Reply To: Scripts 2011

[EKKeymaster]

Recipe for Papaya Extract and Ferment
Take a ripe papaya and peel of outer layer with a potato peeler or thin knife—split the papaya and scoop out the seeds—SAVE THE SEEDS!!!!! Then add 1cup to 1 ½ cup of either a rice wine or a white wine or a clear alcohol of choice ( grappa-spirtus-everclear-gin-vodka) and add cinnamon to this as well about 1 tsp per cycle.
You will add about 2-3 ounces of papaya per cycle, Meaning you will put this in then strain it and then add the strained fluid back in the blender and add another 2-3 oz and repeat this procedure till you use up all the papaya–You will blend all this for about 5 minutes at high speed and from there proceed to strain through a handkerchief or pillow case ( reason being the cheese cloths will leak this is dense and will require a good grip) pour back into the blender the strained material and repeat the process
 
For the Ferment you can take the papaya and sprinkle on it cinnamon and tumeric and paprika add vinegar and allow to sit forseveral weeks in fridge and allow for the ferment to take hold and consume as desired especially after a heavy meal of fat or protein—or you can strain it out as previous and add vinegar to this and allow to sit for several days and then use tablespoon amounts again best to be taken after a meal or for healing an issue or imbalance—this will increase the SOD levels as well which is an extremely potent antioxidant that can protect eyes and brain and liver from infectious issues
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Show of the Week February 14, 2011
 
Manufacturing of Intravenous Vitamin C Banned
 
FDA warns niacin marketers about drug claims
Drinking Wine Lowers Risk Of Barrett’s Esophagus, Precursor To Nation’s Fastest Growing Cancer- Study
 
Drinking Wine May Increase Survival Among Non-Hodgkin’s Lymphoma Patients
 
Red Wine Protects The Prostate -Study
 
Half A Glass Of Wine A Day May Boost Life Expectancy By Five Years
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Manufacturing of Intravenous Vitamin C Banned
 
As you may be aware the largest manufacturers of L Ascor 500, McGuff Pharmaceuticals, has received a notice from the FDA to cease manufacturing the product on December 28th 2010.
 
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm238251.htm
 
McGuff Pharmaceuticals is the largest manufacturer of the product and probably the largest supplier to New Zealand. This could mean the product will be harder to source until other manufacturers build their supply.[U1]
 
We have been in contact with the CEO of McGuff to seek clarification of what has occurred and this was one of the responses: “The FDA told McGuff Pharmaceuticals, Inc. to stop “manufacturing and distribution” of Ascorbic Acid injection. However, the FDA may use its discretionary authority to allow it back into the market[U2]. We just do not know what the FDA’s intentions are as the FDA will not provide policy information.”
 
You’ll note the date is only a few months after Allen Smith’s story of recovery from Swine Flue and Hairy Cell Leukaemia (using L Ascor 500) went global. We are in the process of assessing the impact to New Zealand and our campaign, so any of your ideas would be appreciated.
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FDA warns niacin marketers about drug claims
The Food and Drug Administration has affirmed the principal that references to scientific studies can amount to drug claims under the Federal Food, Drug, and Cosmetic Act (FDCA).
In a January 19, 2011, warning letter to Minnesota-based Upsher Smith Laboratories, the FDA rapped the company over scientific web references that were linked cardiovascular and cholesterol benefits for the company’s niacin-based dietary supplements. Upsher Smith Laboratories has subsequently taken the website for Slo-Niacin products offline.
“The therapeutic claims on your website establish that the product is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” wrote FDA director from the Minneapolis District, Gerald J Berg.[U3]
Diseased citations
Berg went on to highlight the problem of companies referencing scientific studies in online marketing materials.
“Furthermore, the ‘References’ and ‘In the News’ sections of your website for this product cite a number of articles about the usefulness of the ingredient niacin in treating and preventing diseases,” he wrote.
“When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), [of the FDCA] a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.”
Claims at stake
Claims being made on the retracted site included:
SLO-NIACIN…Reduced risk of cardiovascular events* when combined with a statin
• SLO-NIACIN…Halted stenosis progression when combined with a statin.
• Niacin is clinically proven to help manage cholesterol levels, a major factor in heart health
• SLO-NIACIN Offers an affordable option for Cholesterol Management
• Niacin is the oldest of today’s commonly used agents for lowering cholesterol
• See how…niacin complements statin therapy for heart health
The FDA cited numerous examples of studies that contributed to disease marketing including a 1992 study published in the American Journal of Cardiology titled: ‘Marked benefit with sustained-release niacin therapy in patients with ‘isolated’ very low levels of high-density lipoprotein cholesterol and coronary artery disease.’
The letter qualified the drug accusations by noting that Slo-Niacin did not have generally recognized as safe (GRAS) status for use as a food ingredient.
It also highlights several images used on the Slo-Niacin website that can also, “be considered as a claim to diagnose, mitigate, treat, cure, or prevent disease if in the context of the labeling it suggests that the product has an effect on a disease or diseases.”
Niacin, vitamin B3, has been shown to benefit atherosclerosis at high doses by reducing total cholesterol, triglycerides, very-low-density lipoprotein, and low-density lipoprotein.
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Drinking Wine Lowers Risk Of Barrett’s Esophagus, Precursor To Nation’s Fastest Growing Cancer- Study
 
