Vitamins/Herbals/CAM Regs Flashcards
What is a dietary supplement?
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
What is NOT a dietary supplement?
Prescription and OTC Medications
Homeopathic Remedies
Medical Foods (Regulated as Food by FDA)
Homeopathic Remedies
Currently no FDA approved products (Not been evaluated for safety or affectedness)
What aspect of Homeopathic Remedies does FDA regulate?
Manufacturing and Distribution
Still have an NDC
HPUS
Homeopathic Pharmacopeia of United States
Where the active ingredients are listed
Similar info as USP
Low Dilution?
6C and lower
High Dilution?
12C and higher
Highest Dilution usually seen in practice?
30C
C scale vs X scale Dilutions
C scale are 100 times
X scale are 10 times, less common and used for highly toxic substances…typically not homeopathic use
Medical Foods
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.
Examples of Medical Foods
Infant Formulas for children with IEM
Urea for Hyponatremia
IEM
Inborn errors of Metabolism
Examples include:
Phenylketonuria
Maple Syrup Urine Disease
Homocystinuria
Examples of non Medical Foods
Normal infant formula
Foods part of recommended diet for pregnancy, diabetes, and cardiovascular disease
Definitions Medical Foods
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
DSHEA 1994
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.
CMGP
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
FDAMA
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
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
Amendment to FD&C with respect to serious adverse event reporting. Manufacturers must provide contact information and report serious adverse effects to the FDA.
Labeling Required for Supplements
Statement of Identity Net Quantity Directions Facts Panel Other Ingredients Manufacturer Name and Address Disclaimer (If using structure/function claim)
Notable Difference between OTC and Supplement labeling?
OTC have purpose, adverse affects and warnings
Supplements need a Disclaimer*
Allowable structural/function claims for Dietary Supplement
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
Allowable nutritional content claims for Dietary Supplement
most typical with vitamins
must have established recommended daily value
“Good source of……”
Allowable Health claims for Dietary Supplement
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”
DSVP
Dietary Supplement Verification Program
Verifies what’s on label is in the bottle
Good Manufacturing Process
ConsumerLab.com
essentially consumer reports for dietary supplements
subscription service, has a bunch of info
Disclaimer
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.”
Where are adverse effects reported?
FDA MedWatch
