XTEND-15sec-NEWSt
9th August 2006
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Black cohosh in the news…n1
Black cohosh (Cimicifugae racemosae rhizoma) is a member of the buttercup family, and is a perennial plant native to North America. It has a long history of use for by women to reduce menopausal symptoms such as hot flushes.
Over recent years it has become a very popular natural alternative to synthetic HRT (Hormone Replacement Therapy)
In spite of it being used successfully by millions of women worldwide it has now been proposed that products containing Black cohosh should carry a warning against possible liver damage.
To read a good article on this subject please click here.
Warren Matthews’ comments: As Professor Edzard Ernst, Director of Complementary Medicine at the Peninsula Medical School, Universities of Exeter & Plymouth says…”The warning may be throwing the baby out with the bath water”The evidence supporting this warning is flimsy to say the least given that it was based on just a few poorly documented cases, and further that there appears to be no specific research establishing a mechanism of action for Black cohosh's effect on the liver.
This case has parallels to the banning of Kava kava a few years ago due to alleged liver toxicity. It was subsequently found that the few cases of liver toxicity were where the patients had been taking many, many times the recommended daily dose, and combining it with prescription drugs. Some countries that had banned Kava kava have since reinstated it.
The current adverse publicity must be music to the ears of the pharmaceutical companies…particularly those producing HRT! To get such a warning on even an OTC drug usually requires multiple deaths, not a few small poorly documented cases amongst the many thousands of successful cases.
We use a small amount of Black cohosh in our Total Balance Women’s Plus…just 16.66mgs per tablet. I would suspect that if indeed Black cohosh did contribute to liver damage in these cases that it would have been in very high doses…for example, in the several 1000s of mgs per day. In that respect almost any herbal extract if used in excess has the potential to do damage…just like vitamins, and for that matter certainly pharmaceutical drugs.
There is no reason to suspect that modest amounts of Black cohosh will do anything but good for your body…if you are a female…and certainly nothing become alarmed about or discontinue its use.
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Low Lutein, Zeaxanthin levels linked to artery disease…n2
Researchers from Sweden have reported that people suffering from coronary artery disease (CAD) have low levels of the antioxidant carotenoids, lutein and zeaxanthin, and could respond to supplementation.
A debate has been raging concerning the role of carotenoids and heart health with various intervention trials reporting that supplementation with beta-carotene failed to have the effects suggested by epidemiological studies.
These disappointments, suggest the researchers from the University Hospital in Linkoping, may be due to the lack of focus on other carotenoids, such as lutein and zeaxanthin, with several studies already reporting positive links between lutein consumption and heart health (for example: Circulation, 2001, Vol.103, pp. 2922-2927). More...
Warren Matthews' comments: No great surprise with these finding. One of the biggest challenges that we have conveying to people is the importance of ingredient synergy! The negative study that was done some while ago on Beta-carotene was really quite misleading. These ingredients are not designed to work in isolation…they must be combined with each other in the correct proportions. Of course Lutein and Zeaxanthin should be combined with Beta-carotene. This is why we have been using them together in Total Balance for the last six years.
Some scientists believe that combining the correct ingredients in the correct proportions will increase their efficacy by as much as fifteen fold.
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FTC orders Seasilver makers to pay $120mn...n3
The FTC has ordered the makers of ‘cure all’ Seasilver to pay almost $120mn for failing to comply with an earlier order to reimburse consumers – thereby signaling to infringing companies that it stands by its rulings.
In 2004, Seasilver USA and Americaloe agreed to pay $3mn in consumer redress, following Federal Trade Commission allegations that claims they made were false and unsubstantiated. At the time, the $120mn sum was set out in a suspended judgment, which would come into effect if the defendants did not make the agreed payments. While Seasilver USA and Americaloe did in fact comply with some of the 2004 FTC judgments, the FTC's most recent ruling shows the regulatory body means to be taken 100 percent seriously even within the complex legal framework of the dietary supplement industry. More...
Warren Matthews comments: Hmmm…pretty heavy fine…but then they did go right over the top with their claims.
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Black cohosh liver warnings sweep through Europe...m1
By Jess Halliday
19/07/2006 - The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is introducing warnings labels for black cohosh products on potential liver damage, following reports from two committees that have reviewed the safety data – an announcement that coincides with a public safety statement from the European Medicines Agency (EMEA).
Black cohosh (referred to by the European Medicines Agency, or EMEA, as Cimicifugae racemosae rhizoma) is a member of the buttercup family, and is a perennial plant native to North America. It has a long history of use for by women to reduce menopausal symptoms such as hot flushes. Historically it has been a popular alternative to hormone replacement therapy (HRT) in many countries including the UK, where it is estimated that 9 million days worth of black cohosh supplements were purchased in 2004.
Now, however, the MHRA said it wants warning labels to appear on black cohosh containing products. Its opinion was informed by the Commission on Human Medicines and the Herbal Medicines Advisory Committee, both of which have concluded that “the data underlines an association between black cohosh and risk of liver disease”.
