Whaaaaaaaat? Eating healthy is now a mental illness? Who was it in WWII who did the same thing, creating and labeling "disorders," as an excuse to kill people?? And what about all the organic farmers and health food stores that assist in providing this healthy food for "mentally ill" people--what happens to them?????

Is Opting Out of Processed Food the New Eating Disorder?

March 3, 2015

http://www.theorganicprepper.ca/is-opting-out-of-processed-food-the-new-eating-disorder-03032015

It’s time for an intervention. We need to talk.

Are you concerned about the stuff they call “food” at the grocery store? Do you opt for whole foods most of the time, and feel unwell if you eat so-called “junk food”? Are your views about food causing you to make changes in your day-to-day life? Do you believe there is a connection between the food you eat and your physical and mental well-being??

Then, it’s time to face reality. If you choose to eat food without chemicals on a regular basis, you, my friend, are mentally ill.

It’s called Orthorexia Nervosa.
******(see below)***A study found on PubMed explains. (Wow, it’s like they know me.)

Orthorexia is an obsessive-compulsive process characterized by extreme care for and selection of what is considered to be pure ‘healthy’ food. This ritual leads to a very restrictive diet and social isolation as a compensation. Orthorexics obsessively avoid foods which may contain artificial colours, flavours, preservant agents, pesticide residues or genetically modified ingredients, unhealthy fats, foods containing too much salt or too much sugar and other components. The way of preparation, kitchenware and other tools used are also part of the obsessive ritual.

Huh. They say that like it’s a bad thing.

Don’t despair. If you’re a sufferer, there’s help. The same study states:

Treatment of orthorexia require a multidisciplinary team involving physicians, psychoterapists and dietitians. In some cases, antiserotoninergic drugs may be required as part of the treatment.
So the long and the short of it?

If you want to be healthy, you’re sick. You need a team of doctors and dietitians to cure you from trying to be healthy. And maybe some medicine. The desire for good health is an illness, and Big Pharma and Big Medical wants you to be better. And by better, they mean you should have no hesitation whatsoever about consuming the garbage passed off as food in the grocery stores.

Wow, I’ll bet that raising as much of my own food as possible really means I’m in need of intervention.

Just to clear up any confusion, it’s not about weight loss. Doctor Thomas Dunn is an associate professor of psychology at the University of Northern Colorado who co-authored a paper in Psychosomatics, outlining the diagnostic criteria for the disorder. “It’s different than going overboard because you want to be skinny. Rather, it’s linked to people who are trying to be as healthy as they can be.” (source: New American)

Corporations are losing money when you make healthy choices.
Gosh, do you think this could have anything to do with plummeting sales for processed food companies? There are a lot of corporations with skin in the game. An article on Natural Society by Christina Sarich noted that sales are down for the following food manufacturers (Wait – is my orthorexia nervosa showing when I say that the word “food” should never be followed by the word “manufacturer”?)

ConAgra (Hunts, Swiss Miss, Chef Boy Ardee)
Kraft (Oscar Mayer, Jell-O, Maxwell House, Velveeta)
Kellogg
Campbell’s Soup
Coca-Cola

Of course, companies like this have a very vested interest in making you think you’re crazy for not eating their offerings. And they have big advertising dollars. Perhaps that’s why the mainstream media is FULL of articles letting you know you have an eating disorder – because their advertisers need you to think you’re nuts. And it’s a two for one deal for the media outlets – they can push treatment options that are available from their other advertisers.

For example, our good friends at CNN (who, incidentally had an ad in the sidebar for a Big Pharma medication on this article) explain:

There’s now a name for people dangerously addicted to all things healthy — a sufferer of orthorexia nervosa. Characterized by disordered eating fueled by a desire for “clean” or “healthy” foods, those diagnosed with the condition are overly pre-occupied with the nutritional makeup of what they eat. They rigidly avoid any food they deem to be “unhealthy,” or spend excessive amounts of time and money in search of the “most pure” foods…The condition is under-studied, and no one knows how widespread it is.



Articles from The Wall Street Journal and ABC News make it seem as though by refusing to consume processed foods or GMO foods, you are at risk of becoming malnourished. In the extreme examples they give, it’s obvious there is a far deeper issue than a desire to avoid junk food and eat clean. Most of us that opt for healthful, healing diets don’t obsess over things like broken egg yolks, yet we’re all grouped together by the media.

