United States of America

Policy

The US has no official policy, program or regulations regarding the practice of TM/CAM. The National Institutes of Health established a National Center for Complementary and Alternative Medicine to conduct research on various integrative medical modalities. The White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) has made several recommendations for improving the quality and co-ordination of CAM research, including increased funding for Federal agencies that carry out research on CAM (WHCCAMP 2002).

Contact

US Food and Drug Administration 
10903 New Hampshire Avenue Silver Spring, 
MD 20993 
Tel: 1-888-INFO-FDA (1-888-463-6332) 
Website:http://www.fda.gov
Center for Food Safety and Applied Nutrition
Food & Drug Administration
5100 Paint Branch Parkway College Park, MD 20740                                            
Website: http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/default.htm

 

Laws & Regulations

All dietary supplements are regulated by the US Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) under the Dietary Supplement Health and Education Act of 1994. Dietary supplements may carry structure/function claims if those claims can be substantiated by scientific evidence. No medical claims are allowed on dietary supplements. There are specific labeling requirements and all marketers must notify the FDA, CFSAN within 30 days of selling a new product. In 2004, the FDA issued new guidelines that permit the approval of herbal mixtures if they can be shown to be safe and efficacious.

Fortified and functional food products are regulated under the Nutrition Labeling and Education Act. This Act provides guidelines for labeling, nutrient content claims and health claims.

Botanicals may be marketed as foods or as dietary supplements, but not as drugs.

There is no post-marketing surveillance program in effect.

The US has no official policy, program or regulations regarding the practice of TM/CAM.

Contact

US Food and Drug Administration    
http://www.fda.gov

 

Center for Food Safety and Applied Nutrition                                           
http://www.cfsan.fda.gov/list.html