Dietary Supplements

Question 1

Dietary Supplements

Answer 1

• FDA defines dietary supplements as vitamins, minerals, herbs, botanicals, and amino acids
• Purpose of dietary supplements:
- Diet supplementation
- Health and wellness maintenance
- Symptomatic treatment of medical conditions
• Regulated by The Dietary Supplement Health and Education Act (DSHEA)

Question 2

The Dietary Supplement Health and Education Act of 1994

Answer 2

• Created a major difference when compared to Rx drugs
- Excluded from strict purity, potency, consistency and actual identity standards
• A dietary supplement is allowed to enter market without testing for safety or efficacy; however, it can be removed if deemed not safe.
• FDA prohibits manufacturers from marketing products for tx of medical conditions unless they have gone through extensive review and were pre-approved by the FDA for a specific health claim

Question 3

Adulteration

Answer 3

• Significant risk of illness or injury
• Lacks evidence to ensure safety
• Declared a hazard by the Department of Health and Human Services Secretary
• Ingredient present is sufficient to render the product poisonous to human health

Question 4

Choosing a Safer Dietary Supplement

Answer 4

Consumer Labs
• Active ingredient is what it says it in, in the right quantity

NSF (not an acronym)
• Prepared using good manufacturing practice
• Does not contain unacceptable levels of contaminants

US Pharmacopeial Convention
• Prepared using good manufacturing practice
• Strict adherence to quality, purity, potency, performance, and consistency

Question 5

Reliable Sources

Answer 5

• Natural Medicines

- Medline Plus