Meet the “Experts” Who Think Healthy Eating is a Sign of Mental Illness
What’s more, the people who should be able to help identify eating disorders are being professionally indoctrinated. Last year, the Academy of Nutrition and Dietetics received a “fact” *cough* sheet outlining the alleged benefits of processed foods from the International Food Information Council. It’s important to note that the IFIC receives funding from Cargill, Coca-Cola, Dr. Pepper Snapple Group, Yum! Brands (the parent company of Taco Bell, Pizza Hut, KFC, and WingStreet), General Mills, Mars, McDonald’s, Monsanto, PepsiCo, and Red Bull. You know, all of the companies that produce the recommended processed foods that will benefit your diet. Here’s a look at that handout, if you’re interested.

If you wonder why many people are so confused about what constitutes good nutrition you need look no further than the propaganda being spouted by these so-called “experts”. There is a real problem when the people sponsoring the nutrition lessons are the very purveyors of GMO crops, potato chips, soda pop, and fast food.

Many people are out there trying valiantly to make the best possible choices for their families on limited budgets, but they must combat the constant disinformation and now, scrutiny with regard to their mental health. These folks are being deliberately deceived by food manufacturers, but even worse, by professional societies like the American Medical Association, the American Heart Association, the American Psychiatric Association, and the Academy of Nutrition and Dietetics.

Maybe if there wasn’t so much toxic garbage out there being offered as “food”, people wouldn’t have to be so diligent about what they consume. Maybe the people with the real mental disorders are the ones pushing the chemical laden, non-food crap in a bright, cheerful box, a box that contains things which are known to cause cancer, reproductive difficulties, hormone disruption, gut disorders, and inflammation.

Maybe they should come up with a name to identify those who display enduring antisocial behavior, diminished empathy and remorse, and disinhibited or bold behavior.

Oh yeah. Wait. They did that already. There is a diagnosis for those people.

They’re called psychopaths.

And they’re the ones calling healthy eaters crazy.
Let me enable you with these resources:

What to Eat When You’re Broke

The Eat-Clean series

The New Whole Foods Encyclopedia: A Comprehensive Resource for Healthy Eating

Nourishing Traditions: The Cookbook that Challenges Politically Correct Nutrition and the Diet Dictocrats

Nutrition 101: How Processed Foods Make Us Fat, Malnourished, and Sick

 ***********************************************************************************
The study driving this news is found below on PubMed:

http://www.ncbi.nlm.nih.gov/pubmed/18524314
 
Abstract

Orthorexia is an obsessive-compulsive process characterized by extreme care for and selection of what is considered to be pure 'healthy' food. This ritual leads to a very restrictive diet and social isolation as a compensation. Orthorexics obsessively avoid foods which may contain artificial colours, flavours, preservant agents, pesticide residues or genetically modified ingredients, unhealthy fats, foods containing too much salt or too much sugar and other components. The way of preparation, kitchenware and other tools used are also part of the obsessive ritual. People with orthorexia often have a history or features in common with anorexic patients. They are very careful, detailed and tidy persons with an exagerated need for selfcare and protection. Women, adolescents and those who practice sports suchs as bodybuidling or ahthetics are the gruops at higher risk. A short test has been suggested as a screening tool and useful for early diagnosis of the disorder. Treatment of orthorexia require a multidisciplinary team involving physicians, psychoterapists and dietitians. In some cases, antiserotoninergic drugs may be required as part of the treatment.

PMID: 18524314 [PubMed - indexed for MEDLINE]

March 5, 2015 - Fluoride Update

New Study Draws Connections Between Water Fluoridation and ADHD in Children
http://benswann.com/new-study-draws-connections-between-water-fluoridation-and-adhd-in-children/?utm_source=newsletter&utm_medium=text&utm_campaign=nl



A recently published study has found an association between widespread exposure to fluoridated water and increased Attention-Deficit Hyperactivity Disorder (ADHD) prevalence among U.S. children.

The study comes from the Department of Psychology at Toronto’s York University and was published in the Environmental Health journal. The researchers studied data on ADHD among children age four to seventeen collected in 2003, 2007 and 2011 as part of the National Survey of Children’s Health, as well as state water fluoridation data from the Centers for Disease Control and Prevention (CDC) collected between 1992 and 2008 . It is the first study to analyze the relationship between exposure to fluoridated water and ADHD prevalence.

