4_1CAMRegulation Flashcards
What did the Proxmire Amendment on 1976 do?
prohibited standards to limit vitamin potency and regulate as drugs
What did the Nutrition Labeling and Education Act of 1990 do?
1) required nutritional labeling on food and dietary supplements; 2) proposed medication standards being applied to vitamins
What are the 3 categories of claims allowed on food and supplement labels?
1) health claims; 2) structure/function claims; 3) nutrient content claims
What did the Dietary Supplement Health and Education Act of 1994 do?
1) disallowed disease-related claims; 2) allowed either health, structure/function, or nutrient content claims
What is a health claim?
citing a study that states effect on health
What is a structure/function claim?
statement that a product promotes wellness related to a structure/function of body
What are the requirements for structure/function claims?
must have disclaimer according to DSHEA “this statement has not been evaluated”
What are structure/function claims prohibited from doing?
claiming ability to 1) cure, 2) treat 3) mitigate 4) prevent or 5) diagnose
When were label requirements for dietary supplements passed?
1999
What are the label requirements for a dietary supplement?
1) statement of identity; 2) net quantity of contents; 3) disclaimer if structure/function; 4) directions; 5) supplement facts; 6) other ingredients in descending order; 7) name/place of manufacturer
What did the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 do?
required supplement/OTC manufacturers to notify FDA of serious ADRs
When did DSNDCPA reporting begin?
2007
What is a seal of approval program?
a voluntary-participation program provided by non-government organizations to 1) measure proper manufacturing, 2) evaluate the presence of listed ingredients, 3) confirm lack of harmful contaminants
What organizations put on seal of approval programs?
Consumerlab, NSF, USP
Which organization that puts on Seal of Approval program is not credible?
Council for Responsible Nutrition (put on by manufacturers)
What are the causes of Class I recalls for supplements?
mainly undeclared ingredients; also contamination, ADR, tampering, mislabeling
What is a class I recall?
a recall in which people have been harmed
What percentage of class I recalls are from supplements?
50%
What is adulteration?
changing the content of a drug; tampering
What supplements are the most commonly adulterated?
1) male enhancement, 2) weight loss, 3) anabolic steroids
What is the FDA’s role in supplement regulation?
enforcing claims and issuing recalls
What claims may the FDA enforce regarding supplements?
1) adulteration, 2) illegal claims, 3) unsafe ingredients
What committee moved to give the FDA oversight of supplements?
senate special committee on aging
What drove the FDA receiving oversight of the supplement market?
the US GAO report that found 37/40 products contained unsafe levels of contaminants
What drove the passing of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006?
difficulty removing ephedra from the market
What was ephedra?
a drug with stimulant properties that was popular for weight-loss and performance enhancement in the 80s and 90s
When did the FDA propose the ban on ephedra > 8 mg?
1997
When did the FDA officially ban ephedra?
2004
What state overturned the FDA’s ephedra ban on products > 10mg?
UT
When did the FDA determine that no dose of ephedra was safe?
2007
What substance has replaced ephedra on the market?
synephrine
What things are listed in the Supplement Facts section of the label?
serving size, amount, and active ingredient
What drove the passing of the Proxmire Amendment?
manufacturer lobbying
What was the Tryptophan Tragedy of 89?
menstrual and sleep problem warning from the FDA; 1510 cases of eosinophilia and 38 deaths; recall led to discovery of manufacturing problem
How were supplements regulated prior to 1973?
by the FDA; MDR was given but no restrictions; manufacturers claimed megadose benefits; FDA attempted to limit to 150% of RDA and require disclaimer
What was the MDR?
minimum daily requirement
List the legislation passed regarding supplement regulation.
1) Proxmire Amendment in 1976; 2) NLEA of 90; 3) DSHEA ‘94; 4) DSNDCPA ‘06