ScienceDaily (Mar. 7, 2009) — Drinking one glass of wine a day may lower the risk of Barrett’s Esophagus by 56 percent, according to a new study by the Kaiser Permanente Division of Research in the March issue of Gastroenterology. Barrett’s Esophagus is a precursor to esophageal cancer, the nation’s fastest growing cancer with an incidence rate that’s jumped 500 percent in the last 30 years.—Barrett’s Esophagus affects 5 percent of the population and occurs when heartburn or acid reflux permanently damages the esophageal lining. People with Barrett’s Esophagus have a 30- to 40-fold higher risk of developing esophageal adenocarcinoma (a type of esophageal cancer) because the Barrett’s Esophagus cells can grow into cancer cells.—Because there are no symptoms or warning signs of Barrett’s Esophagus, people discover they have Barrett’s Esophagus when an endoscopy for anemia, heartburn or a bleeding ulcer reveals esophageal cells that were damaged, then changed form during the healing process. Currently nothing can be done to treat Barrett’s Esophagus; it can only be monitored.
This is the first and largest population-based study to examine the connection between alcohol consumption and risk of Barrett’s Esophagus. Funded in part by the National Institutes of Health, the Kaiser Permanente study looked at 953 men and women in Northern California between 2002 and 2005 and found that people who drank one or more glasses of red or white wine a day had less than half the risk (or 56 percent reduced risk) of Barrett’s Esophagus. There was no reduction of Barrett’s Esophagus risk among people who drank beer or liquor.–“The rate of esophageal adenocarcinoma in this country is skyrocketing yet very little is known about its precursor, Barrett’s Esophagus. We are trying to figure out how to prevent changes that may lead to esophageal cancer.” said Douglas A. Corley, MD, a Kaiser Permanente gastroenterologist and the study’s principal investigator.
The study findings are echoed by two other studies published in the same issue of the Gastroenterology journal: Australian researchers found that people who drank wine were at a lower risk of esophageal adenocarcinoma, and Irish researchers found that people who drank wine were at a lower risk for esophagitis, an irritation of the esophagus that follows chronic heartburn and often precedes Barrett’s Esophagus and cancer.—Researchers are not certain why wine reduces the risk of Barrett’s Esophagus and esophageal cancer. One theory is that the wine’s antioxidants neutralize the oxidative damage caused by gastroesophageal reflux disease, a risk factor for Barrett’s Esophagus. Another theory is that wine drinkers typically consume food with their wine as opposed to drinking straight liquor without food, thereby reducing the potentially damaging effect of alcohol on esophageal tissue, said Ai Kubo, MD, an epidemiologist at Kaiser Permanente and lead author on the study. “But we cannot preclude the possibility that wine drinking is a proxy for other ‘health-seeking’ behavior,” Kubo added.
This study is part of larger, case-controlled Kaiser Permanente study led by Dr. Corley that looked at abdominal obesity and consumption of dietary antioxidants, fruits and vegetables in connection with Barrett’s Esophagus. It found that people can reduce their risk of Barrett’s Esophagus by eating eight servings of fruits and vegetables a day and maintaining a normal body weight.–“My advice to people trying to prevent Barrett’s Esophagus is: keep a normal body weight and follow a diet high in antioxidants and high in fruits and vegetables,” Corley said. “We already knew that red wine was good for the heart, so perhaps here is another added benefit of a healthy lifestyle and a single glass of wine a day.”–Researchers noted, though, that the protective effect of wine in terms of preventing Barrett’s Esophagus was greatest with just one or two glasses a day. The protective effect of wine did not increase with higher consumption.–“It’s not actually clear that treating the acid reflux will necessarily prevent getting someone from getting Barrett’s Esophagus,” said Dr. Corley. “The best way to prevent reflux is to maintain a normal weight.” Authors of the study include: Ai Kubo, T. R. Levin, Gregory Rumore, Charles P. Quesenberry, Jr., of the Kaiser Permanente Division of Research in Oakland, Gladys Block and Patricia Buffler of the School of Public Health, University of California-Berkeley.
Story Source–The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Kaiser Permanente, via EurekAlert!, a service of AAAS
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Drinking Wine May Increase Survival Among Non-Hodgkin’s Lymphoma Patients
 
ScienceDaily (Apr. 24, 2009) — Pre-diagnostic wine consumption may reduce the risk of death and relapse among non-Hodgkin’s lymphoma patients, according to an epidemiology study presented at the American Association for Cancer Research 100th Annual Meeting 2009.–Xuesong Han, the first author of the abstract and a doctoral candidate at the Yale School of Public Health, said their findings would need to be replicated before any public health recommendations are made, but the evidence is becoming clearer that moderate consumption of wine has numerous benefits.”This conclusion is controversial, because excessive drinking has a negative social and health impact, and it is difficult to define what is moderate and what is excessive,” said Han. “However, we are continually seeing a link between wine and positive outcomes in many cancers.”–This study was the first to examine the link among patients with non-Hodgkin’s lymphoma. Han and her colleagues analyzed data about 546 women with non-Hodgkin’s lymphoma.–They found that those who drank wine had a 76 percent five-year survival compared with 68 percent for non-wine drinkers. Further research found five-year, disease-free survival was 70 percent among those who drank wine compared with 65 percent among non-wine drinkers.–Beer and/or liquor consumption did not show a benefit. The study team at Yale also looked at subgroups of lymphoma patients, and found the strongest link between wine consumption and favorable outcomes among patients with diffuse large B-cell lymphoma. These patients had a 40 to 50 percent reduced risk of death, relapse or secondary cancer.-Researchers then conducted an analysis to examine the effect of wine consumption among those who had drunk wine for at least the previous 25 years before diagnosis. Non-Hodgkin’s lymphoma patients who had been drinking wine for at least this long had a 25 to 35 percent reduced risk of death, relapse or secondary cancer.–Those patients with large B-cell lymphoma had about 60 percent reduced risk of death, relapse or secondary cancer if they had been drinking wine for at least the previous 25 years before diagnosis.–“It is clear that lifestyle factors like alcohol can affect outcome,” said Han. -Story Source-The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by American Association for Cancer Research
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Red Wine Protects The Prostate -Study
ScienceDaily (May 26, 2007) — Researchers have found that men who drink an average of four to seven glasses of red wine per week are only 52% as likely to be diagnosed with prostate cancer as those who do not drink red wine, reports the June 2007 issue of Harvard Men’s Health Watch. In addition, red wine appears particularly protective against advanced or aggressive cancers.–Researchers in Seattle collected information about many factors that might influence the risk of prostate cancer in men between ages 40 and 64, including alcohol consumption. At first the results for alcohol consumption seemed similar to the findings of many earlier studies: There was no relationship between overall consumption and risk. –But the scientists went one step further by evaluating each type of alcoholic beverage independently. Here the news was surprising—wine drinking was linked to a reduced risk of prostate cancer. And when white wine was compared with red, red had the most benefit. Even low amounts seemed to help, and for every additional glass of red wine per week, the relative risk declined by 6%. Why red wine? Doctors don’t know. But much of the speculation focuses on chemicals—including various flavonoids and resveratrol—missing from other alcoholic beverages. These components have antioxidant properties, and some appear to counterbalance androgens, the male hormones that stimulate the prostate.–Many doctors are reluctant to recommend drinking alcohol for health, fearing that their patients might assume that if a little alcohol is good, a lot might be better. The Harvard Men’s Health Watch notes that men who enjoy alcohol and can drink in moderation and responsibly may benefit from a lower risk of heart attack, stroke, diabetes, and cardiac death.
Story Source–The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Harvard Men’s Health Watch, via Newswise
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Half A Glass Of Wine A Day May Boost Life Expectancy By Five Years
 