The team discovered children living in areas with a majority of the population receiving fluoridated water from public water systems “tended to have a greater proportion of children and adolescents diagnosed with ADHD. ” The researchers concluded that “this study has empirically demonstrated an association between more widespread exposure to fluoridated water and increased ADHD prevalence in U.S. children and adolescents, even after controlling for socioeconomic status (SES). The findings suggest that fluoridated water may be an environmental risk factor for ADHD.”

Previous studies have shown rats exposed to fluoride chemicals also exhibit ADHD-like symptoms. Other studies have found impaired learning and memory among rats that drank 5 mg/L of sodium fluoride treated water for six months or 20 mg/L for three months.

The paper advises that further studies are needed to understand the relationship between fluoride exposure and ADHD. ADHD was also prevalent in higher rates for males, children of low socioeconomic status (SES), older children, and for children whose parents had a high school education compared to those whose parents did not graduate highschool.

The team also found that fluoridated water is not the only source of fluoride intake for U.S. citizens. As the authors note, “the U.S. is one of the most widely fluoridated countries in the world, with approximately 74.6% of the population receiving fluoridated water for the prevention of dental caries.” Americans are consuming Fluoride in public water systems via the addition of chemicals, including hydrofluorosicilic acid, sodium fluorosilicate and sodium fluoride.

The study comes on the heels of a study published in the BMJ’s Journal of Epidemiology and Community Health, which confirmed Fluoride’s negative effect on the thyroid gland and a possible connection to depression, weight gain, and other negative health effects. Researchers with the University of Kent in England examined thyroid activity for those in areas with fluoridated water and those without. The team examined 95 percent of the English population in 2012 and 2013 and found high rates of underactive thyroid were 30% more likely in areas with high fluoride concentration. An underactive thyroid can lead to depression, weight gain, fatigue and aching muscles.

The researchers reference a previous study that found exposure to water fluoridated at relatively low concentrations and a reduced IQ among children. Based on that study they believe “it is plausible that fluoride is also contributing to attention-related symptoms given its association with lower IQ.”

Other examples of health problems related to water fluoridation include a 2010 U.S. National Health and Nutrition Survey, which found that approximately 41% of 12-15 year olds suffer from dental fluorosis, a consequence of fluoride overexposure. Dental fluorosis results in yellowing and pitting of the teeth.

For more on the history of Fluoride, health issues, and conflicts of interests with the CDC check this article.

Fluoride Updates - 2015

February 9, 2015  

Good news! Well-known consumer advocate and legal consultant Erin Brockovitch posted the following message on her Facebook account this past week expressing her opposition to fluoridation:

“Hey... Flint, Michigan. I have been conducting my initial review of your water treatment records. Clearly, we all know this mess you are in is economically driven and not a true water quality crisis.

So, if its economics, why are you spending as much as $3.00 per person (person not connection) adding Fluoride to the drinking water? Last time I checked Water Treatment professionals weren't pharmacists... so what's up? This is an expense you don't want or need... adding any drug to Drinking Water is a problem... Please spend your resources on cleaning up the Drinking Water and stop pumping out drugs. 
More to follow.”



Please show Ms. Brockovich that you support her opposition to fluoridation by liking, sharing, and commenting on her post. Let’s help her comments go viral on the internet!

More Mandate Legislation

Last week we told you about new legislation in both Connecticut and Minnesota that could end the existing statewide fluoridation mandates in both states, giving municipalities control over fluoride levels in their drinking water. About a dozen U.S. states mandate fluoridation. This week we learned that there are bills in two more states dealing with fluoridation mandates.

In Georgia, HB129 has been introduced and co-sponsored by five representatives. The legislation would eliminate the requirement for petitioning 10% of voters and a mandatory referendum vote to opt-out of the statewide mandate, and instead gives local governing bodies (county commissioners, select boards, city councils, etc.) the ability to end fluoridation by passing a simple motion or resolution. Just last week the Fayette County Commission passed a resolution supporting this legislation, and the bill has already moved on to second reading, so support is needed ASAP. If you live in Georgia and would like to get involved in this campaign you can contact local organizers End Fluoridation Georgia (email: endfluoridationgeorgia@gmail.com).

