Terra Sigillata

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

Comments

  1. #1 anon3
    April 14, 2008

    You’ll notice those are all ‘chinese herbal’ medicines. There are literature studies where they analyzed random samples of chinese herbal medicine and found that over half were adulterated with prescription and/or illegal substances. Given what’s happened with heparin, even more reason not to get anywhere near this kind of stuff.

  2. #2 Joe
    April 15, 2008

    Thanks for this post. anon3, please give citation(s).

  3. #3 Joe
    April 17, 2008

    Abel asks “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?”

    I think we know the answer- an improved DSHEA was offered on its tenth anniversary; Sen. Hatch said “No.” As for the industry, any policing is a cost to them; and they are the ones who wrote DSHEA. It is “working” exactly as intended.

    A problem with herbal preps is that the effective ones are contaminated drugs. One cannot afford to assay raw materials for every possible contaminant.

    (The only things that can be effectively screened for contaminants are homeopathic preps, which should be pure vehicle (alcohol, water, sugar).)

    Another problem is that, for the most part, we do not know which herbs are effective (or for what). The antimalarial drug, artemisinin, was the only useful product resulting from screening more than 100 “antimalarial” herbs.*
    http://www.ncbi.nlm.nih.gov/pubmed/16722826?ordinalpos=21&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
    Nobody knows if the herbs have activity for some other purpose.

    While I am at it, I should cite Abel’s post Abel asks “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?”

    I think we know the answer- an improved DSHEA was offered on its tenth anniversary; Sen. Hatch said “No.” As for the industry, any policing is a cost to them; and they are the ones who wrote DSHEA. It is “working” exactly as intended.

    A problem with herbal preps is that the effective ones are contaminated drugs. One cannot afford to assay raw materials for every possible contaminant.

    (The only things that can be effectively screened for contaminants are homeopathic preps, which should be pure vehicle (alcohol, water, sugar).)

    Another problem is that, for the most part, we do not know which herbs are effective (or for what). The antimalarial drug, artemisinin, was the only useful product resulting from screening more than 100 “antimalarial” herbs.*
    http://www.ncbi.nlm.nih.gov/pubmed/16722826?ordinalpos=21&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
    Nobody knows if the herbs have activity for some other purpose.

    * A recent TV program in the UK put the number at over 200. Presumably that includes additional screening programs.

  4. #4 Joe
    April 17, 2008

    Ooops! I blame the software- the cursor disappeared and I posted quickly in order to preserve what I had.

    After “While I am at it … ” I meant to cite Abel’s post http://scienceblogs.com/terrasig/2006/12/more_on_black_cohosh_results.php
    explaining that most herbs cannot be standardized because the active ingredient(s) is/are unknown.

    So, there it is. No matter how well-meaning they are, herbalists cannot check raw materials for contamination, do not know if their products are active, and cannot standardize many of those that are.

  5. #5 Lab Cat
    April 17, 2008

    Unfortunately Senator Hatch is from Utah where a number of the supplement companies are based.

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