Chubby Children and Fatty Liver Disease

One of my colleagues is a well know nutrition expert in the UK.  He addresses many of the same issues I do here in Natural Health News.  In a recent newsletter he addresses  the issue of childhood obesity but directs the concern to food.

Half a million children have fatty liver disease

New shocking figures from the Government suggest that with 30% of children obese around 500,000 of those aged four to 14 could be suffering from liver disease. Non-alcoholic liver disease is caused by a build-up of fat within liver cells, stopping the organ functioning properly. This can lead to serious health problems with many requiring liver transplants. The problem is expected to escalate with experts predicting that by 2050, 63% of children will be obese. Professor Martin Lombard at the Department of Health warns that fatty liver disease could be a silent killer among this generation of children.

As well as fatty liver disease, childhood obesity is linked to many health concerns including diabetes, heart disease and cancer. The biggest factor is indisputably diet. Surveys show that the average Brit is eating only half of their recommended five portions of fruit and vegetables a day – with many children not even getting that. The worry is what they are eating in their place. Refined carbohydrates (sugary cereals, white bread, fizzy drinks, sweets and processed foods) now make up a large percentage of the diet for many.

The antidote is choosing wholegrain carbs and balancing your intake with protein and plenty of nutrient-rich fruit and vegetables. Swapping a few common foods for healthier options can make a marked difference, for example, fizzy drinks for fruit juice diluted 50/50 with sparkling water, turkey or chicken nuggets for salmon fish fingers, crisps for unsalted raw nuts or seeds.

While I agree that food is a mjor vector in the obesity epidemic, I also believe that the factors of vaccines, and specific vaccines, also play a major role in this public health outrage.  I see vaccines as sort of the fuse to the dynamite.  Hep B vaccine is also linked to Diabets Type 1 (on the rise) and may be a cause in childhood arthritis (see adverse reactions).

If you look at vaccine ingredients you often find MSG.  Who knows why this needs to be in a vaccine but it is notable when you consider that MSG is linked to obesity, and food allergy as well.

Food allergy, or as Dr Hoffer might have said, brain inflammation, is an issue in obesity.

Recombivax is made in yeast, and it is carried in a solution that contains aluminum.  We know from good science that aluminum compounds cause brain inflammation.

Side effects of the vaccine include elevated liver enzymes and this may correlate to the shutting down of the liver in fact given this jab very soon after birth.  Certainly the question of "experimental" can be and shouldbe considered.

RECOMBIVAX (hepatitis b vaccine (recombinant)) HB and RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation are generally well-tolerated. No adverse experiences were reported during clinical trials which could be related to changes in the titers of antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.

In three clinical studies, 434 doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever ( ≥ 101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.10

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:

LOCAL REACTION (INJECTION SITE)

Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, and nodule formation.

BODY AS A WHOLE

The most frequent systemic complaints include fatigue/weakness; headache; fever ( ≥ 100°F); and malaise.

DIGESTIVE SYSTEM

Nausea; and diarrhea

RESPIRATORY SYSTEM

Pharyngitis; and upper respiratory infection

BODY AS A WHOLE

Sweating; achiness; sensation of warmth; lightheadedness; chills; and flushing

DIGESTIVE SYSTEM

Vomiting; abdominal pains/cramps; dyspepsia; and diminished appetite

RESPIRATORY SYSTEM

Rhinitis; influenza; and cough

NERVOUS SYSTEM

Vertigo/dizziness; and paresthesia

INTEGUMENTARY SYSTEM

Pruritus; rash (non-specified); angioedema; and urticaria

MUSCULOSKELETAL SYSTEM

Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; and neck stiffness

HEMIC/LYMPHATIC SYSTEM

Lymphadenopathy

PSYCHIATRIC/BEHAVIORAL

Insomnia/disturbed sleep

SPECIAL SENSES

Earache

UROGENITAL SYSTEM

Dysuria

CARDIOVASCULAR SYSTEM

Hypotension

Marketed Experience

The following additional adverse reactions have been reported with use of the marketed vaccine. In many instances, the relationship to the vaccine was unclear.

Hypersensitivity

Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, or symptoms consistent with a hypotensive episode have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum (see WARNINGS and PRECAUTIONS).