Meanwhile in Hawaii, legislation has been introduced to create a fluoridation mandate for all communities with 1,000 or more public water connections. Similar legislation has been introduced on an annual basis for years but fortunately has never gotten as far as having a public hearing or vote. In fact, in 2003 Honolulu--the state capitol and largest city--passed ordinance 66 prohibiting the use of the public water supply as a “means for delivery of chemicals for medical or dental purposes.” If you live in Hawaii and would like to organize or join the campaign to keep the drinking water fluoride-free, please email FAN’s Campaign Director (stuart@fluoridealert.org).

Campaign Tactics to Consider

If you live in a community that is currently not fluoridated, then please consider starting a campaign to pass a resolution like Honolulu’s Ordinance 66. Successful passage of a resolution prohibiting the use of the water supply to deliver medical treatments should act as a safety net protecting your community from the pro-fluoridation lobby when they eventually descend upon your city or town.

If you live in a state that mandates fluoridation the ultimate goal is obviously to end the mandate and prohibit fluoridation. However, while you campaign to end the mandate at the state capital, consider also implementing one of these strategies at the local level to increase awareness and reduce fluoride’s impact on the community.

Consider passing a fluoride infant warning
Campaign for fluoride-free bottle-filling stations and water fountains

Urge your council to pass a resolution asking state health department officials to certify that any additives to the city's water supply, including fluoride, are safe and lead-free. Councilors in Eureka Springs, Arkansas passed such a resolution that included a letter signed by councilors stating:

“We ask that the proof be in the form of a letter, both from the supplier and the Carroll-Boone Water Board, showing a complete, independent analysis from reputable laboratories both here and in the country of origin, of the compound, containing all the trace ingredients, a guarantee that the compound is safe for use internally and externally, if added to the water supply, and a guarantee that they will be liable if the compound is proven to be damaging to the health of the individual consumer. We believe that, if this should not come to pass, we have the legal right to ask for an alternative to this water."
The goal is to be creative, to use every resource and tactic available to you, and to end fluoridation by any legal means possible. 

News you may have missed:

-Fluoride Fiasco: Byron Residents Downstream of Plant (Australia)

-Doomadgee Decides Against Fluoride (Australia)

-Op-ed: Sonoma County Fluoride Action Committee Meeting Review (California)

-Novel Fluorinated Surfactants Discovered in Firefighters’ Blood (USA)

-Bethel Selectmen Offer to Schedule Info Session on Fluoridation (Maine)

-Pease Well Contamination. Senator Shaheen Pushes for Blood Tests (New Hampshire)

-Anti-fluoride Movement Intensifies North of Boston (Massachusetts)

-Radio: Fluoride Debate Is Still On In Some Massachusetts Cities (Massachusetts)

For more fluoride media visit FAN’s News Archive.


Thank you,

Stuart Cooper
Campaign Manager

Fluoride Action Network

Salina, Kansas - Fluoride on the Nov. 4th ballot - TV commercials + More

Fluoride Debate - October 20, 2014, Newsradio 1150 KSAL The Truth About Fluoride with Dr. Charles Hinshaw and Dr. Ron Hunninghake Ed Asner: "Fluoride Should Be a Choice, Not a Mandate" Truth about Fluoride hits Mainstream TV in Australia 2010-8-5 its a poison Solution $10 Billion Lien

Sodium Floride is an Industrial Chemical, NOT the Naturally-Occuring Calcium Floride, & Creates Neurodevelopmental Disabilities > Latest publication in Medical Journal > Plus, another new study that proves fluoride calcifies our arteries & validates earlier reports that fluoride causes death for kidney patients!

Fluoride Officially Classified as a Neurotoxin in World’s Most Prestigious Medical Journal


http://www.stage2omega.com/fluoride-officially-classified-as-a-neurotoxin-in-worlds-most-prestigious-medical-journal/


Sept. 28, 2014


Above medical journal report weblink here:  http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(13)70278-3/fulltext#article_upsell


The Lancet Neurology, Volume 13, Issue 3, Pages 330 - 338, March 2014
doi:10.1016/S1474-4422(13)70278-3Cite or Link Using DOI

Copyright © 2014 Elsevier Ltd All rights reserved.

