Vitamins/Herbals/CAM Regs

Question 1

What is a dietary supplement?

Answer 1

Defined by Federal Food Drug Act 1938

Unlike drugs are not intended to treat, diagnose, or cure disease

ie. Vitamins, Minerals, Herbs, Amino acids, Enzymes

Question 2

What is NOT a dietary supplement?

Answer 2

Prescription and OTC Medications
Homeopathic Remedies
Medical Foods (Regulated as Food by FDA)

Question 3

Homeopathic Remedies

Answer 3

Currently no FDA approved products (Not been evaluated for safety or affectedness)

Question 4

What aspect of Homeopathic Remedies does FDA regulate?

Answer 4

Manufacturing and Distribution

Still have an NDC

Question 5

HPUS

Answer 5

Homeopathic Pharmacopeia of United States

Where the active ingredients are listed

Similar info as USP

Question 6

Low Dilution?

Answer 6

6C and lower

Question 7

High Dilution?

Answer 7

12C and higher

Question 8

Highest Dilution usually seen in practice?

Answer 8

30C

Question 9

C scale vs X scale Dilutions

Answer 9

C scale are 100 times

X scale are 10 times, less common and used for highly toxic substances…typically not homeopathic use

Question 10

Medical Foods

Answer 10

Specially formulated and processed for a patients who has limited capacity to ingest, digest, absorb or metabolize food or nutrients

Have special medically determined nutrient requirements that cannot be meet by modification of diet alone.

Question 11

Examples of Medical Foods

Answer 11

Infant Formulas for children with IEM

Urea for Hyponatremia

Question 12

IEM

Answer 12

Inborn errors of Metabolism

Examples include:
Phenylketonuria
Maple Syrup Urine Disease
Homocystinuria

Question 13

Examples of non Medical Foods

Answer 13

Normal infant formula

Foods part of recommended diet for pregnancy, diabetes, and cardiovascular disease

Question 14

Definitions Medical Foods

Answer 14

Patient must be under medical supervision.

No prescription needed

FDA regulates but not FDA approved

Sometimes covered by insurance, but might have high co-pay or be high tier. Might need prescription to go through insurance

Question 15

DSHEA 1994

Answer 15

Definition of Dietary Supplements

Minimum labeling requirements

Manufacturing is responsible for controlling quality and safety

FDA can only take action after product reaches the market

Effectiveness not mentioned, focused on safety and misbranding.

Question 16

CMGP

Answer 16

Current Good Manufacturing Practice

Legislation requiring proper controls are in place for dietary supplements so they are processed in a consistent manner, and meet quality standards

Question 17

FDAMA

Answer 17

FDA Modernization Act of 1997

Amendment to FD&C act that encourages consumerism and dissemination of information. Allows health claims supported by studies done by federal scientific bodies

Question 18

Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

Answer 18

Amendment to FD&C with respect to serious adverse event reporting. Manufacturers must provide contact information and report serious adverse effects to the FDA.

Question 19

Labeling Required for Supplements

Answer 19

Statement of Identity
Net Quantity
Directions
Facts Panel
Other Ingredients
Manufacturer Name and Address
Disclaimer (If using structure/function claim)

Question 20

Notable Difference between OTC and Supplement labeling?

Answer 20

OTC have purpose, adverse affects and warnings

Supplements need a Disclaimer*

Question 21

Allowable structural/function claims for Dietary Supplement

Answer 21

Claim product effects structure or function of body by cant claim effectiveness of prevention or treatment of disease

Example:
Fiber helps maintain bowel regularity = OK
Fiber treats constipation = Not OK

Question 22

Allowable nutritional content claims for Dietary Supplement

Answer 22

most typical with vitamins

must have established recommended daily value

“Good source of……”

Question 23

Allowable Health claims for Dietary Supplement

Answer 23

Approved by FDA

Describe relationship between disease or health condition, and a food, diet or dietary product.

List of authorized claims verified by third party

“Calcium for prevention of osteoporosis”

Question 24

DSVP

Answer 24

Dietary Supplement Verification Program

Verifies what’s on label is in the bottle

Good Manufacturing Process

Question 25

ConsumerLab.com

Answer 25

essentially consumer reports for dietary supplements

subscription service, has a bunch of info

Question 26

Disclaimer

Answer 26

Required for any Structure/Function claims

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”

Question 27

Where are adverse effects reported?

Answer 27

FDA MedWatch