Dietary Supplement Alerts and Safety Information

Alerts

• Aristolochic Acid
  • FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid April 11, 2001
• Comfrey
  • FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market July 6, 2001
• Ephedrine Alkaloids
  • see Consolidated Information on Ephedrine Alkaloids*
•  Kava
  • Hepatic Toxicity Possibly Associated with Kava-Containing Products (CDC MMWR Report, November 29, 2002)
  The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements.
  • Consumer Advisory: Kava-Containing Dietary Supplements May be Associated With Severe Liver Injury March 25, 2002
  • Letter to Health Care Professionals: FDA Issues Consumer Advisory That Kava Products May be Associated with Severe Liver Injury* March 25, 2002
  • Letter to Health Care Professionals about FDA Seeking Information on Liver Injury and Kava products* December 19, 2001
•  LipoKinetix: FDA Warns About Weight Loss Product
  FDA alerts consumers and health care professionals about LipoKinetix, a dietary supplement weight loss product. This product has been implicated in a number of serious adverse reactions related to several cases of liver injury.
  • FDA Warns Consumers Not to Use the Dietary Supplement LipoKinetix* November 19, 2001
  • Letter to Health Care Professionals on Hazardous Dietary Supplement LipoKinetix* November 19, 2001
  • Letter to Distributor on Hazardous Dietary Supplement LipoKinetix* November 19, 2001
•  Liqiang 4
  • FDA Issues Nationwide Alert for "Liqiang 4" Due to Potential Health Risk* July 1, 2005
•  PC SPES and SPES
  • MedWatch Safety Alert: Consumers Warned to Stop Using the Dietary Supplement/Herbal Products PC SPES and SPES* February 8, 2002
•   Red Yeast Rice
  • FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on the Internet as Treatments for High Cholesterol August 9, 2007
•   St. John's Wort and Indinavir
  • FDA Public Health Advisory: Risk of Drug Interactions with St. John's Wort and Indinavir and Other Drugs February 10, 2000
•  Tiractricol
  • FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol* November 21, 2000
• Triax Metabolic Accelerator
  • FDA Warns Against Consuming Triax Metabolic Accelerator* November 11, 1999
• Other FDA Alerts
  • FDA Warns Consumers Not to Feed Infants "Better than Formula Ultra Infant Immune Booster 117" January 23, 2004
  • FDA Warns Public About Chinese Diet Pills Containing Fenfluramine* August 13, 2002
  • FDA Recalls and Safety Alerts
  • FDA Import Alerts and Import Detention Reports

Botanical Dietary Supplements

• Concerns About Botanicals and Other Novel Ingredients in Conventional Foods
• Letter to Health Professionals Regarding Safety Concerns Related to the Use of Botanical Products Containing Aristolochic Acid
• Adverse Events with Ephedra and Other Botanical Dietary Supplements
• FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market

 

Additional Safety Information

• Products Consumers Inquire About*:
  Ephedra or Ephedrine; DHEA (dehydroepiandrosterone); Melatonin; Dieter's Teas; L-Tryptophan; Folic Acid; Gamma Hydroxybutyric Acid (GHB); Gamma Butyrolactone (GBL); and 1,4 Butanediol (BD)
• MedWatch New Safety Information Summaries*:
  2002 / 2001 / 2000 / 1999 / 1998 / 1997
• Archived Information: FDA Warning Statements Issued from 1993 to 2000*
• Buying Medicines and Medical Products Online*
• Other Sources of Safety Information* (such as NIH, USDA, etc.)
• Letter to Stakeholders Regarding Contract on Dietary Supplement Safety Issues* December 15, 2000

 

Reporting Problems

• Adverse Event Reporting
• Reporting Unlawful Sales of Medical Products on the Internet
• MedWatch

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*Document is temporarily unavailable online.