Neurobehavioural effects of developmental toxicity

Original Text

Dr Philippe Grandjean MD a b , Philip J Landrigan MD c

Summary

Neurodevelopmental disabilities, including autism, attention-deficit hyperactivity disorder, dyslexia, and other cognitive impairments, affect millions of children worldwide, and some diagnoses seem to be increasing in frequency. Industrial chemicals that injure the developing brain are among the known causes for this rise in prevalence. In 2006, we did a systematic review and identified five industrial chemicals as developmental neurotoxicants: lead, methylmercury, polychlorinated biphenyls, arsenic, and toluene. Since 2006, epidemiological studies have documented six additional developmental neurotoxicants—manganese, fluoride, chlorpyrifos, dichlorodiphenyltrichloroethane, tetrachloroethylene, and the polybrominated diphenyl ethers. We postulate that even more neurotoxicants remain undiscovered. To control the pandemic of developmental neurotoxicity, we propose a global prevention strategy. Untested chemicals should not be presumed to be safe to brain development, and chemicals in existing use and all new chemicals must therefore be tested for developmental neurotoxicity. To coordinate these efforts and to accelerate translation of science into prevention, we propose the urgent formation of a new international clearinghouse.

Fluoridated Water Can Calcify Arteries, Study Finds

By MRHEALTH • On September 29, 2014September 29, 2014 • In News News 5

http://healthydebates.com/fluoridated-water-can-calcify-arteries-study-finds/

(Sayer Ji)  Fluoride is put in your drinking water ‘for your teeth’ without your consent, but did you know that it could also be calcifying your arteries?
A few years ago, we reported on a study evaluating a new diagnostic technology that inadvertently revealed a link between fluoride exposure and coronary artery disease. Our report stirred up quite a lot of controversy and criticism, even leading one of the most respected figures in alternative medicine (deservedly so) – Dr. Russell Blaylock — to call us out on Infowars for our allegedly sophomoric interpretation of the following article: “Association of vascular fluoride uptake with vascular calcification and coronary artery disease.” As one can see, the study’s results revealed a hitherto largely unknown connection between fluoride exposure, coronary artery disease and cardiovascular events (e.g. heart attack).

“There was significant correlation between history of cardiovascular events and presence of fluoride uptake in coronary arteries. The coronary fluoride uptake value in patients with cardiovascular events was significantly higher than in patients without cardiovascular events.”

The argument, at the time, was the study was simply about a new diagnostic technique and shouldn’t be ‘read into,’ and that, presumably, the increased fluoride uptake value observed in patients with a higher frequency of cardiovascular events was a an ‘effect’ of the heart disease itself and not in any way indicative of fluoride’s causative role as a cardiotoxic agent — despite the fact that fluoride’s cardiotoxicity has already been consistently demonstrated in the biomedical literature.
Now, a provocative new study published in the journal Toxicology not only provides some vindication for our previous interpretations, but also raises serious concern over the cardiovascular complications associated with water fluoridation practices, showing for the first time that despite exhibiting an anti-calcification effect in vitro (cell model) fluoride exposure at levels found in people who drink fluoridated water exhibits artery-calcifying effects in the more important in vivo (animal) model.
Titled, “Effect of water fluoridation on the development of medial vascular calcification in uremic rats,” the study opens with a description of the common medical justification for public water fluoridation:

“In order to improve dental health in the population, fluoride is included in tooth pastes and mouthwash solutions or is added to public water supplies at 0.5–1.5 mg/L (WHO, 2008), which has been a common practice in some countries since 1945.”

And yet, the study acknowledges that fluoride is a well-established toxicant that our body has to either incorporate into its tissues or excrete through the kidney’s to sequester or eliminate:

 “More than 90% of ingested fluoride is absorbed through the intestine and quickly distributed between plasma/soft tissues and calcified structures, where it can be sequestered for years (Buzalaf and Whitford, 2011). When water is fluoridated at the WHO- recommended levels, the range of plasma fluoride concentration is usually 1–6 uM (Husdan et al., 1976; Singer and Ophaug, 1979). Fluoride is not under homeostatic control, and it is cleared from the plasma within few hours by the complementary action of calcified tissues and the kidneys.”