Digestive System

Elevation of liver enzymes; constipation

Nervous System

Guillain-Barré Syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis

Integumentary System

Stevens-Johnson Syndrome; alopecia; petechiae; eczema

Musculoskeletal System

Arthritis

Pain in extremity

Hematologic

Increased erythrocyte sedimentation rate; thrombocytopenia

Immune System

Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis; polyarteritis nodosa

Psychiatric/Behavioral

Irritability; agitation; somnolence

Special Senses

Optic neuritis; tinnitus; conjunctivitis; visual disturbances

Cardiovascular System

Syncope; tachycardia.

The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX (hepatitis b vaccine (recombinant)) HB: keratitis.

Patients, parents and guardians should be instructed to report any serious adverse reactions to their healthcare provider, who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.31

Selections from Natural Health News

Natural Health News: Fructose Worsens Liver Disease

Apr 29, 2010

ScienceDaily (2010-04-27) -- Recent studies suggest that modifiable risk factors such as cigarette smoking and fructose consumption can worsen nonalcoholic fatty liver disease (NAFLD). With NAFLD, fat accumulates in the ...

Promise not to

Jan 02, 2008

It is known to inhibit the synthesis of estradiol and other steroid hormones and can lead to infertility, reproductive problems, thyroid and pancreas and promote fatty liver as well as breast cancer. Soy can also interfere with protein ...

Natural Health News: The Dangers of HFCS
Dec 09, 2008
Excess fructose intake has been associated with adverse health effects such as metabolic syndrome, elevated triglyceride levels, hypertension, non-alcoholic fatty liver disease, excess uric acid levels (associated with ...

Alcohol treatment: Risky Rx or Helpful Herbs
Jun 10, 2008

Their weight, cholesterol and blood pressure dropped, and levels of liver enzymes linked to "fatty liver" disease, the forerunner of cirrhosis, also fell away. Lead researcher Professor Bankole Johnson said: "What we've found is that ...

Another opinion -

Final Conclusions on Soaking Grains

When I started this blog I envisioned my search for truth in food. I imagined my trying out recipes, some working and some not working. But most of all I saw a community of people commenting and giving me tips of what to look and where to look.



When I posted my article last week, Do I Really Need to Soak My Grains? I was kind of nervous. I even weighed whether I should share the heretical post on the normal Real Food Blog Hops that I participate in. But...over 350 hits later and I think I discovered that I am not the only one who is confused.



Usually when one finds bits of information that seem contradictory it is normal to assume that some are true and some are false. Sorting through the true and the false takes time, but makes sense in the long run. But what happens when there are many bits of information that are contradictory but they are all true? What then? In my opinion you have on your hands a good old fashioned mystery. One must find the one situation in which all pieces of the story are in fact true. I LOVE mysteries. But rarely do they get solved in 48 minutes of airtime like on my much beloved Law and Order. In the case of soaking grains, much of my information was obtained from blogs like mine. I love reading blogs, but one must understand that they are opinion based and usually written by people like myself who really have no academic background in the science on which they write. The only thing that qualifies me to write about food is that I got a '5' on my AP English exam 14 years ago and I think I write a damn good research paper. But even I do not spend the time I need to get the fully researched picture all the time. And I assume that other bloggers are the same. That is why no writer is any better than the sources that they quote. Blogs that correctly quote lots of good articles are sure to rise to the top of their game.



But back to my conundrum. In the case of my soaking grains, what was I to do? Let's consider all the information.



* Substances like Lectins, Phytic Acid and other anti-nutrients reside mainly in the bran of the kernel of grain. These substances keep us from accessing all the available nutrition. These substances can also lead to severe gastrointestinal distress in sensitive people and minor gastrointestinal distress is others.



* Most people, about 85%, digest grains with no problem.



* Rates of gluten sensitivity and celiac disease have risen dramatically in the last 50 years, as have most other degenerative diseases and cancers. This has been proven by testing stored blood from 50 years ago. The rates of potential celiac among the stored samples was far lower than folks living today. Here is the Mayo Clinic article that details where and when the study took place.



* Despite what anyone else might tell you, celiac disease is presently found in approximately 1% of the population. Gluten sensitivity, or a more mild form of the disease, is found in an estimated 10-15% of the population.



* Soaking or fermenting grains for 12-48 hours in warm water, water with whey or an acidic liquid like keifer and yogurt does increases the digestibility of the available nutrition on a grain whether the grain is whole or refined. (I am citing Nourishing Traditions by Sally Fallon)



* Soaking grains diminishes the celiac reaction in many sufferers. Some report that while they cannot eat traditionally prepared breads they can have 'soured' or soaked version like sourdough, etc.



