FDA Alerts

FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use.

Links to FDA Alerts

• FDA Issues Warning Letters to Marketers of Unapproved 'Alternative Hormone Therapies' promoted for treatment or prevention of cancer, heart disease, and osteoporosis
  The Food and Drug Administration (FDA) today announced that the agency has taken action against a number of firms marketing unapproved "Alternative Hormone Therapies" because the products these firms are selling are unapproved new drugs that have not been found safe and effective to treat or prevent certain serious or life-threatening diseases or conditions.

• FDA Issues Information for Consumers about Claims for Green Tea and Certain Cancers.

• Study Finds Additional Evidence for Contamination of Herbal Supplement for Prostate Cancer
  A chemical analysis of PC-SPES, a recently recalled herbal dietary supplement commonly used to treat advanced prostate cancer, has shown that the supplement was contaminated with the synthetic drugs warfarin, diethylstilbestrol and indomethacin. Diethylstilbestrol and indomethacin have known anticancer properties.

  For more information, please read the full release

• FDA Warns Consumers to Stop Using PC SPES and SPES Capsules
  Consumers are warned to stop using the dietary supplement / herbal products PC SPES and SPES capsules because they contain undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision. Laboratory analysis of the products by the California Department of Health Services found PC SPES contains warfarin and SPES contains alprazolam, which are available only by prescription and sold either by their generic names or the trade names, Coumadin and Xanax. PC SPES and SPES are respectively marketed "for prostate health" and strengthening the immune system. BotanicLab, the manufacturer of the products, has voluntarily recalled PC SPES and SPES nationwide.

  If you are an applicant using PC SPES, please contact your program officer.

• Potential Risk of Kava-Containing Dietary Supplements
  The FDA Center for Food Safety and Applied Nutrition (CFSAN) notified healthcare professionals and consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Supplements containing the herbal ingredient kava are promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses. Kava-containing products have been associated with liver-related injuries, including hepatitis, cirrhosis, and liver failure. Given these reports, persons who have liver disease or liver problems, or persons who are taking drug products that can affect the liver, should consult a physician before using kava-containing supplements.
• FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market
• FDA Issues a Nationwide Alert on the Recall of Thirteen "Treasure of The East" Herbal Products Because of Possible Health Risk
  On June 20, 2001, the FDA warned consumers to discontinue the use of 13 Chinese herbal products sold under the "Treasure of the East" label containing aristolochic acid because they may present a serious health hazard. This press release lists the 13 products, which were distributed nationwide in small quantities primarily to acupuncturists, herbalists, and herbal stores.
• Letter to Health Professionals Regarding Safety Concerns Related to the Use of Botanical Products Containing Aristolochic Acid
• Aristolochic Acid - FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid