FDA regulation of dietary supplements and requirements regarding adverse event reporting

Clinical Pharmacology and Therapeutics

Volumn 87, Issue 2, 2010, Pages 239-244

  Frankos, V H ^a   Street, D A ^a   O'Neill, R K ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HERBACEOUS AGENT; NON PRESCRIPTION DRUG;

ACT; BLOOD TOXICITY; CONNECTIVE TISSUE DISEASE; DIET SUPPLEMENTATION; DRUG LABELING; DRUG MANUFACTURE; DRUG SAFETY; ENDOCRINE DISEASE; EYE DISEASE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TOXICITY; GENITAL SYSTEM DISEASE; GOOD MANUFACTURING PRACTICE; HEALTH CARE PERSONNEL; HEPATOBILIARY DISEASE; HUMAN; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INJECTION SITE REACTION; INTOXICATION; LYMPHATIC SYSTEM DISEASE; MEDIASTINUM DISEASE; MEDICAL INFORMATION; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; NEPHROTOXICITY; NEUROTOXICITY; NUTRITIONAL DISORDER; POSTMARKETING SURVEILLANCE; PREGNANCY COMPLICATION; PRIORITY JOURNAL; RELIABILITY; RESPIRATORY TRACT DISEASE; SHORT SURVEY; SKIN TOXICITY; UNITED STATES; URINARY TRACT DISEASE; VASCULAR DISEASE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DIETARY SUPPLEMENTS; FOOD INDUSTRY; FOOD LABELING; HUMANS; LEGISLATION, FOOD; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 75749101340     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.263     Document Type: Short Survey

References (2)

1. US food and Drug administration. fDa Warns Consumers about "Total Body formula" and "Total Body Mega formula" http://www.fda.gov/ NewsEvents/Newsroom/Pressannouncements/2008/ucm116873.htm (27 March 2008)
2. US food and Drug administration. fDa finds Hazardous Levels of Selenium in Samples of "Total Body formula" and "Total Body Mega formula" http://www.fda.gov/NewsEvents/Newsroom/Pressannouncements/2008/ ucm116878.htm (9 april 2008).