* Sprouted grains and flours have some of the highest lectin content available because as the plant begins to grow it produces more anti-nutrients that discourage you from eating the plant.



* My great-grandmother and likely her mother and grandmother would never have left a bowl of pancake batter sitting in yogurt overnight on her counter top. Why doesn't the step of soaking (as it is presented today) survive in any recipes? And if the rates of celiac were so much lower 100 years ago, why? Why did so many cultures eat refined white bread daily and not experience the same amount of degenerative disease that we are experiencing today?



* I am not sick. While I have imagined that I have gluten sensitivity in the last couple of years, I only experience symptoms when I eat huge quantities of wheat, like 4-5 servings a day. I am likely just one of those people for whom gluten-free is a fad.

**************************

I asked many of those questions in my post last week. And I have to thank everyone who responded and commented and in general just read the post. Everyone who commented helped me gain more insight. And everyone was so supportive! I imagined being railed against for my heresy. But that didn't happen at all. And this wonderful community of people has given me links and suggestions. You all really added value to my search. And I definitely feel like I am not the only one who is confused. I think if more people were confident about the topic of soaking grains I would not have gotten the immediate traffic bump. Clearly people are confused by the contradictory information.



Writing this post has been a learning experience. Honestly, the topic of soaking grains annoys me. I feel a little criticized, like someone is wagging their finger at me telling me that I have been doing it wrong all these years. I have eschewed most store bought bread, yet I keep getting the impression that my additive free, organic, high-quality sprouted bread is still silently killing me and my ignorance...maybe I am over-internalizing that just a tad. Still, how could all of the above things be true? Surely some of them had to be false. Either soaking wasn't worth the effort or I was damaging my gut by eating improperly prepared food. And what about this so called 'traditional preparation'? It is nothing I have ever heard of before I got interested in food...or had I?



Ruth at Ruth's Real Food posted a very interesting post at her blog last week, just when I was open to hearing about proper preparation of grains. Her take was that modern factory produced bread was allowed to rise only 5 hours, not enough time to properly breakdown the grain for digestion. Add to that additives and dough conditioners and food coloring and you have one scary loaf of bread. EUREKA!! This was the missing link for me! I have heard of the modern bread preparation on the wonderful blog Fooducate, they wrote a post about it last spring. And incidentally, they just published an amazing article on gluten and cealic disease yesterday. Thanks Fooducate!My great grandmother surely would have made bread at home and she surely would have allowed it to rise, probably taking all day. This was starting to make sense. Maybe the step of soaking was hiding in all those old recipes under rising time.



I also in the post lamented my inability to find a good online post detailing the process, what do the bad anti-nutrients do, and what does the soaking, fermenting and sprouting do for them? Why is there little good information for an exacter like me? Am I wasting my time soaking? Then my dear friend Sara commented that she had recently read a great post from Mark's Daily Apple that questioned whether traditionally prepared grains were healthy. Mark details exactly what is IN the grains that makes them bad, then he details what different preparation methods do to reduce the effects of the antinutrients. His information is invaluable. Go and read the article. His conclusions? Sprouting does little to mitigate anti-nutrients and gluten, fermentation does a heck of alot more. But the preparation doesn't do enough to make him want to eat grains (he is one of those Paleo People).



Elizabeth also commented that there are such a thing as Overnight Pancakes. And yes, I did find some recipes online. Although mostly these recipes are to alleviate busy morning schedules, the soaking seemed like it would be helpful. But...since they are all refrigerated there is no fermentation. I don't know how much anti-nutrient eliminations these recipes would offer. But you got me thinking Elizabeth (see tomorrow's post).



And lastly to bobsgirl, I hear you. She commented something many of us are thinking "while reading your post I thought about reports from several years ago on how unhealthy the populace has become from eating 'white' bread/flours ..the answer and improved health we were told, came from eating whole grains. My question; how could so many have improved health and less disease from whole grain consumption if there are so many 'bad' things in it for us?" I haven't done adequate research on this, but my bet is that people who are interested in eating whole grains also are interested in eating lean meats and lots of fresh vegetables. Overall whole grains as part of a larger healthier diet might make it look like whole grains were the catalyst for health, but my gut says no. My gut says that if everyone just changed their hamburger buns and pasta to whole wheat and made no other changes to their Standard American Diet that our national health would be largely unchanged.



