Apologies in advance for just this quick link, but the topic is very timely given our highly-read post last week suggesting the repeal/modification of DSHEA, the primary US legislation directing the weak oversight of the dietary supplement industry.
Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers [press release]. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.
This is not the first case of herbal products containing the carcinogen and nephrotoxin, aristolochic acid, and FDA maintains a page on several similar episodes in 2000/2001.
Part of the reason for this quick post is that I am currently attending a botanical medicine conference addressing the science, or lack thereof, of herbal supplements used worldwide. What I have found most interesting is that representatives from this industry are themselves getting disgusted with the less reputable end of the manufacturer spectrum that draw negative press for general poor quality control over raw materials as seen in today’s announcement.
Will the companies support modifications to DSHEA or is there any influence they can have in self-policing the wild west mentality of the fringes of their industry?
Until then, keep an eye on FDA’s MedWatch website for this and other supplement safety actions:
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s press release regarding this issue and a list of the recalled products at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herbal