Those with chronic kidney disease have a harder time clearing the fluoride, which results in increased blood plasma levels, especially as the length of exposure increases.
The study noted that in healthy people, almost without exception, fluoride accumulates in the aorta, and in the elderly can exceed 100 ug/g [microgram/gram] tissue. Since atherosclerosis involves the gradual hardening and final calcification of the arteries with a form of calcium known as hydroxylapatite, fluoride’s role in replacing hydroxyls within hydroxylapatite crystals to form fluorapatite can be considered enhancing the cardiotoxicity of these calcium deposits due to the fact that fluorapatite is less soluble than hydroxylapatite and therefore more resistant to the body’s demineralization mechanisms (or de-calcification with natural substances such as magnesium, hawthorn or vitamin K2). The authors address this point:

“From a therapeutic point of view, this incorporation [of fluoride into hydroxylapatite as fluorapatite] may involve an additional problem, because these calcifications will be more difficult to eliminate, if at all possible.”

The report discussed how despite the observation that fluoride accumulates in the main arteries, “the effects on the vascular wall are not clear.” A brief review of the literature shows highly contradictory results, with some studies implying fluoride exposure actually reduces aortic calcification and others showing (as would be expected) deleterious effects on the cardiovascular system.  This uncertainty was one of the main reasons they designed their study:

“The aforementioned divergent findings can be explained by the use of different procedures, including very high doses of fluoride, the duration of treatment, and the animal species, in addition to either an experimental or epidemiological setup.
In this work, our objective was to clarify the effect of fluoride, if any, on the development and course of medial vascular calcification (MVC, Mönckeberg’s sclerosis) in uremic rats, using low, recommended concentrations in drinking water. Our rationale was that de novo calcified tissue in aorta should incorporate fluoride when exposure to this halogen is concomitant with the course of calcification, and subsequently the rate of calcium phosphate crystallization and/or mineralization should be altered, similar to the effects in tooth enamel or bone.
We used two established experimental models of calcification, rat aortic smooth muscle cells incubated with 2 mM Pi, and rats with 5/6-nephrectomy [5/6^th of their kidneys removed to model chronic kidney disease] and fed a Pi-enriched diet [Pi = Inorganic phosphate], in combination with low concentrations of fluoride (similar to that of public water fluoridation).
Our findings have shown that the results are inverse depending on the experimental model, which highlights the need to carry out in vivo approaches when studying complex multifactorial processes, such as Mönckeberg’s sclerosis [a type of arterial calcification].”

The study found a striking contrast between the in vitro (cell model) and in vivo (animal model) results: within the former, fluoride prevented calcification, within the later, it enhanced medial [middle portion of the artery] vascular calcification in the arteries of animals whose kidneys were weakened. Keep in mind that they did not use ‘mega doses’ of fluoride in the animal study, opting for the administration of the World Health Organization’s recommended concentration of fluoride in public drinking water to ‘prevent cavities.’
The researchers determined that fluoride’s adverse effects on vascular function in the animal model were mediated by the inherent kidney-damaging properties of fluoride (nephrotoxicity). Whereas healthy individuals are not prone to significant or at least acutely discernible damage from low level fluoride exposure (though some functional damage and proteomic changes are observed at 5-8 ppm), those with chronic kidney disease (CKD), have impaired fluoride clearance, subsequent elevated plasma fluoride levels, which creates a vicious self-perpetuating cycle of fluoride-induced aggravation of their decline in kidney function.
The researchers summarized their main finding as follows:

“The main conclusion of our study is that CKD is aggravated even by low concentrations of fluoride, which in turn accelerates medial vascular calcification (MVC), thereby confirming and extending previous reports on fluorosis in CKD patients exposed to WHO-recommended fluoride concentrations in drinking water (Greenberg et al., 1974; Lyaruu et al., 2008).”

Their final comments are to call for a reappraisal of the risks/benefits associated with fluoridation of municipal drinking water:

“In summary, the effects of fluoride on renal function and vascular health are more complicated than expected. Our findings could help to decide whether the use of fluoride to improve the dental health of the population through indiscriminate practices, such as adding it to municipal drinking water, should be reconsidered and should be replaced by a fluoridation policy based on the health status of individuals.”

It should be noted that fluoride’s association with soft tissue calcification also extends to brain structures, including the pineal gland, which we documented in a previous article: Fluoride: Calcifier of the Soul, and that its neurotoxicity — especially as evidenced by lowered I.Q. — is well documented.