Researchers found that men who drank only wine, and less than half a glass of it a day, lived around 2.5 years longer than those who drank beer and spirits, and almost five years longer than those who drank no alcohol at all –ScienceDaily (Apr. 30, 2009) — Drinking up to half a glass of wine a day may boost life expectancy by five years—at least in men, suggests research published ahead of print in the Journal of Epidemiology and Community Health. The Dutch authors base their findings on a total of 1,373 randomly selected men whose cardiovascular health and life expectancy at age 50 were repeatedly monitored between 1960 and 2000. The researchers looked into how much alcohol the men drank, what type it was, and over what period, in a bid to assess whether this had any impact on the risks of their dying from cardiovascular disease, cerebrovascular disease, and from all causes.
They also tracked weight and diet, whether the men smoked, and for how long, and checked for the presence of serious illness.–During the 40 years of monitoring, 1,130 of the men died. Over half the deaths were caused by cardiovascular disease.–The proportion of men who drank alcohol almost doubled from 45% in 1960 to 86% in 2000, with the proportion of those drinking wine soaring from 2% to 44% during that period.–The researchers found that light long term alcohol consumption of all types—up to 20 g a day— extended life by around two extra years compared with no alcohol at all. Extended life expectancy was slightly less for those who drank more than 20 g.–And men who drank only wine, and less than half a glass of it a day, lived around 2.5 years longer than those who drank beer and spirits, and almost five years longer than those who drank no alcohol at all.–Drinking wine was strongly associated with a lower risk of dying from coronary heart disease, cerebrovascular disease, and death from all causes.–These results held true, irrespective of socioeconomic status, dietary and other lifestyle habits, factors long thought to influence the association between wine drinking and better health.
Story Source-The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by BMJ-British Medical Journal, via EurekAlert!, a service of AAAS.
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[U1]You know why they were told to limit Supply to NZ??/ because a family there had the testicular fortitude to MAKE THE MEDICAL system there DO THERE JOB and actually HEAL someone —a Family MAN was Infected with H1N1 and was given Up for DEAD –and the medical People wanted to Pull the plug and the SONS and Mum SAID NOT TIL YOU TRY VITAMIN C so when they did at 50 grams the Father started to Come Around —what did the Senior Medical Doctor do ? He decided to Discontinue the treatments –NOW look at that eh –someone in the Medical field Playing god and deciding who lives or who Dies!!!!!!!!! as it turned out after a discussion with one of the Sons they had the Father move to another fascility and gave a lower dose of the Vitamin C and when he started to be stronger the Mum or wife gave him bigger doses and he made a full recovery—NOWWW they don’t want anyone else to get this due to the fact they wish to spread widespread infection and eliminate a CURE–this should have everybody Spitting FIRE!!!!!!!
[U2]Sounds Like god playing to me eh!!! must be from the Vatican or the Middle East or even Israel or maybe india or china –this is what happens when you send a religious military wing to control the Access to health and life—-well it appears the FDA has controlled all the High priest ( doctors -since none of them have any testicles) and the heirarchy ( drug companies) are told to bow to the whim of the religious institution –The Father Of Death By Drugs or GMO—Now I wonder who Owns the GMO and Drug Companies?? All roads lead to Rome!! Discretionary??? we will Never See this again–once the EFSA ( FDA ) make article 13 the standard you will see anything of any value will be gone and never to be seen again—and this will be Humanities Lost—the bigger lost is allowing this BS institution have this much Power where even a Gov’t cannot stop them
WE CAN!!!
[U3]This is Ludicrious and since this drug company caved this puts out the illusion you can’t beat the FDA –this is a collusion and deception the FDA Violated DSHEA on this because under the DSHEA you can list research to a product no mattter what it’s intended use the only thing you cannot do is proclaim it can heal—this was allllll Bogus and BS!!!
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Show of the Week February 18, 2011
 