MY CONCLUSIONS??



So now, after reading all these posts, what do I do? Do I soak? Not soak? Do I worry? Do I throw caution to the wind? Well, I think it is yes, maybe, no and sort of.



I do think after reading all this information that it is worth it for me to try and soak my grains more often. I have...gulp...started a sourdough starter. Which is a huge step for me. And I am not sure if my marriage can handle more jars on the countertop. (Haha, just kidding). But seriously, I have two jars of kombucha, keifer, a jar of fermenting pickles and now a sourdough starter sitting on my counter? My husband thinks I am a loon.



But...I agree with Mark from Mark's Daily Apple, reducing grains is one of the best things you can do for your health. They are not really a fantastic source of nutrition and they crowd other healthier things off the plate. And I think we waste alot of time and energy grinding our own flour and hemming and hawing over 'whole this' and 'organic that', when our time would be better served adding another vegetable to our dinner plate daily, eliminating overly processed oils and sourcing grass fed meat. Reducing grains is not a small thing or a 'little tweak' to the Standard American Diet. Reducing grains is what helps people get OFF the SAD. So if I forget to soak the flour to the pancakes that will be my only grains in a day? Screw it. I am making pancakes anyway. And if I feel like having croutons on my salad lovingly made from in house baguettes from my dearest Fairway Grocery Store? Screw it, I am going to enjoy my croutons.



BOTTOM LINE: If grains are not a huge part of your diet, and you generally take care to properly prepare them, don't feel guilty about eating some unsoaked muffins. Save your worries for what is going on in Washington and on Wall Street.



This post is shared with Traditional Tuesdays and Real Food Wednesdays and Simple Lives Thursdays and Fight Back Fridays

Cullowhee Native Plants Conference

Last week (July 27-30) I was able to attend the Cullowhee Native Plant Conference in Cullowhee, NC.  Although it  was the 28th conference, it was only my second one.  I enjoyed the conference my first year, and I was anxious to see if the second one would be just as enjoyable.

The conference is the premier native plant conference in the Southeastern U.S., and I'm sure for many years it was time when native plant enthusiasts could come together, joined by a love of native plants that was not always shared by other people in their every day lives. They would leave the conference with new information and new plants, refreshed and rejuvenated in their passion.

With the rise of information and communications via the Internet, one wonders if such a conference still holds value for people - especially those that travel far to get there.  I think the answer is "Yes".  Despite all that modern communications has to offer, there is value in spending time with others, examining plants in hand, and the spontaneous interactions and discussion that, well, just happen!

In general, I would encourage people to seek out and attend conferences when possible.  Almost every state native plant society has some type of annual conference - check their calendar and email them for more information if you don't find anything.  I have organized the Georgia one for the last four years and am working on my 5th one. Even though it is only a one day conference, I try to ensure that the topics are varied, the vendors are plentiful and the food is palatable!

If you'd like to see what the Cullowhee schedule was, to give you an idea of the topics covered, here is a link to the 2011 schedule.  Click on this link to get even more details about the topics. The dates for 2012 have already been announced - hope to see some of you there July 17-21, 2012.

Here are some pictures from the 2011 Cullowhee conference. I never seem to get a picture of a lot of people - there were over 300 people there.  I guess I'm always just too busy talking to think about taking a picture.

Botanical art by Linda Fraser

A great selection of books

Lots of plant vendors - more than this!

Students explaining their projects

And plenty of beautiful flowers in the area:

Actaea pachypoda

Apios americana

Monarda didyma

Helianthus, I think!

Insulin pump hack exposes medical device danger

The Diabetes Diary is now available, a compendium of natural health options for people with diabetes, in honor of The Longest Walk 3, reversing diabetes.

A computer threat analyst on Saturday will show a gathering of hackers how easy it is to wirelessly take control of an insulin pumpon which a diabetic's life could hinge.

Jerome "Jay" Radcliffe's demonstration at DefCon in Las Vegas will spotlight a critical need to build software defense into pace makers, insulin pumps and other medical gadgets getting "smarter" with computer chips.

"If you look at the history of hacking medical devices, worms and viruses are running rampant," said 'informatics nurse' and hacker Brad Smith, who specializes in medical software.

The list of medical gadgets vulnerable to being hacked wirelessly includes pace makers, intravenous pumps, and blood pressure cuffs, according to Smith.

