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)