Confirmed— Mercury Cancels Out the Health Benefits of Fish Oil
 
Processed Food Diet in Early Childhood May Lower Subsequent IQ
Nitrates may boost performance by helping cellular efficiency- Study
EU herbal directive will close health food stores, say owners
Polyphenol-rich cherry juice may boost exercise recovery
Recipe for the uses of Both the Beet and Cherry juice extracts
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Confirmed— Mercury Cancels Out the Health Benefits of Fish Oil
Submitted by Annie White on January 24, 2011
http://healthfreedoms.org/2011/01/24/confirmed-mercury-cancels-out-the-health-benefits-of-fish-oil/
Omega oils have seen a lot of attention for their benefits to brain function and fish oil is a major source of the nutrient. But there is a problem with eating fish as environmental pollutants have caused marine life to become laden with chemicals by the time they reach maturity for fishing.–Mercury is one of the biggest chemical threats to humans as it is incredibly harmful to the brain, causing degradation of the neurons thereby crippling the minds functional capacity.–So the fish have the omega oils that are great for the brain while at the same time containing mercury which will diminish brain function. Thankfully there are alternatives to its sources that don’t rely on fish- check the list at the bottom of the article and encourage environmental practices that reduce mercury pollution.
~Health Freedoms
Lately, a shadow has perched itself over the fish oil industry. While no one disputes the benefits of a diet rich in omega fatty acids, Rachel wrote about a number of studies pointing to myths associated with fish oil. Most recently, a new study was released that confirms that any benefits that come from fish oil are cancelled out but excessive mercury in the system. According to Environmental Health News, methyl mercury is transferred to people who eat the fish, which is especially concerning for pregnant women whose children are exposed while developing in the womb.The study, published in Environmental Research, said this-“Of the five nutritional components evaluated, only the beneficial effects of DHA – as measured by the children’s test scores – were negatively impacted by increased mercury exposure. The nutritional benefits of DHA were significantly reduced and then disappeared altogether at the higher exposures.”–Bottom line: DHA, an omega fatty acid chain has many health benefits but when paired with mercury-laden fish oil, those benefits are cancelled out by the side effects of mercury poisoning.
Why We Still Need Omega Fatty Acids–No one’s disputing the benefits of the omega fatty acids found in fish oil. These are truly important to the body. They regulate blood clotting, blood pressure, blood lipid levels, and the body’s response to injury and infection. Likely one of the most important benefits is that it greatly reduces inflammation associated with heart disease. But paired with the mercury found in a wide variety of favored fish species like tuna, grouper, or mackerel the mercury exposure makes it not worth the risk.[U1]
Omega 3 Fatty Acids Minus the Mercury
Omega 3 is made up of three acids EPA, DHA, and ALA. ALA can be found in hemp seeds, flax seeds, and chia seeds. DHA and EPA are found in algae, spirulina, blue-green algae, and chlorella.
By Sara Novak
http://planetgreen.discovery.com/food-health/confirmed-mercury-cancels-out-the-health-benefits-of-fish-oil.html
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Processed Food Diet in Early Childhood May Lower Subsequent IQ
ScienceDaily (Feb. 8, 2011) — A diet, high in fats, sugars, and processed foods in early childhood may lower IQ, while a diet packed full of vitamins and nutrients may do the opposite, suggests research published online in the Journal of Epidemiology and Community Health.–The authors base their findings on participants in the Avon Longitudinal Study of Parents and Children (ALSPAC), which is tracking the long term health and wellbeing of around 14,000 children born in 1991 and 1992.–Parents completed questionnaires, detailing the types and frequency of the food and drink their children consumed when they were 3, 4, 7 and 8.5 years old.–Three dietary patterns were identified: “processed” high in fats and sugar intake; “traditional” high in meat and vegetable intake; and “health conscious” high in salad, fruit and vegetables, rice and pasta. Scores were calculated for each pattern for each child.–IQ was measured using a validated test (the Wechsler Intelligence Scale for Children) when they were 8.5 years old. In all, complete data were available for just under 4,000 children.–The results showed that after taking account of potentially influential factors, a predominantly processed food diet at the age of 3 was associated with a lower IQ at the age of 8.5, irrespective of whether the diet improved after that age. Every 1 point increase in dietary pattern score was associated with a 1.67 fall in IQ. On the other hand, a healthy diet was associated with a higher IQ at the age of 8.5, with every 1 point increase in dietary pattern linked to a 1.2 increase in IQ. Dietary patterns between the ages of 4 and 7 had no impact on IQ.–The authors say that these findings, although modest, are in line with previous ALSPAC research showing an association between early childhood diet and later behaviour and school performance. “This suggests that any cognitive/behavioural effects relating to eating habits in early childhood may well persist into later childhood, despite any subsequent changes (including improvements) to dietary intake,” they say.–The brain grows at its fastest rate during the first three years of life, say the authors, by way of a possible explanation for the findings, adding that other research has indicated that head growth at this time is linked to intellectual ability.–“It is possible that good nutrition during this period may encourage optimal brain growth,” they suggest, advocating further research to determine the extent of the effect early diet has on intelligence.–Story Source-The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by BMJ-British Medical Journal, via EurekAlert!, a service of AAAS.–Journal Reference-K. Northstone, C. Joinson, P. Emmett, A. Ness, T. Paus. Are dietary patterns in childhood associated with IQ at 8 years of age? A population-based cohort study. Journal of Epidemiology & Community Health, 2011; DOI: 10.1136/jech.2010.111955
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Nitrates may boost performance by helping cellular efficiency- Study
Dietary inorganic nitrates, as found in green leafy vegetables and beetroot juice, may enhance muscle endurance by boosting mitochondrial efficiency, according to new research.
The study, published in Cell Metabolism, reports that short term increases in dietary nitrates can boost muscle efficiency during exercise, and finds that the that the improved performance is linked to increased efficiency of the mitochondria that power our cells. —Mitochondrial efficiency is usually measured as the amount of oxygen consumed per adenosine triphosphate (ATP) produced – a measure known as the P/O ratio. The new study shows that nitrate “has profound effects on basal human mitochondrial function as well as whole-body oxygen consumption during exercise.” -“In the current study we found a 19 percent increase in P/O ratio after nitrate supplementation. To our knowledge, there are no other dietary regimes described that have this effect,” said the researchers, led by Professor Eddie Weitzberg from the Karolinska Institutet, Sweden. –“Intriguingly, there was a strong correlation between the reduction in whole-body oxygen consumption during cycling and the increase in P/O ratio, which clearly suggests that a large part of the improved exercise efficiency is taking place at the mitochondrial level,” he added. —Dietary nitrates ——Until recently nitrate – which is abundant in green leafy vegetables – had been considered merely as an inert end product of nitric oxide (NO) metabolism or as a potentially toxic constituent in our diet. –However, the last decade has brought understanding of its importance in biological processes, including regulation of blood flow , blood pressure , cellular signaling, glucose homeostasis, and tissue responses to low oxygen levels (hypoxia). –Previous research has also linked nitrate rich foods and beverages, like beetroot juice , to improvements physiological benefits – including improved endurance . Such benefits have been shown to be, at least in part, due to a reduction in the ‘oxygen cost’ of exercise for healthy individuals after short-term dietary supplementation with nitrate. –Weitzberg