TABLE 2–2 Safety Review Systems for Nondietary Supplement Substances

Purpose of Review

Organization

Type of Organization

Endpoints

Premarket safety evaluation of food ingredients/food additives

Food and Drug Administration/Center for Food Safety and Applied Nutrition

Government

Approved

Approval with limitations

Interim approval

Disapproval

Safety evaluation of food additives/food ingredients generally recognized as safe (GRAS) in 1972

Select Committee on GRAS Substancesa

Nongovernment/ nonindustry

Continue as GRAS

Continue as GRAS with limitations

Further testing required

Evidence of adverse effects—may remove GRAS status if safety not established

Remove GRAS status

Safety evaluation and determination of GRAS status of flavor ingredients

Flavor and Extract Manufacturers Association (FEMA) Expert Panel

Industry

GRAS status

Not GRAS

Insufficient data to determine GRAS status

Safety assessment of cosmetic ingredients

Cosmetics Ingredient Review Program

Industry

Safe as used

Safe with qualifications

Unsafe

Insufficient data

Premarket evaluation and approval of new drugs

Food and Drug Administration/Center for Drug Evaluation and Research

Government

Approved

Not approved

Over-the-counter (OTC) Drug Review to establish conditions under which OTC drugs would be considered generally recognized as safe and effective (GRAS/E)

Food and Drug Administration

Government

Category I (GRAS/E)

Category II (not GRAS/E or unacceptable indications)

Category III (insufficient data)

Regulation of entry and use of new chemicals in the marketplace; assessment of human and environmental risk of new chemicals

Environmental Protection Agency New Chemicals Program

Government

No action taken to regulate the chemical

More testing needed

Determination of the Tolerable Upper Intake Level (UL) for nutrientsb

Institute of Medicine/Food and Nutrition Board

Nongovernment/ nonindustry

UL

Scientific evidence insufficient to set UL

a Source: Select Committee on GRAS Substances (1982).

b Note that nutrients are in many cases dietary supplements or dietary supplement ingredients; this safety framework, however, only applies to nutrients and recognized food components thought to play a role in health.



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