Regulatory Concerns for Dietary Supplements Flashcards
Are supplements regulated by the FDA?
Yes
What allows the FDA to regulate dietary supplements?
DSHEA 1994
Are there post-marketing surveillance that occurs by the FDA on dietary supplements?
Yes
Prior to Oct. 15 1994, what was required for supplements?
Reviewed for safety by FDA
After Oct. 15 1994, what was required for supplements?
Sponsor notifies FDA 75 days prior with intent & provide evidence that it is safe
Who requires claims of safety & efficacy to be supported by competent and reliable scientific evidence?
FTC
Which of the following claims requires FDA approval?
Health claim
Nutrient content claim
Structure function claim
Health & Nutrient content
Which of the following claims requires FDA notification to be required?
Structure function claim
If a product states that is has very low sodium, how much sodium could be present
≤35mg sodium
On a structure function claim, what wording is allowed/not allowed?
Good = supports a healthy cholesterol
Bad = Reduces high cholesteral
When is the FDA notification required?
30 days after product is marketed
What is the difference between infusion and decoction methods for tea?
Infusion = plant + pour boiling water + steep
Decoction = plant + cold water, then bring to boil
Which voluntary program is the most rigorous in terms of quality assurance?
United States Pharmacopeia (USP)
Which quality assurance program is the seal of approval for athletic supplements?
National Sanitation Foundation
The ComsumerLab requires testing every ________ to maintain seal of approval
12 months
