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Dietary Supplement Regulations

The following chart, compiled by the Council for Responsible Nutrition (CRN), outlines different regulations as they apply to foods, dietary supplements and drugs when reviewing products. Proper Nutrition, Inc. and Intestive® are currently in compliance with all dietary supplement regulations.

Regulations
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

Proper Nutrition is a member of The Council for Responsible Nutrition (CRN). CRN is dedicated to helping to reduce health care costs and enhancing the public’s health through good nutrition, including the appropriate use of dietary supplements. To fulfill this mission, CRN supports a science-based environment for the responsible marketing of dietary supplement products and provides its member companies with legislative guidance, regulatory interpretation, scientific information on supplement benefits and safety issues, and communications expertise.

For the most recent events in the supplement industry, the regulatory FACTS about how the FDA and FTC handle the supplement industry, or consumer tips like how to properly read a supplement label, visit CRN’s web site at www.crnusa.org.