4-6

Question 1

In the mid 1980s controversey broke out and pressure was put on the food industry to make clearer and more complete nutritional information and more rigorous evaluations of food health claims. This caused the passage of?

What did it do exactly?

Answer 1

Nutrition Labeling and Education Act of 1990

This law strengthened the FDAs authority and required the FDA to adopt sweeping new regulations for food labeling.

This left herbal and other dietary supplements in an interesting position because the rules didnt exactly apply to them.

Question 2

In 1994 ______ was formed? What changes did they make exactly? It also had some draw backs?

So dietary supplements are considered what exactly?

Answer 2

The Dietary Supplement Health Education Act

• This defined what a “Dietary Supplement” was and herbs were included in this
• Under this Act a sense of safety pertaining to herbs was assumed because the FDA had to prove that the herbs were unsafe
• Dietary supplements are considered food supplements and not a medicine at all!

Question 3

Dietary Supplement Health Education Act

The law allows statements on the label describing the products role in ___________________________, however products bearing sich statements must also include the following?

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

B) This statement has not been evaluated by the FDA.

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

Answer 3

• Affecting or maintaining structure or function in humans
• C

Question 4

Further Quality Issues

In 1999 the FDA announced?

What are the issues of quality control?

Answer 4

Dietary Supplement labeling

• Standardization is often unrelated to bioactive constituents
• Adverstising claims are often untrue or misleading.
• In the USA the science is borrowed

Question 5

Germander is ______ and should be _____.

Borage is ______ and should be _____.

Chaparral is ______ and should be _____.

Sassafras is ______ and should be _____.

Aconite is ______ and should be _____.

Pennyroyal is ______ and should be _____.

Poke root is ______ and should be _____.

Jin Ba Haun is ______ and should be _____.

Answer 5

• Hepatotoxic and should be avoided
• hepatotoxic
• Hepatotoxic
• Hepatocarcinogen in animals
• Cardiac and CNS effects
• liver and renal failure
• Hemorrhagic
• Hepatotoxic

Question 6

Ephedra can have certain toxicities and should be avoided in?

Answer 6

CNS and Cardiac

Avoid in patients at risk for stroke, MI, Uncontrolled HTN, Seizures, general anxiety

Question 7

Royal jelly can cause? Should be avoided in?

Answer 7

Bronchospasms and Anaphylaxis

Avoid in patients with chronic or respiratory diseases, asthma, COPD, Emphysema, Atopy

Question 8

Comfrey should be avoided in pts?

Coltsfoot should be avoided in pts?

Answer 8

• Avoid internal ingestion topical use should be limited to 4-6 wks
• Avoid ingestion of any parts, leaves may be used topically for anti=inflammatory effects for up to 4-6 weeks

Question 9

The gold standard when evaluations a drugs safety and efficacy is?

Results and analysis are published in these and are known as?

In general you want to be cautious if information you find if it is lacking?

Answer 9

Controlled clinical trials

• Journals, Known as primary literature
• Lacking primary literature
• Peer reviewed

Question 10

A valuable information source on herbal safety is?

Answer 10

German Commision E Monograph

Rates herbs yo