Council for Responsible Nutrition
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Legislation

DSHEA Summary and Analysis
Before and After DSHEA
Regulation
Food and Drug Administration (FDA)
Federal Trade Commission (FTC)
Self-Regulation
Regulations at a Glance >
CRN Comments
Federal Register Watch
International Policy
TransAtlantic Business Dialogue (TABD)
CODEX
Regulations at a Glance
• Dietary Supplements: Safe, Beneficial and Regulated—Click here for Q&A
• Printable (PDF) of chart below

Safety
Foods
Dietary Supplements
Drugs
FDA has the authority to declare a product misbranded if its labeling is false or misleading; civil and criminal penalties apply.
X
X
X
FDA establishes Good Manufacturing Practices and inspects manufacturing plants to ensure that provisions are followed.
X
X
X
FDA has the authority to declare a product adulterated if it is unsafe (whether the problem involves old or new ingredients or some other factor such as a contaminant or poor manufacturing conditions); civil and criminal penalties apply.
X
X
X
Manufacturers' self-affirmation that a substance is Generally Recognized as Safe (GRAS) is subject to FDA review.
X
X
 
FDA notification is required on the safety of new ingredients; FDA has the authority to disapprove.  
X
 
FDA prior approval of safety and efficacy is required.    
X
FDA prior approval of the safety of new food additives is required.
X
   
Labeling
Foods
Dietary Supplements
Drugs
Mandatory format for labeling required by FDA.
X
X
X
FDA approval of "nutrient content claims" required under the Nutrition Labeling and Education Act (NLEA) and the Dietary Supplement Health and Education Act (DSHEA).
X
X
 
Claims
Foods
Dietary Supplements
Drugs
FDA approval of "health claims" required under NLEA.
X
X
 
FDA has the authority to review label statements about structure and function effects under DSHEA.
X
X
 
Advertising
Foods
Dietary Supplements
Drugs
FTC requires that advertising claims be truthful, not misleading and substantiated by scientific evidence.
X
X
X

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