or the diet

• Do not undergo the stringent and expensive premarket approval process required for prescription or over-the-counter drugs

Question 5

Define food additives.

Answer 5

Means that manufacturers are exempt from the food additive premarket approval process of the FDCA.

Question 6

Define CAM.

Answer 6

Complementary and Alternative Medicine; a group of diverse medical and healthcare systems, practices, and products that are not generally considered part of conventional medicine

• AKA Allopathic medicine

Question 7

Define complementary medicine.

Answer 7

Refers to practices and products used together with conventional medicine.

Question 8

Define alternative medicine.

Answer 8

Refers to systems, practices, and products that are used as a SUBSTITUTE for conventional medicine.

Question 9

Define integrative medicine.

Answer 9

Refers to a practice that combines both conventional and CAM approaches for which there is evidence of safety and effectiveness.

Question 10

Define naturopathy.

Answer 10

A medical system that aims to support the body’s ability to heal itself through dietary and lifestyle changes with therapies including the use of herbal supplements, massage, and joint manipulation.

Question 11

Define phytotherapy.

Answer 11

Is the science of using plant-based medicines to prevent or treat illness.

Question 12

Define nutraceutical.

Answer 12

Can refer to nutrients or other active food ingredients delivered in a pharmaceutical dosage form.

• Example: Vitamin C tablets

Question 13

Define functional food (AND definition)

Answer 13

“Foods that move beyond necessity to provide additional health benefits that may reduce disease risk and/or promote optimal health.” These would include:

• Conventional foods
• Modified foods (fortified, enriched, or enhanced)
• Medical foods, AND
• Foods for special dietary use, such as infant food and weight loss food

Example: OJ, bc it has a high composition of vitamin C

Question 14

Define medical food.

Answer 14

“Food which is formulated to be consumed or administered enterally under the supervision of a MD and which is intended for the specific dietary mgmt of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation”

Medical foods are exempt from both food labeling and dietary supplement labeing requirements, AKA different regulations apply.

• Include protein modulars
• Oral supplements

Question 15

Define homeopathy.

Answer 15

• A system of medicine that originated in Europe in the late 1800s.
• Based on the principle, “principle of similars” or “like-cures-like”
• Meaning, the observation that while high doses of pharmacologically active substances cuase symptoms when administered to healthy people, those same substances when prepared to very dilute form may relieve similar symptoms in conditions resulting from different etiologies.
• Not considered dietary supplements under the legal definition of the FDCA.
• Homeopathic products premarket approval process is controlled by the Homeopathic Pharmacopeia Convention of the US.

Question 16

(TRUE/FALSE)

Under the DSHEA, the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.

Answer 16

TRUE

Question 17

Who is responsible for taking action against an unsafe dietary supplement and its manufacturer after it reaches the market?

Answer 17

The FDA

Question 18

In what situation would a manufacturer need to get FDA approval for their dietary supplement product?

Answer 18

Manufacturers do not need to register their products with the FDA or get FDA approval UNLESS the product contains a NDI (new dietary ingredient).

Question 19

Define NDI.

Answer 19

New Dietary Ingredient; refers to any ingredient not previously marketed in the US before the enactment of the DSHEA (of 1994).

Question 20

Define adulterated.

Answer 20

A dietary supplement is considered adulterated, if it contains an ingredient that was not present in the food supply prior to the DSHEA OR a known ingredient that has been chemically altered and the manufacturer markets it without giving notification to the FDA.

Question 21

What did the passing of DSHEA in 1994 do?

Answer 21

• Established an inclusive definition of dietary supplements, which covers a wide range of products.
• They were not relegated to the category of “foods”
• Congress specifically allowed structure/function claims (basically put the burden on the FDA to show that a product is unsafe AFTER it is already being sold instead of requiring the manufacturer to demostrate safety prior to the product’s sale).

Question 22

Define misbranded.

Answer 22

The product is misbranded if any of the following are true:

• The labeling fails to list (1) the name of each ingredient in the supplement and (2) the quantity of each ingredient or, if it contains a proprietary blend, the total quantity of all the ingredients in the blend.
• The product is a botanical product and the labeling fails to identify the part of hte plant from which the ingredient is derived.
• The product is purported to conform to the specificiations of an official compendium but fails to do so
• The product fails to have the identy and strength that the supplement is represented to have or fails to meet the quality, purity, or compositional specifications based on the assay or method the supplement purports to meet.

Question 23

Define drugs.

Answer 23

Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease and articles (other than food) intended to affect the structure or any fuction of the body.

Question 24

(TRUE/FALSE)

DSHEA specifically allows dietary supplements to make structure/function claims if they meet certain statutory criteria, including a disclaimer statement that the product is not intended to prevent or cure a disease.

Answer 24

TRUE

Question 25

Define a health claim.

Answer 25

An explicit or implied characterization of a relationship between a substance and a disease or a health-related agreement and must be authorized by the FDA.

Question 26

(TRUE/FALSE)

A structure/function claim describes the role of a substance intended to maintain the structure or function of the body.

Answer 26

TRUE

Question 27

(TRUE/FALSE)

The FTC is responsible for ensuring that dietary supplement advertising is truthful, not misleading, and based on sound scientific evidence.

Answer 27

TRUE.

Question 28

Define serious adverse event.

Answer 28

As an event that either results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, or any event that requires a medical or surgical intervention to prevent one of these outcomes.

Question 29

(TRUE/FALSE)

Nonserious events are not reported publicly for healthcare professionals to review.

Answer 29

TRUE

Question 30

(TRUE/FALSE)

The ASHP (American Society of Health-System Pharmacists) discourages use of the supplements in situations where irreversible consequences may occur, such as in conjunction with immune suppression, chemotherapy, HIV infection, anticoagulation therapy, or use of hormonal contraceptives.

Answer 30

TRUE.