Radcliffe was diagnosed with diabetes about 11 years ago, when he was 22, and recently employed his software skills to find out whether an insulin pump trusted to keep his blood sugar levels safe could be hacked.

He found he could remotely toy with dosage levels or turn it off.

"It turns out that with this model there is no security," Radcliffe said. "All you need is a serial number to talk to it."

He said that prices of insulin pumps, which cost in the thousands of dollars, precluded him from expanding his research to determine how widespread the vulnerability is.

Radcliffe didn't disclose his insulin pump model nor did he outline critical details of the hack to allow time for the maker to address the situation and to avoid tempting DefCon attendees known for software mischief.

"We are not talking about $200 dollars on someone's credit card," Radcliffe said in a reference to hacks for profit. "We are talking about somebody's life."

Medical devices built with wireless connectivity can face the kinds of cyber attacks launched on smartphones, tablets, or laptop computers with similar capabilities, according to Smith.

"We have talked about this in the medical community forever," Smith said. "We have swept it under the carpet."

Radcliffe was wearing his insulin pump at DefCon on Friday and urged diabetics not to panic.

"I'm target Number One right here in the middle of all these hackers, and I have my pump on," he told AFP. "I hope that tells people how worried they should be."

He has shared his findings with the pump maker and been approached by a rival company that boasted of building in strong software defenses.  SOURCE: AFP

Polysorbate 80 - One toxic ingredient in vaccines

Pleased be informed.

You may request a copy of herbalYODA Says! on Informed Consent with your donation via PayPal.

By Daniel Dunkin

Polysorbate 80 in vaccines has become a controversial topic. When I worked in a food lab and as a mixologist in food production, we used Tween 80, (another name for Polysorbate 80), as an emulsifier to get flavoring oils to mix with water, and personally I never thought anything of it at the time. I did not suffer any ill effects from contact or from using it, however that was over 20 years ago and I never injected it into the skin.

According to the MSDS sheet at Science lab.com, section 11: Toxicological Information, it was tested for inhalation and ingestion and was shown to be slightly hazardous on skin contact, ingestion and inhalation. however these are minor compared to other potential side effects of it's use especially in an intravenous or immunologic setting. In the same section of toxicological information it states that it may cause reproductive effects, it may cause cancer, and may be a mutagenic, (change the genetics), in animals but this is followed up with the statement, no human data found. Well, unless they use people as lab rats, they won't find this data until it is used on humans to an extent to present this data.

According to PubMed.Gov a service of the U.S. Library of Medicine and the National Institute of Health, a report shows that neonatal rats were injected with small doses of polysorbate 80 and the results were major effects on the reproductive organs of the rats, resulting in infertility. (see the PubMed link below). Considering this is a component of the Gardasil HPV vaccine, (not to mention other vaccines), and they are recommending this to girls at prepubescent ages, there should be some concern to any parent that this could possibly lead to infertility in your child.

Another research article at PubMed studied Polysorbate 80 in an intravenous vitamin mix given to a pregnant woman who suffered anaphylactic shock where polysorbate 80 was identified as the causative agent, and yet another study showed two patients who developed hypersensitive reactions to red blood cell growth hormones and subsequent skin testing indicated polysorbate 80 as the culprit. This finding might have implications in the recent increase in the incidence of pure red cell aplasia.

Polysorbate 80 in vaccines appears to be innocent when looking at the MSDS, but further digging reveals a possible hidden danger, especially a potential sterility to girls, and amplified because it is in all 3 Gardasil vaccines.

Polysorbate 80 in vaccines: a partial listing

Acel-Immune DTaP - diphtheria - tetanus - pertussis / Wyeth-Ayerst

FluShield / Wyeth-Ayerst

Gardasil - HPV / Merck

JE-VAX - Japanese encephalitis / Aventis Pasteur USA

TheraCys BCG - (intravesicle -not licensed in US for tuberculosis) / Aventis Pasteur USA

Tripedia - diphtheria - tetanus - pertussis / Aventis Pasteur USA

Resources:

MSDS: http://www.sciencelab.com/xMSDS-POLYSORBATE_80-9926645

pubMed: infertility in rats  http://www.ncbi.nlm.nih.gov/pubmed/8473002?dopt=Abstract

PubMed: Anaphalactic reactions  http://www.ncbi.nlm.nih.gov/pubmed/16400901?dopt=Citation