and colleagues noted that the findings point toward the mitochondria (the ‘energy factories’ of cells) as a possible target for the effects of nitrate – suggesting that the production of ATP (an important transporter of chemical energy) may become more efficient. However, such mechanisms remain unclear and relatively unknown. –The new study, a double-blind crossover trial, studied the effects of a dietary intervention with inorganic nitrate on mitochondrial function and whole-body oxygen consumption in healthy volunteers. –Improved efficiency –Skeletal muscle biopsies were in conjunction with bicycle exercise tests were used to study the effects of dietary nitrate on mitochondrial efficiency and biochemical parameters, in addition to the expression of proteins involved in energy transfer. –The researchers reported that after taking a small dose of inorganic nitrate for three days volunteers consumed less oxygen while riding an exercise bike. –They said that skeletal muscle mitochondria after nitrate supplementation showed an improvement in efficiency (P/O ratio), which was strongly correlated to the reduction in oxygen cost during exercise. –These effects were found to accompany a reduction in ANT – an important protein involved in mitochondrial energy production. –“The fact that the relatively short term dietary regimen can influence expression of important mitochondrial proteins may have profound impact on exercise physiology,” said Weitzberg. –“Moreover, it may also have implications for metabolic and cardiovascular diseases in which dysfunctional mitochondria play a central role,” he added. –Weitzberg said that the “natural next step” is to repeat the experiment in people with conditions linked to mitochondrial dysfunction, including diabetes and cardiovascular disease, to see if they too enjoy such positive results. –He added that further studies to identify the molecular mechanisms and signaling pathways by which nitrate affects mitochondrial efficiency are clearly needed.
ROS risk?
In an accompanying editorial Dr Sreekumaran Nair and his colleagues from the Mayo Clinic, note that the study provides strong evidence that short-term dietary nitrate supplementation enhances mitochondrial efficiency and enhances exercise performance. However they added that future studies should also address the impact of nitrates on mitochondrial reactive oxygen species (ROS) production. –“It is difficult to ignore the possibility that improved coupling may lead to increased ROS production rates, which may have an adverse effect on proteins, DNA, and cellular functions,” they said.
Research paper:Source: Cell Metabolism
olume 13, Issue 2 , Pages 149-159, doi: 10.1016/j.cmet.2011.01.004
“Dietary Inorganic Nitrate Improves Mitochondrial Efficiency in Humans”Authors: F.J. Larsen, T.A. Schiffer, S. Borniquel, K. Sahlin, B. Ekblom, J.O. Lundberg, E. Weitzberg Accompanying editorial:
Source: Cell Metabolism Volume 13, Issue 2 , Pages 117-118, doi: 10.1016/j.cmet.2011.01.013 “Can Dietary Nitrates Enhance the Efficiency of Mitochondria?” Authors: K.S. Nair, B.A. Irving, I.R. Lanza
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EU herbal directive will close health food stores, say owners
Health food store owners are warning they will be forced to close down after April 30 this year, when the European Union Traditional Herbal Medicinal Products Directive (THMPD) kicks in.
Companies have had a seven year-grace period since the THMPD entered EU law books in 2004, but EU-wide registrations under the regulation have been chronically low, meaning unless thousands of products register in the coming months, they will be stripped from health store and other retail shelves. —Selwyn Soe of the London-based The Herbal Factory told the BBC: “Unfortunately it looks as if we will have to close down because of this legislation.” –“The problem for us is that although we would have to pay many thousands of pounds for a licence to keep making each product, unlike a drug company we would not have a licence to make that product exclusively. It just will not be worth paying out the money.” –The regulation requires all herbal products making health and medicinal claims to be registered. As of December 31, 2010, there had been 187 registrations for individual products in the UK. Eighty four products had been approved and none rejected. The 100 per cent success rate has been attracting the interest of food supplement manufacturers and herbal ingredient suppliers who have struggled to have their science accepted under the 2006 nutrition and health claims regulation (NHCR). But herbal sector observers and associations have been surprised by the lack of THMPD registration applications – with the UK leading the way, followed by Germany, but many member states recording no applications at all. The relative high cost of registrations is deemed as partly to blame for the situation. –The fact that there is a clear discrepancy between the way science is treated under the THMPD and the NHCR has caused some confusion, and was partially responsible for the European Commission recently removing botanicals from the NHCR process to reconsider how science in the sector should be treated.That issue is unlikely to be revisited until the end of 2011.
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Polyphenol-rich cherry juice may boost exercise recovery
Juice made from Montmorency cherries may boost the recovery of muscle strength after intensive exercise, says a new study from London. –The benefits of the juice are reportedly related to its antioxidant activity, which may reverse the “oxidative damage induced by the damaging exercise”, report researchers from the Sports and Exercise Science Research Centre at London South Bank University and UK Anti-Doping. –Writing in Medicine & Science in Sports & Exercise, the London-based researchers report that seven days of consumption of the CherryActive-branded cherry juice prior to, and after intensive exercise produced a significant increase in recovery for knee extension maximum voluntary contractions, compared to an isoenergetic fruit concentrate control beverage. —“Montmorency cherry juice consumption improved the recovery of isometric muscle strength after intensive exercise perhaps due to attenuation of the oxidative damage induced by the damaging exercise,” wrote the authors, led by Dr Joanna Bowtell.
Sports nutrition market –The study supports a number of other studies reporting the potential benefits of cherry, and tart cherries, in particular. Indeed, a previous study (Journal of Nutrition, 2006, Vol. 136, pp. 981-986) reported that daily consumption of 45 cherries could reduce circulating concentrations of inflammatory markers, with the researchers proposing that the flavonoids and anthocyanins in the cherries exert an anti-inflammatory effect and may lessen the damage response to exercise. –Study details –Dr Botwell and her co-workers recruited 10 well-trained men and assigned them to consume the cherry juice or the isoenergetic fruit concentrate beverage for one week before and for two days after a series of single leg knee extensions. –Results showed that the knee extension maximum voluntary contractions (MVC), a measure of muscle function, recovered significantly faster following consumption of the cherry juice, compared with the fruit control. Specifically, the MVC was 90.9 versus 84.9 24 hours after the exercise, and 92.9 versus 88.5 after 48 hours, respectively. No differences between the groups were observed for the activity of the enzyme creatine kinase, which is involved in the production of energy. –According to the researchers, the potential benefits may be linked to the antioxidant activity of the juice. During intense exercise the production levels of oxidative stress are reported to increase and this may damage muscles. However, this may be attenuated with consumption of the antioxidant-rich cherry juice.
Source: Medicine & Science in Sports & Exercise
Published online ahead of print, doi: 10.1249/MSS.0b013e31820e5adc
“Montmorency Cherry Juice Reduces Muscle Damage Caused By Intensive Strength Exercise”–Authors: J.L. Bowtell, D.P. Sumners, A. Dyer, P. Fox, K.N. Mileva
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Recipe for the uses of Both the Beet and Cherry juice extracts—Juice both the beet and cherry and combo them up or even use the one before a work out ( the beet juice ) and one after the work out the Cherry—explore horizons with this adding creatine powder to either drink before and after say 2.5 grams may make a difference as well—adding them to a yogurt or kefir mix for the protein and enzyme and probiotic effect to enhance restoring of strength and recovery
 