Newest info on the battle to keep DSHEA

Negotiating the New Dietary Ingredient Notification Process

September 3, 2014 By Marc Ullman
http://www.naturalproductsinsider.com/articles/2014/09/negotiating-the-new-dietary-ingredient-notificati.aspx

The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires that manufacturers and distributors who wish to market dietary supplements that contain new dietary ingredients (NDI) notify FDA about these ingredients. These are ingredients that were not marketed in the United States prior to Oct. 15, 1994—the date that DSHEA became law. There is, however, no official list of “old dietary ingredients" not requiring notification, and it is up to ingredient suppliers to ensure that any notification requirements are met. Whether an ingredient is actually new can be a difficult question.

When an ingredient supplier determines that notification is necessary, DSHEA requires the material submitted to FDA demonstrates that there is a “reasonable expectation of safety" for its intended use. To date, the only real guidance provided by FDA on how this standard can be satisfied was found in a July 2011 guidance document, which was subsequently withdrawn for revision following nearly unanimous objection by the trade and members of Congress.

Even if the ingredient is new, no notification is required if that specific ingredient has been “present in the food supply as an article used for food in a form in which the food has not been chemically altered." Again, exactly what constitutes “chemically altered" can be a difficult question, though some insight can be gleaned from a review of FDA’s June 2014 guidance discussing changes in manufacturing processes for food and the need for additional regulatory notifications.

Each of these issues has contributed to a situation where FDA finds approximately 75 percent of the NDI notifications it receives fail to satisfy the “reasonable expectation of safety" standard. While this is an alarming failure rate, companies that take the time to understand why others have failed and what those who have succeeded have in common stand a good chance of having their NDI notification filed by FDA without substantive objection.

It is important to remember that the NDI Notification process is just that: a premarket notification of intent to sell. Seventy-five days after a notification is submitted, the statutory requirement has been satisfied, even if FDA has substantive questions concerning safety. Whether it is wise to go to market when FDA has such questions is another question.

Is an Ingredient Really “New?"

While there is no official list of “old dietary ingredients, industry trade associations such as the United Natural Products Alliance (UNPA) and Council for Responsible Nutrition (CRN) have submitted lists of “grandfathered" ingredients to FDA. While these lists have limitations such as not identifying extraction methods and solvents, they can provide a substantive starting point for building a case that an ingredient was marketed prior to the passage of DSHEA and not subject to the NDI notification process. The American Herbal Products Association’s (AHPA) “Herbs of Commerce" was published in 1992 and provides a list of all common and scientific names of botanicals that were sold in the United States at that time. This publication, while not accepted as authoritative by FDA, is generally recognized as strong evidence that a botanical was marketed in the United States prior to Oct. 15, 1994.

How to Show “Reasonably Expected to Be Safe?"

Satisfying this standard can be a daunting challenge. FDA has never provided a clear, concise statement describing the data set that will meet this standard. What we do know, however, is that a significant toxicological profile along with a coherent explanation of why the ingredient is safe for use in dietary supplements must be provided. While the standard of certainty required for a “reasonable expectation of safety" is somewhat less that needed to satisfy the GRAS (generally recognized as safe) standard for food ingredients, companies that attempt to negotiate the NDI notification process on their own are almost certainly doomed to failure. Companies that assemble a team that includes qualified toxicologists and counsel have a far greater chance of success than those that try and go it on their own.

The best way to understand what FDA is looking for to satisfy this standard is to review both successful and unsuccessful NDI notifications. FDA’s efforts to maintain a public docket allows public access to this information (the most recent entry is for NDI notification number 744 from May 2012). The AHPA NDI database has full reports through NDI notification number 779 and reports of results through notification number 820. The AHPA database also has a much more user friendly search function and a table of contents that provides easily accessible information on whether FDA stated any substantive objection to the notification.

Present in the Food Supply?

Often, when NDI notification requirement is discussed, the question is generally framed as “Was the substance present in the food supply in a form not chemically altered?" By pushing the discussion in this direction, companies that do not want to deal with the notification process have been able to bypass the “as an article used for food" clause in the law. However, the inclusion of this clause in the law means the answer to the question of whether a NDI notification is required hinges on whether the particular ingredient has been intentionally consumed as food—=and not merely been consumed because it happens to be a constituent of a food item.

