WEEK 6 QUESTIONS
1. Is Saint John’s Wort supplements accurately labeled? Why or why
not? No, it wasn't. It was missing nutrition information and serving size. The
bottle would not say it was good for treating depression or insomnia.
2. In the 1990’s the FDA became concerned about two
things, what were they? The first thing was that "heart healthy" was being
put on food products. The second concern was the rapidly growing market
in dietary supplements.
3. What was the result of the 1994 marketing law? The result
was that dietary supplement manufacturers were now free to market a
wide variety of products without fear of the FDA considering them to be
drugs. It required solid pre marketing evidence of both safety and
effectiveness.
4. This caused the dietary supplement market to jump from
$3.5 billion in 1992 to ___________ by 2003? It went up to $11 billion in
1995, to an estimated $24.7 in 2007.
5. When did congress grant authority to the FDA to set up
"Adverse Events Reporting"? and what is it they have to put on the
label since 2007? It granted authority in 2006. They had to put a label that
included an address to where a consumer can report any adverse events
that occur after taking the product.
6. What is SAMe? It is short for S-adenosyl-L-methionine. It is a
naturally occurring substance found in the body. It's an active form of
amino acid methionine and it also acts as a methyl donor in a variety of
biochemical pathways.
7. In 1962 Kefauver-Harris amendment required……
______? It required that all drugs be evaluated for both safety and efficacy.
8. Define GRAS. It stands for, generally recognized as safe. It
means that given the current available information, people who are
informed and qualified agree that the ingredients are considered safe.
9. In 2006 the revised Patriot act required that
_____________ be removed from the shelves. Why? It required that
over the counter drugs containing pseudo ephedrine be removed from the
shelves because pseudo ephedrine was being used as a precursor in the
illicit manufacture of methamphetamine.
10. Is PPA safe? Ephedra? Alli? Would you use any of these?
Why or why not? PPA is not safe because women who use it had an
increase risk of hemorrhagic stroke. Ephedra is also not safe and was
banned in 2004. Alli is safe and can be purchased over the counter. I
would only try Alli.
11. What is diphenhydramine? What OTC still contains this? It