 
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[U1]In truth these facts as well have been brought to question and have found to be opposite as to what is common knowledge -1) fish oils actually increase Heart failure if used for more then 4 years 2) they oxidize in the body excessively fast causing more damage then the benefit as a result you bring on problems you otherwise would not 3) the mercury has always been a condition that the food pyramid makers and health “scientist” continue to encourage saying eating the fish outweigh the causal problems–today the FAO has stated that the planet is eating more fish which equates to more illness as a result of all the metals and genetics people are consuming from fish farms–not to mention other sewage contaminants—so I would encourage to grow your own fish in a outdoor aquarium or indoor this way you know what your eating!!!!
 
 
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Show of the Week February 21 2011
 
Fenugreek have insulinotropic and antidiabetic properties
 
Recipe for Respitory and Digestion with Fenugreek
 
Protective effects of fermented ginseng
 
Fermenting Ginseng
 
About Organic Produce
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Fenugreek have insulinotropic and antidiabetic properties
effect of fenugreek 4-hydroxyisoleucine on liver function biomarkers and glucose in diabetic and fructose-fed rats.
Phytother Res. 2009 Jan;23(1):61-4
Authors: Haeri MR, Izaddoost M, Ardekani MR, Nobar MR, White KN
Fenugreek (Trigonella foenum graecum L) is a plant traditionally used for the treatment of diabetes. It contains an unusual amino acid, 4-hydroxyisoleucine, demonstrated to have insulinotropic and antidiabetic properties in animal models. Here we examine the effect of 4-hydroxyisoleucine on liver function and blood glucose in two rat models of insulin resistance, fructose-fed rats and streptozotocin-induced diabetes type 2. In fructose-fed rats, levels of glucose and liver damage marker aspartate transaminase were markedly (84% and 93%, respectively) and significantly elevated compared with controls (p < 0.001 for both). Alanine transaminase was elevated slightly (18%), and all markers were restored to near control values after treatment with 4-hydroxyisoleucine at 50 mg/kg per day for 8 weeks, the effect being significant (p < 0.01) for all markers. This prolonged exposure to 4-hydroxyisoleucine was well tolerated in control animals and did not alter levels of glucose or liver damage markers significantly. In diabetic rats, treatment with 4-hydroxyisoleucine did not affect glucose or liver damage markers, but did improve HDL-cholesterol levels (31% increase, p < 0.05). These findings indicate 4-hydroxyisoleucine as a useful and well-tolerated treatment for insulin resistance, both directly as a hypoglycaemic and also as a protective agent for the liver.- PMID: 18680121 [PubMed – indexed for MEDLINE
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Hypocholesterolaemic activity has been reported for fenugreek in rats(9, G41) and alloxan-diabetic dogs.(10) Activity has been attributed to the fibre and saponin fractions, and not to lipid or amino acid fractions.(9, 10) Studies have reported a reduction in cholesterol but not triglyceride concentrations,(9) or in both
cholesterol and triglyceride concentrations, but without significant alterations in high-density lipoprotein (HDL) and lowdensity lipoprotein (LDL) concentrations.(10) Hypoglycaemic activity has been observed in rabbits, rats and dogs, and attributed to the defatted seed fraction (DSF),(8) trigonelline, nicotinic acid and coumarin.(7, 11) Oral administration of DSF reduced hyperglycaemia in four alloxan-diabetic dogs, and reduced the response to an oral glucose tolerance test in eight normal dogs, whereas the lipid fraction had no effect on serum glucose and insulin concentrations.(8) The high fibre content (50%) of DSF was thought to contribute to its antidiabetic effect although the initial rate of glucose absorption was not affected.(8) Nicotinic acid and coumarin were reported to be the major hypoglycaemic components of fenugreek seeds, following administration to normal and alloxan-diabetic rats.(7) The hypoglycaemic
action exhibited by coumarin was still significant 24 hours post administration.(7) In addition, a slight antidiuretic action was noted for coumarin.(7) Trigonelline inhibited cortisone-induced hyperglycaemia in rabbits if administered (250 mg/kg) concomitantly or two hours before, but not two hours after, cortisone.(11) In addition, trigonelline exhibited significant hypoglycaemic activity in alloxan-diabetic rats (50 mg/kg), lasting 24 hours.(11) A stimulant action on the isolated uterus (guinea-pig),especially during late pregnancy, has been noted for both aqueous and alcoholic extracts.(G41) An aqueous extract is stated to increase the number of heart beats in the isolated mammalian heart.(G41) In vitro antiviral activity against vaccinia virus has been reported for fenugreekine, which also possesses cardiotonic, hypoglycaemic, diuretic, antiphlogistic and antihypertensive properties.(2)
 
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The best-documented medical use of fenugreek is to control blood sugar in both insulin-dependent (type 1) and noninsulin-dependent (type 2) diabetics. Some studies also show that serum cholesterol levels in diabetics, and perhaps in others, are reduced by fenugreek. Doses as low as 15 mg per day may produce beneficial effects on fasting blood sugar, elevation of blood sugar after a meal, and overall glycemic control. The use of fenugreek is likely to alter the diabetic patient’s need for insulin or other medications used to control blood sugar. This treatment should be supervised by a health care provider familiar with the use of herbal therapies for diabetes. The recommended
doses of fenugreek can vary rather widely.- Historically, fenugreek has been used as a topical treatment for abscesses, boils, burns, eczema, gout, and ulceration of the skin as it has an anti-inflammatory effect. It is also reputedly useful for a number of digestive complaints, including gastritis and gastric ulcers. A study published in 2002 found that both an aqueous solution and a gel fraction derived from fenugreek have anti-ulcer effects comparable to those of omeprazole, a standard medication given to reduce gastric secretions. The researchers found that the fenugreek solution protected the gastric mucosa from injury as well as reducing the secretion of gastric acid. Fenugreek reportedly can be helpful in the induction of childbirth, as it is known to stimulate uterine contractions. For this reason it should not be taken during pregnancy. As a gargle, fenugreek may relieve sore throats and coughing. Arthritis, bronchitis, fevers, and male reproductive conditions are other traditional but unsubstantiated indications for this herb.
 
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Chinese Medicine: The drug is used to treat cold pain in the-lower abdomen, impotence, and hernia (said to be due to cold ‘chi’).
 
Indian Medicine: The drug is used for fever, vomiting, anorexia, coughs, bronchitis, and colitis.
 
Recipe for Respitory and Digestion with Fenugreek Complaints take ½ tsp of fenugreek and ½ teaspoon of thyme in a 2 pint pot of boiling water –allow to boil 5 minutes then pour in cup—this will regulate Insulin—assist in the removing of congestion or clogged lungs—absorb and draw out mucous in the lower GI and will remove fungi and bacteria in the system and restore the colon
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Other tidbits The specific indication for fenugreek is cold damp swelling and stagnation in the legs. It also disperses cold and alleviates pain.
Use: (a) Demulcent, (b) Anti-inflammatory, (c) Hypolipidemic, (d) Hypoglycemic, (e) Diuretic, (f) Galactagogue, (g) Antiatherosclerotic.
It is used in gastrointestinal inflammation, coughs, colic, diarrhea in infants, cholesterol level reduction, diabetes and as an eye wash for inflamed eyes. Externally, it can be used as a poultice for inflamed, irritated skin conditions. Research has shown antifertility and antiandrogenic effects on male rats who were fed a fenugreek extract.
Fenugreek contains alkaloids 0.2-0.36% trigonelline, gentianine, carpaine, 45-60% carbohydrate which is chiefly the mucilage galactomannans, 20-30% protein and 6-10% fixed oil. It is rich in tryptophan There are also several steroidal saponins, flavonoids and 0.015% essential oil.
Contraindications: Oral drugs or herbs taken at the same time as fenugreek may have delayed absorption due to mucilage content. Since experimental research has shown fenugreek to stimulate animal uteri and due to its emmenagogue and abortifacient effects, it is contraindicated in pre
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Protective effects of fermented ginseng on streptozotocin-induced pancreatic beta-cell damage through inhibition of NF-kappaB.
Yuan HD, Chung SH.
Department of Life and Nanopharmaceutical Science, College of Pharmacy, Kyung Hee University, Seoul 130-701, Korea.
Abstract
Ginseng (Panax ginseng C.A. Meyer) is widely used in Asian countries as a traditional medicine for the treatment of various diseases. It is known to have anti-inflammatory effects, although the mechanism is not clear. In this study, preventive effects of fermented ginseng (FG) against streptozotocin (STZ)-induced pancreatic beta-cell death was assessed in RINm5F insulinoma cells. FG markedly inhibited the production of nitrite in a dose-dependent manner. The decrease in nitrite production was found to correlate with reduced inducible nitric oxide (iNOS) protein and mRNA levels. To characterize the anti-inflammatory mechanism of FG at the transcriptional level, we examined effects of FG on the activity of nuclear factor-kappaB (NF-kappaB). FG reduced a translocation of the NF-kappaB subunit and NF-kappaB-dependent transcriptional activity. FG blocked signaling upstream of NF-kappaB activation, such as degradation of inhibitor factor-kappaBalpha (IkappaBalpha ) and phosphorylations of extracellular signal-regulated kinase (ERK) and c-Jun NH2-terminal kinase (JNK). These results suggest that FG protects against STZ-induced pancreatic beta-cell damage by downregulation of iNOS, cyclooxygenase-2 (COX-2), and tumor necrosis factor-alpha (TNF-alpha ) gene expressions by blocking NF-kappaB and mitogen-activated protein kinase activities.-=-PMID: 19956901 [PubMed – indexed for MEDLINE
 