Successful NDI Notification

Aside from assembling a qualified team of experts to support a company’s work, it is vitally important to understand why some NDI notifications succeed and nearly three-fourths of the others fail. According to Corey Hilmas, M.D., senior vice president of scientific and regulatory affairs for the Natural Products Association (NPA), and the person who oversaw the NDI program at FDA until June 2014, key factors are repeatedly seen in both successful and unsuccessful Notifications.

For unsuccessful submissions, these include:

· Use of data from another company’s product rather than data on the specific ingredient that is the subject of the submission;

· Failing to ensure that a company has met all regulatory requirements for a notification including translating foreign language scientific articles submitted in support of the notification;

· Providing evidence of “history of use" that is not relevant to the ingredient submitted, including considerations relating to the serving size of the ingredient that users are expected to consume; and

· Not including information on the fermentation media for microbial ingredients.

For successful submissions:

· The company has had met with the FDA NDI review team prior to submitting a notification;

· Understanding FDA’s comments following an unsuccessful notification and resubmitting after those concerns are fully addressed; and

· Testing a high enough dose to determine the no-observed-adverse-effect level to show that the serving level or dose on the label has sufficient safety margin in humans.

Companies that submit poor, rushed and/or incomplete data packages in support of their NDI notifications are certain to receive a letter from FDA stating that the agency disagrees with the company’s belief that their ingredient is safe. However, with the proper resources, commitment to thorough science, the right team of expert consultants and a thorough understanding to the process, a company should be able to successfully negotiate the NDI notification process.

For more tips to help understand laws regulating the supplement and functional foods market, visit INSIDER’s Regulatory Content Library. Also, hear more from Ullman during the panel discussion, "Current Issues Regarding New Dietary Ingredient (NDI) Notifications," on Thursday, Oct. 8, at 9 a.m., during SupplySide West, Las Vegas.

Marc Ullman is a partner at the New York-based law firm Ullman, Shapiro & Ullman LLP.

Peru's world news reveals what a USA 15 year old did two years ago--invented a lab test to detect cancer sooner!! (see the 3 pictures at the article web link) Just one example of what youth are capable of doing!!

http://www.peruthisweek.com/the-break-jack-andraka-boy-wonder-103801

Jack Andraka: Boy Wonder

September 2, 2014
by Valentina Alvarez

Jack Andraka, a 15-year-old from Maryland, was sitting in a biology class when he bubbled up an idea that could revolutionize the detection of pancreatic, lung, and ovarian cancer.

Inspired by the death of a close family friend who was like an uncle to him and with nearly no prior knowledge on the subject, Andraka dug into research using what he calls “a teenager’s best friends”: Google and Wikipedia. He discovered that an astonishing 85% of pancreatic cancers are diagnosed late, leaving the victims with less than a 2% chance at survival. Jack connected this problem to the sixty-year-old technique used to detect it: expensive (valued at $800 per test) and grossly inaccurate (missing 30% of cancers).

Convinced by his “teenage optimism” that there had to be a better way to do it, he investigated for months, individually reading about 4000 proteins to eventually find the correct biomarker for the disease that his sensor could detect. Then, he had his breakthrough idea in class, a place he describes as “possibly the most unlikely place for innovation”. In essence, he single-handedly designed a simplistic, inexpensive, rapid, sensitive, and selective cancer detector out of paper.

However, when he sent his research and procedure to 200 professors at John Hopkins University and the National Institute of Health, he got 199 rejections and only one weak offer to help. Eventually, after working in this professor’s lab for months, he filled all the holes in his procedure and came up with a prototype that is 68 times faster, 26,667 times less expensive, and 400 times more sensitive than existing technologies for detecting cancer.

The best part is that this detector is nearly 100% accurate since the very early stages of the disease. Also, the sensor could eventually be adapted to detect a number of diseases besides pancreatic, lung, and ovarian cancers.

Ever since he developed this method, Andraka has been awarded the Gordon E. Moore Award, the Smithsonian magazine’s American Ingenuity Award in the Youth Achievement category, and the grand prize of the Intel International Science and Engineering Fair where he received a $75,000 award. Additionally, he has had appearances on TEDx, The Colbert Show, and has been interviewed on international news channels like BBC.