PubMed: Red Blood Cell Aplasia  http://www.ncbi.nlm.nih.gov/pubmed/15958049?dopt=Abstract

Informed Choice:  http://www.informedchoice.info/cocktail.html

Gardasil leaflet with Ingredients and Side Effects  http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf

Disclaimer: This article is not intended to give medical advice. It is a call to educate yourself so that in making a decision where your child is concerned, you should take an active role in learning all you can from medical experts on both sides of the fence, then make an educated decision. we did not make an informed decision until one son got Leukemia and another developed Autism immediately after receiving his MMR vaccine. This has sent us on a quest to inform ourselves and others to seriously question what kind of toxic soups are being injected with the vaccines. Odds are if your child is injured by a vaccine, you have little or no recompense against the industry.

Vaccine Ingredients from Natural Health News

http://naturalhealthnews.blogspot.com/2007/10/vaccine-vacillations.html

http://naturalhealthnews.blogspot.com/2008/01/consider-vaccination-risks-above-all.html

  

LIFE



Discussing FDA Current Attack on Supplements

This is from a colleague of mine who is known as the "Vitamin Lawyer".

LEF, Citizen's for Health and other groups already have action established to contact CONgress to make sure this latest round of insanity and Big PhRMA's attack on your supplemnts is stopped.

Remember that currently the FDA is telling you that wlanuts are 'drugs'.

The amount of documentation and safety information that the Food and Drug administration (FDA) now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified the Dietary Supplements Health and Education Act (DSHEA) in 1994 and now establishes a process “ominously like the one for new food additives,” according to the Council for Responsible Nutrition (CRN).

CRN chief executive Steve Mister, in commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications, said that the new NDI process now ‘sounds an awful lot like the food additive petition process.’

The Dietary Supplements Health and Education Act was enacted in overwhelmingly negative consumer and industry response to 1993 Congressional efforts to medicalize the supplements industry. It requires firms filing NDI notifications to establish a ‘reasonable expectation’ of safety, whereas those filing petitions for new food additives were required to demonstrate ‘reasonable certainty’ that no harm will result from use of the new food additive.

But if you look at the section on safety requirements in the new NDI guidelines and all of the studies that are now required, it now sounds an awful lot like the food additives petition process, which is exactly what Congress was trying to avoid.

“It is terribly disheartening to see the FDA going in this direction. They had a chance to create a workable system that would incentivize more companies to follow the law, use the NDI notification process and draw a line between responsible companies and those ignoring the whole process completely. “But instead they have come up with a document that stifles innovation and will deny consumers access to new products. We are terribly disappointed,” Mister added.

As to what now constitutes an NDI, the fact that changes to the manufacturing process, new solvents or new extraction methods could turn scores of old dietary ingredients, which were assumed to have been ‘grandfathered in’ under DSHEA into new NDIs was alarming enough. Ironically, the new requirements could force the industry to revert to extraction processes used nearly 20 years ago.

However, the fact that separate NDI notifications for supplements containing the same NDI are required if the supplement is reformulated in any way, and that notifications are required for finished products, not just ingredients, means that the FDA would be “flooded” with NDI submissions if the guidance were not revised.

‘Absolute nonsense with no basis in science’

A section in the new FDA guidelines claims that a synthetic copy of a constituent or extract of a herb or botanical is not a dietary ingredient at all – even if it is chemically identical to its ‘natural’ counterpart – as in the case of a number of higher dose vitamins, is particularly troubling, although not wholly unexpected.

The FDA recently argued that the synthetic organic compound, homotaurine, which was being investigated as a potential treatment for Alzheimer's disease, was not a dietary ingredient even though it is chemically identical to homotaurine from red algae extract. “Again, the FDA is defining incredibly narrowly what constitutes a dietary ingredient, but very broadly what is a ‘new’ dietary ingredient.”

Marc Ullman, with the New York law firm, Ullman, Shapiro & Ullman, which represents companies in the supplements industry, said he was particularly frustrated by this aspect of the guidance: “It really is preposterous, absolute nonsense, with no basis in science. If we’re talking about something that is chemically identical to a botanical extract, but is synthesized, there really is no rational basis for taking the position that it is not a dietary ingredient.”

from Natural Health News

http://naturalhealthnews.blogspot.com/2011/07/save-your-supplements.html