Fermenting Ginseng—take any type of ginseng and allow to sit in vinegar for at least 6 weeks or longer —when done blend all the components and then strain through filtering materials and use 1 small tsp at a time
 
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About Organic Produce
WHAT MAKES PRODUCE “ORGANIC”?
Contrary to what most people believe, “organic” does not automatically mean “pesticide-free” or “chemical-free”. In fact, under the laws of most states, organic farmers are allowed to use a wide variety of chemical sprays and powders on their crops. So what does organic mean? It means that these pesticides, if used, must be derived from natural sources, not synthetically manufactured. Also, these pesticides must be applied using equipment that has not been used to apply any synthetic materials for the past three years, and the land being planted cannot have been treated with synthetic materials for that period either.
Most organic farmers (and even some conventional farmers, too) employ mechanical and cultural tools to help control pests. These include insect traps, careful crop selection (there are a growing number of disease-resistant varieties), and biological controls (such as predator insects and beneficial microorganisms).
ORGANIC PRODUCE AND PERSONAL HEALTH
When you test synthetic chemicals for their ability to cause cancer, you find that about half of them are carcinogenic.
Until recently, nobody bothered to look at natural chemicals (such as organic pesticides), because it was assumed that they posed little risk. But when the studies were done, the results were somewhat shocking: you find that about half of the natural chemicals studied are carcinogenic as well. -This is a case where everyone (consumers, farmers, researchers) made the same, dangerous mistake. We assumed that “natural” chemicals were automatically better and safer than synthetic materials, and we were wrong. It’s important that we be more prudent in our acceptance of “natural” as being innocuous and harmless.
ORGANIC PESTICIDES VERSUS SYNTHETIC PESTICIDES
3Clearly, the less we impact our environment, the better off we all are. Organic farming practices have greatly advanced the use of non-chemical means to control pests, as mentioned earlier. Unfortunately, these non-chemical methods do not always provide enough protection, and it’s necessary to use chemical pesticides. How do organic pesticides compare with conventional pesticides? A recent study compared the effectiveness of a rotenone-pyrethrin mixture versus a synthetic pesticide, imidan. Rotenone and pyrethrin are two common organic pesticides; imidan is considered a “soft” synthetic pesticide (i.e., designed to have a brief lifetime after application, and other traits that minimize unwanted effects). It was found that up to 7 applications of the rotenone- pyrethrin mixture were required to obtain the level of protection provided by 2 applications of imidan. It seems unlikely that 7 applications of rotenone and pyrethrin are really better for the environment than 2 applications of imidan, especially when rotenone is extremely toxic to fish and other aquatic life. It should be noted, however, that we don’t know for certain which system is more harmful. This is because we do not look at organic pesticides the same way that we look at conventional pesticides. We don’t know how long these organic pesticides persist in the environment, or the full extent of their effects. When you look at lists of pesticides allowed in organic agriculture, you find warnings such as, “Use with caution. The toxicological effects of [organic pesticide X] are largely unknown,” or “Its persistence in the soil is unknown.” Again, researchers haven’t bothered to study the effects of organic pesticides because it is assumed that “natural” chemicals are automatically safe.
WHY HAVEN’T WE HEARD THIS BEFORE?
For obvious reasons, organic farmers have done little, if anything, to dispel the myth that “organic = chemical/pesticide-free”. They would only stand to lose business by making such a disclosure.
Pesticide manufacturers have little concern in the matter. To them, “synthetic pesticides sold” and “organic pesticides sold” are both “pesticides sold”.
As for conventional farmers, they are not really in a position to be critical. It would not be in their interest to draw attention to chemical and pesticide use.
WHAT DOES ALL OF THIS MEAN?
Unless you know your grower personally, there is no guarantee that your produce has been grown without pesticides or other chemicals. It’s a point to consider, given the substantially higher cost of organic foods.
There are many choices and decisions that we, as consumers, are asked to make. Hopefully, this has provided some new information that you will find helpful.
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A formatted MS Word version of this document may be downloaded at:
http://www.ocf.berkeley.edu/~lhom/organics.doc
The data describing the carcinogenicity of natural and synthetic compounds are referenced in Gold, L.S., et al. (1992) _Science_ Vol. 258, pp. 261-265.
Many thanks go to the Organic Crop Improvement Association for their cooperation in this study. The OCIA has chapters in AZ, AR, CA, CO, FL, IL, IN, IA, KS, MD, MI, MN, MO, MT, NE, NM, NC, ND, OH, PA, SD, UT, and WI. Thanks are also extended to the California Certified Organic Farmers, the Ohio Ecological Food and Farm Association, and Oregon Tilth Certified Organic. (The appropriate information has not yet been obtained from the Natural Organic Farmers Association (NOFA), but it is almost certain that all facts stated here apply to their products as well.) The following state Departments of Agriculture have also been very helpful: AL, AK, AZ, CA, CO, DE, FL, HI, IA, LA, MD, MI, MS, MO, ND, OK, SC, TN, VA, and WA. States with no laws governing organic products include Alabama, Delaware, Hawaii, Mississippi, and Tennessee.
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Show of the Week February 25 1011
Online supplements retailer heeds FDA warning letter advice, but fears business impact
WARNING LETTER
Monsanto and FDA move toward healthier GM soybean oil
Restricted diet’ linked to reduction in ADHD
 