Details of the data reviewed by the two committees was not available prior to publication of NutraIngredients.com. But the EMEA's advice to doctors and patients, also published yesterday, was informed by a third evaluation, by the Committee on Herbal Medicinal Products (HMPC), which looked at 42 case reports of hepatoxicity.
Although it found that all the cases were poorly documented, it said that the connection “should be seen as a signal”.
Patients are urged to stop taking black cohosh if they develop symptoms of liver damage, and to tell their doctor if they are already taking it. Health care professionals, meanwhile, are encouraged to ask patients about black cohosh use, and report suspected hepatic reactions to national adverse reaction reporting schemes.
A spokesperson for the EMEA told NutraIngredients.com that, as the body that evaluates medicines for human use, it does not have the jurisdiction to make warning labels on products mandatory. That she said is down to the regulatory bodies of individual countries.
Swedens' Medical Products Agency also issued a statement yesterday, pursuant to the EMEA opinion.
Barbro Gerden, a spokesperson for the agency and physician who has been involved in liver damage cases, said that warnings of the potential link between black cohosh and liver damage have been included on product information leaflets in Sweden for a number of years.
There are no plans to have warnings on the outside of products sold in Sweden at the present time, but discussions are underway on possibly strengthening the language used in the leaflets and requiring companies to describe the symptoms of liver damage.
The present furore in Europe comes five months after Australia's Therapeutic Goods Administration made warnings mandatory on black cohosh products sold within its bailiwick.
The proposed wording to appear on UK product packaging is: “Warning: In rare cases, black cohosh may cause liver problems. Consult your doctor if you already have liver disease or become unwell whilst using this product.”
At this stage, it is not understood to be mandatory. Professor Philip Routledge, chair of the MHRA, said that the agency is “working with the herbal sector to ensure that labels of black cohosh products carry updated product warnings”.
A meeting of the Health Food Manufacturers Association (HFMA) is being held tomorrow to discuss whether or not the proposed warning should be made mandatory for its members.
Rachel Abela, senior nutritionalist at Holland and Barrett, told NutraIngredients.com that her company is waiting on the outcome of the HFMA meeting before it determines its course of action – but it does tend to err on the side of caution.
Abela stressed that the most important part of the proposed statement are the words “in rare cases”.
Professor Edzard Ernst, director of complementary medicine at the Peninsula Medical School, Universities of Exeter & Plymouth, said that only four of the case studies drawn upon by the investigation are such that any meaningful inferences can be drawn from them.
“I understand that regulators have to err on the safe side, but I wonder whether this is not some overreaction as black cohosh has been used for a long time,” he said.
“It is a complex matter. One has a duty as a regulator or health care professional to not do any harm – that is the supreme law of medicine.” But he added: “The warning may be throwing the baby out with the bathwater, as HRT is not very effecting and women are desperate for some means to control symptoms. There needs to be a careful balance.”
Moreover, Professor Ernst said he was not aware of any specific research establishing a mechanism of action for black cohosh's effect on the liver.
As for whether the warnings will turn consumers off black cohosh products, Abela said she does not expect it will make much difference to people who are already committed to using natural products and complementary medicine regularly.
“It may affect people who are sceptical at the moment,” she said.
If Holland and Barrett decides to use the warning it will begin to do so straight away, but the time it takes for new packaging to appear on shelves depends on individual store turnover. When mandatory labelling changes are introduced there is usually a six to 12 month window for compliance.
http://nutraingredients.com/news/ng.asp?id=69240
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Low Lutein, Zeaxanthin levels linked to artery disease...m2
By Stephen Daniells
7/25/2006 - Researchers from Sweden have reported that people suffering from coronary artery disease (CAD) have low levels of the antioxidant carotenoids, lutein and zeaxanthin, and could respond to supplementation.
A debate has been raging concerning the role of carotenoids and heart health with various intervention trials reporting that supplementation with beta-carotene failed to have the effects suggested by epidemiological studies.
These disappointments, suggest the researchers from the University Hospital in Linkoping, may be due to the lack of focus on other carotenoids, such as lutein and zeaxanthin, with several studies already reporting positive links between lutein consumption and heart health (for example: Circulation, 2001, Vol.103, pp. 2922-2927).
“To the best of our knowledge, the present study is the first to have investigated the plasma levels of oxygenated and hydrocarbon carotenoids in CAD patients,” wrote lead author Caroline Lidbjer in the journal Nutrition, Metabolism and Cardiovascular Diseases (doi: 10.1016/j.numecd.2006.02.006).
Alpha- and beta-carotene, as well as lycopene, are so-called hydrocarbon carotenoids, meaning they contain only hydrogen and carbon atoms, while lutein, zeaxanthin and beta-cryptoxanthin are oxygenated carotenoids, meaning they contain oxygen atoms in addition to the hydrocarbon skeleton.
The new study recruited 89 patients with CAD (50 with stable angina, 39 with acute coronary syndrome), as well as 50 healthy control subjects. The researchers used high-performance liquid chromatography (HPLC) to measure plasma carotenoid levels from blood samples.