Alternative Energy Ideas
 
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Online supplements retailer heeds FDA warning letter advice, but fears business impact
“You gotta do what you gotta do,” an exhausted Cathy Keys told NutraIngredients-USA today after spending the best part of two months completely renovating her family-run online supplements business, NutriHerb.net, after receiving an FDA warning letter in December last year.
Keys, the firm’s owner and managing director, said all therapeutic claims that the company had happily been making since building the website in 2001 – and for seven years before that via labelling and print – had been removed, an action she feared could put a severe dent in its profitability. —
“Not being able to make claims could well run us out of business,” she said. “We were surprised to receive this letter as we did not know the claims were illegal but took steps immediately to comply.”
The FDA warning letter, sent December 2 and which can be found Below , highlighted unauthorized drug claims for three products – Custom Advantage Chamomile; Custom Advantage CoQ10 and Custom Advantage Omega-3 Fatty Acids – and gave NutriHerb 15 days to take corrective action.
“We rang them and after discussing it decided to remove all therapeutic claims from our site,” Keys said. “Because there was so much to do they gave us a 60-day extension and we have just written to them to notify them that the work has been completed.” –Keys said she had scanned the FDA-approved list of qualified and unqualified health claims, but said the process was so elongated and expensive that NutriHerb would not be pursuing it. –The firm does also have the option to make structure/function claims provided they can substantiate them. —“Being a small family business, we have a small marketing budget, so I have no idea how we are going to market our products now,” she said. —Another warning letter dated December 21 sent to another Florida-based company regarding unauthorized drug claims for a range of sea algae derived calcium-osteoarthritis supplement products had not as yet been heeded. –Natural Option USA Corporation continues to market OsteOrganiCAL with testimonials and references to studies the FDA has deemed amount to drug claims on its website. –However the company said it was, “in the process of removing the claims”. –That letter can be found here.
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WARNING LETTER–FLA-11-11–December 21, 2010
Claudia Muharram, President/Director
Natural Option USA Corporation
4957 SW 74th Court
Miami, FL 33155
Dear Ms. Muharram:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.natural-option.com/ in December 2010 and has determined that the product OsteOrganicCAL (a sea algae calcium compound packaged with Vitamin D3) is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your web site include:
ðClaims in the form of personal testimonials on the OsteOrganiCAL webpage:
• “My clinical results in reversing osteopenia and osteoporosis have been better than those obtained using Fosamax.”
• “[My bone density test showed considerable improvement. My first bone density test indicated I was at risk for traumatic fracture. After I began the OsteOrganiCAL program, my follow-up test showed considerable improvement.”
• “April of 1995, I had a bone scan. The result: I was diagnosed with severe
osteoporosis. In May I found out about a product called OsteOrganiCAL, I took OsteOrganiCAL for three months, went and had another bone scan. My overall bone density was increased 3.9%. I have never felt better.”
• ” had a hard fall, my hip was black and purple. My chiropractor said she had never seen any bruise that bad, without a broken hip. I am sure it was the Natural Option product [OsteOrganiCAL] that saved me from a break. Thank you so much for stronger bones.”
• “[Seven months my wife has been on OsteOrganiCAL. During this time she has not fractured any bones.”
Claims made under the heading “OsteOrganiCAL® CASE STUDY ANALYSIS”:
• “The fall of 2003 the Osteoporosis Education Project completed a year long pilot study with the sea algae calcium and vitamin D product known as “OsteOrganiCAL®”. The study included eleven postmenopausal women, six of whom experienced impressive gains in bone mineral density from use of the product.”
• “[A]nalysis of these cases documents the potential of this novel Calcium and Vitamin D product [OsteOrganiCAL] to halt and reverse the osteoporosis process in postmenopausal women.”
• “Using OsteOrganiCAL however, the few women in the sample with only moderate bone loss (osteopenia) also benefited significantly from this therapy.”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201[U1](p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section[U2] 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your product OsteOrganiCAL is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because the labeling for this drug fails to bear adequate directions for use.
This letter is not intended to be an all-inclusive review of your website and the products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not recur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which the corrections will be completed.
Your response should be directed to Winston Alejo, U.S. Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Mr. Alejo at (407) 475-4731.
Sincerely, /S/
Emma R. Singleton
Director, Florida District
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Monsanto and FDA move toward healthier GM soybean oil
Monsanto and the Food and Drug Administration (FDA) have completed a biotechnology consultation process for a key component of the company’s high-oleic soybeans, the biotech giant has said.
The company said completion of the consultation process is a significant first step toward commercialization of Monsanto’s Vistive Gold soybeans[U3], which are low in trans and saturated fats, enabling food manufacturers to improve the health profile of foods made with soybean oil.[U4] The crop represents one of the first to be developed through a combination of biotechnology and traditional breeding methods to provide health benefits for consumers. –Monsanto’s global technology lead for food quality traits Joe Cornelius said that the product has been developed with input from the food and nutrition industry. The soybeans have 60 percent less saturated fat than conventional soybean oil, and 70 percent less saturated fat than fry shortening, the company said. –“Vistive Gold soybeans will give farmers an opportunity to produce nutritionally improved soybean oil for food companies and consumers,” Cornelius said. “Monsanto is continuing to provide innovations to the soybean oil market and help growers create additional value within the food supply chain.” –The Vistive Gold soybeans will be combined with the company’s Genuity Roundup Ready 2 Yield soybeans, to increase yield for farmers, as well as providing nutritionally improved oil.
Trans fat substitution
There is a large body of evidence suggesting that trans fatty acids raise levels of LDL-cholesterol (so-called ‘bad’ cholesterol) and reduce levels of HDL-cholesterol (or ‘good’ cholesterol, and can influence other risk factors for cardiovascular disease. This has led to trans fat bans in many parts of the United States.
In the food industry this has been mirrored by an increase the in pressure on manufacturers to eliminate trans fat from their products. But food manufacturers have faced a number of technical difficulties in removing trans fat from their products, and some have expressed concern that trans fats could end up being replaced by saturated fats, which are nearly as unhealthy as the fats they replace, prompting companies to look for healthier replacements. [U5]
Trans fats formed by partial hydrogenation of vegetable oil are attractive to the food industry due to their extended shelf life, flavor and heat stability, and have displaced natural solid fats and liquid oils in many areas of food processing.
“Food companies [U6]continue to look for ways to eliminate trans fats and reduce saturated fat, and Vistive Gold soybean oil is an excellent option that is more economical, sustainable and nutritionally desirable than current solutions,” Cornelius said.
Monsanto’s Vistive Gold soybeans are subject to a number of further regulatory hurdles with both the FDA and the US Department of Agriculture before they can be fully commercialized.
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Restricted diet’ linked to reduction in ADHD–
A restrictive diet, which bans processed foods, may reduce the symptoms of attention-deficit hyperactivity disorder (ADHD) in young children, according to a new study.
New research published in The Lancet, suggests that a diet restricted to just a few basic ingredients could be “a valuable instrument to assess whether ADHD is induced by food.” In the new study, children with ADHD were put on a ‘restricted elimination diet’ – containing only rice, meat, vegetables, pears and water – for five weeks. The authors found that ADHD symptoms were reduced in 78 per cent of children placed on the diet. —“A strictly supervised restricted elimination diet is a valuable instrument to assess whether ADHD is induced by food,” wrote the researchers, led by senior author Professor Jan Buitelaar from Radboud University, The Netherlands. –“We think that dietary intervention should be considered in all children with ADHD, provided parents are willing to follow a diagnostic restricted elimination diet for a five-week period, and provided expert supervision is available,” they said. -However, writing in an accompanying comment piece for The Lancet, Dr Jaswinder Ghuman from the University of Arizona said that in her opinion[U7], the diet should not be continued for more than five weeks, “because long-term effects of dietary elimination on the child’s nutritional status are not known.”
ADHD development