Interestingly, the researchers found that the healthy controls had significantly higher plasma levels of lutein plus zeaxanthin (037 micromoles per litre) and beta-cryptoxanthin (0.17 micromoles per litre) than the CAD patients (0.27 and 0.10 micromoles per litre, respectively). There were no significant differences between controls and CAD patients for the other hydrocarbon carotenoids studied.
Lower levels of the oxygenated carotenoids was also linked to smoking, higher BMI, and lower HDL-cholesterol levels. However, when the researchers accounted for these other factors, there was still a significant link between lutein, zeaxanthin and beta-cryptoxanthin levels and artery health.
“The measure of oxygenated carotenoids in plasma might therefore be a useful tool to identify candidates who are potential responders to antioxidant [supplementation],” wrote the researchers.
In other words, the results of this study suggest that higher levels of these carotenoids may be linked to improved cardiovascular health, which is in-line with the findings from the Los Angeles atherosclerosis study (Circulation, 2001, Vol.103, pp. 2922-2927).
It was also found that lutein and zeaxanthin levels were also associated with levels of the natural killer cells (NK cells), cells that form a major component of the human immune response system.
“This finding suggests a specific link between certain carotenoids, oxidative stress and immune perturbation in CAD,” said Lidebjer. “NK cells have been shown to be particularly sensitive to oxidative stress.”
The mechanism behind potential protective effects of the carotenoids follows this link: The antioxidants reduce the oxidative stress in the body, and therefore benefit NK cell numbers which can then aid the inane immune system response of the individual.
This preliminary proposal of the mechanism and the link between oxygenated carotenoids and immune system function “calls for further investigation”.
This study is sure to re-ignite the debate between these carotenoids and heart health, after a study from Harvard last year came to the conclusion that intake of lutein and zeaxanthin might increase the risk of a heart attack (Journal of Nutrition, 2005, Vol. 135, pp. 1763-1769).
Dietary sources of lutein and zeaxanthin include corn, egg yolk, broccoli, green beans, cabbage, lettuce and kiwi fruit.
http://www.nutraingredients-usa.com/news/ng.asp?n=69367&m=1NIU725&c=cujjvkirggyostq
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FTC orders Seasilver makers to pay $120mn...m3
By Clarisse Douaud7/25/2006 - The FTC has ordered the makers of ‘cure all’ Seasilver to pay almost $120mn for failing to comply with an earlier order to reimburse consumers – thereby signaling to infringing companies that it stands by its rulings.
In 2004, Seasilver USA and Americaloe agreed to pay $3mn in consumer redress, following Federal Trade Commission allegations that claims they made were false and unsubstantiated. At the time, the $120mn sum was set out in a suspended judgment, which would come into effect if the defendants did not make the agreed payments.
While Seasilver USA and Americaloe did in fact comply with some of the 2004 FTC judgments, the FTC's most recent ruling shows the regulatory body means to be taken 100 percent seriously even within the complex legal framework of the dietary supplement industry.
In ads, the Seasilver marketers had claimed the liquid dietary supplement – which contains aloe vera, phyto-silver sea vegetables, herbs, cranberry concentrate, and other ingredients - was clinically proven to treat or cure 650 diseases, including cancer and AIDS, as well as caused rapid, substantial, and permanent weight loss without dieting.
“The claims for Seasilver threatened consumers' health by encouraging delays and replacements for proven treatments,” said director of FTC's Bureau of Consumer Protection Howard Beales at the time. “The FTC and FDA are committed to taking aggressive action against false and unsubstantiated claims in the dietary supplement market”.
To date, Seasilver and Americaloe have paid less than $1 million of the consumer redress they agreed to pay. According to the FTC, under the Court's order, the Seasilver marketers are now severally liable to pay $119,237,000, plus interest, in full.
Seasilver is still marketed over the Internet by Seasilver USA, but without the health claims which brought it so much notoriety. The marketing focus now appears to be centered on supposed customer testimonials.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers are responsible for ensuring the safety and efficacy of their product before marketing it. This gives products with grandiose claims room to try their luck on the market before they may fall under the radar of the US Food & Drug Administration or the FTC.
FTC's actions against Seasilver and Americaloe were part of Operation Cure All, a coordinated effort among the FTC, the FDA, Health Canada, Canada's Competition Bureau, and state Attorneys General to crack down on “unscrupulous marketers who prey on consumers with serious illnesses” especially over the Internet.
“Products touted as cure-alls almost always cure nothing,” said Beales following the initial FTC charges against Seasilver and Americaloe.
Although all the cases under the sweep of Operation Cure All have been closed, the FTC continues to pursue infringers. “We certainly haven't stopped going after companies marketing phony cure-alls,” FTC spokesperson Jacqueline Dizdul told NutraIngredients-USA.com.
http://www.nutraingredients-usa.com/news/ng.asp?n=69395&m=1NIU725&c=cujjvkirggyostq
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